02817.03 NOW FLUAB Waived CLIA · PDF filecomplexity test. It is good laboratory practice to...

CLIA Training Packet

BinaxNOW® Influenza A & B CLIA Waived Inverness Medical Point of Care Diagnostic Products Better Results Mean Better Medicine®

02817.03

BinaxNOW® Influenza A & B Waived CLIA Packet

02817.03 ©2007 Inverness Medical. All rights reserved.

Inverness Medical CLIA Packet

The following materials are provided to all Inverness Medical Customers. Laboratories performing waived tests are expected to follow the manufacturer’s guidelines and good laboratory practice. Included in this packet are the following: • CLIA Quality Control Information Letter for Waived Tests.

• Quality Control and Patient Record Logs.

• List of Important Procedure Steps.

• Training Certificate.

• Proficiency Test Information.

• Test Procedure specifically written according to the standards of CLSI

Guidelines.

• Competency Assessment Forms.

• Appendix: Material Safety Data Sheets (MSDS) to satisfy OSHA requirements.



Dear Customer, Thank you for your interest in the BinaxNOW® Influenza A & B Test Kit. The BinaxNOW Influenza A & B Test has been categorized by CLIA as a waived complexity test. It is good laboratory practice to use Quality Control Material when performing waived tests to ensure that the test results are accurate. The BinaxNOW Influenza A & B Test Package Inserts specifies how often to use Quality Control Material. Per the BinaxNOW Influenza A & B Test Package Inserts, “The BinaxNOW Test has built-in (internal) procedural controls. For daily quality control, Inverness Medical suggests that you record results of these controls for each test run. An untested strip has a blue line at the “control” position. If the test flows correctly and the reagents work, this blue line will always turn pink on the strip. The clearing of background color from the result window is a negative background control. The background color in the window should change from light pink to white within 15 minutes. Background color should not interfere with the reading of the test.” BinaxNOW test kits contain Positive and Negative Control Swabs. These swabs will verify the entire assay. Test these swabs once with each new shipment received. Other controls may be tested in order to conform with local, state and/or federal regulations; accrediting groups, and/or your lab’s standard QC procedures. In summary, good laboratory practice should be used when performing waived tests to ensure accurate results. If you should need assistance, please do not hesitate to call Technical Service at 1-800-637-3717. Inverness Medical Technical Services Office



BinaxNOW® Influenza A & B Quality Control and Patient Record

Lot Number___________________Exp. Date__________ Inverness Medical recommends that external positive and negative controls be run with each new shipment received Record the Date, Patient’s Name, Patient Test Result, Internal Control Results and the performer’s initials. Positive Internal Control = the pink/purple Control Line; Negative Background Control = the clear background in the test window.

Internal Controls Comments

Tech

Date

Patient Name

Patient ID Number

Patient Results

+ -

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

Reviewed By: Date:



BinaxNOW® Influenza A & B Quality Control and Patient Record (Page 2 for Waived BinaxNOW FLU 22 Kit only)

Record the Date, Patient’s Name, Patient Test Result, Internal Control Results and the performer’s initials. Positive Internal Control = the pink/purple Control Line; Negative Background Control = the clear background in the test window.

Internal Controls Comments

Tech

Date

Patient Name

Patient ID Number

Patient Results

+ -

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

18.

19.

20.

21.

22.

Reviewed By: Date:



BinaxNOW® Influenza A & B Test Important Procedure Steps

1. Leave test device sealed in its foil pouch until just before use. 2. Elute swab samples in 0.5 –3.0 mL of elution solution, saline or transport

media within 1 hour of collection. 3. Testing should be performed as soon as possible.

a. Eluted swab samples may be stored refrigerated for up to 24 hours. b. Nasal wash samples may be stored refrigerated for up to 24 hours.

4. Sample should be at room temperature for testing. Swirl gently to mix before

testing. 5. INVALID RESULTS can occur when too little sample is added to the test. Be

sure that the lower part of the transfer pipette is full and does not have any air spaces before you add the sample to the Sample Pad.

6. Add sample slowly (drop-by-drop) to the middle of the white sample pad so

that all of the sample volume absorbs into the pad. DO NOT add sample to the pink/purple colored pad.

7. When testing nasal wash/aspirate samples, avoid viscous areas of the

sample when drawing specimen into the transfer pipette. 8. Read result in window 15 minutes after closing the device. 9. A test is invalid if the Control Line remains blue or is not present at all,

whether a Sample Line (s) is present or not. Repeat Invalid tests with a new test device. If the problem persists call Inverness Medical Technical Service at 1-800-637-3717.



Certification of Training

This is to verify that the office staff and personnel responsible for running the BinaxNOW® Influenza A & B Test at _____________________________ have been thoroughly in-serviced on the test and the test procedure. This has included:

• Review of the package insert • Demonstration of the product assay • Successful performance of the BinaxNOW

Influenza A & B Test and interpretation of results

Names of the personnel who have been trained with the BinaxNOW Influenza A & B Test and are responsible for reporting patient results:

PRINT NAME SIGNATURE DATE Signature of Medical Director(s) responsible for personnel and testing: _____________________________________ Signature Date _____________________________________ Signature Date Inverness Medical Trainer Date


Proficiency Testing Information Page 1 of 3 02817.03 ©2007 Inverness Medical. All rights reserved.

....A Word about Proficiency Testing.... Proficiency Testing (PT) is a type of external quality control. The practice of testing unknown specimens from an outside source provides an additional means to assure quality laboratory testing results. External quality control provides important comparisons to determine the accuracy of your testing procedures. Some states require PT testing for analytes categorized as waived tests or methods by the federal government. Because your state may have its own laboratory regulations, check to see if you must perform PT for the federally-waived tests. Whether required or not, PT for all tests performed in your laboratory can provide documentation regarding the accuracy of waived and non-regulated tests in the event of an inspection. Most importantly, it helps to ensure that all patient testing is accurate.



Tips for Successful PT Performance

♦ Strictly follow the PT provider's storage or handling requirement before testing PT specimens.

♦ Analyze PT specimens within the time frame provided by the PT

provider. ♦ Contact the PT provider promptly when specimens are received

damaged. You may be able to receive a replacement immediately. ♦ Avoid clerical error when filling out PT answer sheets. Be sure to

enter the correct result next to the correct analyte on the answer form.

♦ Remember to identify the instrument or method you are using to

perform your PT so that you are graded among your peer group. ♦ Make copies of all answer forms before submitting them to your PT

provider.



Proficiency Test Providers

American Association of Bioanalysts(AAB) Proficiency Testing Service 205 West Levee Street Brownsville, TX 78520-5596 800-234-5315

College of American Pathologists (CAP) Surveys Program 325 Waukegan Road Northfield, IL 60093-2750 800-323-4040

American Academy of Family Physicians (AAFP) 11400 Tomahawk Creek Pkwy Leawood, Ks 66211-2672 800-274-7911

College of American Pathologists (CAP) EXCEL Program 325 Waukegan Road Northfield, IL 60093-2750 800-323-4040

American Proficiency Institute (API) 1159 Business Park Drive Traverse City, MI 49686 800-333-0958

Medical Laboratory Evaluation (MLE) ACP-ASIM Services 2011 Pennsylvania Avenue, NW Suite 800 Washington, DC 20006-1834 800-338-2746

Accutest P.O. Box 999 Westford, MA 01886 800-356-6788

Some states provide their own in-state proficiency testing programs. Please contact your state CLIA office for more information.


CLSI Procedure Page 1 of 15 02817.03 ©2007 Inverness Medical. All rights reserved.

Laboratory: Date Implemented___________ Address:____________________________________________ ___________________________________________________ ___________________________________________________ BinaxNOW® Influenza A & B Laboratory Procedure I. Test Principle

The BinaxNOW® Influenza A & B test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory specimens. These antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, book-shaped hinged test device. Swab specimens require a sample preparation step, in which the sample is eluted or washed off the swab into elution solution, saline or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test device is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.

II. Specimen Collection/Treatment A. Specimen: Acceptable: Nasal wash/aspirate; Nasopharyngeal or Nasal swab.

Unacceptable: Specimens collected from other sources.

B. Swabs: Acceptable: Cotton, rayon, foam, or polyester flexible-shaft NP swabs. Use cotton, rayon, foam, or polyester solid shaft swabs to collect nasal swab samples. Unacceptable: Calcium alginate swabs.

C. Transport Media: Acceptable: Amies Media, Binax Elution Solution, Hank’s Balanced Salt Solution, M4, M4-RT, M5, Stuart’s Media, Saline, Brain Heart Infusion Broth, Dulbecco Medium, Phosphate Buffer, Stuart’s Media, Tryptose Phosphate Broth, UTM-RT Media, Veal Infusion Broth. Unacceptable: Any other type of media. It has been determined that Sucrose-Phosphate Buffer may not be suitable for use with this test.

D. Specimen Transport: Transport samples in a leak proof container.

E. Specimen Storage: Process samples as soon as possible after collection. Swabs: Elute samples within 1 hr of collection. Eluted swab samples may be stored refrigerated up to 24 hrs. Nasal wash/aspirate: May be stored refrigerated up to 24 hrs.

F. Handling Precautions:

Patient samples, controls and test devices should be handled as though they could transmit disease. Observe established precautions against microbial hazards.



III Reagents and Equipment A. Reagents and Materials Provided Component Content

Test Device A cardboard, book-like, hinged test device containing the test strip. A/Texas/1/77 was the master influenza virus strain used to develop the monoclonal antibodies incorporated into the test device.

Transfer Pipettes Fixed Volume (100ul) transfer pipettes used to transfer sample to the test device. Use only pipettes provided by Binax.

Positive Control Swab Inactivated influenza A/ Beijing or influenza A/Texas 1/77 (H3N2) and inactivated influenza B/ Harbin or influenza B/ Hong Kong 5/72 dried onto swab. The influenza viruses are originally grown in embryonic eggs and are Formalin or gamma radiation inactivated. Formalin treated viruses are tested for inactivation and non-infectiousness by re-growing virus in embryonic eggs. Viruses are considered inactivated when no viral propagation is seen in eggs.

Negative Control Swab Inactivated Streptococcus Group A dried onto swab. Organism used to inoculate the swab is heat inactivated, and then tested for inactivation and non-infectiousness by standard culture. The organisms are determined to be inactivated when no growth is present on the plate.

Elution Solution Vials Vials containing elution solution used to prepare the Control for Control Swabs/ Swabs/Swab Specimens for testing. Swab Specimens NP Swabs Sterile, foam swabs for use in the BinaxNOW Influenza A & B

Test Package Insert B. Materials not Provided

A timer, watch, or clock Nasal wash/aspirate collection containers

C. Storage and Stability

Store Test Kit at room temperature 15° - 30 oC (59° - 86oF). The BinaxNOW Influenza A & B Test kit and reagents are stable until the expiration dates marked on their outer packaging and containers.

D. Quality Control

Internal Procedural Controls The BinaxNOW Influenza A & B test has built-in (internal) procedural controls. For daily quality control, Inverness Medical suggests that you record results of these controls for each test run.

• An untested strip has a blue line at the “Control” position. If the test flows correctly and the reagents work, this blue line will always turn pink on the strip.

• The clearing of background color from the result window is a negative background control. The background color in the window should change from light pink to white within 15 minutes. Background color should not interfere with the reading of the test.



External Quality Control Testing

Good laboratory practice suggests the use of positive and negative controls to guarantee that test reagents are working and the test is correctly performed. The BinaxNOW Test Kits contain Positive and Negative Control Swabs. These swabs will verify the entire assay. Test these swabs once with each new shipment received. Other controls may be tested in order to conform with local, state and/or federal regulations, accrediting groups, and/or your lab’s standard Quality Control procedures.

Remedial Actions When correct control results are not obtained, do not report patient results. Contact Inverness Medical Technical Services at 1-800-637-3717.

E. Precautions • For in vitro diagnostic use. • Leave test sealed in its foil pouch until just before use. • Do not use kit past its expiration date • Do not mix components from different kit lots. • The white sample pad at the top of the test strip contains reagents that extract the

target antigen from the virus. To ensure best performance, add the sample SLOWLY (drop by drop) to the MIDDLE of this pad, without touching with the pipette, such that all of the sample absorbs into the pad. DO NOT add sample to the pink/purple colored pad.

• Solutions used to make the control swabs are inactivated using standard methods. However, patient samples, controls, and tests should be handled as though they could transmit disease. Observe established precautions against microbial hazards. The use of lab coats, gloves, and safety eye glasses is recommended.

• All transfer pipettes and test vials are single use items - do not use with more than one specimen.

• The ability of this test to detect avian influenza was determined using cultured avian influenza viruses; the performance characteristics of this test with specimens collected from humans infected with H5N1 or other avian influenzas is unknown.

• If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3 + facility is available to receive culture specimens.

• Performance characteristics for influenza A were established when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

IV. Test Procedure Sample Preparation Procedure Nasal Wash/Aspirate: Nasal wash/Aspirate samples do not need preparation. Go to

Test Procedure. Precaution: When testing nasal wash/aspirate samples, avoid thick areas of the sample

when drawing it into the transfer pipette. If the pipette becomes clogged, and the lower part of the pipette is not full, put the sample back into container by squeezing the top bulb. Redraw the sample into the pipette. Use a new pipette if needed



Swab (Control & Patient) Elution using Binax Elution Solution: 1. Twist off the test vial cap. 2. Put the swab to be tested into test vial. Rotate the swab vigorously (without making a

lot of bubbles) three (3) times in the liquid. 3. Press the swab against the side of the vial and turn as you remove it from the vial.

This removes sample from the swab. 4. Discard the swab into a container intended for contagious material. 5. Test the liquid sample (from the test vial) in the BinaxNOW Test as soon as possible.

Go to Test Procedure. Swab Elution Using Transport Media: Remove sample from swab in 0.5 to 3.0 ml of saline or transport media/fluid by vigorously rotating the swab in the liquid. Refer to Specimen Collection and Handling section for acceptable transport media. Go to Test Procedure. Test Procedure: WARNING: INVALID RESULTS can occur when too little sample is added to the test. Be sure that the lower part of the transfer pipette is full and does not have any air spaces before you add the sample to the Sample Pad. If there are air spaces, put the sample back into the container by squeezing the top bulb. Redraw the sample from the bottom of the container into the pipette. Use a new pipette if needed.

1. Remove device from the pouch just prior to testing and lay flat on work bench.

2. Fill pipette by firmly squeezing the top bulb and then placing pipette tip into sample.

Slowly release bulb while tip is still in sample. This will pull liquid into the pipette. Make sure there are no air spaces in the lower part of the pipette.

3. See arrow on test to find WHITE Sample Pad at the top of the test strip. SLOWLY (drop

by drop) add entire contents of pipette (100uL) to the MIDDLE of this pad by squeezing the top bulb, such that all of the sample volume absorbs into this pad. DO NOT add sample to the pink/purple colored pad.

4. Immediately peel off brown adhesive liner from the test device. Close and securely seal the device. Read result in window 15 minutes after closing the device.

NOTE: When reading test results, tilt the device to reduce glare on the result window if necessary

V. Interpretation of Test Results

NOTE: Do not read test result before or after 15 minutes as they may not be correct. . Individuals with color impaired vision may not be able to adequately interpret test results.

Negative Result: The BLUE Control Line in the BOTTOM THIRD of the window turns a pink to purple color. No other line appears. Flu A Positive Result: The BLUE Control Line turns a pink to purple color and a SECOND pink to purple Sample Line appears above it in the MIDDLE THIRD of the window. Any shade of a pink to purple Sample Line, even when very faint, indicates a positive result.

Flu B Positive Result: The BLUE Control Line turns a pink to purple color and a SECOND pink to purple Sample Line appears above it in the TOP THIRD of the window. Any shade of a pink to purple Sample Line, even when very faint, indicates a positive result.



Flu A and Flu B Positive Result: The BLUE Control Line turns a pink to purple color, AND two pink to purple Sample Lines appear above it in the MIDDLE and TOP thirds of the window. Any shade of pink to purple Sample Lines indicates positive results. Invalid: A test is invalid if the Control Line remains BLUE or is not present at all, whether a Sample Line(s) is present or not. Remedial Actions Repeat Invalid tests with a new test device. Call Inverness Medical Technical Services at 1-800-637-3717, if problem persists.

VI. Interfering Substances The following substances, naturally present in respiratory specimens or that may be artificially introduced into the nasal cavity or nasopharynx, were evaluated in the BinaxNOW Influenza A & B Test at the concentrations listed and were found not to affect test performance. Whole blood (1%) did not interfere with the interpretation of negative BinaxNOW Test results, but did interfere with the interpretation of Flu A LOD positive samples. Therefore, visibly bloody samples may not be appropriate for use in this test.

Substance Concentration 1 OTC mouthwashes 20% 3 OTC nasal sprays 15% 3 OTC throat drops 15% 2 OTC throat sprays 20% 4-acetamidophenol 10 mg/ml Acetylsalicylic acid 15 mg/ml Albuterol 20 mg/ml Chlorpheniramine 5 mg/ml Dextromethorphan 10 mg/ml Diphenhydramine 5 mg/ml Guaiacol glycerol ether 20 mg/ml Oxymetazoline 0.05% Phenylephrine 50 mg/ml Phenylpropanolamine 20 mg/ml Rebetol® 500 ng/ml Relenza® 20 mg/ml Rimantadine 500 ng/ml Synagis® 0.1 mg/ml Tamiflu® 50 mg/ml



Transport Media: The following transport media were tested in the BinaxNOW Influenza A and/or B Test as negative samples (no virus present) and after inoculation with the LOD levels of Influenza A & B. Media did not impact BinaxNOW test performance, with the media alone testing negative in the BinaxNOW Test and media inoculated with LOD Influenza A & B testing positive on the appropriate test line in BinaxNOW test. Amies Media Hank’s Balanced Salt Solution M4 Media M4-RT Media M5 Media Stuart’s Media Saline Brain Heart Infusion Broth Dulbecco Medium Phosphate Buffer Solution UTM-RT Media Tryptose Phosphate Broth Veal Infusion Broth

It has been determined that Sucrose-Phosphate Buffer may not be suitable for use with this test.

VII. Limitations

• A negative test result does not exclude infection with influenza A and/or B. Therefore, the results obtained with the BinaxNOW Influenza A & B Test should be used in conjunction with clinical findings to make an accurate diagnosis. Additional testing is required to differentiate any specific influenza A and B subtypes of strains, in consultation with state or local public health departments.

• The BinaxNOW Influenza A & B Test detects both viable and non-viable influenza A and B. Test performance depends on the amount of virus (antigen) in the specimen and may or may not compare with cell culture results performed on the same specimen.

• Monoclonal antibodies may fail to detect , or detect with less sensitivity, influenza A and B viruses that have undergone minor amino acid changes in the target epitope region.

• Inadequate specimen collection or improper sample handling/transport may yield a false-negative result.

• Performance of the BinaxNOW Influenza A & B Test has not been established for monitoring antiviral treatment of influenza.

• Positive and negative predictive values of in vitro diagnostic tests are highly dependent on prevalence. False negative test results are more likely during peak activity when prevalence of disease is high. False positive results are more likely during periods of low influenza activity when prevalence is moderate to low.

• Individuals who have received nasally administered influenza A vaccine may test positive in commercially available influenza rapid diagnostic tests for up to three days after vaccination.

• Children tend to shed virus more abundantly and for longer periods of time than adults. Therefore, in vitro diagnostic tests for influenza may have lower sensitivity in adults than in children.

• Use of visibly bloody samples is not recommended with the BinaxNOW Influenza A & B Test.

VIII. Expected Results

The prevalence of influenza varies from year to year, with outbreaks typically occurring during the fall and winter months.1 The rate of positivity found in influenza testing is dependent on many factors including the method of specimen collection, the test method used, geographic location, and the disease prevalence in specific localities. Type A viruses are typically



associated with most serious influenza epidemics, while Type B are typically milder. In multi-center clinical studies conducted by Binax outside the U.S. during the 2004 respiratory season and in the U.S. during the 2004-2005 respiratory season, the average prevalence of influenza A (as determined by viral cell culture) was 18%. The average prevalence of influenza B was 3%.

IX. Analytical Specificity and Cross Reactivity

To determine the analytical specificity of the BinaxNOW® Influenza A & B Test, 36 commensal and pathogenic microorganisms (27 bacteria, 8 viruses and 1 yeast) that may be present in the nasal cavity or nasopharynx were tested. All of the following microorganisms were negative when tested at concentrations ranging from 104 to 108 TCID 50/mL (viruses), 107 to 108 organisms/mL (bacteria) and 106 organisms/mL (yeast).

Bacteria

Acinetobacter Neisseria subflava Bordetella pertussis Proteus vulgaris Enterococcus faecalis Pseudomonas aeruginosa Escherichia coli Serratia marcescens Gardnerella vaginalis Staphylococcus aureus Haemophilus influenzae Staphylococcus aureus (Cowan protein A

producing strain) Klebsiella pneumoniae Staphylococcus epidermidis Lactobacillus casei Streptococcus, Group A Legionella pneumophila Streptococcus, Group B Listeria monocytogenes Streptococcus, Group C Moraxella catarrhalis Streptococcus, Group F Neisseria gonorrhoeae Streptococcus mutans Neisseria meningitidis Streptococcus pneumoniae Neisseria sicca

Virus Yeast

Adenovirus Candida albicans Coronavirus Coxsackie B4 Cytomegalovirus (CMV) Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 Respiratory Syncytial Virus (RSV)



X. Analytical Reactivity The Influenza A and B strains listed tested positive in the BinaxNOW Influenza A & B Test at concentrations specified. Although the specific influenza strains causing infection in humans can vary year to year, all contain the conserved nucleoproteins targeted by the BinaxNOW test.2 Performance characteristics of the BinaxNOW Influenza A & B Test for detecting influenza A virus from human specimens was established when H1 and H3 subtypes were prevalent. Performance characteristics of the test when other influenza A virus subtypes are emerging as human pathogens have not been established.

Influenza Strain ATCC# Concentration Flu A/WS/33 (H1N1) VR-825 102-106 CEID50/ml Flu A/NWS/33 (H1N1) VR-219 102-106 CEID50/ml Flu A/Hong Kong/8/68 (H3N2) VR-544 102-106 CEID50/ml Flu A/Aichi/2/68 (H3N2) VR-547 102-106 CEID50/ml Flu A /New Jersey/8/76 (Hsw1N1) VR-897 102-106 CEID50/ml Flu A/ Mal/302/54 (H1N1) VR-98 102-106 CEID50/ml Flu A/Port Chalmers/1/73 (H3N2) VR-810 102-106 CEID50/ml Flu A/ Hong Kong/156/97 (H5N1) - 1.3 x 102 TCID50/ml Flu A/ Vietnam/1194/04 (H5N1) - 1.0 x 104 TCID50/ml Flu A / Chicken/NY/117228-7/01 (H5N2) - 1.0 x 104 EID50/ml Flu A/ Turkey/VA SEP-66/02 (H7N2) - 1.0 x 105 EID50/ml Flu B/Lee/40 VR-101 102 -106 CEID50/ml Flu B/Brigit VR-786 102 -106 CEID50/ml Flu B/Russia/69 VR790 102 -106 CEID50/ml Flu B/Hong Kong/5/72 VR-791 102 -106 CEID50/ml Flu B/R75 VR-789 102 -106 CEID50/ml

XI. Performance Characteristics

The clinical performance of the BinaxNOW Influenza A & B Test was established in multi-center, prospective, clinical studies conducted at a central testing laboratory outside the US during the 2004 respiratory season and at three US trial sites during the 2005-2006 respiratory season. Additional performance testing was conducted on retrospective frozen clinical samples collected from symptomatic patients at multiple physician offices, clinics and hospitals located in the Southern, Northeastern and Midwestern regions of the United States and from one hospital in Sweden. Clinical Studies: BinaxNOW Influenza A & B Test Performance vs. Cell Culture/ DFA- Prospective Study A total of 846 prospective specimens collected from children (less than 18 years of age) and adults (18 years or older) were evaluated in the BinaxNOW Influenza A & B Test and compared to culture/ DFA. Evaluated specimens include nasopharyngeal and nasal swabs collected from patients presenting with influenza-like symptoms. Forty-four percent (44%) of the population tested was male, 56% female, 54% pediatric (< 18 years), and 46% adult (≥18 years). No differences in test performance were observed based on patient age or gender. A/H3 and A/H1 were the predominant influenza subtypes observed during this time. BinaxNOW Influenza A & B Test performance by sample type versus cell culture/DFA, including 95% confidence intervals, is listed below.



BinaxNOW Influenza A & B Test Performance vs. Cell Culture/DFA for Detection of Flu A

Test Sensitivity Test Specificity

Sample +/+ - /+ %Sens 95% CI - /- +/- %Spec 95% CI

NP Swab 53 16 77% 65-86% 278 3 99% 97-100%

Nasal Swab 85 17 83% 74-90% 378 16 96% 93-98%

Overall 138 33 81% 74-86% 656 19 97% 96-98%

BinaxNOW Influenza A & B Test Performance vs. Cell Culture/DFA for Detection of Flu B



NP Swab 2 2 50% 9-91% 346 0 100% 99-100%

Nasal Swab 9 4 69% 39-90% 481 2 100% 98-100%

Overall 11 6 65% 39-85% 827 2 100% 99-100%

BinaxNOW Influenza A & B Test Performance vs. Cell Culture/ DFA- Retrospective Study A total of 293 retrospective frozen clinical samples were evaluated in the BinaxNOW Influenza A & B Test and compared to culture/ DFA. All clinical samples were collected from symptomatic patients at multiple physician offices, clinics and hospitals located in the Southern, Northeastern and Midwestern regions of the United States and from one hospital in Sweden. Fifty-three percent (53%) of the population tested was male, 47% female, 62% pediatric (<18 years) and 38% adult (≥ 18 years). Nasal wash/aspirate specimens comprised approximately 61% of the samples tested, while NP swabs represented 39%. No differences in test performance were observed based on patient age and gender or based on sample type tested. BinaxNOW A & B Test performance by sample type versus cell culture/ DFA, including 95% confidence intervals, is listed below. BinaxNOW Influenza A & B Test Performance vs. Cell Culture/ DFA for Detection of Flu A



NP Swab 19 8 70% 50-86% 77 9 90% 81-95%

Wash/Aspirate 51 6 89% 78-96% 117 6 95% 89-98%

Overall 70 14 83% 73-90% 194 15 93% 88-96%



BinaxNOW Influenza A & B Test Performance vs. Cell Culture/ DFA for Detection of Flu B



NP Swab 0 0 N/A N/A 111 2 98% 93-100%

Wash/Aspirate 8 7 53% 27-78% 155 10 94% 89-97%

Overall 8 7 53% 27-78% 266 12 96% 92-98%

Analytical Sensitivity The BinaxNOW Test limit of detection (LOD), defined as the concentration of influenza virus that produces positive BinaxNOW test results approximately 95% of the time, was identified by evaluating different concentrations of inactivated Flu A/Beijing and inactivated Flu B/Harbin in the BinaxNOW Test. Twelve (12) different operators each interpreted 2 tests run at each concentration for a total of 24 determinations per level. The following results identify a concentration of 1.03 x 102

ng/ml as the LOD for Flu A/Beijing and 6.05 x 101 ng/ml for Flu B/Harbin.

Flu A/Beijing

Concentration (ng/ml)

# Detected

% Detected

1.03 x 102 (LOD) 23/24 96

5.60 x 101 (Cutoff) * 50

3.27 x 101 (High Neg) 4/24 17

True Negative 0/24 0

*Linear regression was used to calculate a line equation, which was then used to project the cutoff concentration of Flu A/Beijing.

XII. Reproducibility

A blind study of the BinaxNOW Influenza A & B Test was conducted at 3 separate sites using panels of blind coded specimens containing negative, low positive, and moderate positive samples. Participants tested each sample multiple times on 3 different days. There was 97% (242/250) agreement with expected test results, with no significant differences within run (replicates tested by one operator), between run (3 different days), between sites (3 sites), or between operators (6 operators).

Flu B/Harbin

Concentration (ng/ml)

# Detected

% Detected

6.05 x 101 (LOD) 23/24 96

2.42 x 101 (Cutoff) 11/24 46

1.51 x 101 (High Neg) 6/24 25

True Negative 0/24 0



XIII. Consumer Precision Studies: Swab Specimen The BinaxNOW Influenza A & B Test was evaluated by twelve (12) adults with no professional laboratory experience (intended user) at three (3) intended use sites. Each operator at each site tested thirty-five (35) samples from a randomly coded panel of true positive, true negative, limit of detection (LOD) and below LOD for both influenza A and influenza B. In order to demonstrate equivalent performance among intended users and trained laboratorians, twenty-four (24) trained laboratorians, ran blind coded panels of Flu A and Flu B samples containing the same true negative, true positive, below LOD, and LOD samples described above. As indicated by the overlapping 95% confidence intervals in the tables below, no significant differences were observed between the intended users and the expected results established by the trained laboratorians. These results demonstrate that users with no formal laboratory training can read the package insert and perform the Binax test with the same precision as trained laboratorians. Influenza A and Influenza B Sample Testing – Intended Users vs. Trained Laboratorians – Overall Results

Participant

Type

Negative - % Negative

(95% CI)

Below LOD - % Detection

(95% CI)

LOD - % Detection

(95% CI)

True Positive % Detection

(95% CI)

% Invalid Tests

Intended

User

97% (57/59)

(88-99)

79% (46/58)

(67-88)

95% (59/62)

(87-98)

100% (60/60)

(94-100)

1.6%

(4/243)

Flu A Samples

Trained

Laboratorian

99%(179/180)

(97-100)

84%(102/121)

(77-90)

99%(179/180)

(97-100)

100%(120/120)

(97-100)

0%

(0/601)

Intended User

72% (43/60)

(59-81)

97% (59/61)

(89-99)

98% (58/59)

(91-100)

.6%

(1/181)

Flu B Samples

Trained Laboratorian

78% (93/120)

(69-84)

99%

(179/180) (97-100)

100%(120/120)

(97-100)

0%

(0/420)



Influenza A Sample Testing by Site – Intended Users (IU) and Trained Laboratorians (TL)

Site#

Negative % Negative

(95% CI)

Below LOD % Detection

(95% CI)

LOD % Detection

(95% CI)


(95% CI) % Invalid

Tests

1 IU 89% (17/19) (68-97)

63% (12/19) (41-84)

100% (20/20) (84-100)

100% (20/20) (84-100) 2.5% (2/80)

2 IU 100% (20/20) (84-100)

79% (15/19) (56-91)

90% (19/21) (71-97)

100% (20/20) (84-100) 2.4% (2/82)

Intended User (IU) Results

3 IU 100% (20/20) ( 84-100)

95%(19/20) (76-99)

95% (20/21) (77-99)

100% (20/20) (84-100) 0% ( 0/81)

1 TL 100% (25/25) (87-100)

64% (16/25) (44-80)

100% (25/25) (87-100)

100% (25/25) (87-100) 0% (0/100)

2 TL 100% (15/15) (79-100)

87% (13/15) (62-96)

100% (15/15) (79-100)

100% (15/15) (79-100) 0% (0/60)

3 TL 100% (20/20) (84-100)

75% (15/20) (53-89)

100% (20/20) (84-100)

100% (20/20) (84-100) 0% ( 0/80)

Trained Laboratorian (TL) Results

4 TL 99% (119/120) (95-100)

95% (58/61) (87-98)

99% (119-120) (95-100)

100% (60/60) (94-100) 0% (0/361)

Influenza B Sample Testing by Site – Intended Users (IU) and Trained Laboratorians (TL)

Site# Below LOD % Detection

(95% CI)

LOD %Detection

(95% CI)


(95% CI) % Invalid Tests

1 IU 70% (14/20) (48-85)

95% (19/20) (76-99)

100% (19/19) (83-100) 1.7% (1/60)

2 IU 65% (13/20) (43-82)

95% (20/21) (77-99)

100% (20/20) (84-100) 0% (0/61) Intended User (IU)

Results

3 IU 80% (16/20) (58-92)

100% (20/20) (84-100)

95% (19/20) (76-99) 0% ( 0/60)

1 TL 60% (15/25) (41-77)

100% (25/25) (87-100)

100% (25/25) (87-100) 0% (0/75)

2 TL 73% (11/15) (48-89)

100% (15/15) (79-100)

100% (15/15) (79-100) 0% (0/45)

3 TL 65% (13/20) (43-82)

100% (20/20) (84-100)

100% (20/20) (84-100) 0% ( 0/60)

Trained Laboratorian (TL)

Results

4 TL 90% (54/60) (80-95)

99% (119/120) (95-100)

100% (60/60) (94-100) 0% (0/240)



Liquid Specimen According to the 1995 CLIA Rule, Inverness Medical conducted their Consumer Precision testing of the BinaxNOW Influenza A & B Test with a total of 120 lay users at 6 sites. Participants tested proficiency panels consisting of high negative, assay cutoff, and limit of detection (LOD) samples for both influenza A and influenza B, as well as true negative samples. Expected results for each sample type were generated by trained laboratorians. Six percent (6%) of the total tests run by the lay users and 0.4% of the test run by the trained laboratorians resulted in invalid tests. The tables below detail the number of invalid tests generated by each site.

As indicated by the overlapping 95% confidence intervals in the tables below, no significant differences were observed between the lay users and the expected results established by the trained laboratorians. These results demonstrate that users with no formal laboratory training can read the package insert and perform the Inverness Medical tests with a relatively high level of precision.

Influenza A and Influenza B Sample Testing – Lay Users vs. Trained Laboratorians – Overall Results

* These levels are below the detection limit of the test. Warning: Invalid test results can occur when an insufficient volume of sample is added to the test device due to misuse of the transfer pipette. Please see the Test Procedure section for detailed instructions on the proper use of the transfer pipette.

Influenza A Sample Testing by Site – Lay Users (LU) and Trained Laboratorians (TL)

Site# Negative: % Negative (95% CI)

High Negative: % Detection (95% CI)

Assay Cutoff: % Detection (95% CI)

LOD: % Detection (95% CI)

% Invalid Tests

2 LU 100% (18/18) (82-100)

33% (6/18) (16-57)

70% (14/20) (48-85)

90% (18/20) (70-97) 5.0% (4/80)

4 LU 90% (18/20) (70/97)

45% (9/20) (26-66)

85% (17/20) (64-94)

100% (20/20) (84-100) 0% (0/80)

Lay User (LU) Results

6 LU 100% (18/18) (82-100)

16%(3/19) (6-38)

79% (15/19) (56-91)

95% (19/20) (76-99) 5.0% (4/80)

1 TL 100% (3/3) (40-99)

0% (0/12) (0-25)

25% (3/12) (9-54)

100% (12/12) (75-100) 0% (0/39)

2 TL 100% (2/2) (29-99)

33% (4/12) (14-61)

92% (11/12) (64-98)

83% (10/12) (54-95) 3% (1/39)

Trained Laboratorian (TL) Results

3 TL 100% (3/3) (40-99)

33% (4/12) (14-61)

75% (9/12) (46-90)

100% (12/12) (75-100) 0% (0/39)

Participant Type

Negative: % Negative (95% CI)

High Negative*: % Detection (95% CI)

Assay Cutoff*: % Detection (95% CI)


% Invalid Tests

Lay User 96% (54/56) (88-99)

32% (18/57) (21-44)

78% (46/59) (66-87)

95% (57/60) (86-98)

3.3% (8/240)

Flu A Samples

Trained Laboratorian

100% (8/8) (66-100)

22%(8/36) (12-38)

64% (23/36) (47-77)

94% (34/36) (82-98)

0.9% (1/117)

Lay User 96% (53/55) (88-99)

4% (2/52) (1-13)

27% (15/56) (17-40)

82% (45/55) (70-90)

9.2% (22/240)

Flu B Samples Trained Laboratorian

100% (9/9) (69-100)

11% (4/36) (4-25)

49% (17/35) (33-64)

92% (33/36) (78-97)

0.0% (0/116)



Influenza B Sample Testing by Site – Lay Users (LU) and Trained Laboratorians (TL)

XIV. References 1. Williams, KM, Jackson MA, Hamilton M. (2002) Rapid Diagnostic Testing for URIs in

Children: Impact on Physician Decision Making and Cost. Infect. Med. 19(3): 109-111. 2. Dowdle, W.R, Kendal, A.P., and Noble, G.R. 1980. Influenza Virus, p836-884. Manual

of Clinical Microbiology, 3rd edition, in Lennette, et. al (ed.). American Society for Microbiology, Washington, D.C.

3. “Key facts about Avian Influenza (Bird Flu) and Avian Influenza A (H5NI) virus” CDC

Publication, May 24, 2005. http://www.cdc.gov/flu/avian/gen.info/facts.htm.

4. “Avian Influenza Infection in Humans” CDC Publication. May 24, 2005. http://www.cdc.gov/flu/avian/gen.info/avian-flu-humane.htm.

5. “Updated Interim Guidance for Laboratory Testing of Persons with Suspected Infection

with Avian Influenza A (H5N1) Virus in the United States” CDC Health Alert, June 7, 2006. http://www.phppo.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00246

6. BinaxNOW Influenza A & B Package Insert – CLIA Waived

All trademarks referenced are trademarks of their respective owners. All rights reserved.

Site# Negative: % Negative (95% CI)

High Negative: % Detection (95% CI)

Assay Cutoff: % Detection (95% CI)


% Invalid Tests

1 LU 100% (20/20) (84-100

5% (1/19) (1-25)

25% (5/20) (11-47)

85% (17/20) (64-94)

1% (1/80)

3 LU 100% (19/19) (83/100)

0% (0/18) (0-18)

25% (5/20) (11-47)

79% (15/19) (56-91)

5% (4/80)

Lay User (LU)

Results

5 LU 87% (14/16) (63-96)

7%(1/15) (2-30)

31% (5/16) (14-56)

81% (13/16) (57-93)

21% (17/80)

1 TL 100% (3/3) (40-99)

0% (0/12) (0-25)

9% (1/11) (21-38)

75% (9/12) (46-91)

0% (0/38)

2 TL 100% (3/3) (40-99)

33% (4/12) (14-61)

67% (8/12) (39-86)

100% (12/12)

(75-100)

0% (0/39)

Trained Laboratoria

n (TL) Results 3 TL 100% (3/3)

(40-99) 0% (0/12)

(0-25) 67% (8/12)

(39-86) 100%

(12/12) (75-100)

0% (0/39)



Test Procedure Review Supervisor

Date Reviewed

Supervisor

Date Reviewed


Competency Assessment Page 1 of 5 02817.03 ©2007 Inverness Medical. All rights reserved.

BinaxNOW® Influenza A & B Competency Assessment

…A Word about Personnel Competency Assessment … According to the CLIA ’88 Rules and Regulations, laboratories possessing a certificate of waiver are only required to:

Enroll in the CLIA program. Pay applicable certificate fees biennially. Perform only tests that have been classified as waived by the FDA or CDC. Follow manufacturers’ test instructions.

Currently, there are no personnel requirements that must be met by certificate of waiver laboratories. However, certificate of waiver laboratories are expected to follow good laboratory practices. Good Laboratory Practice Good laboratory practices are a set of procedures that span all phases of testing (pre-analytical, analytical and post-analytical) and are employed by a laboratory for the purpose of achieving accurate and timely test results. All laboratories, regardless of complexity, are recommended to follow these practices. At a minimum, laboratories are recommended to have: 1. A procedure manual that contains procedures for all tests performed in the

laboratory. 2. A system to train all employees and ensure their competence to perform laboratory

tests. 3. A system to ensure that patient preparation and specimen collection, identification,

handling, and storage policies and procedures are in place and adequately followed. 4. A system to ensure that all paperwork associated with a patient’s test is handled in a

manner to facilitate the timely reporting of results, including panic values, confidentiality of results, and storage of the results.

5. General policies and procedures written and followed regarding laboratory safety including the use of Universal Precautions and the prohibition of eating, drinking, or storage of food in the laboratory.

6. A system designed to oversee the storage of kits, reagents, and controls as required by the manufacturer and to ensure that when outdated they are properly disposed.

7. A system developed to monitor the use of, and interpret the results of, either the manufacturer’s built-in controls or external quality control material to ensure that the test system is operating correctly.1

Competency Assessment Although not a requirement per CLIA law, evaluation of competency of testing personnel is an important part of good laboratory practice. Providing regular training, appropriate education, and evaluating and maintaining competency of testing personnel is essential to achieving accurate test results. Evaluating and documenting the performance of the individuals responsible for testing can be semi-annually during the first year the individual tests patient specimens. Thereafter, annual evaluations are sufficient unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance can be re-evaluated to include the use of the new test methodology or instrumentation.



The procedures for evaluating the competency of the staff can include but are not limited to: 1. Direct observations of routine patient test performance, including patient preparation,

if applicable, specimen handling, processing and testing. 2. Monitoring the recording and reporting of test results. 3. Review of intermediate test results or worksheets, quality control records, proficiency

testing results, and preventive maintenance records. 4. Direct observation of performance of instrument maintenance and function checks. 5. Assessment of test performance through testing previously analyzed specimens,

internal blind testing samples or external proficiency testing samples. 6. Assessment of problem solving skills. In addition, evaluation of competency may also include a written quiz. Competency Assessment Tools As an Inverness Medical customer you are provided with the following to help maintain and evaluate testing personnel competence: • The Training Certificate in the CLIA packet can be used as documentation that

appropriate training has been provided to all testing personnel for the BinaxNOW Influenza A and B test.

• We have provided you with a written quiz that can be administered to all testing personnel as part of their competency assessment.

• A Competency Assessment Checklist has been created that can be used to verify and document that all areas of competency for the BinaxNOW Influenza A and B test have been evaluated.

1.COLA LabGuide®, General Information on Waived Tests, 11-1, 4/9/97.

Attachments: Competency Assessment Answer Key Competency Assessment Personnel Checklist Competency Assessment Quiz



BinaxNOW® Influenza A & B Quiz Answer Key

1. F The BinaxNOW Influenza A & B kit may be stored at room temperature.

2. T The BinaxNOW Influenza A & B test device should be left in the foil pouch

until just before use. 3. F Nasal Wash/Aspirate and Nasopharyngeal or Nasal swabs are the

acceptable sample types for the Influenza A & B BinaxNOW kit. Throat swabs are unacceptable.

4. F Nasal wash samples should be run as soon as possible or may be

refrigerated for up to 24 hours. 5. T Transport media may be used to elute a nasopharyngeal swab or a nasal

swab. Refer to the Specimen Collection and Handling Section for acceptable media.

6. F Nasopharyngeal swab must be eluted within 1 hour of collection.

7. F Sample should be added SLOWLY to the MIDDLE of the White Sample Pad

such that all of the sample volume absorbs into the pad. 8. T BinaxNOW Influenza A & B test results should be read at 15 minutes.

Results read before or after 15 minutes may be inaccurate. 9. F The Control Line must change from a blue color to a pink-to-purple color in

order for the test result to be valid. 10. T A positive BinaxNOW Influenza A & B test will have a pink-to-purple control

line and a second pink-to-purple sample line appears above it.



Testing Personnel Competency Assessment

Employee: Date: Test Method: BinaxNOW® Influenza A & B Test

Procedure Satisfactory Unsatisfactory Not Applicable Comments/Corrective Actions

Observation of Test Performance: Patient Preparation (if applicable)

Specimen Handling/Processing

Testing

Recording/Reporting Results

Assessment of Test Performance Using Known Samples

Review of Records: Patient/Quality Control Log Sheet Records

Proficiency Testing Records

Assessment of Problem Solving Skills

(Attach all supporting documents) Evaluator: Date: Employee: Date:


BinaxNOW® Influenza A & B Quiz

Name: Date:

Circle T (True) or F (False) for each Question: 1. The BinaxNOW Influenza A& B test kit requires refrigeration at 2° to 8°C. T F

2. The BinaxNOW Influenza A & B test device should not be removed from

the foil pouch until just before use. T F

3. Throat swabs are an acceptable sample type for testing on the BinaxNOW

Influenza A & B test. T F

4. Nasal Wash samples may be stored at room temperature for 24 hours. T F

5. Transport media may be used with the BinaxNOW Influenza A & B test. T F 6. NP swabs may be stored at room temperature for 24 hours before elution. T F

7. Sample should be added quickly to the top of the white sample pad. T F

8. Test Results should be read at 15 minutes. T F

9. If the Control Line remains BLUE in color the test results are valid.

T F

10. The appearance of a pink-to-purple Control Line and a pink-to-purple

Sample Line is a positive result. T F

Reviewed By: Date:

M-013, Rev 2, 4/24/06 Author: Lisa Irish

1 of 3

Material Safety Data Sheet BinaxNOW® Influenza A&B Test Kit

Cat. #416-000, 416-110, 416-022, 41603J, 416-110J Nasopharyngeal Swab Specimen Accessory Pack

Cat. #400-065 Control Swab Accessory Pack

Cat. #416-080 THE FOLLOWING INFORMATION PROVIDED IS BELIEVED TO BE CORRECT AND ACCURATE. IT DOES NOT PURPORT TO BE ALL-INCLUSIVE AND SHALL BE USED AS A GUIDE. BINAX, INC. SHALL NOT BE HELD LIABLE FOR ANY DAMAGE RESULTING FROM HANDLING, CONTACT WITH, OR MIS-USE OF THIS PRODUCT. Section I. General Information Chemical Name & Synonyms: NOT APPLICABLE Trade Name & Catalogue Number: BinaxNOW® Influenza A&B Test Catalogue Numbers 416-000, 416-110, 416-022

BinaxNOW® Nasopharyngeal Swab Specimen Accessory Pack

Catalogue Number 400-065 BinaxNOW® Control Swab Accessory Pack Catalogue Number 416-080 Chemical Family: In Vitro Diagnostic Test Kits Formula: NOT APPLICABLE Proper DOT Shipping Name: NOT APPLICABLE DOT Hazard Classification: NOT APPLICABLE Contact: Binax, Inc. Phone: US: 1-800-257-9525 10 Southgate Road Outside US: 1-609-627-8000 Scarborough, Maine 04074 Fax: 1-207-730-5710 Poison Control Center: 1-800-222-1222 Section II Hazardous Ingredients/Identity Information Item Percent (optional) Exposure Limits Elution Solution Detergent NIOSH REL: none OSHA PEL: none Saline Solution NIOSH REL: none OSHA PEL: none Preservative NIOSH REL: none OSHA PEL: none

Positive Control Swabs Inactivated Flu A NOT APPLICABLE Inactivated Flu B NOT APPLICABLE Negative Control Swabs NOT APPLICABLE Inactivated Streptococcus Group A

Section III Physical Data Boiling Point (°C): Detergent: undetermined Saline Solution (NaCl): 1413C Preservative: 189C

Specific Gravity (water = 1.0): Detergent: 1.065 Saline Solution (NaCl): 2.16 Preservative: 1.03

Vapor Pressure (mm Hg): Detergent: N/A Saline Solution (NaCl): N/A Preservative: 0.06

Percent volatile by Volume (%):N/A Detergent: N/A Saline Solution (NaCl): 0 Preservative: <95

Vapor Density (Air = 1.0): N/A Evaporation Rate: N/A Appearance: Packaged kit with ampoules, test swabs, and test device.

Odor: None known


2 of 3

Section IV. Health Hazard Data Detergent Route(s) of entry: skin? Yes Inhalation? Yes Ingestion? Yes Health hazards: Acute: Irritating to eyes, respiratory system and skin.

Chronic: None known Symptoms of exposure: Irritating to eyes, respiratory system and skin

Carcinogenicity: NTP? Not listed IARC listed? Yes OSHA Regulated? Not listed Medical conditions aggravated by exposure: None known

Emergency and first aid procedures:

ALWAYS CALL A PHYSICIAN OR POISON

CONTROL CENTER 1-800-222-1222

Skin: flush with water for at least 15 minutes. Eyes: flush with copious amounts of water for at least 15 minutes, if symptoms persist, consult physician.

Ingestion: Call physician immediately. Inhalation: remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen.

Saline Solution Route(s) of entry: skin? Yes Inhalation? Yes Ingestion? Yes Health hazards: Acute: May irritate damaged skin, absorption can occur with effects similar to those via ingestion. May cause mild irritation to the respiratory tract.

Chronic: None known.

Symptoms of exposure: Very large doses can cause vomiting, diarrhea, and prostration. Dehydration and congestion occur in most internal organs. Hypertonic salt solutions can produce violent inflammatory reactions in the gastrointestinal tract.

Carcinogenicity: NTP? Not listed IARC listed? Yes OSHA Regulated? Not listed Medical conditions aggravated by exposure:

ACGIH Carcinogen? Rating A4




Eye: Immediately flush eyes with plenty of water for at least 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention if irritation persists. Skin: Wash exposed area with soap and water. Get medical advice if irritation develops.

Inhalation: Remove to fresh air. Get medical attention for any breathing difficulty. Ingestion: If large amounts were swallowed, give water to drink and get medical advice.

Preservative Route(s) of entry: skin? Yes Inhalation? Yes Ingestion? Yes Health hazards: Acute: Causes burns, corrosive. May be harmful if inhaled. Material is extremely destructive to the tissue of the mucous membranes and upper respiratory tract.

Chronic: None known. Symptoms of exposure: May include burning sensation, coughing, wheezing, laryngitis, shortness of breath, headache, nausea and vomiting

Carcinogenicity: NTP? Not listed IARC Monograph? Not Listed OSHA Regulated? Yes. Medical conditions aggravated by exposure: None known.




Skin: Flush with copious amounts of water for at least 15 minutes. Remove contaminated clothing. Eyes: Immediately flush with copious amounts of water for at least 15 minutes.

Inhalation: Remove to fresh air. If not breathing give artificial respiration. If breathing is difficult give oxygen. Ingestion: Wash out mouth with water provided person is conscious.


3 of 3

Section V. Reactivity Data Stability: STABLE Conditions to avoid: NONE KNOWN Incompatibility: NONE KNOWN Materials to avoid: Oxidizing agents, Reducing

agents, Amines, Mercaptans, Lithium, Bromine trifluoride

Hazardous polymerization: WILL NOT OCCUR Hazardous decomposition products Nitrogen oxides, Sulfur oxides, Hydrogen chloride gas

Section VI Fire and Explosion Hazard Data Flash Point (Test Method) Detergent: N/A Saline Solution: N/A Preservative: >151C

Auto Ignition Temperature (°F): N/A

Flammable Limits: LEL: N/A UEL: N/A

Special Fire-fighting Procedures: May emit toxic fumes under extreme fire conditions, wear correct protective equipment during fires.

Extinguishing Media: Dry chemical powder

Unusual Fire and Explosive Hazards:

Section VII. Precautions for Safe Handling and Use Steps to be taken if material is released or spilled: Immediately clean up spilled reagent wearing appropriate personal protective equipment, if necessary. Materials may be washed into a typical laboratory drain or wiped up with absorbent pads and placed into chemical waste container. Waste disposal method: Normal disposal container. Precautions to be taken in handling and storing: Safety glasses, protective clothing and gloves. Other precautions: None required. Section VIII. Control Measures/Personal Protective Equipment Eye Protection: Safety glasses Skin Protection: Lab coats, gloves Respiratory Protection: None required Ventilation: Normal Other Precautions: None required Section IX. Special Precautions Hygienic Practices in Handling and Storage: Store per package insert instructions. Precautions for Repair and Maintenance of contaminated material: NOT APPLICABLE Other precautions: For In Vitro Diagnostic Use only. Do not use internally. Do not apply to eyes or skin, ingest or inhale. Do not mix with reagents from different lots.

Date post:	08-Mar-2018
Category:	Documents
Upload:	ngohuong
View:	216 times
Download:	3 times

02817.03 NOW FLUAB Waived CLIA · PDF filecomplexity test. It is good laboratory practice to...

Documents