การเปรียบเทียบประสิทธิภาพของน้ำยาตรวจไวรัสตับอักเสบบี โดยวิธี อีไลซ่า ที่ผลิตในประเทศกับที่นำเข้าจากต่างประเทศ

บทคัดย่อ

          In this study, 356 sera were sampling from Immunology laboratory and Blood Bank of Nakhonpathom Hospital. Whole sera had been already studied for HBsAg by ELISA ; there were 71 positive sera by Thai product and 73 positive sera by imported product, 303 sera had been already studied for Anti-HBs by ELISA ; there y`were 90 positive sera by Thai product and 91 positive sera by imported product. The rate of HBsAg and Anti-HBs positive sera by Thai product and improted product were not significantly difference. (P > 0.05)

          A comparative study for HBsAg were detected by ELISA test kit : Thai product vs imported. The Thai product gave a sensitivity of 95.9%, specificity 99.6% and an accuracy of 98.9% of imported and Anti-HBs  were detected by Thai product gave a sensitivity of 92.3%, specificity 97.2% and an accuracy of 95.7% of imported. 15.9 IU/1 were the lowest of Anti-HBs had been detected by Thai product, The cosfltest of test kit of HBsAg and Anti-HBs detection by Thai product were 54.8% and 35.0% of imported, respectively. Thai product had been efficiency and low cost and cound detected HBsAg and Anti-HBs were not significantly difference and should be to replace improted.