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.

The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma or whole blood at a level equal to or higher than 1 ng/mL. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment.

The OnSite Troponin I Combo Rapid Test is intended to be used by healthcare professionals as an aid in the diagnosis of acute myocardial infarction (AMI). Any use or interpretation of this preliminary test result must also rely on patient’s symptoms and the professional judgment of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device.

Normally the level of cTnI in the blood is very low. cTnI is released into the blood stream in forms of free cTnI and cTnI-C-T complex at 4-6 hours after myocardial cell damage. The elevated level of cTnI could be as high as 50 ng/mL during 60-80 hours after AMI and remains detectable for up to 10-14 days post AMI. Therefore, circulating cTnI is a specific and sensitive marker for AMI.

The OnSite PSA Semi-quantitative Rapid Test is a lateral flow chromatographic immunoassay for the semi-quantitative detection of prostate specific antigen (PSA) in human whole blood, serum or plasma at a cut-off level of 4 ng/mL.

The OnSite Rota/Adeno Ag Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of rotavirus and adenovirus antigens in fecal specimens.

The OnSite Rotavirus Ag Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of rotavirus antigen in fecal specimens.

The OnSite Typhoid IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the detection and differentiation of IgG and IgM anti-Salmonella typhi (S. typhi) and paratyphi in human serum, plasma or whole blood.

The OnSite Influenza A/B Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of influenza A virus, including H5N1 and H1N1, and influenza B virus in nasal/throat/nasopharyngeal swab or nasopharyngeal aspirate/wash specimens.