【INTENDED USE】

The  HSV 1/2 IgG/IgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of antibodies(IgG and IgM) to Herpes Simplex Virus Type 1/2 in Whole Blood/Serum/Plasma to aid in the diagnosis of HSV infection.The test is based on immunochromatography and can give a result within 15 minutes.

【SUMMARY】

Herpes simplex virus (HSV) is classified in the alpha virus subfamily within the family Herpesviridae. Two closely-related viruses are designated HSV types 1 and 2. HSV-1 is the usual cause of orolabial infection (gingivostomatitis or herpes labialis), whereas HSV-2 is the major cause of genital infection. However,either virus can infect either location. Several modalities are available for the diagnosis of HSV infections.Serology can establish current and past infection with HSV. It has also been used in research studies of the epidemiology of HSV and is very useful in unusual clinical situations. The antibody response to HSV glycoprotein G (IgG) is highly specific, and IgG-based assays can accurately determine whether individuals have past infection with HSV-1 and/or HSV-2. Because genital HSV-2 infection is much more likely to recur than genital HSV-1 infection, the presence of antibody to HSV-2 and a compatible clinical history would be strong presumptive evidence that the disease was recurrent genital herpes. Testing of pregnant women for HSV antibodies is usually done with a type-specific assay for HSV antibodies.

【DIRECTIONS FOR USE】

Allow the test,specimen,buffer and/or controls to reach room temperature(15-30℃) 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 Device on a clean and level surface.

l For Serum or Plasma specimen:

Hold the dropper vertically and transfer 10ul serum or plasma to the specimen area,then add 2 drops of buffer (approximately 80μl),and start the timer.See illustration below.

l For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 20ul whole blood) to the specimen area,then add 2 drops of buffer (approximately 80μl),and start the timer.See illustration below.

l For Fingerstick Whole Blood specimen:

To use a capillary tube:Fill the capillary tube and transfer 20ul fingerstick whole blood specimen to the specimen area of test device,then add 2 drops of buffer (approximately 80μl) and start the timer.

3.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.