自建检测系统常用生化项目校准周期的建立

Calibration cycles establishment of frequently used biochemical items in self-developed detecting system

目的建立我科室自建检测系统24个生化项目的校准周期。方法先更换24个常用生化项目的试剂,然后对这些项目进行校准,取低值浓度水平的质控品,校准当天0h、4h、8h、24h测定,每次重复4次,此后每24h测定1次,连续测定至第30d。当允许总误差(TEa)以相对数表示时,计算第n天以及此前所有质控结果的累积变异系数(CCVn);当TEa以绝对数表示时,计算第n天质控结果均值与第1天质控结果均值之差(QCn-QC1)。以1/6TEa作为判断阈值,当某项目第n天的CCVn或QCn-QC1超过其判断阈值时,(n-1)天即为该项目的校准周期。结果总蛋白(TP)、白蛋白(ALB)、总胆红素(TBIL)、间接胆红素(DBIL)、丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)、γ-谷氨酰转肽酶(GGT)、拟胆碱酯酶(Pche)、尿酸(UA)、肌酐(Cr)、肌酸激酶(CK)、α-羟丁酸脱氢酶(HBDH)、血糖(GLU)、甘油三酯(TG)、钾(K+)、氯(Cl-)、镁(Mg)、磷(P)的校准周期≥30d,钠(Na+)、总胆固醇(TC)、总钙(Ca)、乳酸脱氢酶(LDH)、尿素氮(BUN)的校准周期分别为12d,9d、7d、7d、1d。结论我科建立的校准周期与其他文献报道有一定的差别,不同实验室有必要建立自己的校准周期。

Objective To establish the calibration cycles of 24 biochemlcal items of the self-developed detecting system in our department. Methods These 24 biochemical items were calibrated after replacing the reagents, and the low-concentration quality-control sample was measured 5 times at the 1st day, and measured 1 times from the 2nd day to the 30th day. If the allow- able total error（TEa） was expressed by the relative number, the cumulative coefficient of variation（CCVn） was calculated. If the TEa was expressed by the absolute number, the difference of minus （QC n-QC l） was calculated. Taking the 1/6TEa as the cut^off val- ue, if the CCVn or QC ,-QC 1 of any item was more than its cut-off value, the calibration cycle of this item was （n-l） d. Results The calibration cycles of total protein （TP）, albumin （ALB）, total bilirubin （TBIL）, indirect bilirubin （DBIL）, alanine aminotrans- ferase （ALT）, aspartate aminotransferase （AST）, alkaline phosphatase （ALP）, ~/-glutamyl transpeptidase （GGT）, pseudocholinesterase （Pche）, uric acid （UA）, creatinine （Cr）, creatine kinase （CK）, c^-hydroxybutyrate dehydrogenase （HBDH）, blood glucose （GLU）, triglyceride （TG）, potassium （K＋）, chlorine （C1-）, magnesium （Mg） and phosphorus （P） were all more than or equal to 30d~ and the calibration cycles of sodium （Na＋）, total cholesterol （TC）, total calcium （Ca）, lactate dehydrogenase （LDH） and biood urea nitrogen （BUN） were 12d , 9d , 7d ,3d and ld respectively. Conclusion The calibration cycles of biochemical items in our department were different from other literature reports, so it is necessary to establish their calibration cycles in different laboratories.