HSV-I IgG and IgM Rapid Test

Intended Use

HSV-I IgG and IgM Rapid Test (Whole Blood/Serum/Plasma) is intended for the simultaneous detection and differentiation of IgG and IgM antibodies to herpes simplex virus 1 (HSV-1) in human whole blood/ serum/ plasma.

Principle

HSV-I IgG and IgM Rapid Test (Whole Blood/Serum/Plasma) detects IgG and IgM antibodies to HSV-1 through visual interpretation of color development. Recombinant antigens of HSV-1, anti-human IgG and anti-human IgM antibodies are used to detect the specific antibodies in the human whole blood, serum or plasma samples. When a specimen is added to the sample well, anti-HSV-1 IgG and/or anti-HSV-1 IgM antibodies, if present, will bind to the recombinant HSV-1 antigens conjugated to colored particles on the sample pad. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgG and/or anti-human IgM antibodies immobilized at the detection zone. Excess colored particle are captured at the internal control zone.

The presence of a red band(s) in the test region indicates a positive result for the particular IgG and/or IgM antibodies, while its absence indicates a negative result. A red band at the control region (C) serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working.

Symptoms

● HSV-1 causes sores around the mouth and lips.

● HSV-1 can causes genital herpes, but most cases of genital herpes are caused by HSV-2.

Transmission

● HSV-1 can be spread through kissing or sharing objects such as toothbrushes or eating utensils.

Test Procedure

Allow the test, specimen and/or controls to reach room temperature (15 30°C) 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. Best results will be obtained if the test is performed immediately after opening the foil pouch.

2. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 2 drops of whole blood (or 1 drop of serum or plasma) to the specimen well (S) of the test device, and add 1 drop of buffer, then start the timer.

3. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret results after 20 minutes.

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