Anti-HBc assays: evaluation of end-point sensitivity and performance

Area of Science:

• Clinical diagnostics
• Hepatitis B virus (HBV) serology
• Blood transfusion safety

Background:

• Hepatitis B virus (HBV) infection remains a global health concern, necessitating robust screening methods for blood donations.
• Accurate detection of antibodies to the hepatitis B core antigen (anti-HBc) is crucial for preventing transfusion-transmitted HBV.
• Evaluating commercially available diagnostic assays is essential for optimizing blood donor screening protocols.

Purpose of the Study:

• To assess the performance characteristics of commercially available anti-HBc assays.
• To select an optimal anti-HBc ELISA for routine blood donor screening based on sensitivity, ease of use, and test time.
• To compare the sensitivity of seven ELISAs and one modified hemagglutination assay.

Main Methods:

• Performance evaluation of eight anti-HBc assays (seven ELISAs, one hemagglutination assay).
• Utilized a panel of eight serum samples from anti-HBc-positive blood donors.
• Assessed end-point sensitivity, ease of use, and overall test time for each assay.

Main Results:

• Significant variation in performance characteristics was observed among the evaluated anti-HBc assays.
• The Murex assay demonstrated the highest sensitivity but had an unacceptably long test time.
• The Biokit ELISA was chosen for the second phase due to its acceptable sensitivity and practical test duration.

Conclusions:

• The Biokit ELISA offers a suitable balance of sensitivity and efficiency for routine anti-HBc screening in blood donors.
• Assay selection for blood screening requires consideration of both diagnostic accuracy and operational efficiency.
• Continued evaluation of diagnostic assays is vital for maintaining high standards in blood safety.