国际检验医学杂志
國際檢驗醫學雜誌
국제검험의학잡지
INTERNATIONAL JOURNAL OF LABORATORY MEDICINE
2015年
16期
2360-2362
,共3页
罗卉丽%袁杭%毛源%张厚智
囉卉麗%袁杭%毛源%張厚智
라훼려%원항%모원%장후지
性能验证%正确度%精密度%线性验证%干扰实验
性能驗證%正確度%精密度%線性驗證%榦擾實驗
성능험증%정학도%정밀도%선성험증%간우실험
performance verification%accuracy%precision%linear validation%interference test
目的:探讨分子诊断定量项目的分析性能验证程序。方法依据《医学实验室质量和能力认可准则在分子诊断领域的应用说明》和美国国家临床实验室标准化协会(CLSI)颁布的相关文件对实验室开展 PCR 检测乙型肝炎病毒核酸进行方法学性能验证。结果本实验室乙型肝炎病毒核酸(HBV-DNA)检测的重复不精密度(SD)分别为0.109和0.105;日间不精密度(SD)为0.157和0.137;与参比实验室结果比较回归方程为Y =0.947X +0.343,线性相关系数为0.990;线性范围为5.00~1.10;定量检出限为500 IU/mL;溶血对标本检测没有影响。结论实验室开展分子诊断项目应当进行分析性能验证,选择合适的方法可以进行明确的性能验证,明确检测项目性能指标对项目的临床使用有非常积极的作用。
目的:探討分子診斷定量項目的分析性能驗證程序。方法依據《醫學實驗室質量和能力認可準則在分子診斷領域的應用說明》和美國國傢臨床實驗室標準化協會(CLSI)頒佈的相關文件對實驗室開展 PCR 檢測乙型肝炎病毒覈痠進行方法學性能驗證。結果本實驗室乙型肝炎病毒覈痠(HBV-DNA)檢測的重複不精密度(SD)分彆為0.109和0.105;日間不精密度(SD)為0.157和0.137;與參比實驗室結果比較迴歸方程為Y =0.947X +0.343,線性相關繫數為0.990;線性範圍為5.00~1.10;定量檢齣限為500 IU/mL;溶血對標本檢測沒有影響。結論實驗室開展分子診斷項目應噹進行分析性能驗證,選擇閤適的方法可以進行明確的性能驗證,明確檢測項目性能指標對項目的臨床使用有非常積極的作用。
목적:탐토분자진단정량항목적분석성능험증정서。방법의거《의학실험실질량화능력인가준칙재분자진단영역적응용설명》화미국국가림상실험실표준화협회(CLSI)반포적상관문건대실험실개전 PCR 검측을형간염병독핵산진행방법학성능험증。결과본실험실을형간염병독핵산(HBV-DNA)검측적중복불정밀도(SD)분별위0.109화0.105;일간불정밀도(SD)위0.157화0.137;여삼비실험실결과비교회귀방정위Y =0.947X +0.343,선성상관계수위0.990;선성범위위5.00~1.10;정량검출한위500 IU/mL;용혈대표본검측몰유영향。결론실험실개전분자진단항목응당진행분석성능험증,선택합괄적방법가이진행명학적성능험증,명학검측항목성능지표대항목적림상사용유비상적겁적작용。
Objective To explore the verification process for the analytic performance of the quantitative project of molecular di-agnosis.Methods Based on"Medical laboratory accreditation criteria for quality and competence in the field of molecular diagnos-tics application note"(CL-36)(2014)and the relevant documents published by Clinical and Laboratory Standards Institute (CLSI), the performance verification methodology of PCR detection for hepatitis b virus nucleic acid was achieved.for.Results The within-run precision of DNA detection for the hepatitis b virus was 0.109 and 0.105;and the between-run precisionwas 0.1 57 and 0.137. Compared with the reference laboratory,the regression equation was Y =0.947+0.343X ,and the linear correlation coefficient was 0.990.The linear range was 5.00-1.10 and thequantitative detection limit was 500 IU/mL.Hemolysis had no effect on the detec-tion of samples.Conclusion The laboratory with molecular diagnostic program should conduct analytic performance verification,and the appropriate method should be chosen to clear performance verification.Conclusion Clearing the performance indicators of de-tection projects has a very positive role in the clinical use of detection projects..