CTK Biotech, USA HSV-2 IgG/IgM Rapid 10 Test

The OnSite  HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood.

• Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action.
• Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2.
• High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM.
• Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation.
• Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient.
• Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes.
• Easily transported, and can be stored for 24 months, 2-30 °C.

Each kit contains:

• Individually sealed foil pouches containing:
  • One cassette device
  • One desiccant
• Capillary tubes (10 µL)
• Sample Diluent (REF SB-R0213C, 5 mL/bottle)
• One package insert (instruction for use)

TEST PRINCIPLE : The OnSite HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing HSV antigens conjugated with colloidal gold (HSV conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing two test lines (G and M lines) and a control line (C line). The G line is pre-coated with mouse anti-human IgG for detection of IgG antiHSV-2, the M line is pre-coated with mouse anti-human IgM for detection of IgM anti-HSV-2, and the C line is pre-coated with a control line antibody.    When an adequate volume of test specimen and sample diluent are dispensed into the sample well, the specimen migrates by capillary action across the cassette. IgG anti-HSV-2, if present in the specimen, will bind to the HSV conjugates. The immunocomplex is then captured on the membrane by the precoated mouse anti-human IgG forming a burgundy colored G line, indicating a HSV-2 IgG positive test result. IgM anti-HSV-2, if present in the specimen, will bind to the HSV conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-human IgM forming a burgundy colored M line, indicating a HSV-2 IgM positive test result. Absence of any T lines (G or M) suggests a negative result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of the control antibodies, regardless of color development on the test lines (G and M). If no control line (C line) develops, the test result is invalid and the specimen must be retested with another device.