Abstract:

Objective To investigate the imprecision level of dry chemistry tests in China through analyzing the internal quality control data of dry chemistry tests reported by 374 laboratories in 2014 according to the specifications based on biological variation and the health industry standard WS/T 403-2012 of China. Methods Web-based external quality assessment system was used to collect internal quality control data of 2 concentrations (concentration 1 and concentration 2)of dry chemistry tests from 374 laboratories in February 2014, including the internal quality control coefficients of variation (CV) of 22 items, potassium, sodium, chloride, calcium, phosphorus, blood glucose, urea, uric acid, creatinine, total protein, albumin, total cholesterol, triglyceride, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, amylase, creatine kinase, lactate dehydrogenase, magnesium and gamma-glutamyltransferase. CLinetlab IQC V3.0 were applied for data processing. The percentages of laboratories meeting the quality requirements were calculated to reflect whether the imprecision of different test systems can meet the quality requirements. Results Combined with the concentrations of 1 and 2, for the results according to the specifications based on biological variation, seven projects such as urea, uric acid, triglyceride, total bilirubin, alanine aminotransferase, creatine kinase and gamma-glutamyltransferase were quite satisfied. Laboratories meeting the specifications based on biological variation including the desirable, minimal and optimal allowable imprecisions were above 92%, 95% and 60%, respectively. Blood glucose,total cholesterol,potassium, phosphorus, aspartate aminotransferase, amylase and lactate dehydrogenase were basically satisfied, laboratories who met the desirable allowable imprecision accounted for 60% to 90%, more than 87% laboratories met the minimal specification, but the percentages who met the optimal specification was relatively low which was between 5.70% and 69.74%. However, for items like sodium, chloride, calcium, total protein, albumin and magnesium, laboratories who met the desirable specification was nothing much. For the results based on health industry standard WS/T403-2012, the imprecision level of each laboratory is really satisfied, and the percentages of laboratories meeting the requirement was basically between 47% and 70%. Conclusions Based on the data above, the percentage of laboratories meeting the requirement varies between different items. Laboratories shall set proper quality requirements, strengthen their deficiency and improve the testing quality, so as to improve the present situation of dry chemistry tests in our country.

Key words: Imprecision, Internal quality control, Dry chemistry, Coefficient of variation, Biological variation, Industry standard