HSV 1/2 IgG / IgM Rapid Test Cassette Lateral Flow Chromatographic Immunoassay

HSV 1/2 IgG / IgM Rapid Test Cassette Lateral Flow Chromatographic Immunoassay

Applications:

The HSV 1/2 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM anti-HSV 1/2 and IgG anti- HSV 1/2 in human serum or plasma. This kit is intended to be used as an aid in the diagnosis of infection with HSV 1/2.

Description:

Herpes Simplex Virus (HSV) is a common pathogen of humans. There are two distinct types of HSV: Types 1 and 2. HSV-1 is usually associated with infection in the oropharyngeal area and eyes while HSV-2 causes mostly gennital and neonatal infections.^1,2 However, the tissue specificity is not absolute.³ Both HSV-1 and HSV-2 can be found at either site of infection without being specific for one region, i.e., either genital or orpharynx.. Neonatal HSV infection may remain localized or become disseminated. Localized infection may involve skin, eyes, mouth or central nervous system. The infants with neonatal HSV bear the risk of developing severe neurological or ocular sequelae. Detection of antibodies to HSV has been acknowledged to be a screening method for HSV infections. The methods for such antibodies detection include complement fixation, indirect immunoflorescent antibody, plaque neutralization, and ELISA. Antibody of the IgM class is produced during the first 2-3 weeks of infection with HSV and exists only transiently in most patients. The detection of IgM antibodies against HSV help discriminates between primary and recurrent infections.

The detection of anti-HSV 1/2 IgM and IgG antibodies enables effective diagnosis of acute or recent HSV 1/2 infection. The HSV 1/2 IgG/IgM Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgM and IgG antibodies to HSV 1/2 in serum or plasma specimens.

How to use?

• Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
• Place the test cassette on a clean and level surface. Hold the dropper vertically; draw the specimen up to the Fill Line as shown in illustration below (approximately 10μl). Transfer the specimen to the specimen well each, then add 2 drops of buffer (approximately 80 μl) 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.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE:* Two or three lines appear. One colored line should always appear in the control line region (C) and another one or two apparent colored line(s) should be in the test line region(s) (IgM and/or IgG).

IgM Positive: One colored should be in the control line region (C), another line appears in IgM region. It indicates a positive test result for IgM antibody to HSV1/2.

IgG Positive: One colored should be in the control line region (C), another line appears in IgG region. It indicates a positive test result for IgG antibody to HSV1/2.

*NOTE: The intensity of the color in the test line regions (IgM and IgG) 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 (IgM and/or IgG) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line regions (IgM and IgG).

INVALID: 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.