Pub Date : 2024-09-14DOI: 10.1177/00045632241277506
Katharine Hayden, Sarah Robinson
{"title":"LabMedUK24 conference Brighton – editorial","authors":"Katharine Hayden, Sarah Robinson","doi":"10.1177/00045632241277506","DOIUrl":"https://doi.org/10.1177/00045632241277506","url":null,"abstract":"","PeriodicalId":519215,"journal":{"name":"Annals of Clinical Biochemistry: International Journal of Laboratory Medicine","volume":"46 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-12DOI: 10.1177/00045632241287135
Xiangmei Gong, Shukang He, Li Luo, Chunyu Ding, Xin Qin, Yilong Yuan, Pengcheng Cai, Lihua Yang
Background: To determine delta check limits for immunoglobulins and complements in outpatients and inpatients based on patient data and biological variation due to the lack of relevant studies. Methods: Patient data for IgA, IgG, IgM, IgE, C3 and C4 from January 1st, 2022 to December 31st, 2023 was collected from laboratory information system (LIS) in our clinical laboratory of wuhan union hospital, which includes both outpatients and inpatients. The delta difference (DD), delta percent change (DPC) and reference change value (RCV) were calculated based on patient data and biological variation. Results: For DDs, there are significant differences between outpatients and inpatients in C4, IgE, IgG, and IgM. For DPCs, the corresponding analytes which are significantly different are C3, C4, IgE, IgG, and IgM. Two sources of CVI to calculate the RCV of IgA, IgG, IgM, C3 and C4 were applied in this study, which revealed that two kinds of RCVs based on different biological variation databases are similar to each other, but both were smaller than delta check limits based on patient data, except for C4. Conclusions: The delta check is a useful tool to monitor potential errors which may occur in total testing process. We hope our findings could be helpful for future studies focused on delta checks in immunological analytes. Keywords: Delta check; Patient data; Biological variation; Immunoglobulins; Complements
{"title":"The preliminary study of delta checks for immunoglobulins and complements in the clinical laboratory","authors":"Xiangmei Gong, Shukang He, Li Luo, Chunyu Ding, Xin Qin, Yilong Yuan, Pengcheng Cai, Lihua Yang","doi":"10.1177/00045632241287135","DOIUrl":"https://doi.org/10.1177/00045632241287135","url":null,"abstract":"Background: To determine delta check limits for immunoglobulins and complements in outpatients and inpatients based on patient data and biological variation due to the lack of relevant studies. Methods: Patient data for IgA, IgG, IgM, IgE, C3 and C4 from January 1st, 2022 to December 31st, 2023 was collected from laboratory information system (LIS) in our clinical laboratory of wuhan union hospital, which includes both outpatients and inpatients. The delta difference (DD), delta percent change (DPC) and reference change value (RCV) were calculated based on patient data and biological variation. Results: For DDs, there are significant differences between outpatients and inpatients in C4, IgE, IgG, and IgM. For DPCs, the corresponding analytes which are significantly different are C3, C4, IgE, IgG, and IgM. Two sources of CVI to calculate the RCV of IgA, IgG, IgM, C3 and C4 were applied in this study, which revealed that two kinds of RCVs based on different biological variation databases are similar to each other, but both were smaller than delta check limits based on patient data, except for C4. Conclusions: The delta check is a useful tool to monitor potential errors which may occur in total testing process. We hope our findings could be helpful for future studies focused on delta checks in immunological analytes. Keywords: Delta check; Patient data; Biological variation; Immunoglobulins; Complements","PeriodicalId":519215,"journal":{"name":"Annals of Clinical Biochemistry: International Journal of Laboratory Medicine","volume":"47 1","pages":"45632241287135"},"PeriodicalIF":0.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142192222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-11DOI: 10.1177/00045632241280595
Hung Cao Dinh, Dung Manh Doan, Khanh Quang Tran, Trung The Tran, Si Luc Nguyen
We introduce a 16-year-old female who presented with tender cervical lymphadenopathy, prolonged fever, and hypothyroidism. After excluding common causes of fever of unknown origin, a surgical biopsy of cervical lymph nodes revealed Kikuchi-Fujimoto disease. The patient showed improvement with a short-term course of NSAIDs. An increased titre of thyroperoxidase antibody led to a diagnosis of Hashimoto’s thyroiditis during stable condition. This report underscores the importance of considering Kikuchi-Fujimoto disease in the differential diagnosis of prolonged fever of unknown origin with lymphadenopathy and highlights the association with Hashimoto’s thyroiditis, advocating for vigilance regarding hypothyroidism in long-term follow-up after Kikuchi-Fujimoto disease recovery.
{"title":"Kikuchi-Fujimoto disease co-occuring with Hashimoto thyroiditis: A case report and literature review","authors":"Hung Cao Dinh, Dung Manh Doan, Khanh Quang Tran, Trung The Tran, Si Luc Nguyen","doi":"10.1177/00045632241280595","DOIUrl":"https://doi.org/10.1177/00045632241280595","url":null,"abstract":"We introduce a 16-year-old female who presented with tender cervical lymphadenopathy, prolonged fever, and hypothyroidism. After excluding common causes of fever of unknown origin, a surgical biopsy of cervical lymph nodes revealed Kikuchi-Fujimoto disease. The patient showed improvement with a short-term course of NSAIDs. An increased titre of thyroperoxidase antibody led to a diagnosis of Hashimoto’s thyroiditis during stable condition. This report underscores the importance of considering Kikuchi-Fujimoto disease in the differential diagnosis of prolonged fever of unknown origin with lymphadenopathy and highlights the association with Hashimoto’s thyroiditis, advocating for vigilance regarding hypothyroidism in long-term follow-up after Kikuchi-Fujimoto disease recovery.","PeriodicalId":519215,"journal":{"name":"Annals of Clinical Biochemistry: International Journal of Laboratory Medicine","volume":"44 1","pages":"45632241280595"},"PeriodicalIF":0.0,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142192221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-09DOI: 10.1177/00045632241249702
{"title":"Thank you to reviewers","authors":"","doi":"10.1177/00045632241249702","DOIUrl":"https://doi.org/10.1177/00045632241249702","url":null,"abstract":"","PeriodicalId":519215,"journal":{"name":"Annals of Clinical Biochemistry: International Journal of Laboratory Medicine","volume":"39 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140925799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-18DOI: 10.1177/00045632241252006
William Sadler
Background: Parametric regression analysis is widely used in methods comparisons and more recently in checking the concordance of test results following receipt of new reagent lots. The greater frequency of reagent-lot evaluations increases pressure to detect bias with smallest possible sample sizes (i.e. smallest consumption of time and resources). This study revisits bias detection using the joint slope, intercept confidence region as an alternative to slope and intercept confidence intervals.
Methods: Four cases were considered representing constant errors, proportional errors (constant CV) and two more complicated error patterns typical of immunoassays. Maximum:minimum range ratios varied from 2:1 to 2000:1. After setting a maximum tolerable difference a series of slope, intercept combinations, each of which predicted the critical difference, were systematically evaluated in simulations which determined the minimum sample size required to detect the difference, firstly using slope, intercept confidence intervals and secondly using the joint slope, intercept confidence region.
Results: At small to moderate range ratios, bias detection by joint confidence region required greatly reduced sample sizes to the extent that it should encourage reagent-lot evaluations or, alternatively, transform those already routinely performed into considerably less costly exercises.
Conclusions: While some software is available to calculate joint confidence regions in real-life analyses, shifting this testing method into the mainstream will require a greater number of software developers incorporating the necessary code into their regression programs. The computer program used to conduct this study is freely available and can be used to model any laboratory test.
{"title":"Methods and reagent-lot comparisons by regression analysis: sample size considerations","authors":"William Sadler","doi":"10.1177/00045632241252006","DOIUrl":"https://doi.org/10.1177/00045632241252006","url":null,"abstract":"
 Background: Parametric regression analysis is widely used in methods comparisons and more recently in checking the concordance of test results following receipt of new reagent lots. The greater frequency of reagent-lot evaluations increases pressure to detect bias with smallest possible sample sizes (i.e. smallest consumption of time and resources). This study revisits bias detection using the joint slope, intercept confidence region as an alternative to slope and intercept confidence intervals. 
 Methods: Four cases were considered representing constant errors, proportional errors (constant CV) and two more complicated error patterns typical of immunoassays. Maximum:minimum range ratios varied from 2:1 to 2000:1. After setting a maximum tolerable difference a series of slope, intercept combinations, each of which predicted the critical difference, were systematically evaluated in simulations which determined the minimum sample size required to detect the difference, firstly using slope, intercept confidence intervals and secondly using the joint slope, intercept confidence region.
 Results: At small to moderate range ratios, bias detection by joint confidence region required greatly reduced sample sizes to the extent that it should encourage reagent-lot evaluations or, alternatively, transform those already routinely performed into considerably less costly exercises.
 Conclusions: While some software is available to calculate joint confidence regions in real-life analyses, shifting this testing method into the mainstream will require a greater number of software developers incorporating the necessary code into their regression programs. The computer program used to conduct this study is freely available and can be used to model any laboratory test. 
","PeriodicalId":519215,"journal":{"name":"Annals of Clinical Biochemistry: International Journal of Laboratory Medicine","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140628208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-09DOI: 10.1177/00045632241249087
Jonathan Fenn, Henry Gill, Lauren Starbrook, Loretta Theresa Ford, Hayley Sharrod-Cole, Tejas Kalaria, Clare Ford, Rousseau Gama
Background:
Serum total testosterone (T) decreases postprandially. Postprandial salivary testosterone (SalT) responses, however, have not been studied. We report on the effect of glucose ingestion on fasting SalT concentrations.
Objective:
To investigate the effect of oral glucose ingestion on fasting SalT.
Methods:
Salivary and blood samples were collected between 09.00 and 09.30 and two hours after a 75g oral glucose load in 32 men with mean (standard deviation) age of 52 (5.7) years and body mass index of 32.6 (5.56) kg/m2. Free T and bioavailable testosterone (BAT) were calculated using the Vermeulen equation.
Results:
Two hours following oral glucose, there was a decrease in fasting mean (standard deviation) SalT [178.2 (56.6) vs 146.0 (42.2) pmol/L; p = 0.0003], serum cortisol [332 (105.0) vs 239 (75.3) nmol/L; p = <0.0001], prolactin [193 (75.0) vs 127 (55.9) mIU/L; p = <0.0001] and TSH [1.60 (0.801) vs 1.16 (0.584) mIU/L; p = <0.0001]. Plasma glucose increased [6.2 (0.72) vs 8.1 (3.71) mmol/L; p = 0.0029]. Serum total T, SHBG, albumin, Free T, BAT, gonadotrophins and FT4 remained unchanged.
Conclusions:
SalT decreased postprandially. A concomitant decrease in serum cortisol, prolactin and TSH reflecting diurnal variation offers an alternative explanation for the decrease in SalT independent of food consumption. Further studies are required to determine whether morning temporal changes in SalT are related to food consumption or circadian rhythm or both.
背景：
餐后血清总睾酮（T）会下降。然而，餐后唾液睾酮（SalT）的反应尚未得到研究。我们报告了摄入葡萄糖对空腹唾液睾酮（SalT）浓度的影响。
目的：
研究口服葡萄糖对空腹唾液睾酮（SalT）的影响。
方法：
在平均（标准差）年龄为 52（5.7）岁、体重指数为 32.6（5.56）kg/m2 的 32 名男性中，在 09.00 至 09.30 之间以及口服 75g 葡萄糖后两小时采集唾液和血液样本。结果：
口服葡萄糖两小时后，空腹平均（标准偏差）血浆睾酮（SalT）下降[178.2（56.6） vs 146.0（146.0）]。6) vs 146.0 (42.2) pmol/L；p = 0.0003]、血清皮质醇[332 (105.0) vs 239 (75.3) nmol/L；p = <0.0001], 催乳素 [193 (75.0) vs 127 (55.9) mIU/L; p = <0.0001]和促甲状腺激素 [1.60 (0.801) vs 1.16 (0.584) mIU/L; p = <0.0001]。血浆葡萄糖增加 [6.2 (0.72) vs 8.1 (3.71) mmol/L；p = 0.0029]。血清总 T、SHBG、白蛋白、游离 T、BAT、促性腺激素和 FT4 保持不变。与此同时，反映昼夜变化的血清皮质醇、催乳素和促甲状腺激素的下降为与进食无关的 SalT 下降提供了另一种解释。还需要进一步研究，以确定 SalT 在早晨的时间变化是与进食量有关，还是与昼夜节律有关，或者两者兼而有之；
{"title":"Salivary testosterone changes during oral glucose tolerance tests in overweight and obese men – postprandial or circadian variation?","authors":"Jonathan Fenn, Henry Gill, Lauren Starbrook, Loretta Theresa Ford, Hayley Sharrod-Cole, Tejas Kalaria, Clare Ford, Rousseau Gama","doi":"10.1177/00045632241249087","DOIUrl":"https://doi.org/10.1177/00045632241249087","url":null,"abstract":"Background:
 Serum total testosterone (T) decreases postprandially. Postprandial salivary testosterone (SalT) responses, however, have not been studied. We report on the effect of glucose ingestion on fasting SalT concentrations.
 Objective:
 To investigate the effect of oral glucose ingestion on fasting SalT. 
 Methods:
 Salivary and blood samples were collected between 09.00 and 09.30 and two hours after a 75g oral glucose load in 32 men with mean (standard deviation) age of 52 (5.7) years and body mass index of 32.6 (5.56) kg/m2. Free T and bioavailable testosterone (BAT) were calculated using the Vermeulen equation. 
 Results:
 Two hours following oral glucose, there was a decrease in fasting mean (standard deviation) SalT [178.2 (56.6) vs 146.0 (42.2) pmol/L; p = 0.0003], serum cortisol [332 (105.0) vs 239 (75.3) nmol/L; p = <0.0001], prolactin [193 (75.0) vs 127 (55.9) mIU/L; p = <0.0001] and TSH [1.60 (0.801) vs 1.16 (0.584) mIU/L; p = <0.0001]. Plasma glucose increased [6.2 (0.72) vs 8.1 (3.71) mmol/L; p = 0.0029]. Serum total T, SHBG, albumin, Free T, BAT, gonadotrophins and FT4 remained unchanged.
 Conclusions:
 SalT decreased postprandially. A concomitant decrease in serum cortisol, prolactin and TSH reflecting diurnal variation offers an alternative explanation for the decrease in SalT independent of food consumption. Further studies are required to determine whether morning temporal changes in SalT are related to food consumption or circadian rhythm or both. 
","PeriodicalId":519215,"journal":{"name":"Annals of Clinical Biochemistry: International Journal of Laboratory Medicine","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140603511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: It is important that blood glucose concentrations be accurately and conveniently measured in infants. However, especially in the early neonatal period, point-of-care testing devices used for adults may not accurately measure blood glucose concentrations in neonates.
Methods: In Study 1, the accuracy of neonatal whole-blood glucose measurements was evaluated for the existing glucose analyser Glutest Mint® (hereinafter MINT1; Sanwa Kagaku Kenkyusho, Nagoya, Japan) by comparing the data with reference blood glucose concentrations. In Study 2, we used MINT2, which was modified based on the findings from Study 1, to measure whole-blood glucose concentrations in newborns, and the accuracy of the measurements was compared with that of MINT1.
Results: Blood glucose concentrations were measured in 100 infants each in Study 1 and 2. In Study 1, the whole-blood glucose concentrations measured using MINT1 were found to be significantly lower than the reference blood glucose concentrations in early neonates. The results of Study 1 suggested that characteristics of erythrocyte membranes in early neonates affected the measurements. Therefore, we conducted Study 2 using MINT2, which was modified to be less susceptible. MINT2 was found to accurately measure whole-blood glucose concentrations in the early neonatal period.
Conclusion: The study showed that the point-of-care testing device could be improved to allow for accurate whole-blood glucose measurements in the early neonatal period.
{"title":"Improvement of point of care testing (POCT) device for accurate whole blood glucose measurement in early neonates.","authors":"Kosuke Koyano, Makoto Arioka, Yasuhiro Nakao, Aya Morimoto, Masashiro Sugino, Hirosuke Morita, Shinji Nakamura, Sonoko Kondo, Yukihiko Konishi, Saneyuki Yasuda, Takashi Kusaka","doi":"10.1177/00045632241249034","DOIUrl":"https://doi.org/10.1177/00045632241249034","url":null,"abstract":"Background: It is important that blood glucose concentrations be accurately and conveniently measured in infants. However, especially in the early neonatal period, point-of-care testing devices used for adults may not accurately measure blood glucose concentrations in neonates.
 Methods: In Study 1, the accuracy of neonatal whole-blood glucose measurements was evaluated for the existing glucose analyser Glutest Mint® (hereinafter MINT1; Sanwa Kagaku Kenkyusho, Nagoya, Japan) by comparing the data with reference blood glucose concentrations. In Study 2, we used MINT2, which was modified based on the findings from Study 1, to measure whole-blood glucose concentrations in newborns, and the accuracy of the measurements was compared with that of MINT1.
 Results: Blood glucose concentrations were measured in 100 infants each in Study 1 and 2. In Study 1, the whole-blood glucose concentrations measured using MINT1 were found to be significantly lower than the reference blood glucose concentrations in early neonates. The results of Study 1 suggested that characteristics of erythrocyte membranes in early neonates affected the measurements. Therefore, we conducted Study 2 using MINT2, which was modified to be less susceptible. MINT2 was found to accurately measure whole-blood glucose concentrations in the early neonatal period.
 Conclusion: The study showed that the point-of-care testing device could be improved to allow for accurate whole-blood glucose measurements in the early neonatal period.
","PeriodicalId":519215,"journal":{"name":"Annals of Clinical Biochemistry: International Journal of Laboratory Medicine","volume":"53 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140603510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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