丙型肝炎抗体ELISA诊断试剂质控参考品的建立

以国际2代丙型肝炎诊断试剂为参考，经ABBOTT、UBI、科华、亚利等国内、外试剂对3000余份血清进行反复筛查，还采用了分片段ELISA试剂及RIBA、PCR等方法进一步核检，建立了我国第1代丙型肝炎诊断试剂质控参考品，包括阳性、阴性、灵敏度和精密性参考品。用所建质控参考品对69批次国产试剂进行检测，并与国外试剂相比较，证明有较好的分辨力。并制定了我国丙型肝炎诊断试剂检测标准，此标准及参考品已获卫生部批准。用所建质控参考品对3家攻关单位的丙型肝炎诊断试剂进行了多次检测，结果表明单纯用合成肽抗原制成的试剂都存在灵敏度低、阳性参考品检出少的缺点。

Establishment of National Quality Control Reference Preparation for the Diagnostic Reagent of Hepatitis C by ELISA

More than 3000 serum were repetly screened with imported and domestic reagents(Abbott, UBI, Kehua, Yaii et al) using second-generation international hepatitis C diagnostic reaxentas reference, and further verified by fractional ELISA reagent, RIBA, PCR and so on. By this way,the first national quality control reference preperation for hepatitis C diagnostic reagents, includingpositive, negntive, sensitivity artd precision references, was established.69 lots of domestic reagents were detected by the reference preparation, and the results werecompered with those detocted by imported reagents. lt proved that the reference preperation showedgood resolving capability. The Chinese standard of hepatitis C diagnostic reagent was formulated andapproved by Ministry of Pub1ic Health People's Republic of China as well as the reference preparation.