CTK Biotech, USA ToRCH Panel Rapid 10 Test

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.

• Product Features
• Kit Components
• Support
• Ordering

• • 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:

• 1. Toxo: 5 IU/mL LOD; WHO International Standard Anti-Toxoplasma Serum Ig (TOXM)
  2. Rubella: 15 IU/mL (G1); 250 IU/mL (G2); WHO 1^st 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:

• 1. Toxo (237 specimens): 94.9%
  2. Rubella (214 specimens): 97.7%
  3. CMV (258 specimens): 93.4%
  4. HSV-1 (227 specimens): 90.7%
  5. 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:

• 1. Toxo (231 specimens): 98.8%
  2. Rubella (25 specimens): 96.0%
  3. CMV (212 specimens): 93.9%
  4. HSV-1 (107 specimens): 85.0%
  5. 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%.

Each kit contains:

• Individually sealed foil pouches containing:
  • One cassette device
  • One desiccant
• Capillary tubes (10 µL)
• Sample Diluent (1 vial, 5 mL)
• One package insert (instruction for use)