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Table 2. Additional Studies on the Diagnostic Accuracy of Third-Generation Enzyme-Linked Immunosorbent Assays for Anti-Hepatitis C Virus Antibodies *

Study, Year
(Reference)
Patients Studied Reference Assay Prevalence of Positive Results on Anti-HCV ELISA Sensitivity Specificity Positive Predictive Value Quality Rating
Huber et al., 199687 Patients admitted because of acute liver disease or suspected chronic hepatitis PCR 10%
(107/1090)
94%
(107/114)
97%
(946/976)
78%
(107/137)
Good
Prince et al., 199789 Blood donors with elevated alanine aminotransferase levels PCR 18%
(54/301)
100%
(51/51)
98.8%
(247/250)
94%
(51/54)

Fair

Narrow patient spectrum

Busch et al., 200088 Blood donors with positive screening test who were retested Second-generation RIBA or PCR 100%
(1091/1091)
99.2%
(1082/1091)
Not calculable Not calculable

Fair

Performance of reference assays not standardized, narrow patient spectrum

* ELISA = enzyme-linked immunosorbent assay; HCV = hepatitis C virus; PCR = polymerase chain reaction; RIBA = recombinant immunoblot assay.

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