检验医学
檢驗醫學
검험의학
LABORATORY MEDICINE
2010年
1期
13-16
,共4页
唐立萍%居漪%欧元祝%王美娟%张瑞镐
唐立萍%居漪%歐元祝%王美娟%張瑞鎬
당립평%거의%구원축%왕미연%장서호
血糖仪%床边检测%性能分析
血糖儀%床邊檢測%性能分析
혈당의%상변검측%성능분석
Blood glucometer%Point of care testing%Analytical quality
目的 比对5个品牌9款床边检测(POCT)血糖仪的主要分析性能.方法 用高、中、低3个浓度的质控品在9款POCT血糖仪上进行检测,连续测试30 d,计算变异系数(CV).取高、中、低3种不同葡萄糖浓度的患者样本,同一样本取2份.一份为新鲜全血[乙二胺四乙酸(EDTA)抗凝],在9款POCT血糖仪上进行检测,计算同一样本在9款POCT血糖仪上检测所得结果的均值() 、标准差(s)、CV;另一份为新鲜血清样本,用日立7060全自动生化分析仪进行检测,评价日立7060全自动生化仪与POCT血糖仪测定结果的相关性.结果 质控品在9款POCT血糖仪上所测结果的CV在2.62%～5.86%之间,符合国家对血糖检测系统的测量重复性要求(CV不超过7.5%).高浓度血糖用POCT血糖仪所测结果的CV在10%左右,中、低浓度血糖用POCT血糖仪所测结果的CV均＞10%,与美国临床实验室标准化委员会(NCCLS)对葡萄糖POCT的管理要求(总误差≤10%)不符.Johnson Ultra和ArkRay GT-1810 2款POCT血糖仪与日立7060全自动生化仪所测结果的相关系数(r)＜0.95,相关性略差;其他几款POCT血糖仪与日立7060全自动生化仪所测结果的r均≥0.95,相关性较好.KB CT-X10、Roche Integra、Advantage和Johnson Ultra POCT血糖仪的斜率(b)超出1.0±0.05.结论 POCT血糖仪仅可用于患者空腹血糖的监测或血糖过筛试验,不能代替实验室血糖的检测结果作为确诊试验.同时在选择POCT血糖仪时,不能仅一味追求其检测的快速,应该对血糖仪的分析性能进行综合评价.
目的 比對5箇品牌9款床邊檢測(POCT)血糖儀的主要分析性能.方法 用高、中、低3箇濃度的質控品在9款POCT血糖儀上進行檢測,連續測試30 d,計算變異繫數(CV).取高、中、低3種不同葡萄糖濃度的患者樣本,同一樣本取2份.一份為新鮮全血[乙二胺四乙痠(EDTA)抗凝],在9款POCT血糖儀上進行檢測,計算同一樣本在9款POCT血糖儀上檢測所得結果的均值() 、標準差(s)、CV;另一份為新鮮血清樣本,用日立7060全自動生化分析儀進行檢測,評價日立7060全自動生化儀與POCT血糖儀測定結果的相關性.結果 質控品在9款POCT血糖儀上所測結果的CV在2.62%～5.86%之間,符閤國傢對血糖檢測繫統的測量重複性要求(CV不超過7.5%).高濃度血糖用POCT血糖儀所測結果的CV在10%左右,中、低濃度血糖用POCT血糖儀所測結果的CV均＞10%,與美國臨床實驗室標準化委員會(NCCLS)對葡萄糖POCT的管理要求(總誤差≤10%)不符.Johnson Ultra和ArkRay GT-1810 2款POCT血糖儀與日立7060全自動生化儀所測結果的相關繫數(r)＜0.95,相關性略差;其他幾款POCT血糖儀與日立7060全自動生化儀所測結果的r均≥0.95,相關性較好.KB CT-X10、Roche Integra、Advantage和Johnson Ultra POCT血糖儀的斜率(b)超齣1.0±0.05.結論 POCT血糖儀僅可用于患者空腹血糖的鑑測或血糖過篩試驗,不能代替實驗室血糖的檢測結果作為確診試驗.同時在選擇POCT血糖儀時,不能僅一味追求其檢測的快速,應該對血糖儀的分析性能進行綜閤評價.
목적 비대5개품패9관상변검측(POCT)혈당의적주요분석성능.방법 용고、중、저3개농도적질공품재9관POCT혈당의상진행검측,련속측시30 d,계산변이계수(CV).취고、중、저3충불동포도당농도적환자양본,동일양본취2빈.일빈위신선전혈[을이알사을산(EDTA)항응],재9관POCT혈당의상진행검측,계산동일양본재9관POCT혈당의상검측소득결과적균치() 、표준차(s)、CV;령일빈위신선혈청양본,용일립7060전자동생화분석의진행검측,평개일립7060전자동생화의여POCT혈당의측정결과적상관성.결과 질공품재9관POCT혈당의상소측결과적CV재2.62%～5.86%지간,부합국가대혈당검측계통적측량중복성요구(CV불초과7.5%).고농도혈당용POCT혈당의소측결과적CV재10%좌우,중、저농도혈당용POCT혈당의소측결과적CV균＞10%,여미국림상실험실표준화위원회(NCCLS)대포도당POCT적관리요구(총오차≤10%)불부.Johnson Ultra화ArkRay GT-1810 2관POCT혈당의여일립7060전자동생화의소측결과적상관계수(r)＜0.95,상관성략차;기타궤관POCT혈당의여일립7060전자동생화의소측결과적r균≥0.95,상관성교호.KB CT-X10、Roche Integra、Advantage화Johnson Ultra POCT혈당의적사솔(b)초출1.0±0.05.결론 POCT혈당의부가용우환자공복혈당적감측혹혈당과사시험,불능대체실험실혈당적검측결과작위학진시험.동시재선택POCT혈당의시,불능부일미추구기검측적쾌속,응해대혈당의적분석성능진행종합평개.
Objective To compare the main analytical ability of 9 point of care testing (POCT) glucometers of 5 brands. Methods The control materials with 3 gradual levels (high, medium and low) were detected continually for 30 days and then the coefficient of variation (CV) was calculated. The glucose concentrations were determined from patients′ samples with high, medium and low levels. Each sample was divided into two parts. One part was the fresh whole blood [anti-coagulation with ethylenediaminetetraacetaic acid (EDTA)] which was detected on 9 POCT glucometers and calculated the mean value (), standard deviation (s) and CV (%). The other part was the fresh serum which was detected with Hitachi 7060 automatic biochemical analyzer and the correlation with glucometers was evaluated. Results The control materials CV values of 9 glucometers were from 2.62% to 5.86%, in accordance with the rule that required CV below 7.5%. High blood glucose concentrations had the CV value around 10%, and medium and low ones had the CV value more than 10%, which did not follow the National Committee for Clinical Laboratory Standards (NCCLS) requirements that CV should be below 10%. The results were not consistent with the requirement [total error (bias and imprecision)≤10%] of the NCCLS. POCT glucometers had good correlations (r≥0.95) with automatic biochemical analyzer except Johnson Ultra and ArkRay GT-1810. The slopes (b) of KB CT-X10, Roche Integra, Advantage and Johnson Ultra were above 1.0±0.05. Conclusions POCT glucometer can be used for monitoring the fasting blood-glucose and for the blood-glucose screening test. POCT can not replace the traditional blood-glucose tests and can not act as the diagnostic test. Meanwhile, for selecting the POCT glucometers, we should focus not only on the testing speed but also on their analytical ability.
