Hepatitis C virus confirmation in blood donor screening

Area of Science:

• Virology
• Immunology
• Medical Diagnostics

Background:

• Hepatitis C virus (HCV) screening relies on enzyme immunoassays (EIAs).
• Confirmation of positive screening tests is crucial for accurate diagnosis and patient management.
• Polymerase chain reaction (PCR) is a sensitive method for detecting viral RNA.

Purpose of the Study:

• To evaluate different enzyme immunoassays (EIAs) for confirming hepatitis C virus (HCV) infection.
• To correlate EIA reaction patterns with the likelihood of HCV carrier status determined by PCR.
• To identify specific EIA markers indicative of a persistent HCV infection.

Main Methods:

• Serological confirmation of 508 volunteer blood donor sera initially positive for HCV using second-generation EIAs.
• Further evaluation of 195 repeatedly positive sera using additional EIAs, including one targeting the HCV nucleocapsid protein.
• Detection of HCV RNA via PCR on the 5'-noncoding region of the viral genome.

Main Results:

• A group of 89 sera, strongly positive in four different EIAs, contained 75 of 78 PCR-positive samples.
• All but one PCR-positive serum sample showed reactivity against the HCV nucleocapsid protein.
• Strong reactivity in multiple EIAs, particularly against the nucleocapsid protein, correlated highly with PCR-confirmed HCV infection.

Conclusions:

• A genuine antibody response to the HCV nucleocapsid protein is a strong indicator of the HCV carrier state.
• Combining results from multiple EIAs, especially those detecting anti-nucleocapsid antibodies, enhances diagnostic accuracy for HCV.
• These findings support the use of specific EIA profiles for reliable confirmation of chronic HCV infection.