CAJ | 학술논문

目的：对Sysmex CS 5100（下简称CS 5100）全自动血凝仪进行性能评价。方法对CS 5100血凝仪的准确性、不精密度、Fg 线性（可报告范围）、参考范围、携带污染率进行评价，并与 Sysmex 公司生产的 CA 7000全自动血凝分析仪进行相关性试验，所测指标为 PT、PT（INR）、APTT、Fbg、TT、AT、D 二聚体（DD）和 FDP。结果准确性试验测定结果在质控说明书给定的范围内。批内最大变异系数（CV）与日间最大 CV 均符合符合相关行业文件要求。Fbg 线性验证试验结果显示 Fbg 线性范围为1．071～5．355，相关系数（r）值为0．9950，符合规定要求（r≥0．975）。参考范围验证试验结果显示各项检测指标 R 值均＞0．9，实验室预设参考范围可适用于该仪器。CS 5100与 CA 7000的各项检测项目 r 值均＞0．95，两仪器结果有很好的对比性。结论CS 5100有优异的准确性、精密度良好、Fbg 检测范围宽、抗生物干扰能力强，完全可满足临床实验室要求。
목적：대Sysmex CS 5100（하간칭CS 5100）전자동혈응의진행성능평개。방법대CS 5100혈응의적준학성、불정밀도、Fg 선성（가보고범위）、삼고범위、휴대오염솔진행평개，병여 Sysmex 공사생산적 CA 7000전자동혈응분석의진행상관성시험，소측지표위 PT、PT（INR）、APTT、Fbg、TT、AT、D 이취체（DD）화 FDP。결과준학성시험측정결과재질공설명서급정적범위내。비내최대변이계수（CV）여일간최대 CV 균부합부합상관행업문건요구。Fbg 선성험증시험결과현시 Fbg 선성범위위1．071～5．355，상관계수（r）치위0．9950，부합규정요구（r≥0．975）。삼고범위험증시험결과현시각항검측지표 R 치균＞0．9，실험실예설삼고범위가괄용우해의기。CS 5100여 CA 7000적각항검측항목 r 치균＞0．95，량의기결과유흔호적대비성。결론CS 5100유우이적준학성、정밀도량호、Fbg 검측범위관、항생물간우능력강，완전가만족림상실험실요구。
Objective To evaluate the performance of Sysmex CS 51 00 automatic blood coagulation analyzer. Methods PT,PT(INR),APTT,Fbg,TT,AT,D-dimer (DD)and FDP were measured by Sysmex CS 51 00 automatic blood coagulation analyzer.The accuracy,imprecision,Fg linearity (reportable range),reference range, carry-over rate were evaluated,and the correlation with Sysmex CA 7000 automatic blood coagulation analyzer was analyzed.Results The accuracy was in the range provided by quality control instructions.The maximum within-run and inter-day coefficients of variation met the requirements of Clia′88.Fbg linear validation test showed that the linearity of Fbg was from 1 .071 to 5.355,and the correlation coefficient (r)was 0.9950,which met the specified requirements (r≥0.975).The reference range verification tests showed that the R values of all the tests were >0.9,which proved that the laboratory preset reference range can be applied to the analyzer.The r for several items between CS 51 00 and CA 7000 were >0.95,which showed good correlation between the 2 analyzers.Conclusions CS 51 00 has an excellent accuracy,a good precision,a wide range of Fbg detection as well as a strong anti-interference ability.CS 51 00 can totally meet the requirements of clinical laboratories.