Product Features
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- Clinical performance
Relative sensitivity Relative specificity Overall agreement HIV 1+2 Ab test 100% 99.9% 99.9% Syphilis Ab test 100% 99.1% 99.4% HBsAg test 100% 100% 100% HCV Ab test 100% 99.7% 99.8% - Cross Reactivity: No false positive results were observed on 5-10 positive specimens of dengue, HAV, HBV, HCV, HEV, HIV, pylori, T. pallidum, ANA, HAMA, RF (up to 1500 IU/mL), pregnant women, respectively.
- Interference: No interference was seen with bilirubin (20 mg/dL), EDTA (3.4 µM), salicylic acid (4.34 mmol/L), creatinine (442 µmol/L), heparin (3000 U/L), human IgG (1000 mg/L), glucose (5.5 mmol/L), sodium citrate (3.8%)
- Shelf life: 18 months
Product specifications
- Individually sealed foil pouches containing:
- One cassette holder containing HIV/SYP (left) and HBV/HCV (right) cassettes
- One desiccant
- Plastic droppers
- Sample diluent HS (specific for HIV/Syphilis Ab test, REF SB-R0038HS, pink cap, 5 mL/bottle)
- Sample diluent BC (specific for HBsAg/HCV Ab test, REF SB-R0038BC, white cap, 5 mL/bottle)
- Package insert (instruction for use)
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