【INTENDED USE】

The CMV IgM Rapid Test Device (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibodies to CMV in serum,plasma to aid in the diagnosis of CMV infection.

【SUMMARY】

Cytomegalovirus is a herpes virus.It is a leading etiological agent for congenital abnormalities 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 antibodies enables effective diagnosis of acute or recent CMV infection.The CMV lgM Rapid Test Device (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to CMV in serum,plasma.

【DIRECTIONS FOR USE】

Allow the test,specimen,buffer and/or controls to reach room temperature 15-30℃ (59‐86℉) 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,draw the specimen up to the Fill Line,and transfer 10μl to the specimen well(S) of the test device,then add 2 drops of buffer (approximately 80μl) 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.