The HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of IgG and IgM antibodies to HSV 1/2 in whole blood, serum or plasma specimens. In this test, HSV 1/2 Antigen is coated in the test line regions of the test. During testing, the whole blood, serum or plasma specimen reacts with mouse anti-human IgG or goat anti-human IgM coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the HSV 1/2 Antigen on the membrane in the test line region respectively. The presence of a colored line in the test line region indicates a positive result for HSV 1/2 infection, while its absence indicates a negative result for that infection.
To serve as a procedural control, a colored line will always appear in the respective control line regions of all the two strips indicating that proper volume of specimen has been added and membrane wicking has occurred.
- Test Cassettes
- Package Insert
Directions for use
Allow the test, specimen, buffer and/or controls to reach room temperature (15- 30°C) prior to testing.
- Remove the test cassette from the sealed pouch and use it within one hour. The best results will be obtained if the assay is performed as soon as possible.
- Place the test cassette on a clean and level surface. Hold the dropper vertically; draw the specimen about 1cm above the upper end of the nozzle as shown in the illustration below. Transfer 1 full drop (approx. 20μL) of the specimen to each sample well, then add 2 drops of buffer (approximately 80μL) to each sample well and start the timer. See the illustration below.
- Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20 minutes.
Note: It is suggested not to use the buffer, beyond 30 days after opening the vial.
Interpretation of results
POSITIVE: Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the test line region.
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of HSV 1/2 antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line regions.
INVALID: The control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.