CAJ | 학술논문

目的利用CLSI EP15-A指南对本科新购置的SYSMEX公司生产的CA-7000血凝仪测定凝血酶原时间(P7)和活化部分凝血活酶时间(AP7T)的精密度和准确度进行验证.方法精密度验证实验对3个不同水平的质控品每个每天测定4次,共测定5 d,分别计算其批内不精密度和天间不精密度,然后与厂家声称的不精密度进行比较,若小于厂家声称的不精密度则认为本仪器的精密度达到厂家声称的精密度;若本仪器的不精密度大于厂家声称的不精密度则进一步与验证值比较,若小于验证值则认为本仪器的不精密度达到厂家声称的不精密度,若仍大于验证值则认为本仪器的精密度未达到厂家声称的不精密度.准确度验证实验对3个不同水平的质控品每个测定2次,测定均值与靶值的偏差小于卫生部临床检验中心室间质评的允许误差表示准确度可以接受.结果 CA-7000测定PT、APTT的批内和天间不精密度均达到厂家声称的不精密度,而且均小于本科的不精密度质量目标.3个质控品的PT、APTT结果均落在厂家没定的范围内,与靶值的偏倚均小于卫生部临床检验中心室间质评的允许误差.结论 CA-7000测定PT和APTT的精密度和准确度达到厂家声称的性能.
목적 이용CLSI EP15-A지남대본과신구치적SYSMEX공사생산적CA-7000혈응의측정응혈매원시간(P7)화활화부분응혈활매시간(AP7T)적정밀도화준학도진행험증.방법 정밀도험증실험대3개불동수평적질공품매개매천측정4차,공측정5 d,분별계산기비내불정밀도화천간불정밀도,연후여엄가성칭적불정밀도진행비교,약소우엄가성칭적불정밀도칙인위본의기적정밀도체도엄가성칭적정밀도;약본의기적불정밀도대우엄가성칭적불정밀도칙진일보여험증치비교,약소우험증치칙인위본의기적불정밀도체도엄가성칭적불정밀도,약잉대우험증치칙인위본의기적정밀도미체도엄가성칭적불정밀도.준학도험증실험대3개불동수평적질공품매개측정2차,측정균치여파치적편차소우위생부림상검험중심실간질평적윤허오차표시준학도가이접수.결과 CA-7000측정PT、APTT적비내화천간불정밀도균체도엄가성칭적불정밀도,이차균소우본과적불정밀도질량목표.3개질공품적PT、APTT결과균락재엄가몰정적범위내,여파치적편의균소우위생부림상검험중심실간질평적윤허오차.결론 CA-7000측정PT화APTT적정밀도화준학도체도엄가성칭적성능.
Objective Use CLSI EP15-A to verify the precision and the accuracy of our new coagulation analyzer CA-7000. Methods For precision verifying experiment, three control materials with different concentrations were tested 4 times per day and last five days. Then calculate within-run precision and total precision respectively,and compare the precision with that of claims. If the estimated precision is less than the manufacturer's claimed precision,it indicates the analyzer's precision is consistent with the claimed. If the estimated precision is larger than the claimed precision, it should be comparee with the verification value. If the prior is less than the latter,the manufacturer's claim is verfied,too. Otherwise,the claim is not verified. For accuracy verifying experiment, three control materials were tested two times . If the deviation average of results for each level is less than allowable total error which issued by ministry of health,it means the accuracy is acceptable. Results The within-run precision and total precision of PT, APTT examined by CA-7000 coagulation analyzer are consistent with the manufacturer's claim,and all are less than our laboratory's quality goal. And the bias of three quality control material for PT and APTT are less than the acceptable criteria of proficiency testing,and the results are within the range listed in the packsheet. Conclusion The precision and accuracy of CA-7000 for PT and APTT met with the claim of the manufacturer.