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.
- Distinguishes between IgG and IgM in all five TORCH infections
- Compatible with serum, plasma, and whole blood
- Results available in 15 minutes
- Provides semi-quantitative results for Rubella IgG antibodies
- Distinguishes between HSV-1 and HSV-2
- Shelf life: 18 months
- Analytical Sensitivity of IgG Detection:
- Twenty negative specimens were spiked with appropriate reference standards at various concentrations. Specimens were run on the OnSite TORCH Panel Rapid Test panel member. Defined as the 95% detection level, the limits of detection, or sensitivity, were determined to be as follows:
- Toxo : 5 IU/mL LOD; WHO International Standard Anti-Toxoplasma Serum Ig (TOXM)
- Rubella: 15 IU/mL (G1); 250 IU/mL (G2); WHO 1st International Standard (RUBI-1-94)
- Accuracy of IgG Detection in comparison with commercial ELISA: Clinical IgG positive specimens were collected and tested on each OnSite TORCH Panel Rapid Test panel member as well as by commercial ELISA. Comparison for all subjects showed the following overall agreements:
- Toxo (237 specimens): 94.9%
- Rubella (214 specimens): 97.7%
- CMV (258 specimens): 93.4%
- HSV-1 (227 specimens): 90.7%
- HSV-2 (214 specimens): 95.3%
- Accuracy of IgM Detection in comparison with commercial ELISA:
- Clinical IgM positive specimens -were collected and tested on each OnSite TORCH Panel Rapid Testpanel - member aswell - as by-commercial --- Comparison- for-all - subjects- showed-the following overall agreements
- Toxo (231 specimens): 98.8%
- Rubella (25 specimens): 96.0%
- CMV (212 specimens): 93.9%
- HSV-1 (107 specimens): 85.0%
- HSV-2 (26 specimens): 95.2%
- Cross Reactivity: No false positive IgG and IgM results were observed on 3-14 specimens from the following disease states or special conditions, respectively: Toxo, Rubella, CMV, HSV-1, HSV-2, hCG, HAV, HBV, HCV, HEV, HIV, TB, palladium, Dengue, Malaria, H. pylori, Typhoid, ANA, HAMA, and RF (>1,000 IU/mL).
- During cross-reactivity testing for each TORCH infection, self-reactivity was not considered (i.e. rubella positive samples were not tested on the Rubella IgG/IgM Rapid Test). Specimens tested vary for each panel member of the OnSite TORCH Panel Rapid Test.
- Interference: No interference was seen from the following substances: Albumin 60 g/L; Bilirubin 20 mg/dL; Heparin 3,000 U/L; Hemoglobin 2 g/L; Creatinine 442 -mol/L; EDTA 3.4 -mol/L; Salicylic acid 4.34 mmol/L; Glucose 55 ml/L; and Sodium citrate 3.8%.
- Individually sealed foil pouches containing:
o One cassette device
o Two desiccants
- Plastic droppers
- Sample diluent (REF SB-R0253, 5 mL/bottle)
- One package insert (instruction for use)