CTK Biotech HIV/Syphilis Ab Combo Rapid Test

The OnSite® HIV/Syphilis Ab Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies to HIV-1, HIV-2 and Treponema pallidum (Tp) in human serum, plasma or whole blood. This antibody detection test is a noninvasive diagnostic method and can be performed within 15 minutes by minimally skilled personnel without using laboratory equipment.

Product Features

• A three-line test that detects IgG, IgM & IgA to HIV-1, HIV-2 & T. pallidum
• Cost-effective screening tool by screening for two diseases in a single device
• Compatible with human serum, plasma, or whole blood specimens
• Results available within 15 minutes
• No equipment required
• Shelf Life: 24 months
• Storage Temperature: 2-30°C

Clinical Performance

HIV 1+2 Ab Test (comparing to a commercial rapid test)

• Sensitivity:  100%
• Specificity: 100%

Syphilis Ab Test (comparing to a commercial rapid test)

• Sensitivity:  100%
• Specificity: 99.0%

Cross-Reactivity: No false positive results were observed on 10 specimens from the following disease states or special conditions, respectively: Dengue, HIV, HBV, HAV, T. pallidum, HEV, H. pylori, HCV, ANA, HAMA, RF (up to 8400 IU/mL), pregnant women.

Interference: No interference with some common substances, such as Bilirubin (20 mg/dL), Creatinine (442 µmol/L), EDTA (3.4 µmol/L), Glucose (55 mmol/L), Heparin (3,000 U/L), Human IgG (1,000 mg/L), Salicylic acid (4.34 mmol/L), Sodium citrate (1.5%)

Please contact tech@ctkbiotech.com for further details about pathogens and substances tested for cross-reactivity/interference.

Product Specifications

• 30 tests per kit
• Individually sealed foil pouches containing one test cassette and one desiccant.
• Plastic droppers
• Sample diluent (REF SB-R0035C, 5 mL/bottle)
• Instructions for use