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Objective:To provide consistent data basis for the application of reference intervals for children blood cell analysis in different testing systems.Methods:According to the requirements of American Institute for Clinical and Laboratory Standardization (CLSI) EP9-A3 document, 45 samples were collected and Sysmex XN20-A1 were used as reference system. Beckman DxH800, Siemens ADVIA 2120i, and Mindray BC5310 were comparison systems. Complete blood count and leukocyte classification were performed by four systems. The outliers of the detection results were tested by the generalized extreme student deviate (ESD) method. An optimal regression model was selected by scatter diagram, deviation diagram and frequency distribution diagram, which was used to fit the regression equation and calculate the deviation at the medical decision level and reference interval. The acceptable range for blood count deviation was cited from the Analytical Quality Specifications for Routine Tests in Clinical Hematology. The acceptable range for leukocyte classification was based on the EQA program of Royal College of Pathologists of Australasia (RCPA).Results:After the outliers were deleted, the scatter plot showed a linear relationship between the reference system and the three comparison systems. The deviation plot showed that the differences were variable. Deming regression or Passing-Bablok regression was selected according to the data distribution. The determination coefficient R2 of reference system and three comparison systems ranged from 0.95 to 0.99 in blood count and leukocyte classification. At the upper and lower limits of the reference interval, the deviations between XN-20A1 and ADVIA 2120 system were all acceptable, except for MONO# at 0.12×10 9/L. The deviations of all parameters at medical decision level were within acceptable ranges. The lower limit of PLT is partially unacceptable at the level of medical decision related to treatment and prognosis. Conclusions:The results of complete blood count and leukocyte classification in reference system and the comparison system had good consistency within the children′s reference interval. Our study provided a scientific basis for the feasibility of adopting a unified reference interval for different detection systems.
RESUMO
To establish an HPLC method for the determination of impurity Ⅰ and impurity Ⅱ in latanoprost eye drop.HPLC separation was carried on a Zorbax SB-C1s column (4.6 mm250 mm,5 m) with the mobile phase consisting of methanol-acetonitrile-water (adjusting pH to 3.0 with acetic acid) (56 ∶ 14 ∶ 30).The flow rate was 1.0 mL/min;the detection wavelength was 210 nm;and the injection volume was 100 μL.Impurity Ⅰ,impurity Ⅱ and latanoprost were separated efficiently under the selected HPLC conditions,with good linearity in the range of 0.049 99-0.999 8 g/mL for impurity Ⅰ and 0.049 94-0.998 8 g/mL for impurity II.The average recoveries of impurity Ⅰ and Ⅱ were 96.74％ (n =9) and 94.99％ (n =9),respectively.The established method can be used for the detection of stereoisomers in latanoprost eye drop.
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The pediatric reference intervals in clinical laboratory play an important role in diagnosis of illness,therapeutic monitoring,prediction of prognosis and health evaluation.Compared with establishing reference interval for adults,there are more challenges to establish pediatric reference intervals.Therefore,the procedure and key technologies of direct method and indirect method are stated based on the characteristics of children population and pediatric,by which to define,transfer and validate pediatric reference intervals.This study will provide systematically methodological ideas for clinical laboratories to establish pediatric reference intervals.
