Case report of pseudoelevated serum testosterone in women and literature review / 中华检验医学杂志

Objective:The characteristics of women with false elevated testosterone were analyze and the literature was reviewed to provide reference for clinical laboratory identification of false elevated testosterone.Methods:The characteristics of three patients with false elevated testosterone in Peking Union Medical College Hospital were analyzed retrospectively, and the results of different detection platforms and methods for the determination of testosterone levels were compared. International and domestic literatures related to false elevation of testosterone and detection methods of testosterone were searched for a comprehensive analysis from PUBMED and CNKI.Results:The levels of testosterone in 3 female patients were elevated by immunoassay and normal by mass spectrometry. They were excluded from the diagnosis of hyperandrogenemia. A total of 38 literatures related to testosterone detection were retrieved, of which 9 case reports of pseudohyperandrogenemia, among which 12 cases of pseudohyperandrogenemia were reported in 2 domestic literatures in 2021. All cases were confirmed by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Previous studies have clearly indicated that the result of routine immunoassay in clinical laboratory for the determination of female testosterone have poor correlation with the results of LC-MS/MS, with varying degrees of deviation.Conclusions:Immunoassay tests for female testosterone is susceptible to interference and lead to elevated false results. It is suggested that clinical laboratories evaluate the detection methods used and establish a identification program, and confirm samples with suspected pseudoelevated testosterone elevation using other immune platforms or LC-MS/MS.

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.

Survey for variation of prevalence of hyperuricemia and its correlations with blood glucose and lipid in healthy adults receiv-ing physical examination at Peking Union Medical College Hospital from 2012 to 2017 / 临床检验杂志

Objective To investigate the changes of prevalence of hyperuricemia ( HUA) and its correlations with blood glucose and lipid in healthy adults receiving physical examination at Peking Union Medical College Hospital (PUMCH) from 2012 to 2017. Meth-ods An observational approach was adopted for the data analysis.The test results of uric acid (UA),fasting blood glucose (FBG),to-tal cholesterol (TC),triacylglycerol (TG),low density lipoprotein cholesterol (LDL-C),high density lipoprotein cholesterol (HDL-C), creatinine (Cr) and Urea of 399 089 cases (206 881 males and 192 208 females) at PUMCH from January 2012 to December 2017 were collected and statistically analyzed.Results The total prevalence of HUA was 17.4% in which the prevalence of males was signif-icantly higher than that of females (25.6% vs 8.5%,χ2＝20 234.850,P＜0.01).During the years of 2012 to 2017,the prevalence of HUA was 26.5%,24.7%,28.6%,23.9%,24.8% and 24.5% in males,and 13.8%,6.3%,7.9%,6.1%,6.2% and 6.8% in females for each year respectively.The prevalence of HUA in males aged 18 to 64 years old was significantly higher than that in the age-matched fe-males (all P＜0.05).However, the prevalence of HUA in males aged≥65 years old was similar to the age-matched females.There was no statistically significant difference of HUA prevalence between males and females aged ≥65 in 2013,2015,2016 and 2017 ( χ2＝1.792,0.017,1.440 and 0.205 respectively;all P＞0.05).The percentages of hyperlipidemia in both males and females of HUA group were higher than those of non-HUA group respectively (all P＜0.01).The percentage of hyperglycemia in males of non-HUA group was higher than that of HUA group,but the percentage of hyperglycemia in females of non-HUA group was lower than that of HUA group ( all P＜0.01).High levels of TC,TG and FBG were risk factors of HUA with increased OR values in increased concentrations of TC,TG and FBG,respectively.Conclusion During the recent 6 years, in healthy adults receiving physiced examination at PVMCH, the preva-lence of male HUA diagnosed was at overall high level,but the prevalence of female HUA was in decreasing and relatively stable trend. Hyperlipidemia and hyperglycemia should be the risk factors of HUA.

Quantification of human urine aldosterone by LC-MS/MS / 中华检验医学杂志

Objective To establish a method for quantification of aldosterone (ALD) in urine by LC-MS/MS.Methods This study was the establishment and validation of methodology for urine ALD using LC-MS/MS.The urine samples were hydrolyzed at 37 ℃ by hydrochloric acid and the deuterated isotope internal was then added , followed by protein precipitation and anion exchange solid phase extraction (SPE). After SPE, the eluates were detected in the negative electro-spray ionization mode and multiple reaction monitor mode.The linearity, lower limits of quantification , precision and recovery of LC-MS/MS were evaluated.Urine and serum ALD of 80 subjects were measured by LC-MS/MS to evaluate the correlation of ALD detected in serum and 24 h urine.70 urine samples were collected and measured with LC-MS/MS and CLIA method for ALD comparison.14 participants were recruited to study the distribution of urine ALD in apparent healthy population .Results The analytical time was 4.5 min.Linearity of ALD was good in the range of 2-1 000 pg/ml (R2＞0.990); the repeatability and CV of ALD were less than 4.0% and 5.0%respectively; the recovery of urine ALD ranged between 100.4%and 108.2%; the lower limits of detection was 1 pg/ml.The correlation between urine and serum ALD was 0.396.The method comparison resulted in linear equation Y＝0.998 8X+0.046 4(r＝0.991).The distribution of urine ALD in apparent healthy subjects were 0.74-17.09 μg/24 h.Conclusion A reliable and specific LC-MS/MS method for urine ALD was established.And condition of the acid hydrolyzation for urine ALD was optimized .The method is simple, rapid and it can be used for the diagnosis of primary aldosteronism.

Investigated the prevalence of hypouricemia in Peking Union Medical College Hospital / 中华检验医学杂志

Objective To investigate the prevalence and possible factors of hypouricemia in Peking Union Medical College Hospital.Methods A retrospective investigation.Serum uric acid, lipids, glucose and other chemistry tests were analyzed among 83176 outpatients(Male:30795,Female:52381), 15849 inpatients(Male:7402,Female:8447)and 24081 healthy subjects(Male:11859,Female:12222)in Peking Union Medical College Hospital from December 2015 to April 2016.Grouped by gender and age, the prevalence of hypouricemiawas analyzed in all subjects and the etiology and possible risk factors of hypouricemia were explored among all patients.Results The serum uric acid of outpatients,inpatients and healthy subjects were 286(235-348)μmol/L, 282(226-348)μmol/L and 298(244-358)μmol/L, respectively.And the prevalence were 0.6%(499/83176),2.5%(390/15849)and 0.2%(39/24081), respectively.The prevalence of hypouricemia ofwomen was significantly higher than that ofmen(outpatients:0.7%vs 0.4%,P<0.001;inpatients:2.8%vs 2.1%,P=0.004;healthy subjects:0.30%vs 0.04%, P<0.001).After analyzing 507 hypouricemia patients, the top three clinical diagnoses that related with hypouricemia were kidney diseases, tumor and rheumatic diseases.Compared with the control group, the prevalence of hypouricemia in hypertriglyceridemia group and group with eGFR higher than 90 ml/(min· 1.73 m2)were lower(OR:0.33, 95% CI:0.21-0.50; OR:0.16, 95% CI:0.09-0.29), and the prevalence of hypouricemia in hyperglycemia group was higher(OR:1.62, 95% CI:1.12-2.35). Conclusion The prevalence of hypouricemia of Chinese women was higher than that of men and may be related with TG,Glu and eGFR.

Performance verification of six enzymatic glycated albumin reagents / 中华检验医学杂志

Objective To validate the performance of six enzymatic glycated albumin reagents and evaluate their clinical application.Methods The performance of six enzymatic glycated albumin reagents(labled as A,B,C,D,E,F) from Beijing Jiuqiang Co, Beijing Lideman Co,Ningbomeikang Co, Beijing Haomai Co, Sichuan Maike Co and Asahi Kasei Co were assessed on Olympus AU5800 automatic biochemistry analyzer.According to the standard of CLSI,the precision,interference and linear correlation of these reagents were assessed.To assess the accuracy of GA% ,we used GA standard material whose value had been assigned using ID-LC/MS method provided by ReCCS.To do the method comparison and determine the consistency of assay, 50 fresh serum samples of T2DM outpatient and 80 fresh serum samples of apparently healthy people in Jan 2016 were tested using six kits.According to the EP28-A3C protocol, the reference range for GA%was validated in 122 apparently healthy individuals undertaking medical examination from January to February 2016 in PUMC.Results The precision,and the ability of anti-interference of the six reagents were good.The accuracy percentage deviation of six reagents was-19.3%-9.2%.The correlation coefficient of domestic reagents A to E and imported reagents F in the determination of GA% was 0.966-0.999, the average absolute bias was 7.0%-10.4%.The coincidence rate of A-E and F in determining abnormal GA% was between 88.5% and 96.9%.The coincidence rate was increased after switching to the reference range for preliminary clinical evaluation.Conclusion Six GA enzymatic kits used in automatic biochemical analyzer have high precision and strong anti-interference ability.Accuracy still needs to be improved.