Product Details

Bioline™ HCV

HEPATITIS C VIRUS TEST

When speed matters, choosing a highly sensitive rapid HCV test with a safe fingerstick procedure can make a difference.

In the global effort to eliminating viral hepatitis, fast detection in a wide range of settings and linkage to care are critical for achieving successful outcomes

Bioline™ HCV test is a immunochromatographic rapid test for the qualitative detection of antibodies specific to HCV in human serum, plasma or whole blood.

  • Bioline™ HCV

Product Name

Kit Components

Specimen

Product Code CE-Marked

Product Code Non CE-Marked

Bioline™ HCV 30 Test Kittest devices, diluentSerum, Plasma or Whole blood02FK10CE02FK10
Bioline™ HCV 25 Test Kittest devices, sterile
lancets, capillary pipettes, alcohol
swabs, diluent
Serum, Plasma or Whole blood02FK16CE02FK16
Bioline™ HCV 25 Test Kittest devices, safety
lancets, capillary pipettes, alcohol swabs, diluent
Serum, Plasma or Whole blood02FK17CE02FK17
Bioline™ HCV Multi-Device Type*10 x 10 multi-devices,
2 diluents
Serum, Plasma or Whole blood---02FK11
Bioline™ HCV Strip (Stick) Type*25 test strips, 1 diluentSerum, Plasma---02FK12

* Non WHO Prequalified & Non CE-Marked

  • Specimen :
    - Serum, Plasma, Whole Blood (10 μl) for 02FK10, 02FK10CE, 02FK16, 02FK16CE, 02FK17, 02FK17CE, 02FK11
    - Serum or Plasma (10 μl) for 02FK12
  • Sensitivity :
    - 99.3% (95% CI: 97.9 - 99.8%) for 02FK10CE, 02FK16CE, 02FK17CE
    - 99.3% (95% CI: 96.1 - 99.9%) for 02FK10, 02FK16, 02FK17
    - 100 % (97.6 - 100 %) for 02FK11, 02FK12
  • Specificity :
    - 100% (95% CI: 99.7 - 100 %) for 02FK10CE, 02FK16CE, 02FK17CE
    - 98.1% (95% CI: 94.5 - 99.4%) for 02FK10, 02FK16, 02FK17
    - 99.4 % (98.7 - 99.7 %) for 02FK11, 02FK12
  • Shelf life: 24 months at 1-30°C
  • Qualitative immunochromatographic assay
  • Recombinant HCV core, NS3, NS4, NS5 Ag used as capture materials