实验室内分泌项目测量不确定度的评定研究.docx

实验室内分泌项目测量不确定度的评定研究

曾露云杨晓俊靳晓雯

[关键词]?评定；测量不确定度；自上而下；内分泌项目

[中图分类号]?R446????[文献标识码]?A????[DOI]?10.3969/j.issn.1673-9701.2024.03.010

Evaluation?of?measurement?uncertainty?of?laboratory?endocrine?test?items

ZENG?Luyun1，?YANG?Xiaojun2，?JIN?Xiaowen1

1.Department?of?Clinical?Laboratory，?Beijing?Xicheng?District?Maternal?and?Child?Health?Hospital，?Beijing?100054，?China;?2.Department?of?Epidemiology?and?Health?Statistics，?School?of?Public?Health，?Capital?Medical?University，?Beijing?Municipal?Key?Laboratory?of?Clinical?Epidemiology，?Beijing?100069，?China

[Abstract]?Objective?To?evaluate?the?measurement?uncertainty?of?endocrine?test?items?by?“top-down”?method.?Methods?The?“top-down”?method?in?the?technical?report?of?CNAS-CL01-G003：?2021?“Medical?Laboratory-Evaluation?and?Expression?of?Measurement?Uncertainty”?was?used，?collecting?the?laboratorys?internal?quality?control?data?and?the?external?quality?assurance?results?of?Beijing?Clinical?Laboratory?Center?from?2019?to?2021.?To?evaluate?the?measurement?uncertainty?of?11?endocrine?tests?including?free?triiodothyronine?（FT3），?total?triiodothyronine?（TT3）?and?free?thyroxine?（FT4）.?Results?The?relative?expanded?uncertainties?of?11?endocrine?test?items?in?laboratory?were?FT3：?12.658%，?TT3：?13.372%，?FT4：?10.468%，?total?thyroxine?（TT4）：?32.382%，?thyroid?stimulating?hormone?（TSH）：?8.594%，?estradiol?（E2）：?18.656%，?follicle-stimulating?hormone?（FSH）：?14.650%，?luteinizing?hormone?（LH）：?29.384%，?progesterone?（PRO）：?28.806%，?prolactin?（PRL）：?13.810%?and?testosterone?（TESTO）：?31.610%.?At?the?normal?concentration?level，?the?relative?expanded?uncertainties?were?FT3：?12.424%，?TT3：?12.462%，?FT4：?8.606%，?TT4：?14.130%，?TSH：?12.536%，?E2：?19.586%，?FSH：?14.382%，?LH：?23.400%，?PRO：?38.346%，?PRL：?16.014%?and?TESTO：?39.352%.?The?relative?expanded?uncertainties?at?high?concentration?levels?are?FT3：?13.882%，?TT3：?14.096%，?FT4：?11.040%，?TT4：?8.614%，?TSH：?7.782%，?E2：?14.366%，?FSH：?13.436%，?LH：?14.804%，?PRO：?11.574%，?PRL：?17.742%，?TESTO：?39.322%.?The?relativ