|Kit Size:||40T/Kit||Cut-Off:||See Insert|
|Storage:||2-30℃||Shelf Time:||24 Months|
lateral flow test strips,
lateral flow assay
A rapid test for the qualitative detection of IgM and IgG antibodies to Cytomegalovirus in human whole blood, serum or plasma CE certified
The CMV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to CMV in whole blood, serum or plasma to aid in the diagnosis of CMV infection.
Cytomegalovirus is a herpes virus. It is a leading etiological agent for congenital abnormalities and complications among those who receive massive blood transfusions and immunosuppressive therapy. About half of pregnant women who contract a primary infection spread the disease to their fetus.1,2,3 Infection during pregnancy may cause mental retardation, blindness, and/or deafness of the fetus.
The detection of anti-CMV IgM and IgG antibodies enables effective diagnosis of acute or recent CMV infection. The CMV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to CMV in whole blood, serum or plasma specimens.
How to use?
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test cassette on a clean and level surface. Hold the dropper vertically; draw the specimen up to the Fill Line as shown in illustration below (approximately 10μl). Transfer the specimen to the specimen well, then add 2 drops of buffer (approximately 80 μl) and start the timer. See the illustration below.Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two or three lines appear. One colored line should always appear in the control line region (C) and another one or two apparent colored line(s) should be in the test line region(s) (IgM and/or IgG).
IgM Positive: One colored should be in the control line region (C), another line appears in IgM region. It indicates a positive test result for IgM antibody to CMV.
IgG Positive: One colored should be in the control line region (C), another line appears in IgG region. It indicates a positive test result for IgG antibody to CMV.
*NOTE: The intensity of the color in the test line regions (IgM and IgG) may vary depending on the concentration of CMV antibodies present in the specimen. Therefore, any shade of color in the test line region (IgM and/or IgG) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line regions (IgM and IgG).
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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.