CAJ | 학술논문

目的：评价Innovance测定血浆D‐二聚体的分析性能。方法参照美国临床和实验室标准化协会文件及相关文献，对Innovance在Sysmex CA1500凝血分析仪上检测D‐二聚体的精密度、携带污染率、准确度、分析测量范围、临床可报告范围上限及参考值进行评价。以一套Sysmex CA1500检测系统为目标系统，以mini‐VIDAS和另一相同Sysmex CA1500检测系统为比对系统，对目标系统和比对系统检测D‐二聚体结果进行比对及偏倚评估。结果质控品和混合血浆批内与室内精密度结果均符合厂家声明要求。携带污染率符合要求。测定不同浓度赋值参考物质的准确度试验，平均偏倚－0．80％～1．28％。验证的分析测量范围0．20～4．34 mg／L FEU。临床可报告范围上限70．4 mg／L FEU。40例表面健康人群的90百分位数为0．53 mg／L FEU。与mini‐VIDAS检测系统比对，相关系数（r）＝0．905，结果间差异有统计学意义（P＜0．05），均值处相对偏倚21．37％。与另一相同Sysmex CA1500检测系统比对，r＝0．996，cut off值处的预期偏倚－4．82％。Sysmex CA1500检测系统能准确检测Inno‐vance配套质控品和校准品的D‐二聚体，而检测mini‐VIDAS配套的质控品和校准品D‐二聚体的偏倚不在允许范围。同样，mini‐VIDAS检测系统也只能准确检测相配套的质控品和校准品。结论 Innovance测定血浆D‐二聚体的分析性能符合临床要求，同一实验室D‐二聚体测定应在相同的检测系统上完成。
목적：평개Innovance측정혈장D‐이취체적분석성능。방법삼조미국림상화실험실표준화협회문건급상관문헌，대Innovance재Sysmex CA1500응혈분석의상검측D‐이취체적정밀도、휴대오염솔、준학도、분석측량범위、림상가보고범위상한급삼고치진행평개。이일투Sysmex CA1500검측계통위목표계통，이mini‐VIDAS화령일상동Sysmex CA1500검측계통위비대계통，대목표계통화비대계통검측D‐이취체결과진행비대급편의평고。결과질공품화혼합혈장비내여실내정밀도결과균부합엄가성명요구。휴대오염솔부합요구。측정불동농도부치삼고물질적준학도시험，평균편의－0．80％～1．28％。험증적분석측량범위0．20～4．34 mg／L FEU。림상가보고범위상한70．4 mg／L FEU。40례표면건강인군적90백분위수위0．53 mg／L FEU。여mini‐VIDAS검측계통비대，상관계수（r）＝0．905，결과간차이유통계학의의（P＜0．05），균치처상대편의21．37％。여령일상동Sysmex CA1500검측계통비대，r＝0．996，cut off치처적예기편의－4．82％。Sysmex CA1500검측계통능준학검측Inno‐vance배투질공품화교준품적D‐이취체，이검측mini‐VIDAS배투적질공품화교준품D‐이취체적편의불재윤허범위。동양，mini‐VIDAS검측계통야지능준학검측상배투적질공품화교준품。결론 Innovance측정혈장D‐이취체적분석성능부합림상요구，동일실험실D‐이취체측정응재상동적검측계통상완성。
Objective To evaluate the analytical performance of Innovance assay for detecting plasma D‐Di‐mer .Methods Referring to the documents of Clinical and Laboratory Standards Institute(CLSI) and the related liter‐atures ,the performances of Innovance for detecting plasma D‐dimer on the Sysmex CA 1500 analyzer were evaluated , including precision ,carryover contamination rate ,accuracy ,analytical measurement range ,upper limit of clinical re‐portable range and reference value .With the Sysmex CA 1500 as the objective detection system and the mini‐VIDAS and another same Sysmex CA 1500 detection system as the reference detection system ,the detection results of D‐di‐mer by these systems were perfromed the comparison and bias estimation .Results The within‐run precisions and within‐laboratory precision of control materials and pooled plasma samples conformed to those of manufacturer state‐ment .The carryover contamination rate was in accord with the clinical requirement .The average deviation of Inno‐vance assay for detecting different calibrators were -0 .80% ~1 .28% .The verified analytical measurement range was 0 .20~4 .34mg/L FEU .The upper limit of clinical reportable linear range was 70 .4mg/L FEU .The 90th percen‐tile in 40 cases of apparently healthy adults was 0 .53mg/L FEU .When the test results of the objective detection sys‐tem were compared with those of mini‐VIDAS system (r=0 .905) ,there were significant difference(P<0 .05) and the relative bias in the point of mean value was 21 .37% .When the test results of the objective detection system were compared with those of another Sysmex CA1500 (r= 0 .996) ,the expected bias in the point of cut‐off value was-4 .82% .D‐dimer concentration of Innovance′s control materials and calibrators can be accurately detected by the Sysmex CA1500 ,but the detection results of the mini‐VIDAS′s control materials and calibrators by the Sysmex CA1500 can not be accepted .Similarly ,the D‐dimer concentration of the mini‐VIDAS′s control materials and calibra‐tors could only be accurately detected by the mini‐VIDAS detection system .Conclusion The performance of Inno‐vance assay for detecting plasma D‐dimer conforms to clinical requirement ,and the D‐dimer test at the same laborato‐ry should be accomplished in the same detection system .