Cytomegalovirus IgG and IgM Test

Intended Use

Cytomegalovirus IgG and IgM Test (Whole Blood/Serum/Plasma) is intended for the simultaneous detection and differentiation of IgG and IgM antibody to Cytomegalovirus (CMV) in human whole blood, serum or plasma specimens. Cytomegalovirus IgG and IgM Test is for professional use only.

What is Cytomegalovirus? 

Cytomegalovirus is a genus of viruses in the order Herpesvirales and family Herpesvirales. Primary infection during early pregnancy may lead to congenital abnormalities in the fetus, and infection in immno-deficient patients is the most common infectious cause of mortality.

Transmission

● Sexually transmitted

● Mother-to –child transmission

● Touching your eyes or the inside of your nose or mouth after contact with the body fluids of an infectedperson.

Test Procedure

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use. 

1. Remove the test device from its sealed pouch and use it as soon as possible. For best results, the assay should be performed within one hour.

2. Place the test device on a clean, level surface. Label with specimen ID. 

For venous whole blood specimens:

Hold the dropper vertically and transfer 2 drops of venous whole blood (approximately 50 µL) to the sample well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) and start the timer.

For fingerstick whole blood specimens:

Dispense 2 drops of fingerstick whole blood onto the sample well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) and start the timer.

For serum or plasma specimens:

Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 µL) to the sample well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) and start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

3. Wait for the colored band(s) to appear. Read results at 15 minutes.

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