Lateral Flow Immunochromatographic Assays HSV 1/2 IgG Rapid Test Cassette For Serum Or Plasma

A rapid test for the qualitative detection of IgG antibody to HSV 1/2 in human whole blood, serum or plasma CE certified

Applications:

The HSV 1/2 IgG Rapid Test Cassette is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG anti-HSV 1/2 in human whole blood, 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 theoropharyngeal 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 neurologicalor 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 antibody against HSV help discriminates between primary and recurrent infections.

The detection of anti-HSV 1/2 IgG antibody enable effective diagnosis of acute orrecent HSV 1/2 infection. The HSV 1/2 IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG antibody to HSV 1/2 in whole blood, serum or plasma specimens.

How to use?

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

• 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 10 μl). Transfer the specimen to the specimen well, 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 lines appear. One colored line should always appear in the control line region (C) and another one apparent colored line(s) should be in the test line region.

*NOTE: The intensity of the color in the test line region may vary depending on the concentration of HSV antibody 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 region.

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.