中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2012年
4期
317-321
,共5页
周琦%谢伟%徐建平%李少男%李小鹏
週琦%謝偉%徐建平%李少男%李小鵬
주기%사위%서건평%리소남%리소붕
血糖%校准%实验室
血糖%校準%實驗室
혈당%교준%실험실
Blood glucose%Calibration%Laboratories
目的 对日立和奥林巴斯全自动生化分析仪检测血糖作校准验证,旨在介绍一种作校准验证的方法并对校准验证的结果作评价.方法 按照不同分析仪器将血糖的检测数据分为日立组和奥林巴斯组.利用美国病理学家协会日前使用的校准验证方法对日立和奥林巴斯全自动生化分析仪检测血糖作校准验证,即对校准线的斜率和截距作单样本t检验并计算百分差异值,并将百分差异值与允许误差作比对.如果校准线的斜率与1和截距与0比没有统计学意义且百分差异值没有超过允许误差,判定为验证1；如果校准线的斜率与1和截距与0比没有统计学意义且至少一个百分差异值超过允许误差,判定为差异1；如果校准线的斜率与1或截距与0比有统计学意义且百分差异值没有超过允许误差,判定为验证2；如果校准线的斜率与1或截距与0比有统计学意义且至少一个百分差异值超过允许误差,判定为差异2.结果 在日立组,验证1、差异1、验证2和差异2分别占5.4％(4/74)、0.0％(0/74)、68.9％ (51/74)和25.7％(19/74).在奥林巴斯组,验证1、差异1、验证2和差异2分别占16.4％(12/73)、0.0％ (0/73)、58.9％(43/73)和24.7％(18/73).结论 美国病理学家协会使用的校准验证方法是合理的和可行的.大部分实验室(74 8％,110/147)可以通过这次校准验证评价.
目的 對日立和奧林巴斯全自動生化分析儀檢測血糖作校準驗證,旨在介紹一種作校準驗證的方法併對校準驗證的結果作評價.方法 按照不同分析儀器將血糖的檢測數據分為日立組和奧林巴斯組.利用美國病理學傢協會日前使用的校準驗證方法對日立和奧林巴斯全自動生化分析儀檢測血糖作校準驗證,即對校準線的斜率和截距作單樣本t檢驗併計算百分差異值,併將百分差異值與允許誤差作比對.如果校準線的斜率與1和截距與0比沒有統計學意義且百分差異值沒有超過允許誤差,判定為驗證1；如果校準線的斜率與1和截距與0比沒有統計學意義且至少一箇百分差異值超過允許誤差,判定為差異1；如果校準線的斜率與1或截距與0比有統計學意義且百分差異值沒有超過允許誤差,判定為驗證2；如果校準線的斜率與1或截距與0比有統計學意義且至少一箇百分差異值超過允許誤差,判定為差異2.結果 在日立組,驗證1、差異1、驗證2和差異2分彆佔5.4％(4/74)、0.0％(0/74)、68.9％ (51/74)和25.7％(19/74).在奧林巴斯組,驗證1、差異1、驗證2和差異2分彆佔16.4％(12/73)、0.0％ (0/73)、58.9％(43/73)和24.7％(18/73).結論 美國病理學傢協會使用的校準驗證方法是閤理的和可行的.大部分實驗室(74 8％,110/147)可以通過這次校準驗證評價.
목적 대일립화오림파사전자동생화분석의검측혈당작교준험증,지재개소일충작교준험증적방법병대교준험증적결과작평개.방법 안조불동분석의기장혈당적검측수거분위일립조화오림파사조.이용미국병이학가협회일전사용적교준험증방법대일립화오림파사전자동생화분석의검측혈당작교준험증,즉대교준선적사솔화절거작단양본t검험병계산백분차이치,병장백분차이치여윤허오차작비대.여과교준선적사솔여1화절거여0비몰유통계학의의차백분차이치몰유초과윤허오차,판정위험증1；여과교준선적사솔여1화절거여0비몰유통계학의의차지소일개백분차이치초과윤허오차,판정위차이1；여과교준선적사솔여1혹절거여0비유통계학의의차백분차이치몰유초과윤허오차,판정위험증2；여과교준선적사솔여1혹절거여0비유통계학의의차지소일개백분차이치초과윤허오차,판정위차이2.결과 재일립조,험증1、차이1、험증2화차이2분별점5.4％(4/74)、0.0％(0/74)、68.9％ (51/74)화25.7％(19/74).재오림파사조,험증1、차이1、험증2화차이2분별점16.4％(12/73)、0.0％ (0/73)、58.9％(43/73)화24.7％(18/73).결론 미국병이학가협회사용적교준험증방법시합리적화가행적.대부분실험실(74 8％,110/147)가이통과저차교준험증평개.
Objective To perform calibration verification for the blood glucose test in Hitachi and Olympus automatic biochemistry analyzers and present a method of calibration verification and evaluate the results.Methods The glucose test results were divided into two groups:Hitachi and Olympus groups according to the different analytical instruments.The calibration verification was performed following the current College of American Pathologists strategies.The slope and intercept of the calibration line were tested by one-sample t test and the percentage differences were calculated.The percentage differences were compared with allowable errors.If the slope and intercept had no statistically significant difference from 1 and 0 respectively and the percentage differences were within the limits of allowable errors,the calibration line was evaluated as verified 1 ; if the slope and intercept had no statistically significant difference from 1 and 0 respectively and at least one of the percentage differences exceeded the limits of allowable errors,the calibration line was evaluated as different 1 ; if the slope or intercept had statistically significant difference from 1 and 0 respectively and the percentage differences were within the limits of allowable errors,the calibration line was evaluated as verified 2; if the slope or intercept had statistically significant difference from 1 and 0 respectively and at least one of the percentage differences exceeded the limits of allowable errors,the calibration line was evaluated as different 2.Results In Hitachi group,verified 1,different 1,verified 2 and different 2 were 5.4％ ( 4/74 ),0.0％ ( 0/74 ),68.9％ ( 51/74 ) and 25.7％ ( 19/74 ),respectively.In Olympus group,verified 1,different 1,verified 2 and different 2 were 16.4％ (12/73),0.0％ (0/73),58.9％ (43/73) and 24.7％ ( 18/73 ),respectively.Conclusions The current College of American Pathologist strategies could be performed as a reasonable and feasible method for calibration verification.Most of participating laboratories ( 74.8％,110/147 passed the assessment of calibration verification.
