Pub Date : 2024-05-06DOI: 10.1515/labmed-2023-0131
Weiping Liu, Xia Long, Lulu Chen, Kailan Yang
Objectives In recent years, chemiluminescent microparticle immunoassay (CMIA) has been widely used for determination of high-sensitivity troponin I (hs-cTnI). However, a CMIA analysis is usually affected by the presence of some endogenous or exogenous substances. This case-report aims to unveil the essence of the reoccurrence of false-positive results due to heterophilic antibodies interference with Abbott high-sensitivity cardiac troponin I assay, although the assay method applied a chimeric antibody. Case presentation A 28-year-old female misdiagnosed with myocarditis due to falsely elevated hs-cTnI with an initial test result of 595.0 ng/L considered as critical value was reported. And the false critical value of hs-cTnI reoccurred five times after admission. The heterophilic blocking tube (HBT) procedure caused a decrease in troponin concentrations within the reference values, which suggests the presence of interference from heterophilic antibodies. Conclusions It requires a close and strong collaboration between clinicians and laboratorians to manage the similar case on the interference from heterophilic antibodies. To prevent false-positive results caused by interferences from being used in clinical practice, the clinicians are suggested to contact the laboratorians whenever the clinical picture, historical data and laboratory values are not conclusive.
{"title":"Attention should be paid to false-positive results due to heterophilic antibodies interfering with Abbott high-sensitivity cardiac troponin I assay","authors":"Weiping Liu, Xia Long, Lulu Chen, Kailan Yang","doi":"10.1515/labmed-2023-0131","DOIUrl":"https://doi.org/10.1515/labmed-2023-0131","url":null,"abstract":"Objectives In recent years, chemiluminescent microparticle immunoassay (CMIA) has been widely used for determination of high-sensitivity troponin I (hs-cTnI). However, a CMIA analysis is usually affected by the presence of some endogenous or exogenous substances. This case-report aims to unveil the essence of the reoccurrence of false-positive results due to heterophilic antibodies interference with Abbott high-sensitivity cardiac troponin I assay, although the assay method applied a chimeric antibody. Case presentation A 28-year-old female misdiagnosed with myocarditis due to falsely elevated hs-cTnI with an initial test result of 595.0 ng/L considered as critical value was reported. And the false critical value of hs-cTnI reoccurred five times after admission. The heterophilic blocking tube (HBT) procedure caused a decrease in troponin concentrations within the reference values, which suggests the presence of interference from heterophilic antibodies. Conclusions It requires a close and strong collaboration between clinicians and laboratorians to manage the similar case on the interference from heterophilic antibodies. To prevent false-positive results caused by interferences from being used in clinical practice, the clinicians are suggested to contact the laboratorians whenever the clinical picture, historical data and laboratory values are not conclusive.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"68 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140888654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-18DOI: 10.1515/labmed-2023-0156
Sebastian Sommer, Maximilian Schmutz, Kathrin Hildebrand, Annett Schiwitza, Selinah Benedikt, Maria Eberle, Tatiana Mögele, Aziz Sultan, Lena Reichl, Maria Campillo, Luise Uhrmacher, Ana Antic Nikolic, Ralph Bundschuh, Constantin Lapa, Michaela Kuhlen, Sebastian Dintner, Angela Langer, Bruno Märkl, Thomas Wendler, Kartikay Tehlan, Thomas Kröncke, Maria Wahle, Matthias Mann, Nicolas Casadei, Michaela Pogoda, Simone Hummler, Irmengard Sax, Matthias Schlesner, Boris Kubuschok, Martin Trepel, Rainer Claus
Objectives Liquid biopsy (LBx) provides diagnostic, prognostic and predictive insights for malignant diseases and offers promising applications regarding tumor burden, tumor heterogeneity and clonal evolution. Methods ALPS is a prospective trial for patients with metastatic cancer that comprises sequential collection of LBx samples, tumor tissue, radiological imaging data, clinical information and patient-reported outcomes. Peripheral blood plasma is collected based on the individual patient’s staging intervals and LBx-derived ctDNA analyses are performed using CAncer Personalized Profiling sequencing (CAPP-seq). Results From April 2021 to October 2023, 419 patients have been enrolled. A total of 1,293 LBx samples were collected, 419 samples (100 %) at the beginning of the study and an average of 3 (range 1–12) during the 30-month follow-up period of the current interim analysis. 380 tissue biopsy (TBx) samples (90.7 %) were available at baseline and 39.6 % had ≥1 TBx samples at follow-up. Lung cancer patients are most prevalent in ALPS (n=147), followed by colorectal (n=38), prostate (n=31) and gastroesophageal cancer (n=28). On average, 12.0 ng/mL plasma cell-free DNA (cfDNA) could be isolated. First CAPP-seq analyses in 60 patients comprised 110 samples and demonstrated a detection sensitivity of 0.1 %. Conclusions The first interim analysis of ALPS confirms feasibility for comprehensive longitudinal evaluation of LBx and demonstrates suitability for ctDNA evaluation.
{"title":"Concept and feasibility of the Augsburg longitudinal plasma study (ALPS) – A prospective trial for comprehensive liquid biopsy-based longitudinal monitoring of solid cancer patients","authors":"Sebastian Sommer, Maximilian Schmutz, Kathrin Hildebrand, Annett Schiwitza, Selinah Benedikt, Maria Eberle, Tatiana Mögele, Aziz Sultan, Lena Reichl, Maria Campillo, Luise Uhrmacher, Ana Antic Nikolic, Ralph Bundschuh, Constantin Lapa, Michaela Kuhlen, Sebastian Dintner, Angela Langer, Bruno Märkl, Thomas Wendler, Kartikay Tehlan, Thomas Kröncke, Maria Wahle, Matthias Mann, Nicolas Casadei, Michaela Pogoda, Simone Hummler, Irmengard Sax, Matthias Schlesner, Boris Kubuschok, Martin Trepel, Rainer Claus","doi":"10.1515/labmed-2023-0156","DOIUrl":"https://doi.org/10.1515/labmed-2023-0156","url":null,"abstract":"Objectives Liquid biopsy (LBx) provides diagnostic, prognostic and predictive insights for malignant diseases and offers promising applications regarding tumor burden, tumor heterogeneity and clonal evolution. Methods ALPS is a prospective trial for patients with metastatic cancer that comprises sequential collection of LBx samples, tumor tissue, radiological imaging data, clinical information and patient-reported outcomes. Peripheral blood plasma is collected based on the individual patient’s staging intervals and LBx-derived ctDNA analyses are performed using CAncer Personalized Profiling sequencing (CAPP-seq). Results From April 2021 to October 2023, 419 patients have been enrolled. A total of 1,293 LBx samples were collected, 419 samples (100 %) at the beginning of the study and an average of 3 (range 1–12) during the 30-month follow-up period of the current interim analysis. 380 tissue biopsy (TBx) samples (90.7 %) were available at baseline and 39.6 % had ≥1 TBx samples at follow-up. Lung cancer patients are most prevalent in ALPS (n=147), followed by colorectal (n=38), prostate (n=31) and gastroesophageal cancer (n=28). On average, 12.0 ng/mL plasma cell-free DNA (cfDNA) could be isolated. First CAPP-seq analyses in 60 patients comprised 110 samples and demonstrated a detection sensitivity of 0.1 %. Conclusions The first interim analysis of ALPS confirms feasibility for comprehensive longitudinal evaluation of LBx and demonstrates suitability for ctDNA evaluation.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"66 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140630741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-13DOI: 10.1515/labmed-2024-0014
Lin Chen, Shuangshuang Huang, Hao Wang, Fengqing Cai, Zhaoyang Peng, Shanshan Wang
Objectives Mycoplasma pneumoniae (MP) is known to be a common pathogen causing human respiratory infections. On December 7, 2022, the Chinese government announced 10 new measures of Prevention and Control of COVID-19, marking the onset of the post-COVID-19 era. This study aimed to investigate the epidemiological characteristics of Mycoplasma pneumoniae (MP) infections among children from January 2021 to June 2023. Methods Children with respiratory tract infection were enrolled in the study with fever and one or more respiratory symptoms. A serological diagnosis was confirmed with MP IgM antibodies. Results A total of 18,763 patients were enrolled, of whom 4,867 cases were MP-positive, resulting in a positivity rate of 25.9 %. The MP positivity rate increased annually, with 18.6 , 26.7, and 33.2 % in 2021, 2022, and 2023, respectively. The main disease type of MP infection was Mycoplasma pneumoniae pneumonia (MPP), with 74.0 , 87.8, and 86.4 % in 2021, 2022, and 2023, respectively. Higher positivity rates were concentrated in children aged 6 years and older, and the positivity rate in children under 1 year of age in 2023 is the largest increase among all age groups. Conclusions The positivity rate of MP increased significantly after the adjustment of COVID-19 prevention and control in China, and the most significant increase was seen in the infant group. Effective prevention and control measures should be implemented to reduce the prevalence of MP infection among children aged 6 years older and the infant group (<1 year).
{"title":"Epidemiology of Mycoplasma pneumoniae in children with acute respiratory infections in Hangzhou during January 2021 to June 2023","authors":"Lin Chen, Shuangshuang Huang, Hao Wang, Fengqing Cai, Zhaoyang Peng, Shanshan Wang","doi":"10.1515/labmed-2024-0014","DOIUrl":"https://doi.org/10.1515/labmed-2024-0014","url":null,"abstract":"Objectives <jats:italic>Mycoplasma pneumoniae</jats:italic> (MP) is known to be a common pathogen causing human respiratory infections. On December 7, 2022, the Chinese government announced 10 new measures of Prevention and Control of COVID-19, marking the onset of the post-COVID-19 era. This study aimed to investigate the epidemiological characteristics of Mycoplasma pneumoniae (MP) infections among children from January 2021 to June 2023. Methods Children with respiratory tract infection were enrolled in the study with fever and one or more respiratory symptoms. A serological diagnosis was confirmed with MP IgM antibodies. Results A total of 18,763 patients were enrolled, of whom 4,867 cases were MP-positive, resulting in a positivity rate of 25.9 %. The MP positivity rate increased annually, with 18.6 , 26.7, and 33.2 % in 2021, 2022, and 2023, respectively. The main disease type of MP infection was Mycoplasma pneumoniae pneumonia (MPP), with 74.0 , 87.8, and 86.4 % in 2021, 2022, and 2023, respectively. Higher positivity rates were concentrated in children aged 6 years and older, and the positivity rate in children under 1 year of age in 2023 is the largest increase among all age groups. Conclusions The positivity rate of MP increased significantly after the adjustment of COVID-19 prevention and control in China, and the most significant increase was seen in the infant group. Effective prevention and control measures should be implemented to reduce the prevalence of MP infection among children aged 6 years older and the infant group (<1 year).","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"48 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140562012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives The Treponema pallidum particle agglutination (TPPA) has been used for decades for serological diagnostics of syphilis but is no longer available. Therefore, we evaluated the Treponema IgG ELISA (TpG) alone and in combination with the Treponema IgM ELISA (TpG+M, both from Euroimmun) as possible substitutes for TPPA as a confirmatory test in a two-tier syphilis screening algorithm. Furthermore, we investigated whether a TPPA titer of 5,120 which is used as cut-off for therapeutic decision in pregnant women in Germany can be transferred to an appropriate cut-off value of the TpG. Methods All serum samples with reactive syphilis screening test (CLIA, Diasorin) within a 13-months period were included (n=739). In addition to TPPA and rapid plasma reagin test both ELISA tests were done in all samples. Results Sensitivity, specificity, positive and negative predictive values were 92.2, 100, 100, and 74.5 % for TpG, and 93.2, 85.4, 96.6, and 74.1 % for TpG+M. By ROC analysis the cut-off of TpG corresponding to a TPPA titer ≥5,120 was calculated to be 54 RU/mL with a sensitivity of 99.6 % and a resulting specificity of 58.6 %. Conclusions TpG appears suitable to substitute TPPA as a confirmatory test for syphilis diagnostics but TpG-negative samples have to be evaluated by further tests like FTA-Abs or immunoblot. Treponema IgM determined in addition to TpG did not improve the test performance compared to the TPPA as a reference standard. Valid prediction of a TPPA titer ≥5,120 from TpG result appears not reasonable.
{"title":"Evaluation of a Treponema IgG ELISA alone and in combination with an IgM ELISA as substitutes for Treponema pallidum particle agglutination (TPPA) as confirmatory tests in a two-tier diagnostic algorithm for diagnosis of syphilis infection","authors":"Nele Wellinghausen, Teresa Esthela Rangel Vivar, Dietmar Plonné","doi":"10.1515/labmed-2023-0142","DOIUrl":"https://doi.org/10.1515/labmed-2023-0142","url":null,"abstract":"Objectives The <jats:italic>Treponema pallidum</jats:italic> particle agglutination (TPPA) has been used for decades for serological diagnostics of syphilis but is no longer available. Therefore, we evaluated the <jats:italic>Treponema</jats:italic> IgG ELISA (TpG) alone and in combination with the <jats:italic>Treponema</jats:italic> IgM ELISA (TpG+M, both from Euroimmun) as possible substitutes for TPPA as a confirmatory test in a two-tier syphilis screening algorithm. Furthermore, we investigated whether a TPPA titer of 5,120 which is used as cut-off for therapeutic decision in pregnant women in Germany can be transferred to an appropriate cut-off value of the TpG. Methods All serum samples with reactive syphilis screening test (CLIA, Diasorin) within a 13-months period were included (n=739). In addition to TPPA and rapid plasma reagin test both ELISA tests were done in all samples. Results Sensitivity, specificity, positive and negative predictive values were 92.2, 100, 100, and 74.5 % for TpG, and 93.2, 85.4, 96.6, and 74.1 % for TpG+M. By ROC analysis the cut-off of TpG corresponding to a TPPA titer ≥5,120 was calculated to be 54 RU/mL with a sensitivity of 99.6 % and a resulting specificity of 58.6 %. Conclusions TpG appears suitable to substitute TPPA as a confirmatory test for syphilis diagnostics but TpG-negative samples have to be evaluated by further tests like FTA-Abs or immunoblot. <jats:italic>Treponema</jats:italic> IgM determined in addition to TpG did not improve the test performance compared to the TPPA as a reference standard. Valid prediction of a TPPA titer ≥5,120 from TpG result appears not reasonable.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"174 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139953658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-09DOI: 10.1515/labmed-2023-0138
Matthias Nauck, Stefan Holdenrieder, Hanns-Georg Klein, Peter Findeisen, Christof Winter, Uta Ceglarek, Astrid Petersmann, Mariam Klouche, Ralf Lichtinghagen, Ronald Biemann, Jakob Adler, Thomas Streichert, Alexander von Meyer, Eberhard Wieland, Walter Hofmann, Johannes Aufenanger, Matthias Orth, Maria Shipkova, Martin Bidlingmaier, Ingvild Birschmann, Martin Blüthner, Karsten Conrad, Peter B. Luppa, Michael Kiehntopf, Andreas Bietenbeck, Hannsjörg Baum, Harald Renz
The programme of the German Congress for Laboratory Medicine 2022 was essentially designed by the divisions of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL). Almost all chairpersons of the divisions organised a 90-min symposium on current topics, i.e. conceptualised the symposia and invited speakers. For this article all chairpersons summarised the lectures that were given within the symposia. The DGKL’s work is structured into 5 areas of expertise: Molecular Diagnostics, Learning & Teaching, Quality & Management, Laboratory & Diagnostics and Biobanks & Informatics. The areas of expertise are in turn subdivided into divisions. About the history of the establishment of this new structure within the DGKL you can find information in the editorial of this issue.
{"title":"German Society for Clinical Chemistry and Laboratory Medicine – areas of expertise: Division reports from the German Congress of Laboratory Medicine 2022 in Mannheim, 13–14 October 2022","authors":"Matthias Nauck, Stefan Holdenrieder, Hanns-Georg Klein, Peter Findeisen, Christof Winter, Uta Ceglarek, Astrid Petersmann, Mariam Klouche, Ralf Lichtinghagen, Ronald Biemann, Jakob Adler, Thomas Streichert, Alexander von Meyer, Eberhard Wieland, Walter Hofmann, Johannes Aufenanger, Matthias Orth, Maria Shipkova, Martin Bidlingmaier, Ingvild Birschmann, Martin Blüthner, Karsten Conrad, Peter B. Luppa, Michael Kiehntopf, Andreas Bietenbeck, Hannsjörg Baum, Harald Renz","doi":"10.1515/labmed-2023-0138","DOIUrl":"https://doi.org/10.1515/labmed-2023-0138","url":null,"abstract":"The programme of the German Congress for Laboratory Medicine 2022 was essentially designed by the divisions of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL). Almost all chairpersons of the divisions organised a 90-min symposium on current topics, i.e. conceptualised the symposia and invited speakers. For this article all chairpersons summarised the lectures that were given within the symposia. The DGKL’s work is structured into 5 areas of expertise: Molecular Diagnostics, Learning & Teaching, Quality & Management, Laboratory & Diagnostics and Biobanks & Informatics. The areas of expertise are in turn subdivided into divisions. About the history of the establishment of this new structure within the DGKL you can find information in the editorial of this issue.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"15 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139772279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-08DOI: 10.1515/labmed-2023-0145
Dandan Yuan, Xue Yang, Chen Ji, Guo Sun, Yang Xu, Ye Cao, Yan Ye, Tingting Wang, Zhigang Hu
Objectives Detection of specific antinuclear antibodies is very important in term of diagnosis, prognosis and management of patients with systemic autoimmune rheumatic diseases. Chemiluminescence microarray immunoassay (CLMIA) is a microdot array-based method that allows simultaneous detection of multiple antinuclear antibodies, which received increasing attention. Methods A CLMIA method that can detect 14 kinds of antinuclear antibodies was established and optimized. Basic performance and diagnostic performance of CLMIA was evaluated by comparing it with line immunoassay (LIA) and indirect immunofluorescence (IIF). Results Through conditional exploration, the optimal blocking time and blocking temperature were determined to be 18 h and 25 °C, respectively. The enzyme-labeled secondary antibody reaction concentration was 0.1 μg/mL, the incubation temperature of serum and enzyme-labeled secondary antibody were 30 °C, and the incubation time of serum and enzyme-labeled secondary antibody were 40 min. After parameter optimization, CLMIA demonstrated high accuracy with a relative bias <15 %; high sensitivity with detection limits below 3 IU/mL for dsDNA and below 1 RU/mL for other ANAs; and high reproducibility with both intra-assay and inter-assay coefficients of variation (CV) <15 %.The CLMIA detection method established in this study was also demonstrated to have good clinical diagnostic performance, showing the highest area under curve (AUC=0.87, p=0.042 and p=0.03). The CLMIA and LIA revealed substantial to good agreements on specific antinuclear antibodies except anti-dsDNA, with the Cohen’s kappa from 0.72 to 0.89. Samples that produced discrepant results between the CLMIA and LIA methods were further analyzed. Upon additional testing, most of these samples were ultimately determined to have been correctly detected by the CLMIA assay rather than the LIA assay, suggesting that CLMIA also shows some superiority in diagnosing dsDNA. Conclusions The CLMIA could become a potential routine method for detecting ANAs with the advantages of good detection performance.
目的 检测特异性抗核抗体对于系统性自身免疫性风湿病患者的诊断、预后和治疗非常重要。化学发光微阵列免疫分析法（CLMIA）是一种基于微点阵列的方法，可同时检测多种抗核抗体，受到越来越多的关注。方法 建立并优化了可检测 14 种抗核抗体的 CLMIA 方法。通过与线性免疫分析法（LIA）和间接免疫荧光法（IIF）比较，评估了 CLMIA 的基本性能和诊断效果。结果 通过条件探索，确定最佳阻断时间和阻断温度分别为 18 h 和 25 °C。酶标记二抗反应浓度为 0.1 μg/mL，血清和酶标记二抗的孵育温度为 30 ℃，血清和酶标记二抗的孵育时间为 40 分钟。参数优化后，CLMIA 的准确度高，相对偏差为 15%；灵敏度高，dsDNA 的检测限低于 3 IU/mL，其他 ANA 的检测限低于 1 RU/mL；重现性高，测定内和测定间变异系数均为 15%。除抗dsDNA外，CLMIA和LIA对特异性抗核抗体的检测结果基本一致，科恩卡帕（Cohen's kappa）从0.72到0.89不等。对 CLMIA 和 LIA 方法结果不一致的样本进行了进一步分析。经进一步检测，这些样本中的大多数最终被确定为 CLMIA 检测法而非 LIA 检测法检测正确，这表明 CLMIA 在诊断 dsDNA 方面也显示出一定的优势。结论 CLMIA 具有良好的检测性能，有可能成为检测 ANA 的常规方法。
{"title":"Fully automated chemiluminescence microarray immunoassay for detection of antinuclear antibodies in systemic autoimmune rheumatic diseases","authors":"Dandan Yuan, Xue Yang, Chen Ji, Guo Sun, Yang Xu, Ye Cao, Yan Ye, Tingting Wang, Zhigang Hu","doi":"10.1515/labmed-2023-0145","DOIUrl":"https://doi.org/10.1515/labmed-2023-0145","url":null,"abstract":"Objectives Detection of specific antinuclear antibodies is very important in term of diagnosis, prognosis and management of patients with systemic autoimmune rheumatic diseases. Chemiluminescence microarray immunoassay (CLMIA) is a microdot array-based method that allows simultaneous detection of multiple antinuclear antibodies, which received increasing attention. Methods A CLMIA method that can detect 14 kinds of antinuclear antibodies was established and optimized. Basic performance and diagnostic performance of CLMIA was evaluated by comparing it with line immunoassay (LIA) and indirect immunofluorescence (IIF). Results Through conditional exploration, the optimal blocking time and blocking temperature were determined to be 18 h and 25 °C, respectively. The enzyme-labeled secondary antibody reaction concentration was 0.1 μg/mL, the incubation temperature of serum and enzyme-labeled secondary antibody were 30 °C, and the incubation time of serum and enzyme-labeled secondary antibody were 40 min. After parameter optimization, CLMIA demonstrated high accuracy with a relative bias <15 %; high sensitivity with detection limits below 3 IU/mL for dsDNA and below 1 RU/mL for other ANAs; and high reproducibility with both intra-assay and inter-assay coefficients of variation (CV) <15 %.The CLMIA detection method established in this study was also demonstrated to have good clinical diagnostic performance, showing the highest area under curve (AUC=0.87, p=0.042 and p=0.03). The CLMIA and LIA revealed substantial to good agreements on specific antinuclear antibodies except anti-dsDNA, with the Cohen’s kappa from 0.72 to 0.89. Samples that produced discrepant results between the CLMIA and LIA methods were further analyzed. Upon additional testing, most of these samples were ultimately determined to have been correctly detected by the CLMIA assay rather than the LIA assay, suggesting that CLMIA also shows some superiority in diagnosing dsDNA. Conclusions The CLMIA could become a potential routine method for detecting ANAs with the advantages of good detection performance.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"93 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139773294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives To evaluate the ovarian reserve (OR) in women with antiphospholipid syndrome (APS), systemic lupus erythematosus (SLE), especially SLE-associated APS, and to determine the association between OR and clinical and laboratory parameters. Methods We compared the antral follicle count (AFC), anticardiolipin antibody, and anti-Müllerian hormone (AMH), inhibin B (INHB), antiphospholipid (aPL) antibody, follicle-stimulating hormone (FSH), progesterone (P), testosterone (T), and estradiol (E2) among patients with primary APS (PAPS), SLE-APS, and SLE who were treated at Jinhua Central Hospital between 2017 and 2020. We conducted correlations and logistic regression analyses to identify the risk factors of OR failure in women with APS. Results Serum AMH were positively correlated with AFC and INHB in APS patients, and low AMH was independent risk factor for OR decline in APS patients. The ROC curve showed a high accuracy for AMH in the prediction of OR failure. Compared to healthy subjects (HS), patients with PAPS, SLE-APS, and SLE exhibited lower serum AMH, AFC, INHB, and E2 levels and higher FSH and levels (p<0.05). Of all the patients, those with SLE-APS manifested the lowest serum AMH, AFC, INHB, and E2 levels and the highest FSH levels (p<0.05). Conclusions APS and SLE patients showed lower indications of OR, including AFC and AMH, compared to HS. SLE-APS patients also appeared to have a lower OR than either SLE or PAPS patients.
{"title":"Female patients with SLE-associated APS have a lower ovarian reserve than either PAPS or SLE patients","authors":"xiaoping xu, Hua-bin Wang, Shu-qian Cai, Jun-Qi Wu","doi":"10.1515/labmed-2023-0126","DOIUrl":"https://doi.org/10.1515/labmed-2023-0126","url":null,"abstract":"Objectives To evaluate the ovarian reserve (OR) in women with antiphospholipid syndrome (APS), systemic lupus erythematosus (SLE), especially SLE-associated APS, and to determine the association between OR and clinical and laboratory parameters. Methods We compared the antral follicle count (AFC), anticardiolipin antibody, and anti-Müllerian hormone (AMH), inhibin B (INHB), antiphospholipid (aPL) antibody, follicle-stimulating hormone (FSH), progesterone (P), testosterone (T), and estradiol (E2) among patients with primary APS (PAPS), SLE-APS, and SLE who were treated at Jinhua Central Hospital between 2017 and 2020. We conducted correlations and logistic regression analyses to identify the risk factors of OR failure in women with APS. Results Serum AMH were positively correlated with AFC and INHB in APS patients, and low AMH was independent risk factor for OR decline in APS patients. The ROC curve showed a high accuracy for AMH in the prediction of OR failure. Compared to healthy subjects (HS), patients with PAPS, SLE-APS, and SLE exhibited lower serum AMH, AFC, INHB, and E2 levels and higher FSH and levels (p<0.05). Of all the patients, those with SLE-APS manifested the lowest serum AMH, AFC, INHB, and E2 levels and the highest FSH levels (p<0.05). Conclusions APS and SLE patients showed lower indications of OR, including AFC and AMH, compared to HS. SLE-APS patients also appeared to have a lower OR than either SLE or PAPS patients.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"223 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139664432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-04DOI: 10.1515/labmed-2023-0086
Lizhen Dong, Tianqi Hao, Jiawei Chen, Yamin Chai, Zichao Jia, Wenbin Tuo, Chunhui Yuan, Wei Luo
Objectives Adrenocorticotropic hormone (ACTH) is extremely unstable and can easily degrade at room temperature. The experts agreed that the samples should be transported in an ice bath. If it cannot be detected immediately, the plasma should be separated and frozen, which is difficult to carry out in routine practice. This study was performed to explore the preanalytical factors that influence the stability of adrenocorticotrophic hormone (ACTH) measurements. Methods ACTH levels in 21 EDTA whole-blood samples were measured immediately after 0 h and then divided into three equal groups according to the corresponding values (low, L; median, M; and high, H). Next, three sample processing methods (including seven subtypes) were used: whole blood was uncentrifuged (named the A method), stored at 4 °C or 22 °C, centrifuged but not subjected to plasma removal (the B method), stored at 4 °C or 22 °C, and centrifuged with the plasma removed and stored (the C method) at 4 °C, 22 °C, and −20 °C. Each subtype contained three samples, namely, L, M, and H; these samples were retested using a Siemens XP2000 at different times. The change bias was calculated at 0 h. Results Compared to that at 0 h, there was no significant change in ACTH up to 24 h when the sample was stored at 4 °C or 22 °C with the B method (p>0.05), while it significantly changed (up or down >10 %) at 4 °C/24 h (bias is expressed as the mean±SEM; 13.37±21 %, p<0.05) and 22 °C/12 h (9.13±7.68 %, p<0.05) with the A method; and 4 °C/24 h (8.93±5.54 %, p<0.05), 22 °C/12 h (9.5±4.47 %, p<0.05) and −20 °C/3 h (12.03±4.8 %, p<0.05) with the C method. Conclusions After ACTH samples were centrifuged, the presence of plasma without removal did not affect the detection value, and the sample was stored at 4 °C for up to 24 h. There was a significant difference in the detection of ATCH when the sample was stored at −20 °C and thawed again (p<0.05).
目标 促肾上腺皮质激素（ACTH）极不稳定，在室温下很容易降解。专家们一致认为，样本应在冰浴中运输。如果不能立即检测到，则应将血浆分离并冷冻，而这在日常工作中很难进行。本研究旨在探讨影响肾上腺皮质激素（ACTH）测定结果稳定性的分析前因素。方法 0 小时后立即测量 21 份 EDTA 全血样本中的促肾上腺皮质激素（ACTH）水平，然后根据相应值将样本分为三个等量组（低，L；中值，M；高，H）。然后，采用三种样本处理方法（包括七种亚型）：全血不离心（命名为 A 法），在 4 °C 或 22 °C 下保存；离心但不去除血浆（B 法），在 4 °C 或 22 °C 下保存；离心并去除血浆，在 4 °C 、22 °C 和 -20 °C 下保存（C 法）。每个亚型包含三个样本，即 L、M 和 H；使用西门子 XP2000 在不同时间对这些样本进行复测。结果 与 0 h 时相比，用 B 方法将样本保存在 4 °C 或 22 °C 时，ACTH 在 24 h 前没有显著变化（p>0.05），而在 4 °C/24 h 时，ACTH 有显著变化（上升或下降 >10%）（偏差用均数±标准平均值表示；13.用 A 法，4 °C/24 h (8.93±5.54 %，p<0.05)、22 °C/12 h (9.5±4.47 %，p<0.05) 和 -20 °C/3 h (12.03±4.8 %，p<0.05)；用 C 法，4 °C/24 h (8.93±5.54 %，p<0.05)、22 °C/12 h (9.5±4.47 %，p<0.05) 和 -20 °C/3 h (12.03±4.8 %，p<0.05)。结论 ACTH 样品离心后，未去除的血浆的存在不影响检测值，样品在 4 °C 下可保存 24 小时。
{"title":"Research on the stability changes in expert consensus of the ACTH detection preprocessing scheme","authors":"Lizhen Dong, Tianqi Hao, Jiawei Chen, Yamin Chai, Zichao Jia, Wenbin Tuo, Chunhui Yuan, Wei Luo","doi":"10.1515/labmed-2023-0086","DOIUrl":"https://doi.org/10.1515/labmed-2023-0086","url":null,"abstract":"Objectives Adrenocorticotropic hormone (ACTH) is extremely unstable and can easily degrade at room temperature. The experts agreed that the samples should be transported in an ice bath. If it cannot be detected immediately, the plasma should be separated and frozen, which is difficult to carry out in routine practice. This study was performed to explore the preanalytical factors that influence the stability of adrenocorticotrophic hormone (ACTH) measurements. Methods ACTH levels in 21 EDTA whole-blood samples were measured immediately after 0 h and then divided into three equal groups according to the corresponding values (low, L; median, M; and high, H). Next, three sample processing methods (including seven subtypes) were used: whole blood was uncentrifuged (named the A method), stored at 4 °C or 22 °C, centrifuged but not subjected to plasma removal (the B method), stored at 4 °C or 22 °C, and centrifuged with the plasma removed and stored (the C method) at 4 °C, 22 °C, and −20 °C. Each subtype contained three samples, namely, L, M, and H; these samples were retested using a Siemens XP2000 at different times. The change bias was calculated at 0 h. Results Compared to that at 0 h, there was no significant change in ACTH up to 24 h when the sample was stored at 4 °C or 22 °C with the B method (p>0.05), while it significantly changed (up or down >10 %) at 4 °C/24 h (bias is expressed as the mean±SEM; 13.37±21 %, p<0.05) and 22 °C/12 h (9.13±7.68 %, p<0.05) with the A method; and 4 °C/24 h (8.93±5.54 %, p<0.05), 22 °C/12 h (9.5±4.47 %, p<0.05) and −20 °C/3 h (12.03±4.8 %, p<0.05) with the C method. Conclusions After ACTH samples were centrifuged, the presence of plasma without removal did not affect the detection value, and the sample was stored at 4 °C for up to 24 h. There was a significant difference in the detection of ATCH when the sample was stored at −20 °C and thawed again (p<0.05).","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"33 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139104394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-31DOI: 10.1515/labmed-2023-0098
Nicholas C. Spies, Christopher W. Farnsworth
Objectives Clinical laboratories invest substantial time and resources to mitigate measurement error but potential errors during the preanalytical phase of testing are not subjected to the same level of scrutiny. Herein, we assess the proportions of intravenous (IV) fluid contamination sufficient to exceed common performance metrics and compare it to contaminated results flagged by current protocols. Methods Basic metabolic panels performed between 01/2017 and 07/2022 were extracted from the laboratory information system (n=928,742). Contamination was simulated for common IV fluid types. The thresholds at which contaminated results exceeded total allowable error (TEa), reference change values (RCV), or changed normality/critical flags were calculated. The mixture ratio of IV fluid contamination detected by technologists during routine analysis was estimated. Results The TEa and RCV was exceeded at a mixture ratio ≤0.10 for chloride, glucose, calcium, and potassium for both normal saline (NS) and 5 % dextrose in water (D5W). At a simulated mixture ratio of 0.10, 51.39 % of calcium and 21.17 % of potassium results would be expected to be incorrectly reported with an abnormal/critical flag with NS contamination and 99.74 % of sodium and 100 % of glucose results to be incorrectly flagged with D5W. Retrospective results flagged as contaminated revealed a median mixture ratio of 0.18 and 0.24 for D5 and non-D5 fluids. Conclusions At a mixture ratio of at least 0.10, IV fluid contamination causes relevant error between patients’ true concentrations and those reported. However, current procedures cannot reliably detect 10 % contamination.
{"title":"Impact and frequency of IV fluid contamination on basic metabolic panel results using quality metrics","authors":"Nicholas C. Spies, Christopher W. Farnsworth","doi":"10.1515/labmed-2023-0098","DOIUrl":"https://doi.org/10.1515/labmed-2023-0098","url":null,"abstract":"Objectives Clinical laboratories invest substantial time and resources to mitigate measurement error but potential errors during the preanalytical phase of testing are not subjected to the same level of scrutiny. Herein, we assess the proportions of intravenous (IV) fluid contamination sufficient to exceed common performance metrics and compare it to contaminated results flagged by current protocols. Methods Basic metabolic panels performed between 01/2017 and 07/2022 were extracted from the laboratory information system (n=928,742). Contamination was simulated for common IV fluid types. The thresholds at which contaminated results exceeded total allowable error (TEa), reference change values (RCV), or changed normality/critical flags were calculated. The mixture ratio of IV fluid contamination detected by technologists during routine analysis was estimated. Results The TEa and RCV was exceeded at a mixture ratio ≤0.10 for chloride, glucose, calcium, and potassium for both normal saline (NS) and 5 % dextrose in water (D5W). At a simulated mixture ratio of 0.10, 51.39 % of calcium and 21.17 % of potassium results would be expected to be incorrectly reported with an abnormal/critical flag with NS contamination and 99.74 % of sodium and 100 % of glucose results to be incorrectly flagged with D5W. Retrospective results flagged as contaminated revealed a median mixture ratio of 0.18 and 0.24 for D5 and non-D5 fluids. Conclusions At a mixture ratio of at least 0.10, IV fluid contamination causes relevant error between patients’ true concentrations and those reported. However, current procedures cannot reliably detect 10 % contamination.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"10 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139065119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-31DOI: 10.1515/labmed-2022-0173
Lei Chen, Wei-Hua Wang, Li-Peng Wang, Na Wang, Sheng-Jie Dong, Yan-Jie Ding, Guo-Zhen Chen, Hui-Hui Jiang, Yu Xin, Cheng-Ming Sun
Objectives This study aimed to evaluate the distribution of plasma troponin I concentration and establish the 99th percentile reference for hs-cTnI in a hospitalized population without a cardiovascular discharge diagnosis from the Shandong area. Methods The hs-cTnI data of anonymous paediatric patients were collected from Qingdao University-Affiliated Yantai Yuhuangding Hospital from 2016 to 2020. Indirect methods were used to calculate the hs-cTnI 99th percentile reference of the whole population and different age groups. Fitting curves and corresponding equations were displayed to determine the relationship between age and hs-cTnI level using the analysis of covariate variance. Results Hs-cTnI plasma levels were highest in the first week of life and declined with age in days. This study found significant differences in the troponin reference intervals for children in different age stratification. The serum hs-cTnI concentration decreased with age in days. In some subgroups, hs-cTnI levels between genders showed a significant difference after the analysis of covariance showed that age was the only predictor of hs-cTnI plasma levels. A non-linear relationship was observed between age and hs-cTnI levels. Thus, curvilinear fitting curve equations for each group were constructed to evaluate the possible relationship between age and hs-cTnI concentration. Conclusions During paediatric period, the highest hs-cTnI concentrations were observed in children aged <1 year, especially those under 7 days. This study presented the 99th percentile cut-offs for different age groups in children aged 0–14 years, which can provide a certain reference value for the clinical diagnosis and treatment of myocardial injury in children.
{"title":"Establishment of high-sensitivity cardiac troponin I reference interval for a hospitalized paediatric population under improved selection criteria in the Shandong area","authors":"Lei Chen, Wei-Hua Wang, Li-Peng Wang, Na Wang, Sheng-Jie Dong, Yan-Jie Ding, Guo-Zhen Chen, Hui-Hui Jiang, Yu Xin, Cheng-Ming Sun","doi":"10.1515/labmed-2022-0173","DOIUrl":"https://doi.org/10.1515/labmed-2022-0173","url":null,"abstract":"Objectives This study aimed to evaluate the distribution of plasma troponin I concentration and establish the 99th percentile reference for hs-cTnI in a hospitalized population without a cardiovascular discharge diagnosis from the Shandong area. Methods The hs-cTnI data of anonymous paediatric patients were collected from Qingdao University-Affiliated Yantai Yuhuangding Hospital from 2016 to 2020. Indirect methods were used to calculate the hs-cTnI 99th percentile reference of the whole population and different age groups. Fitting curves and corresponding equations were displayed to determine the relationship between age and hs-cTnI level using the analysis of covariate variance. Results Hs-cTnI plasma levels were highest in the first week of life and declined with age in days. This study found significant differences in the troponin reference intervals for children in different age stratification. The serum hs-cTnI concentration decreased with age in days. In some subgroups, hs-cTnI levels between genders showed a significant difference after the analysis of covariance showed that age was the only predictor of hs-cTnI plasma levels. A non-linear relationship was observed between age and hs-cTnI levels. Thus, curvilinear fitting curve equations for each group were constructed to evaluate the possible relationship between age and hs-cTnI concentration. Conclusions During paediatric period, the highest hs-cTnI concentrations were observed in children aged <1 year, especially those under 7 days. This study presented the 99th percentile cut-offs for different age groups in children aged 0–14 years, which can provide a certain reference value for the clinical diagnosis and treatment of myocardial injury in children.","PeriodicalId":55986,"journal":{"name":"Journal of Laboratory Medicine","volume":"74 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2023-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139066223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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