Evaluation and application of automated quality control of automatic pipeline in clinical biochemical and immunological detection / 中华检验医学杂志

Objective:To assess the applicability of fully automatic pipeline automated testing for internal quality control (automated quality control).Methods:Stability, assay efficiency and implementation costs of 18 biochemical tests, 5 immunoturbidimetric tests and 11 chemical illuminescent tests in the Department of Laboratory Medicine of Peking Union Hospital from January 2019 to July 2022 were evaluated using automated quality control implementation methods. The detailed method is as follows: quality control materials for biochemical, immunoturbidimetric and chemiluminescent tests were stored in the refrigerator in the pipeline which was controlled by the intermediate software, and were automatically retrieved and tested as pre-set followed by documenting and storing. The quality control setup for the biochemical tests included refreshing quality control materials daily and weekly,both of which were paralleled for 3 months. The on-line storage stability of quality control materials in the pipeline was evaluated by comparing the coefficients of variation ( CV) of the quality control results between the two patterns. Effect of automated quality control application was evaluated using 6 indicators, including the results′ variation of automatically performed and manually performed quality controls, the out-of-controlled rate, the consumption of quality control materials, the change of staff workload, the impact on the testing time of the first sample, and the failure rate of automated quality control. Results:(1) Storage stability of quality control materials in the pipeline: under the pattern of weekly refresh of the biochemical quality control materials, except for total carbon dioxide (TCO 2) (the CVs of low and high level quality control were respectively 20.24% and 21.82%) and sodium (the CV of low level quality control was 1.51%) that were greater than the allowable variation set by the laboratory, the CVs of the rest tests meet the lab requirements on the allowable variations. (2) The results′ variation of quality control in automatically performed and manually performed control patterns: in the patterns of daily refresh of biochemical quality control materials and weekly refresh of immunoturbidimetric and chemiluminescent quality control materials, the CVs of both low and high levels of quality control were lower in the automatically performed control pattern than that in manually performed pattern for 8 chemiluminescent items of dehydroepiandrosterone sulfate, estradiol, follicle stimulating hormone, luteinizing hormone, serum ferritin, serum folic acid, vitamin B12 and testosterone, 3 immunologic items of complement 3, C reactive protein and immunoglobulin G, and 10 biochemical items of alkaline phosphatase, glucose, calcium, chloride, potassium, lactate dehydrogenase, sodium, urea, low density lipoprotein cholesterol, and adenosine deaminase. The out-of-control rates of biochemistry, immunoturbidimetric and chemiluminescence tests in both quality control patterns conformed with the clinical routine work requirements. (3) Comparison of quality control materials′ consumption: compared with manually performed quality control, weekly consumption of automatically performed chemiluminescent quality control materials decreased 37.5% (from 8 ml to 5 ml); weekly consumption of automatically performed immunoturbidimetric quality control materials decreased 33.3% (from 3 ml to 2 ml). (4)Comparison of staff workload and first sample testing time: compared with manually performed quality control, automatical quality control reduced manual work by about 156 steps per week, and the daily initial testing time was earlier by 15 min on average. The failure rate was 54.5% (37/64) during the early-stage application of the automated quality control which dropped to 10.2% (13/128) in the late-stage. Conclusion:The results of automated quality control detected in the pipeline system meet the quality indicators′ requirements of the laboratory, and the application of automated quality control can improve the quality control, save costs, reduce workload, and improve work efficiency.

Explore the reasons affecting the consistency of reference intervals established by two types of indirect methods for 34 biochemical analytes / 中华检验医学杂志

Objective:To compare the differences of reference intervals (RI) established by two types of indirect methods for 34 biochemical analytes, and to explore the possible factors that affect the consistency of the two methods.Methods:This was a retrospective study. Based on data of albumin (Alb), alkaline phosphatase (ALP), alanine aminotransferase (ALT), apolipoprotein A1(ApoA1), ApolipoproteinB (ApoB), aspartate aminotransferase (AST), calcium (Ca), cholinesterase (ChE), chloride (Cl), creatinine (Cr), high-sensitivity C-reactive protein (hsCRP), Cystatin (CysC), direct bilirubin (DBil), free fatty acid (FFA), glycated albumin(GA), gamma-glutamyltransferase (GGT), glucose (Glu), high density lipoprotein cholesterol (HDL-C), potassium (K), lactate dehydrogenase (LD), low density lipoprotein cholesterol (LDL-C), lipoprotein a [Lp (a)], sodium (Na), phosphorus (P), prealbumin (PA), superoxide dismutase (SOD), total bile acid (TBA), total bilirubin (TBil), total cholesterol (TC), total carbon dioxide (TCO 2), triglyceride (TG), total protein (TP), uric acid (UA) and urea (UR) of individuals who underwent physical examination at Peking Union Medical College Hospital from January 1, 2018 to December 31, 2019, Box-Cox algorithm was used to improve the data distribution and Tukey method was used to identify outliers. Variance component model was established, and standard deviation ratio (SDR) was calculated to determine whether the RIs of 34 biochemical analytes should be established according to age or sex The non-parametric method and kosmic algorithm were used to establish the RIs and 90% confidence intervals (CIs) of 34 biochemical analytes, and the coincidence of the 90% CIs of the reference limits for two methods was compared. Results:The skewness coefficients of ALP(male, female18-59), ALT, AST, hsCRP, DBil, GGT, Lp (a), TBA, TBil, TG, Glu, HDL-C(male) and CysC, GA, UR in the elderly group deviated from 0, and their kurtosis coefficients also deviated from 3. For these biochemical analytes, the point estimates of the RIs established by the two methods differed greatly and the 90% CIs did not overlap. The analytes with good normality were Alb, ApoA1, ApoB, Ca, ChE, Cl, Cr(E), CysC(18-59), FFA, GA(18-59), HDL-C(female), K, LDL-C, Na, P, PA, SOD, TC, TCO 2, TP and UR. The consistency is good. Except for Ca, 90% CIs of reference limits for some analyte between the two methods coincide with each other. Conclusions:The consistency of different indirect methods is affected by the normality of data.

Reference Intervals for Thyroid-Associated Hormones and the Prevalence of Thyroid Diseases in the Chinese Population

Background@#Thyroid diseases are highly prevalent worldwide, but their diagnosis remains a challenge. We established reference intervals (RIs) for thyroid-associated hormones and evaluated the prevalence of thyroid diseases in China. @*Methods@#After excluding outliers based on the results of ultrasound screening, thyroid antibody tests, and the Tukey method, the medical records of 20,303 euthyroid adults, who visited the Department of Health Care at Peking Union Medical College Hospital from January 2014 to December 2018, were analyzed. Thyroid-associated hormones were measured by the Siemens Advia Centaur XP analyzer. The RIs for thyroid-associated hormones were calculated according to the CLSI C28-A3 guidelines, and were compared with the RIs provided by Siemens. The prevalence of thyroid diseases over the five years was evaluated and compared using the chi-square test. @*Results@#The RIs for thyroid stimulating hormone (TSH), free thyroxine (FT4), free triiodothyronine (FT3), total thyroxine (TT4), and total triiodothyronine (TT3) were 0.71–4.92 mIU/L, 12.2–20.1 pmol/L, 3.9–6.0 pmol/L, 65.6–135.1 nmol/L, and 1.2–2.2 nmol/L, respectively. The RIs of all hormones except TT4 differed significantly between males and females. The RIs of TSH increased with increasing age. The prevalence of overt hypothyroidism, overt hyperthyroidism, subclinical hypothyroidism, and subclinical hyperthyroidism was 0.5% and 0.8%, 0.2% and 0.6%, 3.8% and 6.1%, and 3.3% and 4.7% in males and females, respectively, which differed from those provided by Siemens. @*Conclusions@#Sex-specific RIs were established for thyroid-associated hormones, and the prevalence of thyroid diseases was determined in the Chinese population.

Consistency evaluation of thyroid stimulating hormone results from 4 chemiluminescence assays / 临床检验杂志

Objective@#To compare the consistency of thyroid stimulating hormone (TSH) results from four chemiluminescence assays. @*Methods@#A total of 102 fresh serum samples from Peking Union Medical College Hospital during March 2018 and April 2018 were collected for precision evaluation and methodological comparison referring to CLSI EP15-A2 and EP9-A2 protocols. The levels of serum TSH were detected by Abbott i2000 (system A), Beckman DXI800 (system B), Siemens ADVIA Centaur XP (system C) and Roche e601 (system D) automatic chemiluminescence analyzers and their matching reagents, respectively. The obtained results were compared with the passing-bablok and Bland Altman methods. Taking 0.27 μIU/mL and 5.33 μIU/mL as the medical decision level, the expected bias of each detection system was compared. @*Results@#The precisions of systems A,B,C and D were 1.7%-3.3%， 2.3%- 3.9%，0.7%-2.3% and 0.6%-1.5%,respectively. The median (P 25,P 75) of TSH concentrations detected by systems A,B,C and D were 1.898 (0.518,4.809)μIU/mL, 2.819 (0.719,7.020)μIU/mL,2.502 (0.692,6.888)μIU/mL and 3.105 (0.886, 7.905)μIU/mL, respectively. The coefficients of determination (R 2 ) of regression equation were above 0.975 for 4 detection systems. The correlation coefficients (r), intercepts and slopes of 4 detection systems were 0.993 5-0.997 1, 0-0.06 and 0.59-1.15, respectively, and systems B and C had the best correlations with 1.02 of slope and 0 of intercept. The deviation plot showed that the bias% of 4 detection systems was between -48.1% and 17.3%. Among them, systems A and D had the largest bias, while systems B and C had the lowest bias. The expected bias of 4 detection systems at the medical decision level was -40.7%-37.2%. @*Conclusion@#The consistency between Beckman and Siemens TSH detection systems is good, while those of Roche and Abbott TSH detection systems are different from the other two.

Comparative analysis of biochemical test results between arterial and venous blood / 中华检验医学杂志

Objective To investigate whether there are differences in the detection of biochemical items such as electrolytes , total protein and urea between arterial plasma and venous plasma .Methods Self paired design was used to compare and study the biochemical results of different samples .70 samples ( 36 samples from male patients and 34 from female patients ) that were performed with both arterial blood gas analysis and biochemical item test of venous blood in Clinical Laboratory of Peking Union Medical College Hospital during the period from June to September of 2017 were collected.18 biochemical items like electrolytes in arterial blood and venous blood were synchronously detected by automatic biochemical analyzer.Statistic analyses were carried out by SPSS 18.00.Whether the deviation was of clinic significance was determined by National Health Standards ( WS/T 403-2012 ) and the total error admitted by Royal Society of Pathology of Australia .Regression analysis of Passing-Bablok was performed by MedCalc software . The difference between the results of different samples was investigated by drawing Bland -Altman diagram.Results The results of Ca, Cl, K, Na, P, TP, ALB, ALT, AST, LDH, Glu, Cr, Urea, TG, CHO, UA, CHE, TBA in the samples of arterial blood plasma were 2.46(2.25-2.56) mmol/L,(105.68 ±7.29)mmol/L, 3.81(3.54-4.03) mmol/L, 140.45(137.08-144.20) mmol/L, 0.97(0.77-1.11) mmol/L,(60.39 ±9.40)g/L,(31.23 ±6.81)g/L, 17.4(11.95 -30.05)U/L, 20.85(14.9 -34.03) U/L, 210.1(163.15-342.60) U/L, 7.58(5.95-10.04) mmol/L, 76.35(51.05-110.7) μmol/L, 6.94(3.98-11.08) mmol/L, 1.15(0.84-1.89) mmol/L, 3.31(2.73-4.35) mmol/L, 271.55(187.78-423.30) μmol/L,(4.71 ±2.17)KU/L, 2.19(1.09 -4.19) μmol/L,respectively, and 2.24(2.05-2.35) mmol/L,(103.98 ±7.32)mmol/L, 3.84(3.58 -4.19) mmol/L, 139.30(136.08 -142.33) mmol/L, 0.99(0.78-1.14) mmol/L,(60.37 ±9.67) g/L,(32.62 ±6.89) g/L, 17.6(12.75-31.2) U/L, 20.6(15.28-36.6) U/L, 233.95(176.48-363.75) U/L, 7.55(5.62-9.52) mmol/L, 77.15 (56.08-111.98) μmol/L, 6.94(3.97 -10.53) mmol/L, 1.13(0.83 -1.93) mmol/L, 3.23(2.71-4.37) mmol/L, 273.4(187.30-401.55) μmol/L,(4.74 ±2.21) KU/L, 2.29(1.02 -4.23) μmol/L respectively in the samples of venous blood plasma .The difference of results of TP、Glu、Cr、TG、CHE、TBA between two types of samples were of no statistic significance ( the values of t or Z were 0.121,-0.054,-0.269,-0.480,-1.730 and -1.843 respectively, P>0.05), among these items the difference of Glu was of notable clinical significance (>1/2 TE percentage:50％).The difference of results of Ca , Cl, K, Na, P, ALB, ALT, AST, LDH, Urea, CHO, UA between two types of samples were of statistic significance (the values of t or Z were -7.115,6.794,-2.119,-4.996,-3.483,-8.839,-2.419,-2.742,-3.833,-5.010,-2.060 and -2.467 respectively, P<0.05), among these items the difference of Urea, CHO, UA, Na, P and ALT was of no notable clinical significance ( >total TE percentage: 0％, 2.86％, 0％, 2.9％, 4.3％, 1.43％ respectively), while the difference of Ca, Cl, K, ALB, AST and LDH was of clinical significance (>total TE percentage:90％, 10％, 14.3％, 32.9％, 10.00％, 32.9％respectively).Conclusions The differences in the detected data of some biochemical items between venous plasma and arterial plasma demonstrated clinical significance .When detecting those biochemical items , clinicians should pay attention to the selection of arterial blood sample .It should be considered to establish a reference interval for related biochemical items of arterial blood when necessary .

Clinical application of companion diagnostics:Present and future / 中华检验医学杂志

The companion diagnostics (CD), which is closely linked to a particular therapeutic product ( including drugs and biologicals ) , can determine patients who are likely to benefit from the treatment, and which patients have significant increased risks of serious adverse reactions to this treatment . With the release of 2014 US Food and Drug Administration ( FDA)′s In Vitro Companion Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff , the concept , scope, and usage specifications of the CD have become clearer .As the precision medicine and individualized treatment rapidly develops , the CD is progressing from the traditional field of oncology treatment to the treatment and prevention of other diseases.At the same time, the technology of CD is no longer limited to molecular biology test .More biomarkers are gradually being concerned about and the tests to detect them are expected to develop into CD .

Revision of the Effort-Reward Imbalance for Learning Scale / 中国心理卫生杂志

Objective:To revise the Chinese version of the Effort-Reward Imbalance for Learning Scale (LE-RIS)and examine its validity and reliability. Methods:Totally 230 middle school students from Shaanxi Province were recruited for the preliminary survey of the LERIS (214 valid questionnaires). The formal LERIS was set through item analysis and exploratory factor analysis. Then,5 10 middle school students from Shandong and Shaanxi Province were selected to complete the formal LERI for the confirmatory factor analysis and the Internal consistency analysis. The Study Stress Questionnaire for Middle School Students (SSQMSS )were selected as the criterion measurement which to examine the association between study stress and effort-reward imbalance. Test-retest relia-bility were examined by 260 participants random selected after one month. Result:The Chinese version of the LERI with 10 items had 3 dimensional structures,which were effort,reward and overcommitment. Confirmatory factor a-nalysis showed that the Chinese version of the LERI had good structure validity (RMSEA=0. 0,NFI=0. 901,CFI=0. 910,GFI=0. 905,PGFI=0. 521). The Cronbach's αcoefficients were 0. 86 to 0. 89 for the three subscales, and the test-retest reliability coefficients were 0. 63 -0. 7 1 for the three subscales. Conclusion:It suggests that the Chinese version of the Effort-Reward Imbalance for Learning (LERI)is a reliable and valid assessment and couldbe used as an effective and reliable tool for assessing academic pressure of middle school students in china.