The OnSite TORCH Panel Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to Toxoplasma gondii (T. gondii), rubella virus, cytomegalovirus (CMV), herpes simplex virus 1 (HSV-1), and herpes simplex virus 2 (HSV-2) in human serum, plasma, or whole blood.
This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with T. gondii, rubella virus, CMV, HSV-1 and HSV-2. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.
Recommended for use:
- Any person presenting with clinical signs or symptoms consistent with TORCH infection.
- Women who are pregnant or who are planning to become pregnant
- Individuals with a compromised immune system
The OnSite TORCH Panel Rapid Test detects and differentiates IgG and IgM antibodies for all 5 TORCH infections. In general, a negative test result indicates that the individual is at risk for acquiring a primary infection. A positive IgM result only indicates acute infection, a positive IgM and IgG test indicate acute, late phase infection, and a positive IgG test result only indicates past or chronic infection.
The presence of IgM anti-rubella virus or high titers of IgG anti-rubella virus (> 200 IU/mL) are suggestive of acute rubella infection. Lower titers of IgG anti-rubella virus (≥ 10-15 IU/mL) are suggestive of previous exposure and protective immunity. An individual with an IgG anti-rubella virus titer less than 10-15 IU/mL is considered to be at risk of acquiring a rubella virus infection.
The TORCH Panel Rapid test also differentiates between HSV-1 and HSV-2 antibodies using HSV-1 specific glycoprotein G1 and HSV-2 specific glycoprotein G2.