Catalog # 601396 – 96 tests

Description

Microplate Enzyme-Immunoassay for the qualitative detection of Helicobacter pylori Antigens in human stool, based on monoclonal antibodies.

Unlike serological tests, this patented technique is able to identify current infections using a truly non-invasive method. The test can be used for diagnosing the infection, as well as for confirming the eradication four weeks after the end of the therapy.

A rapid one-step single test is also available, ImmunoCard STAT! HpSA.

Features

-          Break-away microtiter strips

-          Color coded ready-to-use reagents

-          Room temperature incubation

-          Visual or spectrophotometer reading

-          1 positive + 1 negative controls per run

Specimen handling

The stool specimen, collected in an empty container, can be stored up to 3 days at 2-8°C before testing.

If testing is not performed within this time frame, specimens should be frozen upon receipt (-20°C to –80°C).

No centrifugation or filtration is required.

Kit Components

Antibody coated microwells, Positive control, Negative control, Sample diluent, Wash buffer, Enzyme conjugate, Substrate, Stop solution, Transfer pipets, Strip holder, Strip sealer, Wooden stick applicators.

Assay Protocol:

1.    Emulsify 5-6 mm diameter portion of stool into 500 mcl of sample diluent in a test tube

2.    Transfer 100 mcl of diluted stools and controls in the appropriate wells

3.    Add one drop of Enzyme conjugate to each well, seal and incubate at room temperature for one hour.

4.    Wash 5 times with the wash buffer

5.    Add 2 drop of substrate to all wells and incubate at room temperature for 10 minutes

6.    Add 1 drop of stop solution and read at 450 nm or visually

Storage

The kit must be stored at 2-8°C.

Performance

The Premier Platinum HpSA was extensively validated in studies including more than 5000 patients, in many different countries world-wide. The test proved to be highly accurate in all age groups in comparison to endoscopy based tests.

The stool antigen test is recommended by the Maastricht 2000 consensus guidelines for non-invasive diagnosis and therapy follow-up test.

References

1.     D. Vaira, P. Malfertheiner, F. Mègraud, A. Axon, M. Deltenre,  A.M. Hirschl, G. Gasbarrini, C. O'Morain, J.M. Pajares, M. Quina, G.N. J. Tytgat  and the HpSA European Study Group.. Diagnosis of Helicobacter pylori infection with a new non-invasive antigen-based assay. The Lancet July1999; 354:30-33

2.     G. Oderda, A. Rapa, B. Ronchi, P. Lerro, M. Pastore, A. Staiano, G.L. dè Angelis, P. Strisciuglio. Detection of Helicobacter pylori in stool specimens by non-invasive antigen enzyme immunoassay in children: multicentre Italian study. British Medical Journal, 2000; 320; 347-8

3.     D. Vaira, P. Malfertheiner, F. Megraud, A. T.R. Axon, M. Deltenre, G. Gasbarrini, C. O'Morain, J. M. Pajares Garcia, M. Quina, G. N.J. Tytgat. Non-invasive antigen based assay for assessing Helicobacter pylori eradication. A European multicenter study.. The American Journal of Gastroenterology, 2000, 95, 925-929

The complete list of references is available upon request.

Additional Information

Click here for more information (complete procedure, safety data sheet, literature).