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2016-17 Catalog

Redefining Autoimmunity

ConnectedWelcome to the fully integrated autoimmune lab.

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2016-17 Products Catalog

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Table of ContentsCompany Overview ................................................................................................... 3The Integrated Lab ..................................................................................................... 4Systems and Instrumentation ................................................................................ 6 QUANTA Link® ...................................................................................... 6 BIO-FLASH® ........................................................................................... 8 NOVA View® ........................................................................................10 QUANTA-Lyser® ..................................................................................12 QUANTA-Lyser® 2 ..............................................................................13 QUANTA-Lyser® 4000 .......................................................................14 AUTOLoader .......................................................................................16 DS2® .......................................................................................................18 DSX®/best 2000 .................................................................................19QUANTA Flash® ..........................................................................................................20 Celiac Disease.....................................................................................21 Vasculitis ..............................................................................................21 Rheumatoid Arthritis .......................................................................21 Connective Tissue Disease ............................................................22 Antiphospholipid Syndrome ........................................................23 Liver Disease .......................................................................................23QUANTA Lite® .............................................................................................................24 Gastrointestinal Disease .................................................................25 Celiac Disease.....................................................................................28 Liver Disease .......................................................................................30 Antiphospholipid Syndrome ........................................................32 Rheumatoid Arthritis .......................................................................35 Connective Tissue Diseases...........................................................36 Vasculitis .............................................................................................39 Autoimmune Thyroid Disease ......................................................39 QUANTA Chek™ Quality Control Panels .....................................40 Calibration and Standard Sets .....................................................41NOVA Dot® .................................................................................................... 42 Connective Tissue Disease ............................................................43 Liver Disease .......................................................................................43 NOVA Dot Common Components .............................................43NOVA Lite® .................................................................................................... 44 IFA Slide Kits ........................................................................................45 IFA Substrate Slides ..........................................................................54 Common Components ...................................................................57 Demonstration Slides ......................................................................57 IFA Antibody Controls .....................................................................58 IFA Conjugates ...................................................................................60Customer Support ...................................................................................................62

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INSTRUMENTS

� QUANTA Link® data management system

� BIO-FLASH® random access chemiluminescent analyzer

� NOVA View® digital IFA microscope

� QUANTA-Lyser® automated EIA/IFA analyzer platforms

� AUTOLoader automated slide handling

� DS2® and DSX®/best 2000 automated EIA microtiter plate platforms

ASSAYS

� QUANTA Flash® CIA

� QUANTA Lite® ELISA

� NOVA Lite® IFA

� NOVA Dot® Immunoblot

Redefining Autoimmunity

Innovative Instruments and Assays

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Inova Diagnostics, a Werfen company, is redefining autoimmunity by delivering solutions which anticipate the needs of the autoimmune laboratory. We develop new biomarkers to enhance patient care, and systems to help your laboratory improve the efficiency and quality of testing.

Our innovative Integrated Lab systems include BIO-FLASH®, a rapid-response chemiluminescent analyzer, NOVA View®, an automated digital IFA microscope, QUANTA-Lyser®, for increased EIA/IFA processing speed and flexibility, and QUANTA Link® data management system to make workflow management easier.

Our comprehensive portfolio of reagents supports diagnosis, stratification and monitoring of complex disorders such as connective tissue disease, rheumatoid arthritis, antiphospholipid syndrome, vasculitis, inflammatory bowel disease and celiac disease.

At Inova Diagnostics, we want to be your first choice for autoimmune testing. We work to accomplish this through a persistent focus on quality and the needs of our customers, and by leading the field with new product innovation. We look forward to working with you.

Redefining autoimmune testing with innovative systems and reagents

Inova Diagnostics Company Overview

Systems and Instrumentation

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55

Inova instruments are seamlessly connected to the LIS by QUANTA Link, a centralized data management system. This integrated system delivers increased productivity, improved sample integrity and more streamlined workflow for the autoimmune laboratory.

QUANTA Link®Seamlessly integrates Inova Diagnostics instruments with your LIS to efficiently manage workflow and quality control.

NOVA Lite® IFA SlidesContain smart barcodes that connect patient samples to a well location.

BIO-FLASH®Fully automated random access chemiluminescent benchtop analyzer for the autoimmunity laboratory.

QUANTA-Lyser®An automated EIA/IFA slide processor capable of reading IFA slide barcodes.

NOVA View®Automates IFA slide interpretation.

AUTOLoaderRobotic arm that transfers IFA slides to and from NOVA View.

The Integrated Lab Data Driven Workflow and Cost Efficiency


6

QUANTA Link®Centralized Intelligent Network

Workflow management made easyData management system that consolidates autoimmune results from Inova Diagnostics instruments in a centralized location to improve workflow

• Eliminates transcription errors in IFA sample processing and analysis

• Single point location to access patient data and result history

• Organize, prioritize and streamline workflow

• Centralized location for QC data

• Review and report IFA results

• Digital image training atlas for IFA

• Single LIS connection

• Positive patient identification for IFA

Description Part Number

QUANTA Link Workstation License LINK001

QUANTA Link Workstation LINK010

Barcode Scanner LINK019

LED Fluorescent Microscope OLY1000

LED Fluorescent Microscope with digital camera OLY2000

7

Allows the technologist to view ANCA Ethanol, ANCA Formalin and HEp-2 results from the same patient simultaneously.

Multi-Analyte Screen

QUANTA Link transforms your dark room into a paperless, transcription free environment. Simply enter the information directly on the touch screen.

Paperless Interpretation

User defined atlas used for reference and training.

Atlas

All quality control information is centralized in a single location using Levey-Jennings and employing Westgard rules.

Optimize Quality Control


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BIO-FLASH®

Rapid-Response Chemiluminescent AnalyzerA progressive solution to common problems

Eliminates isotype batching and reagent waste

• Stable on-board reagents allow for samples to be run as they arrive

Improves turn-around time

• Simultaneous random access processing of all isotypes and assays on a single sample

• Delivers results, including STAT orders, in as little as 30 minutes

• Generates up to 450 results in a single shift

Helps reduce test send outs

• Makes even the most specialized assays efficient to perform with stable calibration curves

Frees up floor space

• Small benchtop analyzer achieves excellent throughput


BIO-FLASH System T3710-0344

High Capacity Rinse Accessory T3410-0887

99

QUANTA Flash® reagents• Chemiluminescent technology delivers precise quantitation

and a broad analytical measuring range

• Cartridge barcode is internally scanned to import the master calibration curve, lot number, expiration date and assay type

Reagent carousel • Stores up to 20 reagent packs with on-board refrigeration• Monitors reagent use and reports inventory• Dedicated reagent probe

Sample carousel• Primary samples placed directly onto the rack and scanned by internal barcode reader• Samples processed in random access with continuous load capability• STAT orders can be run at any time• Dedicated sample probe

230k

200k

170k

140k

110k

90k

60k

30k

0

IU/mL

RLU

0 60 130 190 250 310 380 500440

xx

x

*

*

**

**

Calibration curves• Master calibration curve uploaded through the reagent pack barcode• Calibrators are processed in the sample carousel• BIO-FLASH determines a stable working calibration curve

Intuitive software and touchscreen• Simplifies training and day-to-day operation• Status screen allows immediate access to system information

BIO-FLASH Common Components

NAME DESCRIPTION PACKAGE PART #

BIO-FLASH System Rinse System rinse for use with the BIO-FLASH instrument. 1 X 5L T3000-8205

Trigger 1&2 Package of both triggers for use with the BIO-FLASH instrument 2 x 250mL T3000-8204

Cuvettes Cuvettes for use with the BIO-FLASH instrument 1,400 per box T3000-8206

System Cleaning Solution Cleaning solution for BIO-FLASH instrument maintenance 6 x 4mL T3000-8211

Low Volume Cups Low volume sample cups for use with the BIO-FLASH system 500 Cups T3000-8209

Low Volume Caps Low volume sample cup caps for use with the BIO-FLASH system 500 Caps T3000-8210


1010

NOVA View®

The new world of digital IFA testingNOVA View® helps automate the reading and interpretation of HEp-2, ANCA* and Crithidia* IFA slides.

• NOVA View provides positive/negative interpretation, as well as pattern recognition for HEp-2 and ANCA

• Single well titer (SWT) can reduce IFA workload by up to 43% and lower material costs

• DAPI stain provides a built-in control to visualize cells in a negative well

• Calibration technique delivers excellent agreement with manual IFA and improves standardization


NOVA View Instrument NV2000

HEp-2 Module License NV1050

ANCA Module License* NV1051

Crithidia Module License* NV1052

* Available Outside The USA Only

1111

NOVA View single well -ter predic-on reduces IFA workflow

0

10,000

20,000

30,000

40,000

50,000

60,000

Manual IFA NOVA View SWT

26,000 26,000

26,000

1,300

# of

wel

ls

IFA screen wells IFA titer wells

48% reduction

•  NOVA View SWT does not change the number of screening wells needed

•  NOVA View SWT reduces the number of extra dilution wells by approximately 48% or 24,700 wells each year

•  NOVA View SWT improves turnaround time, lowers material costs and reduces technologist hands-on time

NOVA View single well titer reduces the overall number of HEp-2 wells used

Example in a laboratory with an average volume of 100 ANA tests per day, a 20% positive rate, 5% of which are mixed patterns and performing 5 dilutions per well 260 days per year.

• ANA screen: Both methods require the same number of wells for screening

• Titer: NOVA View SWT uses light intensity from a screening well to predict a titer, whereas manual IFA requires additional wells to provide a similar result

NOVA View single well titer determination improves IFA workflow

• NOVA View SWT does not change the number of screening wells needed• NOVA View SWT can reduce the number of extra dilution wells up to 48%

or 24,700 wells each year• NOVA View SWT improves turnaround time, lowers material costs and

reduces technologist hands-on time

VS.One well using NOVA View

with SWT

Up to six wells using traditional

manual IFA

NOVA View® helps automate the reading and interpretation of HEp-2, ANCA* and Crithidia* IFA slides.

• NOVA View provides positive/negative interpretation, as well as pattern recognition for HEp-2 and ANCA

• Single well titer (SWT) can reduce IFA workload by up to 43% and lower material costs

• DAPI stain provides a built-in control to visualize cells in a negative well

• Calibration technique delivers excellent agreement with manual IFA and improves standardization


1212

QUANTA-Lyser®

Automated EIA/IFA Analyser Platform Processing flexibility – different configurations for different tasks

• Both configurations process up to 6 plates or 30 slides per run

• Allows you to meet future challenges without changing platforms

• Operational flexibility – on-board scheduler determines optimal workflow sequence to maximize productivity

• Reads and interprets NOVA Lite IFA barcoded slides to ensure sample and assay integrity

Efficiency

• Automation efficiency – walk-away system minimizes hands-on time

• Training efficiency – easy-to-use software and hardware components

• Throughput efficiency – independent 4-probe system allows for rapid sample pipetting to maximize throughput

• Ceramic coated probes eliminate the need for costly disposable pipette tips


160 Sample IFA GS0162

160 Sample EIA + IFA GS0160

160 Sample EIA + IFA with incubator GS0163

240 Sample IFA GS0242

240 Sample EIA GS0161

240 Sample EIA + IFA GS0240

240 Sample EIA + IFA with incubator GS0243

QUANTA-Lyser® 160/240

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QUANTA-Lyser® 2Automated EIA/IFA Analyser Platform


IFA Only GS2002

EIA + IFA GS2000

QUANTA-Lyser® 2

Easy-to-use platform satisfies all your EIA and IFA processing needs

Processing flexibility – three configurations to maximize flexibility and efficiency

• A combination 5 slide, 1 plate layout

• A dedicated 15 slide layout

• A dedicated 2 plate layout

Allows you to choose the configuration to meet your testing demands

• Operational flexibility – on-board scheduler maximizes productivity

• Assay Integrity – reads and interprets NOVA Lite IFA barcoded slides

• Automation efficiency – offers walk-away capability with minimal hands-on time

• Training efficiency – easy-to-use software and hardware components

• Ceramic coated probe – eliminates the need for costly pipette tips


1414

QUANTA-Lyser® 4000High-throughput IFA processor

QUANTA-Lyser® 4000 is a high throughput IFA slide processor designed for the high-volume laboratory

• Fast operation, first 120 samples completed in 2 hours

• Sample deck holds up to 480 samples for high volume processing

• Automated barcode scanner for NOVA Lite IFA slides and reagents to ensure positive patient identification and reagent integrity

• Proprietary 5-slide carrier can be directly transferred to NOVA View without the need to handle slides

• Pipettes mounting media to protect stained cells


QUANTA-Lyser 4000 VS4000

1515

Holds up to 480 primary samples for high volume processing

Automated NOVA Lite IFA slide and reagent barcode scanning ensure positive patient identification and assay integrity

Pipettes mounting media to protect stained cells

Slides do not require a coverslip when interpreted using NOVA View

5-slide carrier with open base can be transferred directly to NOVA View to reduce individual slide handling

5-slide carrier lid minimizes exposure to ambient light and evaporation

High throughput and automated scanning

Pipettes mounting media, direct slide transfer

Directly transfer slides to NOVA View


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AUTOLoaderEfficiently automates slide transfer with NOVA View®

AUTOLoader is a fully automated robotic system that transfers NOVA Lite® IFA slides to and from NOVA View® and reduces hands-on time for the high volume laboratory

• Direct transfer of 5-slide carrier from QUANTA-Lyser® 4000 to AUTOLoader eliminates the need to handle individual slides

• Slides can be added to AUTOLoader at any time without interrupting NOVA View interpretation

• Automated barcode scanner ensures positive patient identification

• Capacity for up to 100 slides or 1,200 wells allows for overnight interpretation


AUTOLoader ALDR1000

1717

Reduces hands on time

Robotic ArmSlide Stack5-Slide Carrier

Barcode Scanner


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DS2®

Reliable sample in/result out microtiter plate processor

• Compact design is ideally suited for laboratories where space is limited

• Processes two 96-well microplates and up to 12 different assays simultaneously

• Walk-away automation provides up to two hours of free time for other laboratory tasks

DS2 is a registered trademark of DYNEX Technologies, Inc.


DS2 D62010

1919

DSX®/best 2000A high-performance walk-away EIA processing system

• A fully automated 4-plate processing system capable of performing up to 12 different assays simultaneously

• Employs a modular design that provides flexible configuration and ease of use

• Incorporates many features to ensure the quality and security of results

• Ability to handle a wide variety of assay protocols

DSX is a registered trademark of DYNEX Technologies, Inc.


With No Incubators D65100

With 2 Incubators D65200

With 4 Incubators T3710-0337

QUANTA Flash®

Chemiluminescent Immunoassays (CIA)QUANTA Flash CIA technology offers a faster response and broader analytical measuring range than enzyme-based assays for more precise quantitation and confidence in results.

� Antiphospholipid Syndrome

� Connective Tissue Diseases

� Celiac Disease

� Rheumatoid Arthritis

� Vasculitis

� Liver Disease

1. Martis P, et al. The QUANTA Flash® Chemiluminescent Immunoassays for Celiac Disease Show Excellent Analytical and Clinical Performance Characteristics. AMLI Minneapolis, 2011.

Chemiluminescence immunoassay (CIA) technology can significantly increase the analytical measuring range1

QUANTA Flash

ELISA

Measured units

ANALYTICAL MEASURING RANGE

2020

2121

Celiac DiseaseQUANTA Flash celiac assays provide accurate results across multiple markers and isotypes.

NAME DESCRIPTION PRODUCT ITEM PACKAGE PART #

QUANTA Flash h-tTG IgA

Semi-quantitative determination of IgA anti-human tissue transglutaminase (h-tTG) antibodies in human serum on the BIO-FLASH system

Reagents

Calibrators Controls

50 Test Cartridge100 Test Cartridge

2 X 2 vials (0.3 mL each)2 X 2 vials (0.5 mL each)

701103701100701101701102

QUANTA Flash h-tTG IgG

Semi-quantitative determination of IgG anti-human tissue transglutaminase (h-tTG) antibodies in human serum on the BIO-FLASH system

ReagentsCalibrators

Controls

50 Test Cartridge2 X 2 vials (0.3 mL each)2 X 2 vials (0.5 mL each)

701108701106701107

QUANTA Flash DGP IgA

Semi-quantitative determination of IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH system

ReagentsCalibrators

Controls


701168701166701167

QUANTA Flash DGP IgG

Semi-quantitative determination of IgG anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH system

Reagents

CalibratorsControls

50 Test Cartridge100 Test Cartidge

2 X 2 vials (0.3 mL each)2 X 2 vials (0.5 mL each)

701173701170701171701172


QUANTA Flash MPO

Semi-quantitative determination of IgG autoantibodies to myeloperoxidase (MPO) in human serum on the BIO-FLASH system

ReagentsCalibratorControls


701133701131701132

QUANTA Flash PR3

Semi-quantitative determination of IgG autoantibodies to serine protease 3 (PR3) in human serum on the BIO-FLASH system



701138701136701137

QUANTA Flash GBM

Semi-quantitative determination of IgG autoantibodies to glomerular basement membrane (GBM) in human serum on the BIO-FLASH system



701143701141701142


QUANTA Flash CCP3

Semi-quantitative determination of IgG autoantibodies to CCP3 in human serum on the BIO-FLASH system



701125701126701127

VasculitisQUANTA Flash MPO, PR3 and GBM allow for rapid response in critical cases.

Celiac DiseaseQUANTA Flash celiac assays provide accurate results across multiple markers and isotypes.

Rheumatoid ArthritisQUANTA Flash CCP3 assay adds certainty to the diagnosis of Rheumatoid Arthritis.

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2222

QUANTA Flash® (CIA)

Connective Tissue DiseaseQUANTA Flash CTD assays fully leverage the capabilities of the BIO-FLASH® system to accurately detect analytes at a combined screening level as well as the more disease specific autoantibodies.


QUANTA Flash CTD Screen Plus*

Qualitative detection of total anti-nuclear antibodies against dsDNA, Ro52, Ro60, SS-B, Scl-70, centromere, Mi-2, Ku, Th/To, RNA Pol III, Pm/Scl, PCNA, Jo-1, anti Sm, anti-RNP and Ribosomal-P antibodies on the BIO-FLASH System

ReagentsCalibrators

Controls

100 Test Cartridge2 x 2 vials (0.3mL each)2 x 2 vials (0.5mL each)

701220701221701222

QUANTA Flash ENA7

Qualitative determination of IgG anti Sm, anti-RNP, anti-Ro60, anti-Ro52, anti-SS-B, anti-Scl-70 and anti-Jo-1 antibodies

Reagents


50 Test Cartridge 100 Test Cartridge

2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)

701258701255701256701257

QUANTA Flash Jo-1

Semi-quantitative determination of anti-Jo-1 antibodies on the BIO-FLASH system

ReagentsCalibrators

Controls

50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)

701163 701161 701162

QUANTA Flash RNP

Semi-quantitative determination of anti-RNP antibodies on the BIO-FLASH system

ReagentsCalibrators

Controls


701118 701116 701117

QUANTA Flash Sm

Semi-quantitative determination of anti-Sm antibodies on the BIO-FLASH system

ReagentsCalibrators

Controls


701123 701121 701122

QUANTA Flash Ro60

Semi-quantitative determination of anti-Ro60 (SSA) antibodies on the BIO-FLASH system

ReagentsCalibrators

Controls


701148 701146 701147

QUANTA Flash Ro52

Semi-quantitative determination of anti-Ro52 (TRIM21) antibodies on the BIO-FLASH system

ReagentsCalibrators

Controls


701263 701261 701262

QUANTA Flash SS-B

Semi-quantitative determination of anti-SSB (La) antibodies on the BIO-FLASH system

ReagentsCalibrators

Controls


701153 701151 701152

QUANTA Flash Scl-70*

Semi-quantitative determination of anti-Scl-70 antibodies on the BIO-FLASH system.

ReagentsCalibrators

Controls


701328 701326 701327

QUANTA Flash Centromere

Semi-quantitative determination of anti-centromere antibodies on the BIO-FLASH system

ReagentsCalibrators

Controls


701198701196701197

QUANTA Flash Ribosomal P*

Semi-quantitative determination of anti-RiboP antibodies on the BIO-FLASH system

ReagentsCalibrators

Controls


701193701191701192

QUANTA Flash DFS70*

Semi-quantitative determination of anti-DFS70 antibodies on the BIO-FLASH system

ReagentsCalibrators

Controls


701268701266701267

QUANTA Flash dsDNA

Quantitative determination of anti-dsDNA antibodies on the BIO-FLASH system

Reagents


50 Test Cartridge100 Test Cartridge

2 X 2 vials (0.5mL each) 2 X 2 vials (0.5mL each)

701178701175701176701177


2323

Antiphospholipid SyndromeQUANTA Flash APS assays can bring clarity to the complicated diagnosis of Antiphospolipid Syndrome.

Liver DiseaseQUANTA Flash Liver assays increase confidence in the diagnosis of autoimmune liver disease and aid the discrimination of its distinct subtypes.


QUANTA Flash aPL Controls*

aPL controls are intended for the quality control of the QUANTA Flash APS assays performed on the BIO-FLASH system

Low aPL ControlHigh aPL Control

2 X 3 vials (2mL each)2 X 3 vials (2mL each) 701050

QUANTA Flash aCL IgG

Semi-quantitative determination of anti-cardiolipin (aCL) IgG antibodies in human citrated plasma and serum on the BIO-FLASH system

ReagentsControls

50 Test Catridge2 X 3 vials (1 mL each)

701233701232

QUANTA Flash aCL IgM

Semi-quantitative determination of anti-cardiolipin (aCL) IgM antibodies in human citrated plasma and serum on the BIO-FLASH system

ReagentsControls


701238701237

QUANTA Flash aCL IgA

Semi-quantitative determination of anti-cardiolipin (aCL) IgA antibodies in human citrated plasma and serum on the BIO-FLASH system

ReagentsControls

50 Test Cartridge2 X 3 vials (1 mL each)

701228701227

QUANTA Flash β2 GP1 IgG

Semi-quantitative determination of anti-β2 glycoprotein-1 (β2GP1) IgG antibodies in human citrated plasma and serum on the BIO-FLASH system

ReagentsControls


701248701247

QUANTA Flash β2 GP1 IgM

Semi-quantitative determination of anti-β2 glycoprotein-1 (β2GP1) IgM antibodies in human citrated plasma and serum on the BIO-FLASH system

ReagentsControls

50 Test Cartridge2 X 3 vials (1 mL each)

701253701252

QUANTA Flash β2 GP1 IgA

Semi-quantitative determination of anti-β2 glycoprotein-1 (β2GP1) IgA antibodies in human citrated plasma and serum on the BIO-FLASH system

ReagentsControls


701243701242

QUANTA Flash β2 GP1-Domain1

Semi-quantitative determination of anti-B2 GP1 Domain1 antibodies in human citrated plasma and serum on the BIO-FLASH system

ReagentsControls


701188701187


QUANTA Flash LKM-1*

Semi-quantitative determination of IgG autoantibodies against LKM-1 (cytochrome P450 2D6) antigens in human serum on the BIO-FLASH system

ReagentsCalibrators

Controls

50 test cartridge2 X 2 vials (0.3mL each)2 X 2 vials (0.5mL each)

701298701296701297

QUANTA Flash M2 (MIT3)*

Semi-quantitative determination of IgG autoantibodies against mitochondrial antigens in human serum on the BIO-FLASH system

ReagentsCalibrators

Controls

50 test cartridge2 X 2 vials (0.3mL each)2 X 2 vials (0.5mL each)

701303701301701302

Calibrators are included in the QUANTA FLASH aCL and β2 GP1-kits


QUANTA Lite®

ELISAQUANTA Lite ELISA tests are made of the highest quality components to enable semi-quantitative† detection of autoantibodies for a variety of disease states:

� Antiphospholipid Syndrome

� Connective Tissue Diseases

� Rheumatoid Arthritis � Gastrointestinal Disease

� Celiac Disease � Liver Disease � Vasculitis � Autoimmune Thyroid Disease

†QUANTA Lite ELISA tests are semi-quantitative unless otherwise indicated in the product description2424

2525

The cause of chronic intestinal upset can come from a number of sources, often making diagnosis difficult. The QUANTA Lite and NOVA Lite (in the case of ANCA) tests below provide reliable results to help clinicians assess the root cause.

Gastrointestinal Disease

Consider irritable bowel syndrome, proceed

with additional testing

(–) (+)

(–)

(–)

Suggestive of Crohn’s Disease

(+)ASCA

Suggestive ofUlcerative Colitis

(+)pANCA

CELIAC & GI DIAGNOSTIC PATHWAY

Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.

1. Green, P. H. (2009). "Mortality in celiac disease, intestinal inflammation, and gluten sensitivity." JAMA 302(11): 1225-1226.2. Rubio-Tapia, A. and Murray, J. A. (2010). "Celiac disease." Curr Opin Gastroenterol 26(2): 116-122.3. Leffler, D. A. and D. Schuppan (2010). "Update on serologic testing in celiac disease." Am J Gastroenterol 105(12): 2520-2524.

AbbreviationsANCA Anti-neutrophil cytoplasmic antibodiesASCA Anti-Saccharomyces cerevisiae antibodyDGP Anti-deamidated gliadin peptideEMA Anti-endomysial antibodytTG Anti-tissue transglutaminase antibody

Test Associated disease state

Non-celiac gluten sensitivity testingGliadin IgG

tTG, DGP, EMA

ASCA, pANCA

Suggestive of Celiac Disease

(+)

Suggestive ofnon-celiac gluten

sensitivity

2626

Gastrointestinal Disease

QUANTA Lite® (ELISA)

Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.1. Desplat-Jego, S., Johanet, C., et al. (2007). "Update on Anti-Saccharomyces cerevisiae antibodies, anti-nuclear associated anti-neutrophil antibodies and

antibodies to exocrine pancreas detected by indirect immunofluorescence as biomarkers in chronic inflammatory bowel diseases: results of a multicenter study." World J Gastroenterol 13(16): 2312-2318.

2. Arai, R. (2010). "Serologic markers: impact on early diagnosis and disease stratification in inflammatory bowel disease." Postgrad Med 122(4): 177-185.3. Arias-Loste, et al. (2012). "Presence of Anti-proteinase 3 Antineutrophil Cytoplasmic Antibodies (Anti-PR3 ANCA) as Serologic Markers in Inflammatory Bowel

Disease" Clin Rev Allergy Immunol 45(1):109-16.4. Lewis, JD. "The utility of biomarkers in the diagnosis and therapy of inflammatory bowel disease." Gastroenterology 140(6):1817-1826.5. Corrocio, A. et al. (2003) Diagnostic Accuracy of fecal calprotectin assay in distinguishing organic causes of chronic diarrhea from irritable bowel syndrome: a

prospective study in adults and children. Clin Chem 49:861-7.

AbbreviationsASCA Anti-Saccharomyces cerevisiae antibodypANCA Perinuclear anti-neutrophil cytoplasmic antibodyPR3 Proteinase 3

RESULT PROFILE:

ASCA IgG +ASCA IgA +pANCA -(atypical)

RESULT PROFILE:

ASCA IgG -ASCA IgA -pANCA +(atypical)PR3+

Suggestive of ULCERATIVE

COLITIS

Suggestive of CROHN’S DISEASE

IBD Diagnostic Pathway

DIFFERENTIAL DIAGNOSIS OF ULCERATIVE COLITIS

AND CROHN'S

OVERLAP CONDITIONS

(+) (–)

Suggestive of IBS

MIXED RESULTSMIXED RESULTS

Calprotectin

ASCA, pANCA, PR3

27

Gastrointestinal DiseaseNAME DESCRIPTION ANTIGEN PACKAGE PART #

QUANTA Lite Calprotectin

A quantitative ELISA for detecting the concentration of calprotectin in human feces. The presence of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD) and to differentiate IBD from Irritable Bowel Syndrome (IBS)

Native 1 x 96 wells 704770

QUANTA Lite Calprotectin Extended Range*

A quantitative ELISA for detecting the concentration of calprotectin in human feces. The presence of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD) and to differentiate IBD from Irritable Bowel Syndrome (IBS)


QUANTA Lite Intrinsic Factor

This assay is designed for the detection of anti-Intrinsic Factor IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of pernicious anemia

Recombinant 1 X 96 wells 708780

QUANTA Lite H. pylori IgA

A qualitative ELISA assay for the detection of anti-H. pylori (Helicobacter pylori) IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of H. pylori infection in adult patients with clinical signs and symptoms of gastrointestinal disease

Native 1 X 96 wells 708720

QUANTA Lite H. pylori IgG

A qualitative ELISA assay for the detection of anti-H. pylori (Helicobacter pylori) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of H. pylori infections in adult patients with clinical signs and symptoms of gastrointestinal disease


QUANTA Lite ASCA IgA (S. cerevisiae)

This assay is designed for the detection of anti-Saccharomyces cerevisiae IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of patients with Crohn's disease


QUANTA Lite ASCA IgG (S. cerevisiae)

This assay is designed for the detection of anti-Saccharomyces cerevisiae IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of patients with Crohn's disease


QUANTA Lite GPA (Gastric Parietal Cell Antibody)

This assay is designed for the detection of anti-gastric parietal cell (H+/K+) ATPase IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of conditions with elevated levels of anti-gastric parietal cell antibodies including pernicious anemia



Fecal Collection Device* This device has been designed as an aid in the preparation of fecal samples 100 devices 504837

Common Components


2828

Celiac disease remains highly under diagnosed, especially in children. Inova Diagnostics is very proud to have introduced QUANTA Lite Gliadin II (DGP), the first commercial deamidated gliadin peptide (DGP) ELISA, in 2005. This assay is particularly useful in pediatric populations.

NAME DESCRIPTION ANTIGEN PACKAGE PART #

QUANTA Lite h-tTG IgA(Human Tissue Transglutaminase)

Detection of anti-tissue transglutaminase (endomysium) IgA antibodies in human serum

Native(human red blood cell)

1 X 96 wells10 X 96 wells

708760708760.10

QUANTA Lite h-tTG IgG(Human Tissue Transglutaminase)

Detection of anti-tissue transglutaminase (endomysium) IgG antibodies in human serum


1 X 96 wells 708755

QUANTA Lite R h-tTG IgAIn-vitro measurement of specific IgA autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of celiac disease

Recombinant 1 X 96 wells

10 X 96 wells704605

704605.10

QUANTA Lite R h-tTG IgGIn-vitro measurement of specific IgG autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of celiac disease


10 X 96 wells704610

704610.10

QUANTA Lite h-tTG Screen

Detection of IgA and IgG human tissue transglutaminase (h-tTG) antibodies in human serum


1 X 96 wells 704570

QUANTA Lite Gliadin IgA II

Detection of IgA antibodies to synthetic, deamidated gliadin-derived peptides (DGP) in human serum

Synthetic, deamidated

peptide


704525704525.10

QUANTA Lite Gliadin IgG II

Detection of IgG antibodies to synthetic, deamidated gliadin-derived peptides (DGP) in human serum


peptide


704520704520.10

QUANTA Lite Celiac DGP Screen

Detection of IgA and IgG antibodies to synthetic, deamidated gliadin-derived peptides in human serum


peptide1 X 96 wells 704545

Celiac Disease


2929


QUANTA Lite h-tTG/DGP Screen

Detection of IgA and IgG antibodies to synthetic, deamidated gliadin-derived peptides (DGP) and human tissue transglutaminase (h-tTG) in human serum

h-tTG native (human red blood cell);

DGP peptide (synthetic,

deamidated)

1 X 96 wells 704575

QUANTA Lite Gliadin IgA Detection of anti-gliadin IgA antibodies in human serum Native 1 X 96 wells 708655

QUANTA Lite Gliadin IgG Detection of anti-gliadin IgG antibodies in human serum Native 1 X 96 wells 708650

QUANTA Lite F-Actin IgA Detection of IgA antibodies to the F-Actin component of smooth muscle in human serum


Celiac Disease (continued)

3030

Inova Diagnostics offers a comprehensive menu of tests to aid in the diagnosis of autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).

Liver Disease

DIAGNOSTIC ALGORITHMLiver Disease of Unknown Cause

ANA+

AIH


PBC CeliacCryptogenic

chronichepatitis

AIC

AIH

F-actin+(lgG) SLA/LP+ LC1+

AMA specificantigens

M2EP (MIT3)*+

gp210+&/or

sp100+

EMA+tTG+DGP+

Negative

PBC AIH PSC

SMA+ LKM+ AMA+ AtypicalANCA+

Additional assays toestablish &/or clarify

diagnosis**


From: A.J. Czaja & G.L. Norman, J. Clin. Gastrenterol, 2003, 37:315-327, modified by G.L. Norman 01/09

** Other assays with possible prognostic value: chromatin and dsDNA* M2 EP (MIT3) ELISA contains immunodominant epitope of PDC-E2, OGDC-E2 & BCOADC-E2

AbbreviationsAIH autoimmune hepatitisAMA anti-mitochondrial antibodiesANA anti-nuclear antibodiesANCA anti-neutrophil cytoplasmic antibodiesDGP deamidated gliadin peptideEMA endomysium antibodyLKM liver-kidney microsomal antibodyPBC primary biliary cirrhosisPSC primary sclerotic cholangitisSLA soluble liver antigenSMA smooth muscle antibodytTG tissue transglutaminaseAIC autoimmune cholangitis


3131

Liver Disease


QUANTA Lite Actin IgGDetection of IgG antibodies to the actin component of smooth muscle in human serum

Native1 X 96 wells

10 X 96 wells708785

708785.10

QUANTA Lite M2 EP (MIT3)

Detection of anti-mitochondria IgG antibodies in human serum


10 X 96 wells704540

704540.10

QUANTA Lite gp210 Detection of anti-gp210 IgG antibodies in human serumSynthetic peptide

1 X 96 wells 708995

QUANTA Lite sp100 Detection of anti-sp100 IgG antibodies in human serumSynthetic peptide

1 X 96 wells 708990

QUANTA Lite PBC Screen IgG/IgA

Detection of anti-mitochondrial, -gp210 and -sp100 IgG and/or IgA antibodies in human serum

MIT3 recombinant;

sp100 & gp210

synthetic peptides

1 X 96 wells 704560

QUANTA Lite SLA (Soluble Liver Antigen)

Detection of anti-Soluble Liver Antigen (SLA) IgG antibodies in human serum


QUANTA Lite LKM-1 Detection of anti-LKM-1 IgG antibodies in human serum Recombinant 1 X 96 wells 708745

3232

Antiphospholipid SyndromeInova Diagnostics has long been at the forefront of laboratory tests that aid in the diagnosis of antiphospholipid syndrome, offering a comprehensive menu of serological markers including criteria as well as specialty non-criteria markers. 1


NegativeAny Positive

PS/PT (IgG/IgM) and β2GP1 Domain 1

Likelihood of APS is moderate to high

Likelihood of APS is

moderate

Potential Testing Algorithm for APS

Likelihood of APS is high

β2GP1 Domain 1

Triple positive

Moderate Risk

Possible Risk

High Risk

Moderate risk for recurring thrombosis

Unlikely

Moderate to High Risk

High risk for recurring thrombosis

Negative

Additional testing in cases of high clinical

suspicion

Positive

High risk for recurring thrombosis

Moderate risk for recurring

thrombosis

Negative

Negative

Negative

Positive

Positive

APS is possible

APS unlikely


moderate

aCL IgA, β2GP1 IgA

PS/PT (IgG/IgM)

APS unlikely

One or two positive


moderate

aCL (IgG/IgM)β2GP1 (IgM/IgG)

LAC

Likelihood of APS based on testing outcome Risk outcome

High • Triple positivity is the strongest risk factor for clinical manifestations2-6, 9

Moderate to high• Titers and isotype need to be considered4-6

• Inclusion of PS/PT results in excellent diagnostic accuracy and a predictor of adverse events2-6, 9

Moderate

• PS/PT may identify patients with APS who are negative for serological criteria markers10

• Positivity for at least one of the criteria markers increases likelihood for APS• Titers and isotype need to be considered (Antibodies of IgG isotype represent higher risk than that

of IgM, and higher antibody level implies higher risk)4-6

Possible• All criteria markers negative but one or more esoteric marker positive; APS possible, but

likelihood only marginally increased11-12

• Isolated IgA antibody positivity has been described in association with APS9, 13-14

Unlikely • All markers are negative which makes APS unlikely, but can not be excluded11-12

Suspicion of APS

33

Antiphospholipid Syndrome


QUANTA Lite ACA IgG III Detection of anti-cardiolipin IgG antibodies in human serum Native1 X 96 wells

10 X 96 wells708625

708625.10

QUANTA Lite ACA IgM III Detection of anti-cardiolipin IgM antibodies in human serum Native1 X 96 wells

10 X 96 wells708630

708630.10

QUANTA Lite ACA IgA III Detection of anti-cardiolipin IgA antibodies in human serum Native1 X 96 wells

10 X 96 wells708635

708635.10

QUANTA Lite ACA Screen III

Detection of anti-cardiolipin IgG, IgM and IgA antibodies in human serum


QUANTA Lite β2GPI IgG Detection of anti-β2GPI IgG antibodies in human serum Native1 X 96 wells

10 X 96 wells708665

708665.10

QUANTA Lite β2GPI IgM Detection of IgM anti-β2GPI antibodies in human serum Native1 X 96 wells

10 X 96 wells708670

708670.10

QUANTA Lite β2GPI IgA Detection of anti-β2GPI IgA antibodies in human serum Native1 X 96 wells

10 X 96 wells708675

708675.10

QUANTA Lite β2GPI Screen ELISA

A qualitative ELISA assay for the detection of anti-β2GPI IgG, IgM and IgA antibodies in human serum


1. Pengo V, Ruffatti A, Del Ross T, Tonello M, Cuffaro S, Hoxha A, Banzato A, Bison E, Denas G, Bracco A, Padayattil Jose S. Confirmation of the initial antiphospholipid antibody positivity depends on antiphospholipid antibody profile. J Thromb Haemost. 2013 Apr; 11(8):1527-31.

2. Sciascia S, Murru V, Sanna G, Roccatello D, Khamashta MA, Bertolaccini ML. Clinical accuracy for diagnosis of antiphospholipid syndrome in systemic lupus erythematosus: evaluation of 23 possible combinations of antiphospholipid antibody specificities. J Thromb Haemost. 2012 Dec;10(12):2512-8.

3. Otomo K, Atsumi T, Amengual O, Fujieda Y, Kato M, Oku K, Horita T, Yasuda S, Koike T. Efficacy of the antiphospholipid score for the diagnosis of antiphospholipid syndrome and its predictive value for thrombotic events.Arthritis Rheum. 2012 Feb;64(2):504-12.

4. Roubey RA. Risky business: the interpretation, use, and abuse of antiphospholipid antibody tests in clinical practice. Lupus. 2010 Apr;19(4):440-5.

5. Andreoli L, Tincani A. Beyond the "syndrome": antiphospholipid antibodies as risk factors. Arthritis Rheum. 2012 Feb;64(2):342-5.

6. Tarr T, Lakos G, Bhattoa HP, Shoenfeld Y, Szegedi G, Kiss E. Analysis of risk factors for the development of thrombotic complications in antiphospholipid antibody positive lupus patients. Lupus. 2007;16(1):39-45.

7. Mahler M, Norman GL, Meroni PL, Khamashta, M. Autoantibodies to domain 1 of beta 2 glycoprotein 1: a promising candidate biomarker for risk management in antiphospholipid syndrome. Autoimmun Rev. 2012 Dec; 12(2):313-317.

8. V. Pengo, A. Ruffatti, M. Tonello, S. Cuffaro, A. Banzato, E. Bison, G. Denas, S. Padayattil Jose. Antiphospholipid syndrome: Antibodies to Domain 1 of β2-glycoprotein 1 correctly classify patients at risk. J Thromb Haemost 2015

9. Meijide H, Sciascia S, Sanna G, Khamashta MA, Bertolaccini ML. The clinical relevance of IgA anticardiolipin and IgA anti-β2 glycoprotein I antiphospholipid antibodies: a systematic review. Autoimmun Rev. 2013 Jan;12(3):421-5.

10. Pregnolato F, Chighizola CB, Encabo S, Shums Z, Norman GL, Tripodi A,Chantarangkul V, Bertero T, De Micheli V, Borghi MO, Meroni PL. Anti-phosphatidylserine/prothrombin antibodies: an additional diagnostic marker for APS? Immunol Res. 2013 Jul; 56(2-3):432-8.

11. Nayfe R, Uthman I, Aoun J, Saad Aldin E, Merashli M, Khamashta MA. Seronegative antiphospholipid syndrome. Rheumatology (Oxford). 2013

12. Rodriguez-Garcia JL, Bertolaccini ML, Cuadrado MJ, Sanna G, Ateka-Barrutia O, Khamashta MA. Clinical manifestations of antiphospholipid syndrome (APS) with and without antiphospholipid antibodies (the so-called 'seronegative APS'). Ann Rheum Dis. 2012 Feb;71(2):242-4.

13. Kumar S, Papalardo E, Sunkureddi P, Najam S, González EB, Pierangeli SS. Isolated elevation of IgA anti-beta2glycoprotein I antibodies with manifestations of antiphospholipid syndrome: a case series of five patients. Lupus. 2009 Oct;18(11):1011-4.

14. Mehrani T, Petri M. Association of IgA Anti-beta2 glycoprotein I with clinical and laboratory manifestations of systemic lupus erythematosus. J Rheumatol. 2011; 38(3):450-3.

15. Amengual O, Atsumi T, Khamashta M, Hughes, G. Advances in APS. Ann Acad Med Singapore. 1998;27:61-66.16. Bertolaccini M, Amengual O, Atsumi T, Binder W, et al. Non-criteria aPL tests: report of a task force and

workshop at the 13th International Congress on aPL. Lupus 2011;20:191-205 17. Nash M, Camilleri R, Kunka S, et al. The anticardiolipin assay is required for sensitive screening of aPL. J

Thromb Haemost. 2004; 2:1077-1081.18. Pengo V, Tripodi A, Reber G, Rand JH, Ortel TL, Galli M, De Groot, PG. Update of the guidelines for lupus

anticoagulant detection. J Thromb Haemost 2009 7:1737-1740.19. Vlagea A, Gil A, Cuesta MV, Arribas F, Diez J, Lavilla P, Pascual-Salcedo D. aPS/PT as potential markers of APS.

Clin Appl Thromb Hemost 2012 doi: 10.117/107602961243757820. Scascia S, Sanna G, Murru V, Roccatello D, Khamashta MA, Bertolaccini, ML. aPT and aPS/PT antibodies and

the risk of thrombosis in the APS. J Thromb Haemost. 2014; 111: 354-364.

References

3434

Antiphospholipid Syndrome (continued)


QUANTA Lite aPS/PT IgG

Detection of IgG class antibodies to phosphatidylserine/prothrombin complex (PS/PT) in serum or plasma


QUANTA Lite aPS/PT IgM

Detection of IgM class antibodies to phosphatidylserine/prothrombin complex (PS/PT) in serum or plasma


QUANTA Lite Phosphatidylserine IgG

In-vitro measurement of IgG anti-phosphatidylserine antibodies in human serum, as an aid in the diagnosis of anti-phospholipid syndrome (APS)

Native1 X 96 wells

10 X 96 wells704625

704625.10

QUANTA Lite Phosphatidylserine IgM

In-vitro measurement of IgM anti-phosphatidylserine antibodies in human serum, as an aid in the diagnosis of anti-phospholipid syndrome (APS)

Native1 X 96 wells

10 X 96 wells704630

704630.10

QUANTA Lite Phosphatidylserine IgA

In-vitro measurement of IgA anti-phosphatidylserine antibodies in human serum, as an aid in the diagnosis of anti-phospholipid syndrome (APS)

Native1 X 96 wells

10 X 96 wells704635

704635.10


35

The revised classification criteria issued in 2010 for rheumatoid arthritis (RA) emphasize the need for early and accurate diagnosis. The QUANTA Lite® CCP3.1 IgG/IgA ELISA offers superior detection of early RA compared with CCP21. Clearly defined positive and high positive cut-offs provide results that rheumatologists require.


QUANTA Lite CCP3.1 IgG/IgA

Detection of anti-CCP 3.1 IgG and IgA antibodies in patient sera, citrated or EDTA plasma

Synthetic peptide


704550704550.10

QUANTA Lite CCP3 IgGDetection of anti-CCP 3 IgG antibodies in patient sera, citrated or EDTA plasma

Synthetic peptide

1 X 96 wells 10 X 96 wells

704535704535.10

QUANTA Lite RF IgGDetection of anti-rheumatoid factor (RF) IgG antibodies in human serum


QUANTA Lite RF IgM Detection of anti-rheumatoid factor (RF) IgM antibodies in human serum


QUANTA Lite RF IgA Detection of anti-rheumatoid factor (RF) IgA antibodies in human serum


Rheumatoid Arthritis

1. Source : QUANTA Lite CCP 3.1 IgG/IgA ELISA direction insert. Early RA defined as detection within 2 years of onset of symptoms.

3636


QUANTA Lite ANA Detection of anti-nuclear IgG antibodies (ANA) in human serum

Native, recombinant, extracts from HEp-2 nuclei and nucleoli

1 X 96 wells 708750

QUANTA Lite dsDNA Detection of anti-dsDNA IgG antibodies in human serum Native 1 X 96 wells 708510

QUANTA Lite dsDNA SC (Double Stranded DNA)

In-vitro measurement of specific IgG autoantibodies against dsDNA present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings. Five calibrators allow for creation of standard curve (SC)


QUANTA Lite HA dsDNA

In-vitro measurement of specific high avidity IgG autoantibodies against dsDNA present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings. Five calibrators allow for creation of standard curve


QUANTA Lite Chromatin

Detection of anti-chromatin IgG antibodies in human serum Native 1 X 96 wells 708710

QUANTA Lite C1q CIC

In-vitro measurement of circulating immune complexes (CIC) that bind C1q, present in human serum. It is intended for the determination of CIC in serum of patients with various autoimmune and other CIC-related diseases, and is used in conjunction with other clinical findings


QUANTA Lite Anti-C1q*

Detection of anti-C1q antibodies in human serum Native 1 X 96 wells 704565

QUANTA Lite Centromere

Detection of anti-centromere IgG antibodies specifically reactive to the CENP-A and CENP-B antigens in human serum



Connective Tissue DiseasesLupus and lupus-like diseases present clinicians with a tremendous diagnostic challenge. Tests which stand apart from the rest include the QUANTA Lite® ANA ELISA with a broad array of antigens as well as HEp-2 nuclear extracts, and the QUANTA Lite Chromatin ELISA with excellent performance.


37


Connective Tissue Diseases (continued)


QUANTA Lite HMGCR*

Semi-quantitative detection of IgG anti-HMGCR antibodies in human serum


QUANTA Lite Histone

Detection of anti-histone IgG antibodies in human serum Native 1 X 96 wells 708510

QUANTA Lite Jo-1

Detection of anti-Jo-1 IgG antibodies in human serum Recombinant 1 X 96 wells 708585

QUANTA Lite Ribosome P

Detection of anti-Ribosome P IgG antibodies in human serumSynthetic peptide

1 X 96 wells 708600

QUANTA Lite RNA Pol III

Detection of anti-RNA Polymerase III IgG antibodies in human serum Recombinant 1 X 96 wells 704555

QUANTA Lite RNP

Detection of anti-RNP IgG antibodies in human serum Native 1 X 96 wells 708565

QUANTA Lite Scl-70

Detection of anti-Scl-70 IgG antibodies in human serum Native 1 X 96 wells 708580

QUANTA Lite Sm

Detection of anti-Sm IgG antibodies in human serum Native 1 X 96 wells 708560

QUANTA Lite SS-A

Detection of anti-SS-A (60kDa & 52kDA) IgG antibodies in human serum

SS-A 52 recombinant;

SS-A 60 native

1 X 96 wells 708570

QUANTA Lite SS-A 52

Detection of anti-SS-A 52 IgG antibodies in human serum Recombinant 1 X 96 wells 704505

3838


Connective Tissue Diseases (continued)


QUANTA Lite SS-B Detection of anti-SS-B IgG antibodies in human serum Recombinant 1 X 96 wells 708575

QUANTA Lite ssDNA(Single Stranded DNA)

Detection of anti-ssDNA IgG antibodies in human serum. When used in conjunction with QUANTA Lite dsDNA, can aid in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases


QUANTA Lite ENA 4 (Sm, RNP, SS-A and SS-B Screening Test)

Detection of anti-Sm, RNP, SS-A (60kDa and 52kDA) and SS-B IgG antibodies in human serum

SS-A 52 recombinant; SS-A 60 native; SS-B

recombinant; Sm native; RNP native

1 X 96 wells 708555

QUANTA Lite ENA 5 (Sm, RNP, SS-A, SS-B and Scl-70 Screening Test)

This assay is designed for the detection of anti-Sm, RNP, SS-A (60kDa and 52kDa), SS-B and Scl-70 IgG antibodies in human serum


recombinant; Sm native; RNP native; Scl-70 native

1 X 96 wells 708610

QUANTA Lite ENA 6 (Sm, RNP, SS-A, SS-B, Scl-70 and Jo-1 Screening Test)

This assay is designed for the detection of anti-Sm, RNP, SS-A (60kDa and 52kDa), SS-B, Scl-70 and Jo-1 IgG antibodies in human serum


recombinant; Sm native; RNP native; Scl-70 native;

Jo-1 recombinant

1 X 96 wells 708615

QUANTA Lite ENA Profile EIA*

This kit is designed for the in-vitro qualitative screening of human serum for the presence of specific IgG autoantibodies against extractable nuclear antigens (ENAs) namely; SSA/Ro (60 and 52kD), SSB/La, Sm, Sm/RNP, Scl-70 and Jo-1, as an aid in the diagnosis of certain systemic rheumatic diseases


recombinant; Sm native; RNP native; Scl-70 native;

Jo-1 recombinant

1 X 96 wells 704715


39

Inova Diagnostics' vasculitis menu has expanded with the addition of the QUANTA Lite PR3 SC and QUANTA Lite MPO SC, both offering 5 point standard curve calibration.

Vasculitis


QUANTA Lite Thyroid T Detection of anti-thyroglobulin IgG antibodies in human serum


QUANTA Lite TPO Anti-thyroid peroxidase (TPO) IgG antibodies in human serum


Autoimmune Thyroid Disease


QUANTA Lite MPO IgGDetection of anti-myeloperoxidase (MPO) IgG antibodies in human serum

Native1 X 96 wells

10 X 96 wells708700

708700.10

QUANTA Lite MPO SC

In-vitro measurement of specific IgG autoantibodies against myeloperoxidase (MPO) present in serum, as an aid to the diagnosis of certain types of autoimmune vasculitis. Five calibrators allow for creation of standard curve

Native1 X 96 wells

10 X 96 wells704655

704655.10

QUANTA Lite PR-3 IgG Anti-serine protease 3 (PR-3) IgG antibodies in human serum Native1 X 96 wells

10 X 96 wells708705

708705.10

QUANTA Lite PR3 SC

In-vitro measurement of specific IgG autoantibodies against proteinase 3 (PR3) present in human serum, as an aid in the diagnosis of Wegener's granulomatosis and certain forms of autoimmune vasculitis. Five calibrators allow for creation of standard curve

Native1 X 96 wells

10 X 96 wells704660

704660.10

QUANTA Lite GBMAnti-glomerular basement membrane (GBM) IgG antibodies in human serum

Native1 X 96 wells

10 X 96 wells708740

708740.10

4040

‡ Lead times for delivery may vary, items are manufactured to order


QUANTA ChekANA Panel

Quality control of IFA and ELISA antinuclear antibody procedures. Each serum serves as both a pattern control and a titratable sensitivity control. The staining pattern and intensity for each serum has been calibrated by testing it on NOVA Lite HEp-2 slides and QUANTA Lite ANA kits

10 X 0.15mL 708111

QUANTA ChekANCA Panel

Quality control of IFA and ELISA autoantibody procedures. Each serum serves as both a pattern control and a titratable sensitivity control. The staining pattern and intensity for each serum has been calibrated by testing it on Inova Diagnostics' Neutrophil slides and QUANTA Lite MPO and PR-3 kits

8 X 0.15mL 708112

QUANTA Chek Celiac Panel

Quality control of IFA and ELISA autoantibody procedures. Each serum serves as both a pattern control and a titratable sensitivity control. The staining pattern and intensity for each serum has been calibrated by testing it on NOVA Lite Endomysial slides and QUANTA Lite h-tTG IgA, h-tTG IgG, Gliadin IgG II and Gliadin IgA II kits

8 X 0.15mL 708113

QUANTA Chek Coagulation Panel

Quality control of ACA and β2GPI autoantibody ELISA procedures. Each serum serves as both a sensitivity and specificity control. Each serum has been calibrated by testing it on QUANTA Lite ACA and QUANTA Lite β2GPI kits

8 X 0.15mL 708114

QUANTA ChekENA Panel

Quality control of extractable nuclear antibody (ENA) assay in the QUANTA Lite ENA ELISA procedure. Each serum serves as both a sensitivity and a specificity control. Each serum has been calibrated by testing it on QUANTA Lite ENA ELISA kits

8 X 0.15mL 708115

QUANTA Chek™ Quality Control Panels‡


41


IgG Sapporo Standard (HCAL)

International standard for the quality control of anti-cardiolipin IgG (aCL) and anti-β2 glycoprotein I (β2GPI) IgG antibody ELISA products. The IgG Sapporo Standard (HCAL) can be serially diluted in order to make a standard curve, or it can be used as a single point control

1 X 0.1mL 508668

IgM Sapporo Standard (EY2C9)

International standard for the quality control of anti-cardiolipin IgM (aCL) and anti-β2glycoprotein I (β2GPI) IgM antibody ELISA products. The IgM Sapporo Standard (EY2C9) can be serially diluted in order to make a standard curve, or it can be used as a single point control

1 X 0.1mL 508673

QUANTA Lite dsDNA Standard Set*

Pre-diluted 5-point standard curve and positive curve to be used in conjunction with QUANTA Lite dsDNA (708510)

5 X 1.2mL 508512

QUANTA Lite Gliadin IgA II Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite Gliadin IgA II ELISA (704525)

6 X 1.2mL 504528

QUANTA Lite Gliadin IgG II Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite Gliadin IgG II ELISA (704520)

6 X 1.2mL 504524

QUANTA Lite h-tTG IgA Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite h-tTG IgA ELISA (708760)

5 X 1.2mL 508763

QUANTA Lite GBM Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite GBM ELISA (708740)

6 X 1.2mL 508744

QUANTA Lite MPO IgG Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite MPO IgG ELISA (708700)

6 X 1.2mL 508703

QUANTA Lite PR3 IgG Calibrator Set*

Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite PR-3 IgG ELISA (708705)

6 X 1.2mL 508708

Calibration and Standard Sets


NOVA Dot®*

42

NOVA Dot® for autoantibody testingNOVA Dot® immunoblots allow for the detection and identification of autoantibodies for up to 12 specific antigens from a single serum sample. The NOVA Dot immunoblot product line was developed with advanced membrane technology and optimized combinations of antigens. NOVA Dot immunoblots provide an alternative approach to autoantibody testing that complements NOVA Lite® IFA, QUANTA Lite® ELISA or QUANTA Flash® chemiluminescent assays.

• Test systems for disease specific antibody profiles

• Up to 12 antigens in a single blot strip

• Simple processing from a single serum sample

• Refined antigen allows for optimized signaling of DFS70 by focusing on core auto-epitopes


43

NAME DESCRIPTION PART #

NOVA Dot Scanner* Scanner for use with NOVA Dot assays DOT1000

NOVA Dot Software License*

Software License to be used with NOVA Dot assays DOT1100

Connective Tissue Disease

Liver Disease

NOVA Dot Common Components


NOVA Dot CTD Profile*

This immunodot assay allows for the simultaneous detection in human sera of IgG autoantibodies against Nucleosome, Sm, Sm/RNP, SSA/Ro60, Ro52, SSB, Jo-1, Scl-70, CENP-B, PCNA, Ribosome P0 and DFS-70 antigens

Nucleosome native; Sm native; RNP/Sm native; Ro60 native, Ro52 recombinant; SSB recombinant; Jo-1 recombinant; Scl-70 recombinant; CENP-B recombinant; PCNA recombinant; Ribosome P0 recombinant; DFS70 recombinant

24 strips 704800

NOVA Dot Scleroderma Profile In Development

NOVA Dot Myositis Profile In Development

NOVA Dot CTD Confirm

In Development


NOVA Dot Liver Profile In Development


NOVA Lite®

4444

NOVA Lite IFA Barcoded SlidesAs your partner in autoimmunity testing, Inova Diagnostics is redefining autoimmunity with innovative systems and products. Barcoded slides offer the opportunity to advance your IFA process. Barcoded slides, in combination with QUANTA Link software and QUANTA-Lyser, allow for:

To learn more about NOVA Lite barcoded slides, scan this QR code using your PDA or smartphone or visit barcodedslide.com

� Efficiency by eliminating transcription and related errors � Patient sample traceability

4545

IFA Slide Kits

PR3 positiveMPO positive

Consider microscopic polyangiitis

(60% positive) or granulomatosis with polyangiitis

(Wegener's) (25% positive)

Consider microscopic polyangiitis

(30% positive) or granulomatosis with polyangiitis

(Wegener's) (60% positive)

pANCA / cANCA negative

pANCA or cANCA positive

atypical ANCA positive

Clinical suspicion of autoimmune small vessel

vasculitis low

Order PR3 and MPO ELISA

Clinical suspicion of autoimmune small vessel

vasculitis low; considertesting for ASCA


Savige, J. et al, Am J Clin Path 112 (1), 1999

ANCA IFA


AbbreviationsMPO myeloperoxidasePR-3 proteinase 3ANCA anti-neutrophil cytoplasmic antibodiesASCA anti-Saccharomyces cerevisiae antibody

NOVA Lite® has long been synonymous with quality immunofluorescence assays. Inova Diagnostics is commited to customer support and provides training. Proprietary methods used to craft our slides make NOVA Lite assays easy to read and interpret, helping your lab provide the reliable and consistent results demanded by the current healthcare environment.

4646

sp100

Nuclear Dots

Various rheumatic diseases

Spindle

MitoticCytoplasmic staining

gp 210

Nuclear membrane

(rim)

Marker antibody for

SLE

PCNA

CREST variant of Progressive

Systemic Sclerosis

Centromere Coarse

speckledFine

speckledDense �ne speckled

Centromere

CREST

Homogeneous Mitochondrial

Retest on rodent tissue

M2 EP (MIT-3)

Primary Biliary Cirrhosis (PBC)

NEGATIVE

No further follow-up testing indicated. (SS-A testing may be indicated if there is strong clinical evidence of connective tissue disease)

POSITlVE

Con�rmatoryTesting

Nucleolar

Consider Progressive Systemic Sclerosis or

Polymyositis/ Scleroderma overlap (mixed pattern with

positive chromosomes may indicate ScI-70)

Sm

SLE marker antibody

RNP

MCTD or milder SLE

RNA Pol III

Scleroderma, especially

di�use cutaneous form; also associated

with risk of renal crisis

Low % of SLE patients but

highly speci�c

Golgi

PM/DM

Jo-1

Jo-1Ribosomal

Nuclearstaining

Ribosomal P

Immuno�uorescent (IF) major patterns

Re�ex test

Associated disease state

Scl-70

Scleroderma marker

antibodyassociated

with Scleroderma

SS-B

SLE,Sjögren's

Syndrome,Neonatal

SLE

SS-A 60

SLESjögren's

Syndrome, Systemic Sclerosis

,

SS-A 52

SLESjögren's

Syndrome, Systemic Sclerosis, PM/DM

,

dsDNA and/or chromatin

ActiveSLE

Histone

Drug induced SLE

DFS70

When present in isolation,

excludes AARD

HEp-2


AbbreviationsAARDCREST

ANA Associated Rheumatic DiseaseCalcinosis, Raynaud's phenomenon, Esophageal dysmotility, Sclerodactyly, Telangiectasia

ds-DNA Double Stranded DNAENA Extractable Nuclear AntibodyMCTD Mixed Connective Tissue DiseasePBC Primary Biliary CirrhosisPCNA Proliferating Cell Nuclear Antigen

PM/DM Polymyositis/DematomyositisRNP RibonucleoproteinScl-70 Scleroderma antigen (70kD)SS-A Sjögren’s Syndrome A antigenSS-B Sjögren’s Syndrome B antigenSm Smith antigenSLE Systemic Lupus Erythematosus

NOVA Lite® (IFA)

HEp-2Diagnositic Algorithm

4747

sp100

Nuclear Dots

Various rheumatic diseases

Spindle

MitoticCytoplasmic staining

gp 210

Nuclear membrane

(rim)

Marker antibody for

SLE

PCNA

CREST variant of Progressive

Systemic Sclerosis

Centromere Coarse

speckledFine

speckledDense �ne speckled

Centromere

CREST

Homogeneous Mitochondrial

Retest on rodent tissue

M2 EP (MIT-3)

Primary Biliary Cirrhosis (PBC)

NEGATIVE

No further follow-up testing indicated. (SS-A testing may be indicated if there is strong clinical evidence of connective tissue disease)

POSITlVE

Con�rmatoryTesting

Nucleolar

Consider Progressive Systemic Sclerosis or

Polymyositis/ Scleroderma overlap (mixed pattern with

positive chromosomes may indicate ScI-70)

Sm

SLE marker antibody

RNP

MCTD or milder SLE

RNA Pol III

Scleroderma, especially

di�use cutaneous form; also associated

with risk of renal crisis

Low % of SLE patients but

highly speci�c

Golgi

PM/DM

Jo-1

Jo-1Ribosomal

Nuclearstaining

Ribosomal P

Immuno�uorescent (IF) major patterns

Re�ex test

Associated disease state

Scl-70

Scleroderma marker

antibodyassociated

with Scleroderma

SS-B

SLE,Sjögren's

Syndrome,Neonatal

SLE

SS-A 60

SLESjögren's

Syndrome, Systemic Sclerosis

,

SS-A 52

SLESjögren's

Syndrome, Systemic Sclerosis, PM/DM

,

dsDNA and/or chromatin

ActiveSLE

Histone

Drug induced SLE

DFS70

When present in isolation,

excludes AARD

HEp-2

THE HEp-2 DIAGNOSTIC ALGORITHMFor additional information on HEp-2 testing or to view additional images, please visit our website at www.inovadx.com. This diagnostic algorithm was assembled by a panel of experts and is based on years of experience in conjunction with published guidelines. It is provided as a guide to aid in the diagnosis of disease based on laboratory results and is not intended as a definitive diagnosis of any disease condition. Please consider all clinical findings when making diagnostic decisions.

4848

SUBSTRATE

C·ANCA*

P·ANCA*

ATYPICAL P-ANCA*

ANA POSITIVE

NEGATIVE

Granular Cytoplasmic


Negative

Negative

Negative

FORMALIN FIXED SLIDE

Negative

Negative

Negative

Positive

Negative

HEp-2 SLIDE

* Consider confirmatory testing with QUANTA Lite® or QUANTA Flash MPO and PR3.

ANCA ASSOCIATED PATTERN CHART

Perinuclear

Very Perinuclear

Perinuclear or Homogeneous

Negative

ETHANOLFIXED SLIDE


NOVA Lite® (IFA)

ANCA PatternsSubstrate Pattern Chart

4949

Find below a collection of immunfluorescent (IFA) images highlighting a few of the substrate offerings available from Inova Diagnostics. To review our complete product offering and to view additional images please visit our website at www.inovadx.com.

AMA on NOVA Lite ANA Plus

F-Actin antibody on IEC-6 NOVA Lite IgG F-Actin

ASMA on NOVA Lite ANA Plus

GBM antibody on NOVA Lite GBM (Primate Kidney)

Pemphigoid antibody on NOVA Lite Endomysial (Primate Esophagus)

Endomysial antibody on NOVA Lite Monkey Esophagus

AMA on NOVA Lite Rat Kidney/Stomach/Liver

Thyroid antibody on NOVA Lite Thyroid

Pemphigus antibody on NOVA Lite Endomysial (Primate Esophagus)

Additional IFA SubstratesSelected Images

5050

NOVA Lite HEp-2 Immunofluorescence Patterns

HOMOGENEOUS

Uniform, diffuse fluorescence of entire nucleus in interphase cells with pronounced fluorescence of mitotic cells.

SPECKLED

Coarse speckles in interphase cells with nucleolar sparing and negative metaphase mitotic cells.

LAMIN

Homogeneous or fine, ground glass appearance of nuclei in interphase cells associated with staining of

the nuclear rim and negative mitotic cells.

gp210

Rim like staining of the cell nucleus.

RNA POL I

RNA POL I speckling of the nuclei in interphase cells with speckled nucleolar staining.

RIBOSOMAL

Fine, dense granular to homogeneous cytoplasmic staining with weak

nucleolar staining.

Jo-1

Fine cytoplasmic staining concentrated around the nucleus which diminishes towards the periphery of

the cytoplasm.

CENTRIOLE

Metaphase mitotic spindles display discrete fluorescent dots at each pole. Interphase cells adjacent to nucleus display 1 or 2 bright dots.

SS-A

Fine to discrete, uniformly distributed, speckles in the nuclei of the interphase cells. Unstained

metaphase mitotic cells and possible weak cytoplasmic staining.

Scl-70

Homogeneous or dense fine speckling of nuclei with many of these cells having weak

nucleolar staining. Positive mitotic cells.

DFS-70

Dense fine speckling of interphase nuclei with positive mitotic cells.

HEp-2 cell substrate provide a valuable test for the screening and titration of circulating autoantibodies in human serum. The ability to identify key patterns will aid in the laboratory diagnosis of systemic lupus erythematosus (SLE), Sjögren’s Syndrome, Scleroderma and other connective tissue disorders.

NOVA Lite® (IFA)

51

NOVA Lite HEp-2 Immunofluorescence Patterns

CENTROMERE

Discrete speckles throughout the interphase cells. Condensed, speckled

metaphase mitotic cells.

NUCLEOLAR

Large, typically homogeneous clustered granules in nucleoli of interphase cells with surface staining of the

mitotic cells.

.

CENP-F

Fine speckling throughout nucleus in interphase cells; staining of centromeres in prophase and

metaphase; spindle poles in metaphase; spindle and midbody of mitotic cells in anaphase and telophase.

NuMA

Diffuse fine speckled nuclear staining of the interphase cells. Fluorescence of the spindle poles and spindle fibers in metaphase and

anaphase mitotic cells.

PERICENTROSOMES

1-2 large dots at the periphery of the nucleus in interphase cells.

RODS AND RINGS

Multiform cytoplasmic structures. with negative mitotic cells.

GW BODIES

Large, discrete speckles throughout the cytoplasm of interphase cells with negative

mitotic cells.

GOLGI

Speckled polar staining adjacent to one part of the nucleus with negative mitotics.

.

PM-Scl

Homogeneous nucleolar staining associated with weak, diffuse staining of the nuclei and negative

mitotic cells.

PCNA

Highly variable staining in both pattern and intensity of interphase cells. Fine to coarse

speckling in approximately 30-60% of interphase cells (S phase cells).

AMA + sp100

Coarse granular staining throughout the cytoplasm. Multiple nuclear dots throughout the nuclei with

negative metaphase cells.

5252

IFA Slide Kits


NOVA Lite ANCA(Ethanol Fixed)

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-neutrophil cytoplasmic IgG antibodies (ANCA) in human serum. The presence of these antibodies can aid in the assessment of various systemic vasculitides. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use

10 X 6 wells(new formulation)

(classic formulation)

20 X 12 wells(new formulation)

(classic formulation)

DAPI conjugate#*

708299708290

708298708296

708338

NOVA Lite ANCA (Formalin Fixed)

An indirect immunofluorescent assay for the screening and titration of circulating anti- neutrophil cytoplasmic antibodies (ANCA). These antibodies are markers to aid in the diagnosis and treatment of various systemic vasculitides. Fluorescein labeled IgG conjugate with Evan's Blue - ready to use


DAPI conjugate#*

708295 708297708300

NOVA Lite HEp-2 ANA

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-nuclear IgG antibodies (ANA) in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use


DAPI conjugate#

708101708100704320

NOVA Lite HEp-2 Select®*

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-HEp-2 IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorscein labeled anti-human IgG conjugate with Evan's blue- ready to use. This kit contains a special specimen diluent, which adsorbs DFS70 antibodies from samples and minimizes their detection during ANA screening

20 x 12 wells 704315

NOVA Lite HEp-2 ANA External EB

An indirect immunofluorescent assay for the screening and titration of circulating antinuclear antibodies by means of an immunofluorescence test. It is to be used as an aid in the diagnosis and treatment of systemic lupus erythematosus (SLE), Sjögren's Syndrome, rheumatoid arthritis and other connective tissue disorders. External Evans blue provided as optional counterstain


704230704235

NOVA Lite dsDNA Crithidia luciliae

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-double stranded DNA (dsDNA) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE). Fluorescein labeled anti-human IgG conjugate no Evan's Blue - ready to use


DAPI conjugate#*

708200708205708210

NOVA Lite ANA KSL

An indirect immunofluorescent assay for the screening and semi-quantitative determination of IgG anti-nuclear antibodies (ANA), anti-mitochondrial (AMA), anti-smooth muscle (ASMA) and gastric parietal antibodies (GPA) in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use


708390708380

# DAPI conjugate does not contain Evan's Blue *Available Outside the USA Only

NOVA Lite® (IFA)

5353

†Monkey and Primate used interchangeably

*Available Outside the USA Only

IFA Slide Kits (continued)


NOVA Lite Rat Liver, Kidney, Stomach

This product is intended for use in the screening and titration of circulating autoantibodies in human serum as an aid in the diagnosis and treatment of various autoimmune diseases. The four major autoantibodies detected are antinuclear antibodies (ANA), antimitochondrial antibodies (AMA), antismooth muscle antibodies (ASMA) and antigastric parietal cell antibodies (AGPCA). Fluorescein labeled anti-human IgG (H&L) conjugate - ready to use


704170704180

NOVA Lite ANA Plus Mouse Kidney & Stomach

An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-nuclear antibodies (ANA), anti-mitochondrial (AMA), anti-smooth muscle (ASMA) and gastric parietal IgG antibodies (GPA) in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use


708155708150

NOVA Lite IgG F-Actin*

An indirect immunofluorescent assay for the screening and semi quantitative determination of IgG anti-F-Actin antibodies in human serum The presence of IgG anti-F-Actin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC)

5 x 6 wells 708255

NOVA Lite Monkey Esophagus†

(IgG and IgA conjugates)

Monkey esophagus sections are intended for use as a substrate for the screening of antibodies to intra-epidermal antigens or basement membrane zones in human serum, as an aid in the diagnosis of pemphigus and bullous pemphigoid respectively. The sections can also be used for detection of endomysial antibodies as an aid in the diagnosis of celiac disease. Fluorescein labeled anti-human IgG (H&L) conjugate and anti-human IgA conjugate - ready to use


704145704150

NOVA Lite Monkey Esophagus†

(IgA conjugate only)

Monkey esophagus sections are intended for use as a substrate for the detection of endomysial antibodies as an aid in the diagnosis of celiac disease. Includes IgA conjugate only. Fluorescein labeled anti-human IgA conjugate - ready to use

25 X 10 wells 704155

NOVA Lite Monkey Kidney*†

This product is intended for use in the screening of circulating antiglomerular basement membrane (GBM) autoantibodies in human serum. Anti-human IgG (H&L) biotin conjugate and fluorescein labeled-strepavidin conjugate - ready to use

10 X 5 wells 704240

NOVA Lite Thyroid

An indirect immunofluorescent assay for the screening and semi-quantitative determination of antithyroid microsomal and colloid/thyroglobulin IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of autoimmune thyroid disease. Fluorescein labeled primate absorbed anti-human IgG conjugate (FC specific) with Evan's Blue - ready to use

10 X 8 wells 708350

5454

‡ Item not part of a kit, analytical and performance characteristics are not established.


NOVA Lite ANCA (Ethanol Fixed)

Ethanol-fixed human neutrophil substrate slide

1 X 6 wells1 X 12 wells10 X 6 wells20 X12 wells

508299508298

508299.10508298.20

NOVA Lite ANCA (Formalin Fixed)

Formalin-fixed human neutrophil substrate slide

1 X 6 wells10 X 6 wells1 X 12 wells

20 X 12 wells

508295508295.10

508297508297.20

NOVA Lite ANCA (Methanol Fixed)*

Methanol-fixed human neutrophil substrate slide 1 X 6 wells 508280

NOVA Lite HEp-2 ANA HEp-2 (human epithelial cell) substrate slide

1 X 6 wells1 X 12 wells10 x 12 wells20 x 12 wells80 x 12 wells 10 X 6 wells

508105508100

508100.10508100.20508100.80508105.10

NOVA Lite ANA(HEp-2 actin)

HEp-2 (human epithelial cell) substrate slide fixed to detect actin fibers1 X 6 wells

1 X 12 wells508095508090

NOVA Lite dsDNA (Crithidia luciliae)

Crithidia luciliae substrate slide



508200508205

508200.10508205.20508205.80

NOVA Lite ANA(Mouse Kidney)

ANA (Mouse Kidney) tissue section slide 1 X 8 wells 508170

NOVA Lite ANA Plus Mouse kidney and stomach tissue substrate slide



508155508150

508155.10508150.30

NOVA Lite ANA KSL (Mouse Kidney/ Stomach/Liver)

Mouse kidney, stomach and liver tissue substrate slide

1 X 4 well1 X 8 wells


508385508380

508385.10508380.30

NOVA Lite Rat Liver/Kidney/Stomach

Rat Liver, Kidney, Stomach IFA slide


25 X 10 wells

504170504180

504170.10504180.25

IFA Substrate Slides‡

With a comprehensive offering of slide configurations and robust quality standards, Inova stands ready to meet your IFA substrate slide needs.

NOVA Lite® (IFA)

55




NOVA Lite Monkey Esophagus

Monkey esophagus substrate slide


25 X 10 wells

504145504150

504145.10504150.25

NOVA Lite Monkey Espohagus/Jejunum*

Monkey esophagus/jejunum tissue substrate slide1 X 5 wells

10 X 5 wells504215

504215.10

NOVA Lite Thyroid (Primate)

Primate thyroid tissue substrate slide1 X 4 wells1 X 8 wells

508355*508350

NOVA Lite Adrenal (Primate)*

Primate adrenal tissue substrate slide1 X 4 wells 1 X 8 wells

10 X 4 wells

508375508370

508375.10

NOVA Lite Monkey Cerebellum/Cerebrum Mouse Stomach*

Monkey cerebellum/cerebrum & mouse stomach tissue section slide1 X 5 wells

10 X 5 wells504225

504225.10

NOVA Lite Cerebellum (Primate)*

Primate cerebellum tissue substrate slide1 X 4 wells

10 X 4 wells508357

508357.10

NOVA Lite Cerebrum (Primate)*

Primate cerebrum tissue substrate slide 1 X 4 wells 508362

NOVA Lite Ear (Primate)* Primate ear tissue substrate slide 1 X 4 wells 508358

NOVA Lite GBM (Primate Kidney)*

Primate kidney tissue substrate slide 1 X 4 wells 508345

NOVA Lite Heart (Primate)*

Primate heart tissue substrate slide1 X 4 wells

10 X 4 wells508356

508356.10

NOVA Lite ICA (Primate Pancreas)*

Primate pancreas tissue substrate slide1 X 4 wells1 X 8 wells

10 X 4 wells

508315508310

508315.10

IFA Substrate Slides‡ (continued)

5656

IFA Substrate Slides‡ (continued)


NOVA Lite Lip (Primate)* Primate lip tissue substrate slide 1 X 4 wells 508364

NOVA Lite Liver (Primate)* Primate liver tissue substrate slide 1 X 4 wells 508373

NOVA Lite Monkey Ovary, Testis, Adrenal * Monkey ovary, testis, adrenal tissue section slide1 X 5 wells

10 X 5 wells504220

504220.10

NOVA Lite Ovary (Primate)* Primate ovary tissue substrate slide1 X 4 wells

10 X 4 wells508366

508366.10

NOVA Lite Salivary Gland (Primate)* Primate salivary gland tissue substrate slide1 X 4 wells

10 X 4 wells508367

508367.10

NOVA Lite Sciatic Nerve (Primate)* Primate sciatic nerve tissue substrate slide 1 X 4 wells 508368

NOVA Lite Skeletal Muscle (Primate)* Primate skeletal muscle tissue substrate slide1 X 4 wells

10 X 4 wells508320

508320.10

NOVA Lite Stomach (Primate)* Primate stomach tissue substrate slide 1 X 4 wells 508369

NOVA Lite Testes (Primate)* Primate testes tissue substrate slide 1 X 4 wells 508372

NOVA Lite Urinary Bladder (Primate)* Primate urinary bladder tissue substrate slide 1 X 4 wells 508360

NOVA Lite Peripheral Nerve* Monkey peripheral nerve tissue substrate slide1 X 5 wells

10 X 5 wells504210

504210.10

NOVA Lite Monkey Kidney* Monkey kidney tissue substrate slide1 X 5 wells

10 X 5 wells504240

504240.10

NOVA Lite F-Actin* Rat Intestinal Epithelial Cells

Optimally fixed rat epithelial cell substrate slide 1 X 6 wells 508255


NOVA Lite® (IFA)


57

* Available Outside The USA Only* Available Outside The USA Only

* Available Outside The USA Only** Available upon request with adequate lead time


IFA System Negative Control

IFA System Negative Control - ready to use 1 X 1.0mL 508007

IFA System Negative Control

IFA System Pre-diluted Negative Control - ready to use 1 X 0.5mL 508186

0.5% Evans Blue 0.5% Evan's Blue Stain 1 X 2.5mL 508115

1.0% Evans Blue 1.0% Evan's Blue Stain 1 X 2.5mL 504049

High Contrast Diluent High contrast diluent - ready to use 1 X 25.0mL 508003‡

PBS Concentrate (40X) 40X concentrate of PBS 1 X 25.0mL 508002

PBS II Concentrate (40X) 40X concentrate of PBS (New Formulation) 1 X 25.0mL 508998

Mounting Medium Mounting medium - ready to use1 X 3.0mL 1 X 7.0mL

1 X 10.0mL

508006 508001508005

PVA Mounting Medium Mounting medium polyvinyl alcohol (PVA) - ready to use 1 X 3.0mL1 X10.0mL

504046504047

Urea Buffer* Urea Buffer (as used with the NOVA Lite Monkey Kidney Kit 704240) 1 X 13.0mL 504084

Anti AB Neutralising Reagent *

Anti AB Neutralising Reagent 1 X 5.0mL 504056‡

Coverslips10 coverslips20 coverslips

10 each20 each

508122508112


HEp-2 with DAPI Demonstration Slide

HEp-2 Demonstration Slide. 12 wells/slide pre-stained with antibodies/patterns

1 X 12 wells 518100

HEp-2 Demonstration Slide Actin**

HEp-2 Demonstration Slide. HEp-2 Actin specific 12 wells/slide pre-stained with antibodies/patterns

1 X 12 wells 518090

ANCA with DAPI Demonstration Slide

ANCA Demonstration Slide. 1 Ethanol and 1 Formalin, 2x6 wells 2 X 6 wells 518290

Distal Esophagus Demonstration Slide**

Primate distal esophagus substrate slide pre-stained with antibodies/patterns (pemphigus, pemphigoid, ASMA, endomysial)

1 X 5 wells 518336

NOVA Lite; ANA Plus ** (Mouse Kidney/Stomach)

Mouse kidney/stomach substrate slide pre-stained with antibodies/patterns (ANA homogenous, speckled, nucleolar, dsDNA, negative control, AMA, ASMA, GPA)

1 X 8 wells 518150

Common Components

Demonstration Slides


5858



ANA Homogenous/dsDNA Pattern Control

Pre-diluted human serum antibodies to the cell nucleus and dsDNA 1 X 0.5mL 508181

ANA Speckled Pattern Control Pre-diluted human serum antibodies to the cell nucleus 1 X 0.5mL 508182

ANA Nucleolar Pattern Control Pre-diluted human serum antibodies to the cell nucleus 1 X 0.5mL 508183

ANA Centromere Pattern Control

Pre-diluted human serum antibodies to the cell nucleus1 X 0.5mL1 X 1.0mL

508184504089‡

ANA Scl-70 Pattern Control Pre-diluted human serum antibodies to the cell nucleoli 1 X 0.5mL 508185

ANA Nuclear Dot Pattern Control

Pre-diluted human serum antibodies to the cell nucleus 1 X 0.5mL 508193

ANA PCNA Pattern Control Pre-diluted human serum antibodies to PCNA 1 X 0.5mL 508192

ANA Ribsomal Pattern Control Pre-diluted human serum antibodies to ribosomes in cell cytoplasm 1 X 0.5mL 508195

Autoantibody Control PanelPanel of five vials of pre-diluted controls including ANA Homogeneous/dsDNA Pattern, ANA Speckled Pattern, ANA Nucleolar Pattern, ANA Centromere Pattern and ANA Scl-70 Pattern

5 X 0.5mL 708180

ANA Homogenous Pattern Control

Pre-diluted human serum antibodies to the cell nucleus1 X 0.5mL1 X 1.0mL

508101504054

Homogeneous Pattern ControlPre-diluted homogeneous pattern controls for use with conjugate 504070 or 504088

1 X 1.0mL 504090

ANA Titratable Pattern Pre-diluted human serum antibodies to the cell nucleus 1 X 0.5mL 508171

cANCA Positive Control Pre-diluted human serum antibodies to cANCA antigens1 X 0.5mL1 X 1.0mL

508191 504087

pANCA Positive Control Pre-diluted human serum antibodies to pANCA antigens1 X 0.5mL1 X 1.0mL

508291504086

Atypical ANCA Positive Control Pre-diluted human serum antibodies to aANCA antigens 1 X 0.5mL 508292

Glomerular Basement Membrane Positive Control

Pre-diluted human serum antibodies to GBM1 X 0.5mL1 X 1.0mL

508194504085

dsDNA Positive Control Pre-diluted human serum antibodies to dsDNA 1 X 0.5mL 508211

Gastric Parietal Cell (GPA) Pattern Control

Pre-diluted human serum antibodies to gastric parietal cell 1 X 0.5mL 508190

Yo (Purkinje Cell) Positive Control*

Pre-diluted human serum antibodies to Yo (Purkinje cell) 1 X 0.5mL 504009

Hu ANNA-1 Positive Control* Pre-diluted human ANNA-1 positive control 1 X 0.5mL 504073

IFA Antibody Controls‡

NOVA Lite® antibody controls are designed for use with the NOVA Lite slides. Convenient volumes and ready to use dilutions make these a sensible choice for any laboratory.

NOVA Lite® (IFA)


59



IFA System Negative Control Pre-diluted negative control1 X 0.5mL1 X 1.0mL

508186508007

IgG F-Actin Positive Control* Pre-diluted human serum antibodies to F-Actin 1 X 0.5mL 508251

Myelin Associated Glycoprotein Positive Control

Pre-diluted human serum antibodies to MAG (Myelin Associated Glycoprotein)

1 X 0.5mL 504003

Mitochondrial (AMA) Pattern Control

Pre-diluted human serum antibodies to the cell mitochondria1 X 0.5mL1 X 1.0mL

508187504052

Endomysial (Celiac) Positive Control

Pre-diluted human serum antibodies to endomysium1 X 0.5mL1 X 1.0mL

508154504050

Pancreatic Islet Cell Positive Control

Pre-diluted human serum antibodies to pancreatic islet cell 1 X 0.5mL 504005

Skeletal Muscle Positive Control Pre-diluted human serum antibodies to skeletal muscle 1 X 0.5mL 508321

Pemphigoid Positive Control Pre-diluted human serum antibodies to pemphigoid1 X 0.5mL1 x 1.0mL

508331504055

Pemphigus Positive Control Pre-diluted human serum antibodies to pemphigus1 X 0.5mL1 X 1.0mL

508332504051

Smooth Muscle (ASMA) Pattern Control

Pre-diluted human serum antibodies to smooth muscle1 X 0.5mL1 X 1.0mL

508188504053

Thyroid Positive Control Pre-diluted human serum antibodies to thyroid 1 X 0.5mL 508351

IFA Antibody Controls‡ (continued)


6060


FITC IgA Monkey Absorbed Conjugate

Fluorescein labeled anti-human monkey absorbed IgA conjugate 1 X 1.0mL 504016

FITC IgA Conjugate Fluorescein labeled anti-human IgA conjugate 1 X 1.0mL 504034

FITC IgG Conjugate* Fluorescein labeled anti-human IgG conjugate 1 X 1.0mL 504033

FITC IgG Conjugate Primate Absorbed

Fluorescein labeled anti-human monkey absorbed IgG (gamma) conjugate 1 X 1.0mL 504014

FITC IgG (H&L) Monkey Adsorbed Conjugate*

Fluorescein labeled anti-human monkey adsorbed IgG (H&L) conjugate 1 X 1.0mL 504012

FITC IgG (H+L) Conjugate*

Fluorescein labeled anti-human IgG (H+L) conjugate 1 X 1.0mL 504032

FITC IgGAM Conjugate* Fluorescein labeled anti-human IgG, IgA and IgM (H+L) conjugate 1 X 1.0mL 504031

Undiluted Antibody Conjugates



FITC High Sensitivity IgG Conjugate with EB

Fluorescein labeled high sensitivity anti-human IgG conjugate with Evan's Blue

1 X 7.0mL 508126

IgG High Sensitivity Conjugate no EB

Fluorescein labeled high sensitivity anti-human IgG conjugate no Evan's Blue

1 X 15.0mL 504022

FITC IgG (H+L) Conjugate no EB

Fluorescein labeled anti-human IgG (H+L) Conjugate no Evan's Blue 1 X 15.0mL 504021

a HU IgA (Monkey Absorbed) Conjugate

Fluorescein labeled anti-human IgA (Monkey Absorbed) conjugate no Evan's Blue

1 X 7.0mL 504015

FITC IgA Conjugate with EB

Fluorescein labeled anti-human IgA conjugate with Evan's Blue1 X 4.0mL1 X 7.0mL

508152508153

IFA Conjugates‡

Conjugates are arguably the most critical component of the immunofluorescence assay process. The vast menu of NOVA Lite conjugates provides a host of concentrations, specificities and contrast levels to fit individual laboratory needs.

Prediluted Antibody Conjugates

NOVA Lite® (IFA)


61


IFA Conjugates‡ (continued)Prediluted Antibody Conjugates (continued)


FITC IgA Conjugate no EB*

Fluorescein labeled anti-human IgA conjugate no Evan's Blue1 X 7.0mL

1 X 15.0mL504045504023

FITC IgG (H&L) Conjugate

FITC IgG (H&L) chain Conjugate - ready to use 1 X 7.0mL 504072

FITC IgG (H+L) HEp-2 Conjugate no EB

Fluorescein labeled anti-human IgG (H+L) HEp-2 Conjugate no Evan's Blue 1 X 7.0mL 504070

FITC IgG (H+L) Monkey Adsorbed Conjugate no EB

Fluorescein labeled anti-human monkey adsorbed IgG (H+L) conjugate no Evan's Blue

1 X 7.0mL1 X 15.0mL

504011 504071

FITC IgG Conjugate EB Fluorescein labeled anti-human IgG conjugate with Evan's Blue1 X 4.0mL1 X 7.0mL

1 X 15.0mL

508123508125508113

FITC IgG Conjugate no EB Fluorescein labeled anti-human IgG conjugate no Evan's Blue1 X 4.0mL

1 X 15.0mL508124508114

FITC IgG Conjugate Primate Absorbed EB*

Fluorescein labeled primate absorbed anti-human IgG conjugate with Evan's Blue

1 X 7.0mL 508128

FITC IgG (Mky Abs) Conjugate, NEB*

FITC IgG (Monkey Absorbed) Conjugate - ready to use 1 X 7.0mL 504013

FITC IgGAM Conjugate no EB

Fluorescein labeled anti-human IgG, IgA and IgM conjugate no Evan's Blue1 X 4.0mL

1 X 15.0mL508127508117

FITC IgM, no EB FITC IgM Conjugate 1 X 15.0mL 504018

Streptavidin FITC Conjugate*

Streptavidin FITC Conjugate (as used with the NOVA Lite Monkey Kidney Kit 704240)

1 X 3.0mL 504082

a HU IgG (H&L) Monkey Adsorbed Biotin Conjugate

Biotin FITC Conjugate (as used with the NOVA Lite Monkey Kidney Kit 704240)

1 X 3.0mL 504083


62

Conditions of Sale• ORDERS: Orders may be placed by fax or e-mail. Please specify the catalog

number and product description.• SHIPMENTS: All shipping charges will be prepaid FOB San Diego, CA and

added to the invoice. Unless otherwise specified, shipments will be made via Federal Express or UPS. Customers requesting other carriers should specify at the time of order.

• TERMS: All invoices are net 30 days unless otherwise prearranged. All invoices are in U.S. dollars.

• TITLE: Title to the products passes to the customer upon delivery of items ordered to the carrier.

• LOSS OR DAMAGE: Claims for loss or damage of products are the responsibility of the customer and should be reported to Inova at the earliest possible time.

• PARTIAL SHIPMENTS: Inova will make every possible attempt to fill orders promptly and completely. When this cannot be done, we will make partial shipments unless otherwise notified at the time of order confirmation.

• RETURNS: Prior to returning any products, customers must contact Inova technical services for approval. Please provide the reason for the return (ordering error, shipping error, technical problem, etc.). A restocking fee may apply.

• CONDITIONS: Unless otherwise indicated the products listed herein are for ‘in vitro’ diagnostic use only. Nothing disclosed herein is to be construed as a recommendation to use our products in violation of any patents. The information presented is believed to be accurate. However, said information and products are offered without warranty or guarantee since the ultimate conditions of use and the variability of the materials tested are beyond our control. We cannot be responsible for patent infringements or other violations that may occur with the use of these products.

Customer Support

Service is important to us. We believe that we have some of the finest customer service professionals in the industry.

But don't take our word for it – give us a call at +1-800-545-9495 or +1-858-586-9900, email us at [email protected] or visit us at www.inovadx.com for product information.

QUANTA-Lyser, QUANTA Lite, QUANTA Link, QUANTA Flash, NOVA View, NOVA Lite, NOVA Dot are registered trademarks of Inova Diagnostics, Inc. QUANTA CHEK is a trademark of Inova Diagnostics, Inc. BIO-FLASH is a registered trademark of Biokit S.A. DS2 and DSX are registered trademarks of DYNEX Technologies, Inc. © 2016 Inova Diagnostics, Inc. All rights reserved.

63

Technical Assistance/ConsultationOur professional staff is available to answer questions or discuss any aspect regarding the use and interpretation of our products. In addition to our own scientific staff, Inova retains consultants from both the clinical and academic communities. These resources are available to help resolve any unusual cases involving autoimmune disease diagnosis. Email us for assistance at [email protected] or call us at +1-877-829-4745 (U.S. & Canada Only), or + 1-858-805-7950 (Outside the U.S.).

To Order ProductInova Diagnostics, Inc.9900 Old Grove Road San Diego CA, 92131-1638, [email protected] service fax: +1-858-586-9905

US toll free phone: 1-800-545-9495Tel. +1-858-586-9900

Business Hours 6:30 am to 4:00 pm PTMonday thru Friday

6464

We proudly serve customers in over 90 countries worldwide. For more information on your local distributor please contact Inova Diagnostics at [email protected]

690033 March 2016 Rev. 8

Inova Diagnostics Global Affiliates

Inova Diagnostics, Inc.9900 Old Grove Road • San Diego • CA • 92131-1638Tel. 858-586-9900 • Toll free 800-545-9495 • Fax 858-586-9911www.inovadx.com

Corporate Headquarters

UNITED STATES OF AMERICAInova Diagnostics, Inc.Tel. +1-858-586-9900Toll free [email protected]

North and South America

BRAZILWerfenTel. +55 11 4622 [email protected]

COLOMBIAWerfenTel. +571 616 7513www.werfen.com

MEXICOIL Werfen Help Line 01800-8311309 Tel. +52 (55) 5262 1760www.ilmexico.com

Asia Pacific

AUSTRALIAWerfenTel. +61 2 9098 [email protected]

CHINAWerfenTel. +86 10 59756055www.cn.werfen.com

HONG KONGWerfenTel. +852 2792 7773www.werfen.com

INDIA Werfen Tel. +91 11 49029550 www.in.ilwerfen.com

JAPANWerfenTel. +81 3 54191301www.werfen.com

SOUTH KOREAWerfenTel. +82 2 571 [email protected]

THAILANDIL WerfenTel. +662 7122628www.werfen.com

Europe and Middle East

AUSTRIA Werfen Tel. +43 1 2565800-0 [email protected] www.at.werfen.com

BELGIUMWerfenTel. +32 2 [email protected]

CZECH REPUBLICWerfenTel. +42 (0) 246 090 [email protected]

FRANCEWerfenTel. +33 (0) 1 823 086 00www.fr.werfen.com

GERMANYWerfenTel. +49(0)89 909 [email protected]

HUNGARYWerfenTel. +36 1 [email protected]

ITALYWerfenTel. +39 0225221www.it.werfen.com

LITHUANIAWerfenTel. +37 0 37313157www.ill.lt

POLANDWerfen PolskaTel. +48 22 336 18 [email protected]

PORTUGALWerfenTel. +351 214247312www.werfen.com

RUSSIA IL Werfen Tel. +7 499 124 45 59 www.ru.ilwerfen.com

SAUDI ARABIA Werfen Tel. +966 504940854 [email protected]

SLOVAK REPUBLICWerfenTel. +42 (0) 246 090 [email protected]

SPAINWerfenTel. +34 902203090www.es.werfen.com

THE NETHERLANDSWerfenTel. +31 76 [email protected]

TURKEY Werfen Tel. +90 544 2416765 [email protected]

UNITED KINGDOMWerfenTel. +44 1925 810 [email protected]

For all other countries visit www.international.werfen.com

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