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Last Updated 2013-11-06.

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Presentation on theme: "Last Updated 2013-11-06."— Presentation transcript:

1 Last Updated

2 Summary 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

3 Company Profile 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.

4 Rapid membrane test 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. 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.

5 Dipstick - Methodology

6 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)

7 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)

8 Human Rapid Tests: Respiratory 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)

9 Human Rapid Tests: Gastric Products
Pylori-Strip > Rapid test to detect HELICOBACTER PYLORI in stool (C-1019)

10 Human 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

11 A quick and reliable answer for diagnostic labs
Enteric Products Rota-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Rota Uni-Strip Bibliography a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, … Human rapid tests

12 A quick and reliable answer for diagnostic labs
Enteric Products Adeno-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Adeno Uni-Strip Bibliography a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, … Human rapid tests

13 A quick and reliable answer for diagnostic labs
Enteric Products 40/41 Adeno-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use 40/41 Adeno Uni-Strip Bibliography a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, … Human rapid tests

14 A quick and reliable answer for diagnostic labs
Enteric Products Combi-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

15 A quick and reliable answer for diagnostic labs
Enteric Products Crypto-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Crypto Uni-Strip Bibliography a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, … Human rapid tests

16 A quick and reliable answer for diagnostic labs
Enteric Products O157 Coli-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use O157 Coli Uni-Strip Bibliography a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, … Human rapid tests

17 A quick and reliable answer for diagnostic labs
Enteric Products Giardia-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

18 A quick and reliable answer for diagnostic labs
Enteric Products GastroVir-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

19 A quick and reliable answer for diagnostic labs
Enteric Products Crypto/Giardia Duo-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Crypto/Giardia Uni-Strip Bibliography a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, … Human rapid tests

20 A quick and reliable answer for diagnostic labs
Enteric Products C. diff-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

21 A quick and reliable answer for diagnostic labs
Respiratory Products RSV Respi-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

22 A quick and reliable answer for diagnostic labs
Respiratory Products Adeno Respi-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

23 A quick and reliable answer for diagnostic labs
Respiratory Products Influ-A&B Respi-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Influ-A&B Uni-Strip Bibliography a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, … Human rapid tests

24 A quick and reliable answer for diagnostic labs
Gastric Products Pylori-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

25 A quick and reliable answer for diagnostic labs
Drug Range Mefloquine-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Human rapid tests

26 A quick and reliable answer for diagnostic labs
Drug Range Proguanil-Strip: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Human rapid tests

27 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

28 Uni-Strip Range Enteric Range: Respiratory Range: Rota Uni-Strip
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 Enteric 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 Influ-A&B Uni-Strip Legionella 10 V-TesT

29 Cassette - Methodology

30 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)

31 Human Rapid Tests: Respiratory 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)

32 Human Rapid Tests: Gastric Products
Pylori K-SeT > Rapid test to detect HELICOBACTER PYLORI in stool (K-1219 & K-1519)

33 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)

34 A quick and reliable answer for diagnostic labs
Enteric Products Combi K-SeT: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

35 A quick and reliable answer for diagnostic labs
Enteric Products Giardia K-SeT: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

36 A quick and reliable answer for diagnostic labs
Enteric Products GastroVir K-SeT: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

37 A quick and reliable answer for diagnostic labs
Enteric Products Clostridium K-SeT: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

38 A quick and reliable answer for diagnostic labs
Respiratory Products RSV K-SeT: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

39 A quick and reliable answer for diagnostic labs
Respiratory Products Adeno Respi K-SeT: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

40 A quick and reliable answer for diagnostic labs
Gastric Products Pylori K-SeT: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

41 A quick and reliable answer for diagnostic labs
Other HAT Sero K-SeT: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Bibliography Human rapid tests

42 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

43 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).

44 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

45 Human Rapid Tests: Respiratory Products
Legionella V-TesT > Rapid test to detect LEGIONELLA PNEUMOPHILA antigen in urine (C-1815 & C-1915)

46 A quick and reliable answer for diagnostic labs
Respiratory Products Legionella V-TesT: A quick and reliable answer for diagnostic labs General Information Product File Advantages of the kit Instructions for use Legionella 10 V-TesT Bibliography a quick solution for small laboratories, emergency centres, doctors’ offices, paediatricians, … Human rapid tests

47 Oligochromatography 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) Side A Side B

48 Methodology - 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.

49 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)

50 A quick and reliable answer for diagnostic labs
Oligochromatographic Products T.cruzi OligoC-TesT: Product File Instructions for use A quick and reliable answer for diagnostic labs Bibliography Advantages of the kit: HIGH SENSITIVITY HIGH SPECIFICITY SINGLE SAMPLE ANALYSIS CARRY-OVER CONTAMINATION PROOF SAFETY (NO ETHIDIUM BROMIDE) RAPID GENUINE PCR INTERNAL CONTROL QUALITY GUARANTEED PRODUCT

51 A quick and reliable answer for diagnostic labs
Oligochromatographic Products Leishmania OligoC-TesT: Product File Instructions for use A quick and reliable answer for diagnostic labs Bibliography Advantages of the kit: HIGH SENSITIVITY HIGH SPECIFICITY SINGLE SAMPLE ANALYSIS CARRY-OVER CONTAMINATION PROOF SAFETY (NO ETHIDIUM BROMIDE) RAPID GENUINE PCR INTERNAL CONTROL QUALITY GUARANTEED PRODUCT

52 A quick and reliable answer for diagnostic labs
Oligochromatographic Products mex Q-TesT: Product File Instructions for use A quick and reliable answer for diagnostic labs Bibliography Advantages of the kit: 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

53 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)

54 A quick and reliable answer for diagnostic labs
Veterinary Rapid Tests Quatro Vet Uni-Strip: A quick and reliable answer for diagnostic labs Bibliography Product File Instruction for Use

55 A quick and reliable answer for diagnostic labs
Veterinary Rapid Tests Surra Sero K-SeT: A quick and reliable answer for diagnostic labs Product File Instruction for Use

56 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) – Fax: +32 (0)


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