Hepatitis B test kit

hepatitis CHIVHCV

Product overview
The HIV/HCV/HBsAg Combo Test Device (whole blood, serum and plasma) is a rapid chromatographic immunoassay using colloidal gold for qualitative detection of HIV and HCV antibodies and HBsAg in whole blood, serum and plasma.

Product details

• Product name: HIV HCV HBsAg combo rapid test device
• Specimen: Whole blood / Serum / Plasma
• Method: Colloidal gold immunochromatographic assay
• Form: In vitro diagnostic rapid test cassette or strip
• Reading time: read result at 10 minutes; do not interpret after 20 minutes
• Analytical accuracy: ~99.9%
• Certifications: ISO9001, ISO13485
• Shelf life: 24 months
• Package: 25 tests / box

Intended use
The device is intended as a rapid chromatographic immunoassay for qualitative detection of antibodies to HIV and HCV and for detection of HBsAg in whole blood, serum and plasma to support clinical screening and diagnostic workflows.

Operating steps

• Allow device, specimen, buffer and controls to equilibrate to room temperature (15–30°C) prior to testing.
• Open the foil pouch and use the device immediately; perform the assay within one hour of opening for best results.
• Place the device on a clean, level surface. Transfer specimen using a pipette or disposable dropper:
  • Pipette: apply 5 µL of whole blood to the specimen well, then add 3 drops of buffer (≈180 µL) and start timer.
  • Disposable dropper: draw specimen to the Fill Line (≈5 µL), transfer to specimen well, add 3 drops of buffer (≈180 µL) and start timer.
• Wait for coloured lines to appear; read result at 10 minutes. Do not interpret results after 20 minutes.

Packaging & formats
Available in strip or cassette format. Typical packaging: 25 tests per box.

Technical specifications

• Specimen types: Whole blood, serum, plasma
• Assay method: Colloidal gold immunochromatography
• Result reading time: 10–15 minutes (read at 10 min; invalid after 20 min)
• Analytical accuracy: ~99.9%
• Format: Strip or cassette
• Certifications: ISO9001, ISO13485
• Shelf life: 24 months
• Storage: equilibrate reagents and specimens to 15–30°C prior to testing
• Package size: 25 tests / box