Testsealabs Mycoplasma Pneumoniae Ab IgG/IgM Test
Intended Use
This kit is used to qualitatively detect the existence of MP -IgM antibodies in serum or plasma sample, as an auxiliary diagnostic reagent of MP infection in clinic. Mycoplasma pneumoniae(MP) is the common pathogenic microorganisms that caused the primary atypical pneumonia and other respiratory infections diseases. In addition to the respiratory tract that MP can cause other serious complication. MP infection is widespread and it can cause pharyngitis, tonsillitis, bronchitis, lung abscess, pulmonary bullae and pleurisy and multi system damage. It is not easy to identify the pneumonia is caused by MP, viruses, bacteria and other pathogens infection. And the treatment of MP infection is different to other bacterial or viral infections. After MP infection, MP-IgM appeared first and then decreasing with the climbing and remaining on a high level of MP-IgG titer. In addition, IgM antibody is weak positive generally at the first infection. Therefore, IgM negative do not means inexistence of MP infection. IgG antibody detection is essential and necessary.
Test Procedure:
Allow the test, specimen, buffer and/or controls to reach room temperature 15-30ºC (59-86ºF) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. Hold the dropper vertically and transfer 1 drop of specimen (approximately 10μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 70μl) and start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
Notes:
Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of buffer to the specimen well.
Interpretation of Results
Positive:Two lines appear. One line should always appear in the control line region(C), and another one apparent colored line should appear in the test line region.
Negative: One colored line appears in the control region(C).No apparent colored line appear in the test line region.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
FAQs:
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Q: Can you make OEM or ODM service?
A: Yes. We can accept OEM service. Meanwhile it's also welcome to choose our ODM products.