CTK Biotech, USA Leptospira IgG/IgM Combo Rapid 30 Test

The OnSite Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay that can be performed within 15-20 minutes by minimally skilled personnel, and without the use of laboratory equipment. This test is intended to be used for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals, and provides a preliminary test result to aid in the diagnosis of infection with L. interrogans. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Recommended for use:

• Any person presenting with clinical signs or symptoms consistent with acute infection with interrogans including: high fever, headache, chills, muscle aches, vomiting, jaundice, red eyes, abdominal pain, diarrhea, skin rash
• After exposure to a known contaminated source.

• Accuracy: 100% specificity and 100% sensitivity in comparison with a reference rapid test on the market
• Cross Reactivity: No false positive results were observed on specimens from TP, HIV, Dengue, TB, Typhoid Ab , HBsAg, HCV Ab, HEV Ab, H.P Ab, HAV, HCG, RF, ANA, HAMA
• Interference: No interference were seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 3.8 %; Heparin: 3,000 U/L; Creatinine: 442 µmol/L; Bilirubin: 20 mg/dL; EDTA: 3.4 µmol/L; Hemoglobin: 2 g/L; Human IgG: 1000 mg/dL; AlbuminL 60 g/L
• Shelf life: 24 month  at 2-30 °C

Each kit contains:

• Individually sealed foil pouches containing:
  • One cassette device
  • One desiccant
• 5 µL capillary tubes
• Sample diluent (5 mL/bottle)
• One package insert (instruction for use)

TEST PRINCIPLE: The OnSite Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing L. interrogans antigens conjugated with colloidal gold (Leptospira conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing two test lines (M and G lines) and a control line (C line). The M line is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-L. interrogans, G line is pre-coated with monoclonal anti-human IgG for the detection of IgG antiL. interrogans, and the C line is pre-coated with a control line antibody.  When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. IgM anti-L. interrogans, if present in the specimen, will bind to the Leptospira conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody forming a burgundy colored M line, indicating an IgM anti-L. interrogans positive test result. IgG anti-L. interrogans, if present in the specimen, will bind to the Leptospira conjugates. The immunocomplex is then captured on the membrane by the pre-coated antihuman IgG forming a burgundy colored G line, indicating an IgG anti-L. interrogans positive test result. Absence of any test lines (M and G) suggests a negative result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of the control antibodies regardless of color development on any of the test lines. If the C line does not develop, the test result is invalid and the specimen must be retested with another device.