DIMDI Reg.-Nr.: DE/CA22/1116-257-IVD
Immunochromatographic rapid test card for qualitative detection of IgA antibody against human tTG in serum/plasma
Celiac Disease (CD) is a gluten intolerance enteropathy caused by a permanent intolerance to gluten and specifically to its proteic fragment called gliadine. The ingestion of such protein for in people with genetic predisposition, induce a severe injury of the intestinal mucosa that is histologically characterized by one hyperplasia of cryptas with total or subtotal atrophy of the intestinal microvilli. Though the definitive diagnosis of the celiac disease is based in characteristic histological changes observed in intestinal biopsies, the serological tests, such as the detection of antibodies anti-tTG and anti-endomysium, represent methods of analyses cheaper and less invasive to the detection of the disease.
Keul-o-test Zöliakie is a immunochromatographic tests designed for the detection of IgA antibody against transglutaminase in serum and plasma. The transglutaminase is the principal auto-antigen recognised by the antiendomisial antibodies.
PRINCIPLE OF THE TEST
The Keul-o-test Zöliakie employs red gold-conjugated recombinant tTG antigen, and solid-phase coated with mouse anti-human IgA monoclonal antibody. In this test the specimen is first diluted in the buffer and then add 3drops to the sample wells. As the sample flows through the test membrane, the colored particles migrate. In the case of a positive result the specific antibodies present on the membrane will capture the colored particles. Red color lines will be visible, depending upon the virus content of the sample. These lines, after 5-15 minutes of incubation at room temperature, are used to interpret the result.
REAGENTS AND MATERIALS
- Keul-o-test Zöliakie 25pcs
- Buffer Vials 25pcs
- Instruction for use 1
PRECAUTION FOR USERS
- For in-vitro diagnostic use only.
- Handle all specimens as if they contain infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving for at least one hour. Alternatively, treat with a 0.5 or 1% solution of sodium hypochlorite for one hour before disposal.
- Wear protective clothing (laboratory coats and disposable gloves) when assaying samples.
- Do not eat, drink or smoke in areas where specimens and kit reagents are handled.
- Avoid contact between hands and eyes or nose during specimen collection and testing.
Serum should be prepared from a whole blood specimen obtained by acceptable medical techniques. Either serum or plasma can be used in this test. Remove serum or plasma from the clot or blood cells as soon as possible to avoid hemolysis. Specimen with extensive particulate should be clarified by centrifugation prior to use. Specimen frozen at -20°C or colder may be used. Avoid repeated freeze thaw.
STORAGE OF TEST KIT
The Keul-o-test Zöliakie can be stored at any temperature between 2-30°C. Do not freeze. The stability of the kit under these storage conditions is 24 months. Use up the reagents as soon as possible after the kit is unpacked within 3 months.
Allow all reagents and samples to equilibrate to room temperature before proceeding with the test.
Write the specimen number on the cassette and sample preparation device.
- Unscrew the cap of the Buffer Vial. Using an appropriate pipette, add 10ul serum into the vial and re-cap it.
- Shake the vial.
- Add 3 drops to the sample well of the test device.
- Incubate the test at room temperature and read the test after 5-15 minutes.
INTERPRETATION OF RESULTS
Negative: One pink line appears in control line, showing the test has been carried out correctly. There will be no line in test region
Positive: In addition to a pink colored control line, a distinct pink colored band will also appear in the test region.
Invalid: A total absence of color in both regions is an indication of procedure error and/or that the test reagent has deteriorated. The test should be repeated using a new strip.
LIMITATIONS OF THE ASSAY
- The test is qualitative and no quantitative interpretation should be made with respect to the intensity of the positive line, when reporting the result.
- Test results should be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures.
- It is very important to add the correct quantity of sample. If it is lower than the suggest one, the sample may not arrive to the reaction area and the test would not run. If it is higher, If it is higher, the reactive could be diluted and the line very slight.
- It is very important to control the reaction time. If the reaction time is lower than the suggested, samples in the detection limit would not appear. If the reaction time is higher than the suggested, sensitivity would be affected and interpretations could be wrong.
Commercial CD Test
Specificity: 405/(405+2)= 99 %
Sensitivity: 24(24+1)=96 %
- Drago S. et al. „Recent developments in the patogenesis, diagnosis and treatment of celiac disease“. Expert Opinion in Theraphy Patents (2002) 12 (1): 45-51.
- Hansson T. et al. „Recombinant human tissue transglutaminasa for diagnosis and follow-up of childhood coeliac disease“. Pediatric Research (2002) 51 (6): 700-705.
- Jennings J. et al. „New developments in celiac disease“. Current Opinion in Gastroenterology (2003) 19 (2): 118-129.
Qualitätssicherung und Vorkommnisse
Sollten Sie den Eindruck eines Qualitätsmangels haben oder unklare oder ihrerseits falsch-positive oder falsch-negative Ergebnisse erhalten, bitten wir Sie, die betreffende Patientenprobe zurückzustellen und für einen Abruf für uns bereitzuhalten.
Bitte informieren Sie uns umgehend. Sie helfen uns dadurch die Sicherheit der Produkte und damit die Qualität zu gewährleisten.
Günter Keul GmbH
Tel.: 02551/2097 Fax.: 02551/80883