CAJ | 학술논문

目的：自主研发酶联免疫吸附法（ELISA法）检测乙型病毒性肝炎（简称“乙肝”）五项室内质控品。方法将ELISA法检测乙肝五项阳性的血清进行最佳比例稀释，自制室内质控品。结果自制质控品与商品质控品同时以ELISA法检测，对其各项检测结果进行比较，二者比较差异无统计学意义（P＞0．05）；自制质控品以ELISA法连续检测，其批间变异小于15％，稳定性符合要求。结论自主研发的乙肝五项室内质控品制作简单，稳定性良好，控制效果满意，具有推广价值。
목적：자주연발매련면역흡부법（ELISA법）검측을형병독성간염（간칭“을간”）오항실내질공품。방법장ELISA법검측을간오항양성적혈청진행최가비례희석，자제실내질공품。결과자제질공품여상품질공품동시이ELISA법검측，대기각항검측결과진행비교，이자비교차이무통계학의의（P＞0．05）；자제질공품이ELISA법련속검측，기비간변이소우15％，은정성부합요구。결론자주연발적을간오항실내질공품제작간단，은정성량호，공제효과만의，구유추엄개치。
Objective To use ELISA detecting self‐developed hepatitis B five internal quality control products .Methods Hepa‐titis B five positive sera by the detection of ELISA were diluted through optimal ratio ,and were homemade indoor quality control materials .Results Self‐control materials and commodities were simultaneously detected by ELISA ,and the test results were com‐pared ,the two were no significant difference(P>0 .05);Self‐control materials continuously detected by ELISA ,its batch variation were less than 15% ,and stability was in line with the requirements .Conclusion Self‐developed hepatitis B five indoor quality con‐trol materials are made simply ,have good stability ,are satisfied control effect ,and have promotional value .