激光杂志
激光雜誌
격광잡지
LASER JOURNAL
2014年
10期
131-133
,共3页
性能验证%聚合酶链反应%乙型肝炎病毒%核酸检测
性能驗證%聚閤酶鏈反應%乙型肝炎病毒%覈痠檢測
성능험증%취합매련반응%을형간염병독%핵산검측
Performance verification%Polymerase chain reaction%HBV%DNA tests
目的：探讨一种适合于临床实际应用的荧光定量PCR检测HBV-DNA性能验证方法。方法：参考美国临床实验室标准化协会（CLSI）性能验证的相关文件，应用实验室检测病人标本，室内质控数据，能力验证结果，按方法学性能评价指标设计验证试验，通过对实验结果的统计学分析，评价检测方法的性能是否符合临床预期用途。结果：本文荧光定量PCR检测HBV-DNA批内CV高、中、低水平分别为2.9%、2.6%和9.7%；批间CV高、低水平分别为3.7%和4.5%；实验室结果与参考靶值比较的回归方程为：y=0.9909x+0.0008；r2=0.9945；线性范围验证为7.30E2～2.51E7，线性回归方程为：y=1.0247x-0.2232；r2=0.9941；溶血时血红蛋白≤5g/l对本实验结果无影响。结论：经验证本实验荧光定量PCR检测HBV-DNA性能指标满足临床预期要求，常规应用结果满意；荧光定量PCR的性能验证是保证其检验质量的必要手段，选择适合的验证方案将会大大提高性能验证的临床应用。
目的：探討一種適閤于臨床實際應用的熒光定量PCR檢測HBV-DNA性能驗證方法。方法：參攷美國臨床實驗室標準化協會（CLSI）性能驗證的相關文件，應用實驗室檢測病人標本，室內質控數據，能力驗證結果，按方法學性能評價指標設計驗證試驗，通過對實驗結果的統計學分析，評價檢測方法的性能是否符閤臨床預期用途。結果：本文熒光定量PCR檢測HBV-DNA批內CV高、中、低水平分彆為2.9%、2.6%和9.7%；批間CV高、低水平分彆為3.7%和4.5%；實驗室結果與參攷靶值比較的迴歸方程為：y=0.9909x+0.0008；r2=0.9945；線性範圍驗證為7.30E2～2.51E7，線性迴歸方程為：y=1.0247x-0.2232；r2=0.9941；溶血時血紅蛋白≤5g/l對本實驗結果無影響。結論：經驗證本實驗熒光定量PCR檢測HBV-DNA性能指標滿足臨床預期要求，常規應用結果滿意；熒光定量PCR的性能驗證是保證其檢驗質量的必要手段，選擇適閤的驗證方案將會大大提高性能驗證的臨床應用。
목적：탐토일충괄합우림상실제응용적형광정량PCR검측HBV-DNA성능험증방법。방법：삼고미국림상실험실표준화협회（CLSI）성능험증적상관문건，응용실험실검측병인표본，실내질공수거，능력험증결과，안방법학성능평개지표설계험증시험，통과대실험결과적통계학분석，평개검측방법적성능시부부합림상예기용도。결과：본문형광정량PCR검측HBV-DNA비내CV고、중、저수평분별위2.9%、2.6%화9.7%；비간CV고、저수평분별위3.7%화4.5%；실험실결과여삼고파치비교적회귀방정위：y=0.9909x+0.0008；r2=0.9945；선성범위험증위7.30E2～2.51E7，선성회귀방정위：y=1.0247x-0.2232；r2=0.9941；용혈시혈홍단백≤5g/l대본실험결과무영향。결론：경험증본실험형광정량PCR검측HBV-DNA성능지표만족림상예기요구，상규응용결과만의；형광정량PCR적성능험증시보증기검험질량적필요수단，선택괄합적험증방안장회대대제고성능험증적림상응용。
Objective: To establish a new way of evaluating performance verification tests in detecting HBV-DNA by real-time PCR clinically. Methods:According to reference documents from Clinical and Laboratory Standards Institute (CLSI), we designed verification tests from the performance evaluation methodology using pa-tient samples, internal quality control data and proficiency test results, and evaluated if performance verification tests could be carried out in routing clinical tests. Results:The high, medium and low level of within-run precision CV in detecting HBV-DNA by real-time PCR is 2.9%、2.6% and 9.7%, respectively, and the high and low level of be-tween-run precision CV is 3.7%and 4.5%, respectively. By calculating test data and target values, one-dimensional linear regression equation is y=0.9909x+0.0008;r2=0.9945;linearity range is 7.30E2~2.51E7;equation of linear re-gression is y=1.0247x-0.2232;r2=0.9941;when hemoglobin is≤5g/l, hematolysis has no effects on HBV-DNA data. Conclusion:Performance verification indexes could be applied to routing clinical tests and satisfied clinical expecta-tions. Performance verification test is essential for the quality of real-time PCR, and appropriate performance verifi-cation test could improve clinical laboratory work.
