Evaluation of HBsAg screening methods and reagents on blood donors

    SUN Wenª²Li, ZHANG Xianª²Qing, MU Shiª²Jie, WU Yuanª²Ru, HU Xingª²Bin

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

    ¡¾Abstract¡¿ AIM: To evaluate the HBsAg screening methods and the reagents in blood donors. METHODS: 60 HBsAg serum plates for clinical scientific research from the Clinical Testing Center of the National Ministry of Health and 200 sets of serum from blood donors in Xi'an were used as samples for the evaluation. The samples underwent blind screening with homemade reagent paper, Chinaª²made ELISA kit and imported ELISA kit respectively. With the serum plates from the Clinical Testing Center of the National Ministry of Health and HBsAg positive of the blood donors plus its corresponding confirmation with neutralization test as the golden criteria, the validity and reliability were tested with the fourª²fold table and the cutª²off values of ELISA kits were evaluated. RESULTS: The sensitivity of Chinaª²made ACON reagent paper, Chinaª²made INTEC ELISA kit and imported Diasorin ELISA kit was 62%, 86% and 100%, respectively, the specificity was 99%, 100% and 96%, respectively and the Youden's indices were 0.61, 0.86, 0.96, respectively. The repetition coincidence rate of all the three reagents was 100%. The due cutª²off value of Chinaª²made INTEC ELISA kit was reasonable, while the due cutª²off value of the imported DiaSorin ELISA kit tended to be low. CONCLUSION: Of the three methods and three reagents, the imported DiaSorin ELISA kit has the best sensitivity, but its specificity is poorer than that of the Chinaª²made reagents. As all the three reagents have good repeatability, the combined screening by the three reagents can ensure the safety of blood transfusion. Though the reagent paper has poor sensitivity, its specificity is as high as 99%. So it still of high value in clinical application. If the sensitivity of Chinaª²made HBsAg screening reagents and the specificity of imported HBsAg screening reagents are enhanced ......