Evaluation of three antiª²HCV screening reagents in blood donors

    MU Shiª²Jie, ZHANG Xianª²Qing, SUN Wenª²Li, WU Yuanª²RU

    Department of Blood Transfusion, Xijing Hospital, Fourth Military Medical University, Xi¬ðan 710033, China

    ¡¾Abstract¡¿ AIM: To evaluate three antiª²HCV screening reagents in blood donors. METHODS: Samples for evaluation were 50 antiª²HCV serum plates for clinical scientific research from the Clinical Testing Center of the State Ministry of Health. The samples underwent blind screening by fast reagent method, Chinaª²made ELISA kit and imported ELISA kit, respectively. Using the antiª²HCV positive and negative serum plates from Clinical Testing Center of the State Ministry of Health as the golden criteria, the validity and reliability were tested with fourª²fold table and the cutª²off of ELISA was reasonably evaluated. RESULTS: The sensitivity of fast reagent method, Chinaª²made INTEC ELISA kit and imported ORTHO ELISA kit was 48.0%, 88.0% and 76.0%, respectively. Their specificity was all 100.0% and their accuracy was 74.0%, 94.0% and 88.0%, respectively. Their Youden's index was 0.48, 0.88 and 0.76, respectively and the repetition coincidence rate of all the three reagents was 100.0%. The due cutª²off value of homemade INTEC ELISA kit was reasonable, while the due cutª²off value of imported ORTHO ELISA kit was too high. CONCLUSION: Of the three reagents under study, the Chinaª²made INTEC ELISA kit has the best sensitivity and accuracy .The repetition coincidence rate of all the three reagents is satisfactory. The combined screening of two optimized Chinaª²made ELISA kits can ensure the safety of blood transfusion and low cost of screening. ......