[Quality Evaluation of the Performance Study of Diagnostic Tests Using STARD Checklist and Meta-Analysis for the...

The third generation anti-hepatitis C virus (HCV) enzyme immunoassay (EIA) is now in use for screening HCV infection. The aim of this study was to pool the data on the sensitivity and specificity of third generation anti-HCV EIA tests after evaluating the quality of the studies using Standards for Reporting of Diagnostic Accuracy studies (STARD) checklist.

We searched MEDLINE and PubMed databases using keywords about the accuracy of diagnostic tests for HCV infections. Methodological quality was assessed by two persons with a modified STARD checklist. A heterogeneity test was performed, and in case heterogeneity was present, a sub-group analysis was done. Fixed-effects model was used to obtain pool sensitivity and specificity with 95% confidence intervals (CI).

A total of 41 studies from 16 papers were selected. The quality score ranged from 6 to 13 (median 10.5); Inter-observer agreement was 93.62% (k=0.69); and 41 studies revealed heterogeneity. We performed a sub-group analysis with only 28 studies from 13 papers that were evaluated to be of high quality. A subgroup using polymerase chain reaction as the reference test revealed homogeneity and was calculated the pooled sensitivity and specificity of 99.92% (CI 99.77-100.07%) and 99.66% (CI 99.45-99.86%) respectively. Studies on test kits with an increased reactivity to the core region also showed homogeneity in sensitivity and the pooled sensitivity was 99.78% (CI 99.53-100.03%).

For the first time in Korea, the diagnostic accuracy of test kits was evaluated by meta-analysis using STARD checklist. The methodology shown in this study should help extending laboratory medicine to an evidence-based medicine.