R0251C (CTK BIOTECH ToRCH PANEL (5panel IGGIGM))

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 Test  panel  member  as  well  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 µmol/L; EDTA 3.4 µmol/L; Salicylic acid 4.34 mmol/L; Glucose 55 mmol/L; and Sodium citrate 3.8%.