Elecsys® Anti-HCV II

anti-hcv-ii-assay-com

High quality assay for screening and diagnosis of hepatitis C virus (HCV) infection

  • HCV is a leading cause of liver disease and a major healthcare concern with over 170 million people (about 3% of the human population) infected worldwide
  • Clinical diagnosis is difficult due to the high rate of asymptomatic infections so effective screening assays are hugely important
  • Chronic HCV infection may lead to cirrhosis and hepatocellular carcinoma, so early anti-HCV detection is the first step in the management of chronic hepatitis and in the selection of patients needing treatment
  • The Elecsys anti-HCV II assay is used to demonstrate the presence of antibodies against HCV during acute or chronic infection and after a passed infection
Assay time 18 min
Sample material Li-heparin, Na-heparin, K2-EDTA, K3-EDTA, serum gel separation, plasma gel separation and sodium citrate plasma
Sample volume 50 µL
Intermediate imprecision cobas e 411 analyzer, Elecsys® 2010 analyzer: 4.2 - 5.2 %
cobas e 601 / e 602 module, E170: 1.6 - 4.0%
Onboard stability 31 days
Reagents Liquid, ready to use
Clinical sensitivity 100 % (n=765)
Clinical specificity 99.84 % (n=6850, blood donors)
99.66 % (n=3922, hospitalized patients)

Earlier detection of infection with high sensitivity and specificity

The Elecsys® Anti-HCV II assay delivers benefits in a number of key areas:

Earlier detection of infection

  • High seroconversion sensitivity means earlier detection of infection

Reliable diagnosis

  • Reliable detection of all genotypes

Increased efficiency

  • Short assay time (18 minutes)
  • Excellent specificity in blood donor samples (99.84%) and daily routine (99.66%) means less retesting

Esteban, J. I., van Helden, J., Alborino, F., Bürgisser, P., Cellerai, C., et al. (2013), Multicenter evaluation of the elecsys® anti-HCV II assay for the diagnosis of hepatitis C virus infection. J. Med. Virol., 85: 1362–1368. doi: 10.1002/jmv.23536

Summary:

  • Detected more positive bleeds than the comparator assays
  • Was more sensitive in recognizing early HCV infection C
  • Correctly identified all 765 samples known to be HCV positive, regardless of genotype
  • The overall specificity of the Elecsys® Anti-HCV II assay was:
    • 99.84% (n = 6,850) using blood donor samples
    • 99.66% (n = 3,922) using samples from unselected hospitalized patients
    • 99.66% (n = 2,397) using samples from patients with potentially cross-reacting factors or from high-risk groups

Conclusion:

The Elecsys® Anti-HCV II assay is a sensitive and specific assay suitable for routine use in the reliable detection of anti-HCV antibodies.