Last Updated 2013-11-06. Company Profile Rapid membrane test – Dipstick - MethodologyRapid...

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Last Updated 2013-11-06

Company Profile

Rapid membrane test – Dipstick - Methodology

Human Rapid Tests - Dipstick:

Enteric products – Respiratory products – Gastric products – Drug Range

Uni-Strip Range

Rapid membrane test – Cassette – Methodology

Human Rapid Tests - Cassette:

Enteric products – Respiratory products – Gastric products - Other

V-TesT Gravity – Methodology - Product

Oligochromatography – Methodology - Products

Veterinary Rapid Tests

SummarySummary

Coris BioConcept was founded in 1996 by 2 biologists and 2 investors.

It is a biotechnology company offering innovative, rapid solutions to biomedical and research laboratories. The achievement of « Quality » is a consideration in all CORIS’ activities.

Coris BioConcept produces and markets diagnostic kits for the rapid detection of pathogens involved in infectious diseases.

24 persons presently work in the company.

Coris BioConcept is present in more than 80 countries in the 5 continents.

To meet the demands of its customers, Coris BioConcept works in a QC/QA frame.

The Quality Policy has been certified ISO 9001:2008 and ISO 13485:2003 by SGS.

Moreover all Coris BioConcept’s products fulfil the CE marking requirements.

Company ProfileCompany Profile

Coris BioConcept has developed mainly rapid kits to detect human enteric and respiratory pathogens. Tests are suitable for single sample analysis, require minimal sample manipulation and give unequivocal diagnostic within 5 to 15 minutes for positive samples. No sophisticated extra material is required to perform the test.

Rapid membrane testRapid membrane test

Test are performed on coated nitrocellulose strips and results are observed with colloidal gold particles or latex microspheres.

Once the strip is dipped into diluted sample, liquid samples and conjugate(s) migrate by capillary movement.

At the end of the migration process, one or two coloured lines appear indicating either a negative or a positive result respectively.

Dipstick - Methodology Dipstick - Methodology

Human Rapid Tests: Enteric Products Human Rapid Tests: Enteric Products

Rota-Strip > Rapid test to detect ROTAVIRUS in stool (C-1001)

Adeno-Strip > Rapid test to detect ADENOVIRUS group A to F in stool (C-1002)

40/41 Adeno-Strip > Rapid test to detect ADENOVIRUS group F (40/41) in stool (C-1003)

Combi-Strip > Rapid test to detect both ROTAVIRUS and ADENOVIRUS group A to F in stool (C-1004)

Crypto-Strip > Rapid test to detect CRYPTOSPORIDIUM in stool (C-1005)

Human Rapid Tests: Enteric Products (2)Human Rapid Tests: Enteric Products (2)

O157 Coli-Strip > Rapid test to detect ESCHERICHIA COLI O157 after broth enrichment (C-1011)

Giardia-Strip > Rapid test to detect GIARDIA in stool (C-1013)

GastroVir-Strip > Rapid test to detect both ROTAVIRUS and ADENOVIRUS group F (40/41) in stool (C-1016)

Crypto/Giardia Duo-Strip > Rapid test to detect both CRYPTOSPORIDIUM and GIARDIA in stool (C-1018)

C. diff-Strip > Rapid test to detect CLOSTRIDIUM DIFFICILE in stool (C-1020)

Human Rapid Tests: Respiratory Human Rapid Tests: Respiratory Products Products

RSV Respi-Strip > Rapid test to detect RESPIRATORY SYNCYTIAL VIRUS in nasopharyngeal specimens (C-1006)

Adeno Respi-Strip > Rapid test to detect RESPIRATORY ADENOVIRUS in nasopharyngeal secretions and/or culture supernatants (C-1009)

Influ-A&B Respi-Strip > Rapid test to detect INFLUENZA A and INFLUENZA B VIRUS in swabs, washings or aspirates of nasopharyngeal secretions

(C-1012)

Human Rapid Tests: Gastric Products Human Rapid Tests: Gastric Products

Pylori-Strip > Rapid test to detect HELICOBACTER PYLORI in stool (C-1019)

Human Rapid Tests: Drug RangeHuman Rapid Tests: Drug Range

Mefloquine-Strip> In vitro rapid test for detection of Mefloquine in urine

Proguanil-Strip > In vitro rapid test for detection of Proguanil in urine

Enteric ProductsEnteric Products

Rota-Strip:Rota-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

Rota Uni-Strip a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, …

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

Adeno-Adeno-Strip:Strip:

General Information

Product File

Advantages of the kit

Instructions for use

Adeno Uni-Strip a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, …

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

40/41 Adeno-Strip:40/41 Adeno-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

40/41 Adeno Uni-Strip a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, …

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

Combi-Strip:Combi-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

Crypto-Strip:Crypto-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

Crypto Uni-Strip a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, …

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

O157 Coli-Strip:O157 Coli-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

O157 Coli Uni-Strip a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, …

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

Giardia-Strip:Giardia-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

GastroVir-Strip:GastroVir-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

Crypto/Giardia Duo-Crypto/Giardia Duo-Strip:Strip:

a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, …

General Information

Product File

Advantages of the kit

Instructions for use

Crypto/Giardia Uni-Strip

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

C. diff-Strip:C. diff-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Respiratory ProductsRespiratory Products

RSV Respi-Strip:RSV Respi-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Respiratory ProductsRespiratory Products

Adeno Respi-Strip:Adeno Respi-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Respiratory ProductsRespiratory Products

Influ-AInflu-A&&B Respi-Strip:B Respi-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

Influ-A&B Uni-Strip a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, …

A quick and reliable answer for diagnostic labs

Gastric ProductsGastric Products

Pylori-Strip:Pylori-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Drug RangeDrug Range

Mefloquine-Strip:Mefloquine-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Drug RangeDrug Range

Proguanil-Strip:Proguanil-Strip:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Advantages of dipstick kits Advantages of dipstick kits

SENSITIVE

SPECIFIC

SIMPLE

EASY TO USE

EASY TO READ

RELIABLE

RAPID FORMAT

CONVENIENT

MINIMAL SAMPLE MANIPULATION

NO SPECIAL TRAINING NEEDED

NO SPECIAL EQUIPMENT REQUIRED

RESULTS OBTAINED WITHIN 15 MINUTES

Intended for small labs, emergency centres, doctors’ offices, paediatricians, …

Contains the necessary material to easily perform the test: - ten single strips

- ten tubes

- one dilution buffer

- ten sampling systems

- one tube rack

- instructions for use

Uni-Strip Range Uni-Strip Range

Influ-A&B Uni-Strip

Legionella 10 V-TesT

Enteric Range:Enteric Range: Respiratory Range:Respiratory Range:

Rota Uni-Strip

Adeno Uni-Strip

40/41 Adeno Uni-Strip

Crypto Uni-Strip

O157 Coli Uni-Strip

Crypto/Giardia Uni-Strip

Cassette - Methodology Cassette - Methodology

Human Rapid Tests: Enteric Products Human Rapid Tests: Enteric Products

Combi K-SeT > Rapid test to detect both ROTAVIRUS and ADENOVIRUS group A to F in stool (K-1204 & K-1504)

Giardia K-SeT> Rapid test to detect GIARDIA in stool (K-1213 & K-1513)

GastroVir K-SeT> Rapid test to detect both ROTAVIRUS and ADENOVIRUS group F (40/41) in stool (K-1216 & K-1516)

Clostridium K-SeT> Rapid test to detect CLOSTRIDIUM DIFFICILE antigen in human stool samples (K-1220 & K-1520)

Human Rapid Tests: Respiratory Human Rapid Tests: Respiratory Products Products

RSV K-SeT > Rapid test to detect RESPIRATORY SYNCYTIAL VIRUS in nasopharyngeal specimens (K-1206 & K-1506)

Adeno Respi K-SeT > Rapid test to detect RESPIRATORY ADENOVIRUS in nasopharyngeal secretions and/or culture supernatants (K-1209 & K-1509)

Human Rapid Tests: Gastric Products Human Rapid Tests: Gastric Products

Pylori K-SeT > Rapid test to detect HELICOBACTER PYLORI in stool (K-1219 & K-1519)

Human Rapid Tests: Other Human Rapid Tests: Other

HAT Sero K-SeT > Rapid test to detect antibodies specific to TRYPANOSOMA BRUCEI GAMBIENSE in human whole blood, serum or plasma (K-12S2 & K-

15S2)

Enteric ProductsEnteric Products

Combi Combi KK-SeT:-SeT:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

Giardia Giardia KK-SeT:-SeT:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

GastroVir GastroVir KK-SeT:-SeT:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Enteric ProductsEnteric Products

ClostridiumClostridium K K-SeT:-SeT:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Respiratory ProductsRespiratory Products

RSV RSV KK-SeT:-SeT:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Respiratory ProductsRespiratory Products

Adeno Respi Adeno Respi KK--SeT:SeT:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Gastric ProductsGastric Products

PyloriPylori K K-SeT:-SeT:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

OtherOther

HAT SeroHAT Sero K K-SeT:-SeT:

General Information

Product File

Advantages of the kit

Instructions for use

A quick and reliable answer for diagnostic labs

Advantages of cassette kits Advantages of cassette kits

SENSITIVE

SPECIFIC

SIMPLE

EASY TO USE

EASY TO INTERPRET

RELIABLE

RAPID FORMAT

CONVENIENT

MINIMAL SAMPLE MANIPULATION

NO SPECIAL TRAINING NEEDED

NO SPECIAL EQUIPMENT REQUIRED

RESULTS OBTAINED WITHIN 15 MINUTES

ACCURATE: same performances as dipsticks

Coris BioConcept has developed a new legionella antigen detection assay based on colloidal gold nanoparticles with antibodies directed against LPS of L. pneumophila serogroup 1. This proprietary sandwich-type assay, is a ready-to-use test that does not require dilution of urine with a reaction buffer. Liquid sample moves by gravity along the stick within a specific designed device.

Freshly collected urine is simply deposited on the top of the device and result is observed after 15 minutes in the reading window, the upper purple line appearing in case of a positive test. A build-in control is used as migration control (lower purple line).

Methodology Methodology

Gravity Driven Test is a new technology aimed at the development of rapid membrane diagnostic test in urine samples with improved performances such as speed, detectability and safety

Human Rapid Tests: Respiratory Human Rapid Tests: Respiratory Products Products

Legionella V-TesT > Rapid test to detect LEGIONELLA PNEUMOPHILA antigen in urine (C-1815 & C-1915)

Respiratory ProductsRespiratory Products

Legionella Legionella VV-TesT:-TesT:

General Information

Product File

Advantages of the kit

Instructions for use

Legionella 10 V-TesT a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, …

A quick and reliable answer for diagnostic labs

OligochromatographyOligochromatography

Oligochromatography is a proprietary technique aimed at the specific detection of amplified products after molecular amplification.

The test is completed without need of specific extra material within 5 minutes.

A positive result means that :

polymerisation process was performed without any inhibitors interference (genuine control probe)

polymerisation process produces amplicons specific for the organism to be detected (specific probe)

Oligochromatography takes advantage of two classical known techniques :

1. Molecular amplification (PCR)

2. Membrane chromatography (MC)

Sid

e A

Sid

e B

Methodology - OligochromatographyMethodology - Oligochromatography

OligoC-TesT consists of a DNA amplification mix and an oligochromatographic strip detecting specifically the pathogen amplified DNA. The ready-to-use PCR mix contains an internal control (IC) template which allows verifying that the PCR occurs properly in each sample tube without any effect of PCR inhibitors.

After PCR, amplified products are allowed to migrate by passive diffusion in the oligochromatographic strip.They hybridize with the target specific and internal control gold-probes, and accumulate on the capture reagent areas. Pink/Purple lines develop at these sites if corresponding amplicons are present. Excess gold-probes hybridize on their complementary sequence at the sites of migration control lines to confirm proper migration.

Oligochromatographic Products Oligochromatographic Products

T.cruzi OligoC-TesT > Rapid Diagnostic of Trypanosoma cruzi by amplification followed by oligochromatographic detection (C-3404)

Leishmania OligoC-TesT > Rapid Diagnostic of Leishmania by amplification and oligochromatographic detection (C-3405)

mex Q-TesT > In vitro mexAB-oprM and meXY-oprM efflux detection in P. aeruginosa by Real Time

PCR (C-3806)

Oligochromatographic ProductsOligochromatographic Products

T.cruzi OligoC-TesT:T.cruzi OligoC-TesT:

Product File

Instructions for use

HIGH SENSITIVITY

HIGH SPECIFICITY

SINGLE SAMPLE ANALYSIS

CARRY-OVER CONTAMINATION PROOF

SAFETY (NO ETHIDIUM BROMIDE)

RAPID

GENUINE PCR INTERNAL CONTROL

QUALITY GUARANTEED PRODUCT

Advantages of the kit:Advantages of the kit:

A quick and reliable answer for diagnostic labs

Oligochromatographic ProductsOligochromatographic Products

Leishmania OligoC-Leishmania OligoC-TesT:TesT:Product File

Instructions for use

HIGH SENSITIVITY

HIGH SPECIFICITY

SINGLE SAMPLE ANALYSIS

CARRY-OVER CONTAMINATION PROOF

SAFETY (NO ETHIDIUM BROMIDE)

RAPID

GENUINE PCR INTERNAL CONTROL

QUALITY GUARANTEED PRODUCT

Advantages of the kit:Advantages of the kit:

A quick and reliable answer for diagnostic labs

Oligochromatographic ProductsOligochromatographic Products

mex Q-TesT:mex Q-TesT:

Product File

Instructions for use

Determination of the status of the efflux pump expression

Two housekeeping genes for standardization

Validation of the PCR product specificity

Relative and absolute quantifications

Certified IVD primers

RNA purity check

PCR efficiency

Advantages of the kit:Advantages of the kit:

A quick and reliable answer for diagnostic labs

Veterinary Rapid Tests Veterinary Rapid Tests

Quatro Vet Uni-Strip > Kit to detect ROTAVIRUS, CRYPTOSPORIDIUM PARVUM, CORONAVIRUS and E. COLI K99 in bovine stool specimen (C-1540)

Surra Sero K-SeT > Rapid test to detect antibodies specific to TRYPANOSOMA EVANSI in animal whole blood or plasma (K-12S1)

Veterinary Rapid Tests Veterinary Rapid Tests

Product File

Instruction for Use

Quatro Vet Uni-Quatro Vet Uni-Strip:Strip:

A quick and reliable answer for diagnostic labs

Veterinary Rapid Tests Veterinary Rapid Tests

Product File

Instruction for Use

Surra Sero Surra Sero KK-SeT:-SeT: A quick and reliable answer for diagnostic labs

http://www.corisbio.com

Thank you for your collaboration and the confidence you place in Coris BioConcept

Coris BioConcept – Science Park CREALYS

Rue Jean Sonet 4A – 5032 Gembloux – BELGIUM

Ph.: +32 (0)81 719 917 – Fax: +32 (0)81 719 919

sales@corisbio.com