Herpes Simplex Virus HSV 1/2 IgG//gM Rapid Test

The Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to HSV 1/2 in whole blood, serum or plasma to aid in the diagnosis of HSV 1/2 infection.

MATERIALS

Materials Provided

Materials Required but Not provided

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.

1. 1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. 2. Place the test device on a clean and level surface.

For Serum or Plasma Specimens: 

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5μl), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90μl) and start the timer. Avoid trapping air bubbles in the specimen well (S).

For Whole Blood (Venipuncture/Fingerstick) Specimens:

To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90μl) and start the timer. See illustration below.

To use a micropipette: Pipette and dispense 10µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90µL) and start the timer.

3. 3. Wait for the colored line(s) to appear. Read results at 10 minutes.Do not interpret the result after 20 minutes.

4. INTERPRETATION OF RESULTS
   
   
   

   LIMITATIONS OF THE TEST

   1. 1. The Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Testis for in vitro diagnostic use only. This test should be used for detection of IgM and IgG antibodies to HSV 1/2 in whole blood, serum or plasma specimens.
   2. 2. Neither the quantitative value nor the rate of increase in the concentration of IgM and IgG antibodies to HSV 1/2 can be determined by this qualitative test.
   3. 3. The Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Testwill only indicate the presence of IgM or IgG antibodies to HSV 1/2 in the specimen and should not be used as the sole criteria for the diagnosis of HSV 1/2 infections.
   4. 4. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
   5. 5. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of HSV 1/2 infection.
   6. 6. The hematocrit level of the whole blood can affect the test results. Hematocrit level needs to be between 25% and 65% for accurate results.
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