Clinical biochemistry最新文献

{"title":"A validated method for simultaneous quantification of four antiretrovirals in dried blood spot and plasma using LC-MS/MS: Application to efavirenz therapeutic drug monitoring in pregnant patients","authors":"Maira Ludna Duarte ,&nbsp;Aurylanne Mikaelle Brandão Silva ,&nbsp;José Wellithom Viturino da Silva ,&nbsp;Davi Pereira Santana ,&nbsp;Whocely Victor de Castro ,&nbsp;Luiz Cláudio Arraes de Alencar ,&nbsp;Danilo César Galindo Bedor ,&nbsp;Leila Bastos Leal","doi":"10.1016/j.clinbiochem.2024.110765","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2024.110765","url":null,"abstract":"<div><h3>Introduction</h3><p>The specific physiological background induced by pregnancy leads to significant changes in maternal pharmacokinetics, suggesting potential variability in plasma concentrations of antiretrovirals. Pregnant HIV patients exposed to subtherapeutic doses, particularly in the last trimester of the pregnancy, have higher chances to transmit the infection to their children. Therefore, the therapeutic drug monitoring of antiretrovirals in HIV pregnant patients would be of great value.</p></div><div><h3>Objectives</h3><p>This study aimed to develop and validate a sensitive liquid chromatograph tandem mass spectrometry (LC-MS/MS) method for simultaneous quantification of efavirenz, raltegravir, atazanavir, and ritonavir in dried blood spots (DBS) and plasma.</p></div><div><h3>Design and Methods</h3><p>The analytes were extracted from the DBS punch and plasma with a mixture of methanol:zinc sulfate 200 mM (50:50, v/v) and 100 % methanol, respectively. For the chromatographic separation a Shim-pack® C18, 4.6 mm × 150 mm, 5 μm column was used. Detection was performed in a 3200-QTRAP® mass spectrometer, with a run time of 6 min.</p></div><div><h3>Results</h3><p>The assay was linear in the range of 15–1,000 ng/mL for raltegravir, 50–10,000 ng/mL for both atazanavir and ritonavir, 50–5,000 ng/mL for efavirenz. Precision and accuracy at these concentrations were less than 15 % for all analytes. Raltegravir, atazanavir, and ritonavir were stable for seven days at 23 °C and 40 °C, whereas efavirenz was stable for twenty-four hours at the same conditions.</p></div><div><h3>Conclusions</h3><p>The method was successfully applied to quantify efavirenz in DBS samples obtained from HIV-1 infected pregnant volunteers under antiretroviral therapy. The concentrations of efavirenz in DBS and plasma were comparable according to Passing-Bablok regression and Bland-Altman analysis.</p></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"127 ","pages":"Article 110765"},"PeriodicalIF":2.8,"publicationDate":"2024-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140644373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Primer Part 1 − Preparing a laboratory quality improvement project","authors":"Mary Kathryn Bohn ,&nbsp;Roy Augustin ,&nbsp;Lucas Chartier ,&nbsp;Luke Devine ,&nbsp;Samik Doshi ,&nbsp;Leanne Ginty ,&nbsp;Elliot Lass ,&nbsp;Felix Leung ,&nbsp;William Mundle ,&nbsp;Graeme Nimmo ,&nbsp;Alyson Sandy ,&nbsp;Kelly Shillington ,&nbsp;Amanda Simon ,&nbsp;Amanda Steiman ,&nbsp;Ahmed Taher ,&nbsp;Cindy Tang Friesner ,&nbsp;Cristina Zanchetta ,&nbsp;Jennifer Taher","doi":"10.1016/j.clinbiochem.2024.110764","DOIUrl":"10.1016/j.clinbiochem.2024.110764","url":null,"abstract":"<div><p>Quality in laboratory medicine encompasses multiple components related to total quality management, including quality control (QC), quality assurance (QA), quality indicators, and quality improvement (QI). Together, they contribute to minimizing errors (pre-analytical, analytical, or post-analytical) in clinical service delivery and improving process appropriateness and efficiency. In contrast to static quality benchmarks (QC, QA, quality indicators), the QI paradigm is a continuous approach to systemic process improvement for optimizing patient safety, timeliness, effectiveness, and efficiency. Healthcare institutions have placed emphasis on applying the QI framework to identify and improve healthcare delivery. Despite QI’s increasing importance, there is a lack of guidance on preparing, executing, and sustaining QI initiatives in the field of laboratory medicine. This has presented a significant barrier for clinical laboratorians to participate in and lead QI initiatives. This three-part primer series will bridge this knowledge gap by providing a guide for clinical laboratories to implement a QI project that is<!--> <!-->successful and sustainable. In the first article, we introduce the steps needed to prepare a QI project with focus on relevant methodology and tools related to problem identification, stakeholder engagement, root cause analysis (<em>e.g.</em>, fishbone diagrams, Pareto charts and process mapping), and SMART aim establishment. Throughout, we describe a clinical vignette of a real QI project completed at our institution focused on serum protein electrophoresis (SPEP) utilization. This primer series is the first of its kind in laboratory medicine and will serve as a useful resource for future engagement of clinical laboratory leaders in QI initiatives.</p></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"127 ","pages":"Article 110764"},"PeriodicalIF":2.8,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0009912024000584/pdfft?md5=66156f0419453caa9b111944d4512899&pid=1-s2.0-S0009912024000584-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140772726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New solutions to old problems: A practical approach to identify samples with intravenous fluid contamination in clinical laboratories","authors":"Ashley Newbigging ,&nbsp;Natalie Landry ,&nbsp;Miranda Brun ,&nbsp;Dustin Proctor ,&nbsp;Michelle Parker ,&nbsp;Carmen Zimmer ,&nbsp;Laurel Thorlacius ,&nbsp;Joshua E. Raizman ,&nbsp;Albert K.Y. Tsui","doi":"10.1016/j.clinbiochem.2024.110763","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2024.110763","url":null,"abstract":"<div><h3>Objectives</h3><p>Contamination with intravenous (IV) fluids is a common cause of specimen rejection or erroneous results in hospitalized patients. Identification of contaminated samples can be difficult. Common measures such as failed delta checks may not be adequately sensitive nor specific. This study aimed to determine detection criteria using commonly ordered tests to identify IV fluid contamination and validate the use of these criteria.</p></div><div><h3>Methods</h3><p>Confirmed contaminated and non-contaminated samples were used to identify patterns in laboratory results to develop criteria to detect IV fluid contamination. The proposed criteria were implemented at a tertiary care hospital laboratory to assess performance prospectively for 6 months, and applied to retrospective chemistry results from 3 hospitals and 1 community lab to determine feasibility and flagging rates. The algorithm was also tested at an external institution for transferability.</p></div><div><h3>Results</h3><p>The proposed algorithm had a positive predictive value of 92 %, negative predictive value of 91 % and overall agreement of 92 % when two or more criteria are met (n = 214). The flagging rates were 0.03 % to 0.07 % for hospital and 0.003 % for community laboratories.</p></div><div><h3>Conclusions</h3><p>The proposed algorithm identified true contamination with low false flagging rates in tertiary care urban hospital laboratories. Retrospective and prospective analysis suggest the algorithm is suitable for implementation in clinical laboratories to identify samples with possible IV fluid contamination for further investigation.</p></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"127 ","pages":"Article 110763"},"PeriodicalIF":2.8,"publicationDate":"2024-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140555620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prostate Health Index (PHI) as a triage tool for reducing unnecessary magnetic resonance imaging (MRI) in patients at risk of prostate cancer","authors":"Luisa Agnello ,&nbsp;Matteo Vidali ,&nbsp;Giuseppe Salvaggio ,&nbsp;Francesco Agnello ,&nbsp;Bruna Lo Sasso ,&nbsp;Caterina Maria Gambino ,&nbsp;Marcello Ciaccio","doi":"10.1016/j.clinbiochem.2024.110759","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2024.110759","url":null,"abstract":"<div><h3>Introduction</h3><p>The aim of this study is to assess the usefulness of the Prostate Health Index (PHI) as a triage tool for selecting patients at risk of prostate cancer (PCa) who should undergo multiparametric Magnetic Resonance Imaging (mpMRI).</p></div><div><h3>Material and methods</h3><p>We enrolled 204 patients with suspected PCa. For each patient, a blood sample was collected before mpMRI to measure PHI. Findings on mpMRI were assessed according to the Prostate Imaging Reporting &amp; Data System version 2.0 (PI-RADSv2) category scale.</p></div><div><h3>Results</h3><p>According to PI-RADSv2, patients were classified into two groups: PI-RADS &lt; 3 (48 %) and ≥ 3 (52 %). PHI showed the best performance for predicting PI-RADS ≥ 3 [AUC: 0,747 (0,679–0,815), 0,680(0,607–0,754), and 0,613 (0,535–0,690) for PHI, PSA ratio, and total PSA, respectively]. The best PHI cut-off was 30, with a sensitivity of 90%.</p><p>At the univariate logistic regression, total PSA (p = 0.007), PSA ratio (p = 0.001), [-2]proPSA (p = 0.019) and PHI (p &lt; 0.001) were associated with PI-RADS ≥ 3; however, at the multivariate analysis, only PHI (p &lt; 0.001) was found to be an independent predictor of PI-RADS ≥ 3.</p></div><div><h3>Conclusion</h3><p>PHI could represent a reliable noninvasive tool for selecting patients to undergo mpMRI.</p></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"127 ","pages":"Article 110759"},"PeriodicalIF":2.8,"publicationDate":"2024-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140536401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Age- and sex-specific 99th percentile upper reference limits for high-sensitivity cardiac troponin T in Chinese older people: Real-world data mining","authors":"Qian Zhang ,&nbsp;Huiyi Chen ,&nbsp;Meng Wang ,&nbsp;Huiying Lai ,&nbsp;Wensong Liu ,&nbsp;Lijuan Wang ,&nbsp;Jiaqi Zhang ,&nbsp;Chuanbao Li ,&nbsp;Weiyan Zhou","doi":"10.1016/j.clinbiochem.2024.110762","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2024.110762","url":null,"abstract":"<div><h3>Background</h3><p>This study aims to investigate the impact of age and sex on high-sensitivity cardiac troponin T (hs-cTnT) and establish 99th percentile upper reference limits (URLs) in older individuals utilizing large-scale real-world data.</p></div><div><h3>Methods</h3><p>40,530 outpatient hs-cTnT results were obtained from the laboratory database from January 1, 2018, to December 31, 2023. Our study included 4,199 elderly outpatients (aged ≥ 60) without cardiovascular disease or other heart-related chronic conditions. Nested analysis of variance was used to explore the necessity of partitioning reference intervals (RIs) by sex and age groups. RIs were established by the refineR algorithm and assessed based on ≤ 10% test results of validation data set outside the new RIs.</p></div><div><h3>Results</h3><p>RIs for hs-cTnT in the older population needed to be partitioned by sex and age groups ([standard deviation ratio] SDR_age = 0.75; SDR_sex = 0.49). URLs in older Chinese adults were 21.8 ng/L for males, 16.5 ng/L for females, and 20.7 ng/L for the overall participant group. URLs for males aged 60–69, 70–79, and ≥ 80 were 13.7, 19.4, and 31.0 ng/L, respectively. Female values were 10.1, 17.2, and 22.0 ng/L. Importantly, manufacturer-reported RIs do not suffice for Chinese individuals aged ≥ 70. Validation data showed that 2.7–5.2% of test results fell outside the new RIs, confirming the validity of the results.</p></div><div><h3>Conclusion</h3><p>This study establishes age- and sex-specific 99th percentile URLs for hs-cTnT in Chinese older individuals, thereby enhancing the accuracy of clinical assessments.</p></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"127 ","pages":"Article 110762"},"PeriodicalIF":2.8,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140542359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics of isatuximab-derived interference in serum protein electrophoresis and immunofixation, and an absence of sustained in vivo interference due to belantamab mafodotin and denosumab","authors":"Adam Jimenez ,&nbsp;Ashley Rose Scholl ,&nbsp;Bangchen Wang ,&nbsp;Michael Schilke ,&nbsp;Eric D. Carlsen","doi":"10.1016/j.clinbiochem.2024.110761","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2024.110761","url":null,"abstract":"<div><h3>Objectives</h3><p>Some therapeutic monoclonal antibodies, like daratumumab and elotuzumab, produce interfering monoclonal bands on serum protein electrophoresis (SPEP) and immunofixation electrophoresis (IFE). Whether other common therapeutic antibodies also produce interference has not been systematically evaluated.</p></div><div><h3>Design and methods</h3><p>SPEP/IFE from patients receiving isatuximab (48 patients), belantamab mafodotin (BM; 41), and denosumab (41) were retrospectively reviewed for therapeutic antibody interference. Cases exhibiting isatuximab interference were quantified and the maximum duration of isatuximab effect was evaluated. To characterize band position, neat human serum was spiked with BM or denosumab at supratherapeutic concentrations. Band migration patterns were compared on SPEP and IFE, with band position expressed relative to other constant protein fractions.</p></div><div><h3>Results</h3><p>Isatuximab-induced IFE interference was common (81.3 % of evaluated patients) with a maximum observed duration of 8 weeks. 10.4 % of isatuximab patients had IgG kappa monoclonal gammopathies that co-migrated with the drug; this subset could benefit from HYDRASHIFT 2/4 isatuximab testing. 8.3 % of IFE cases were negative for an isatuximab band but showed large, endogenous M-spikes migrating elsewhere. All patients in this group expired within 1 year of this finding. We hypothesize that an inability to detect isatuximab in this setting corresponds to a large residual myeloma burden that reduces isatuximab serum concentration. This observation may serve as a negative prognostic factor. Spiking studies demonstrated that BM and denosumab produce interference <em>in vitro</em>, but sustained interference was not observed in &gt;40 treated patients.</p></div><div><h3>Conclusions</h3><p>Therapeutic antibody interference in patients receiving isatuximab is common, and can persist for at least 8 weeks after administration. &gt;10 % of patients receiving isatuximab may benefit from HYDRASHIFT testing post-therapy. In contrast, BM and denosumab fail to produce sustained interference in treated patients.</p></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"127 ","pages":"Article 110761"},"PeriodicalIF":2.8,"publicationDate":"2024-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140339550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum netrin-1 levels are high in Rheumatoid arthritis associated interstitial lung disease","authors":"Ahmet Kor ,&nbsp;Serdar Can Güven ,&nbsp;Selçuk Akan ,&nbsp;Funda Eren ,&nbsp;Hatice Ecem Konak ,&nbsp;Yüksel Maraş ,&nbsp;Kevser Orhan ,&nbsp;Salim Neşelioğlu ,&nbsp;Şükran Erten","doi":"10.1016/j.clinbiochem.2024.110760","DOIUrl":"https://doi.org/10.1016/j.clinbiochem.2024.110760","url":null,"abstract":"<div><h3>Background</h3><p>Recent data show that netrin-1 has a role in development of pulmonary fibrosis. This study was aimed to investigate serum netrin-1 level and its relation to interstitial lung disease(ILD) in patients with rheumatoid arthritis (RA).</p></div><div><h3>Method</h3><p>42 RA patients with RA-ILD, 58 RA patients without RA-ILD (RA non-ILD group), and 61 healthy volunteers were included in this study. The modified DAS28-ESR score was used to calculate disease activity in RA patients. Using the quantitative immunoassay method, Serum netrin-1 levels were measured with an ELISA kit (Catalog number: E-EL-H2328; lab science, lot number: GZWTKZ5SWK, Texas, USA).</p></div><div><h3>Results</h3><p>The median value of netrin-1 was found to be significantly higher in the RA-ILD group (82.9 [59.9–124]) compared to both the RA non-ILD group(52.9 [49.5–73.1])(B = −0.006, OR = 0.994, CI 95 %=0.989–0.999, P = 0.018) and the control group(53.5 [49.5–87.5]) (B: −0.005, OR: 0.994, CI 95 %: 0.990–0.999, p: 0.022). A cut-off value of 61.78 for netrin-1 was found to have a sensitivity of 73.8 % and a specificity of 69 % for the diagnosis of RA-ILD (AUC [95 %Cl] = 0.771 [0.679–0.862], p &lt; 0.0001).It was found that high serum netrin-1 level was strongly associated with the RA-usual interstitial pneumonia(UIP) pattern and poorly related to the RA-nonspecific interstitial pneumonia(NSIP) pattern compared to the RA non-ILD group.</p></div><div><h3>Conclusions</h3><p>Netrin-1 is elevated in the serum of patients with RA-ILD, especially in the UIP pattern. Netrin-1 may be a potential candidate for predicting the development of RA-ILD that should be investigated in the pathophysiological and therapeutic fields..</p></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"127 ","pages":"Article 110760"},"PeriodicalIF":2.8,"publicationDate":"2024-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140328624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retraction notice to “Distributions of alcohol use biomarkers including ethanol, phosphatidylethanol, ethyl glucuronide and ethyl sulfate in clinical and forensic testing” [Clin. Biochem. 82 (2020) 85–89]","authors":"Rebecca Mastrovito,&nbsp;Frederick G. Strathmann","doi":"10.1016/j.clinbiochem.2024.110749","DOIUrl":"10.1016/j.clinbiochem.2024.110749","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"126 ","pages":"Article 110749"},"PeriodicalIF":2.8,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0009912024000432/pdfft?md5=cb8cdb714087525a658c277f134b83b7&pid=1-s2.0-S0009912024000432-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140173879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical usefulness of a host signature based on TRAIL, IP10, and CRP (MeMed BV) as infection biomarkers in intensive care units’ patients. A retrospective observational study","authors":"Karol P. Steckiewicz ,&nbsp;Magdalena A. Wujtewicz ,&nbsp;Michał Okrągły ,&nbsp;Aleksander Aszkiełowicz ,&nbsp;Małgorzata Dąbrowska ,&nbsp;Radosław Owczuk","doi":"10.1016/j.clinbiochem.2024.110748","DOIUrl":"10.1016/j.clinbiochem.2024.110748","url":null,"abstract":"<div><h3>Introduction</h3><p>Infection complications are common in intensive care unit patients, and early detection remains a diagnostic challenge. Procalcitonin (PCT) and C-reactive protein (CRP) are commonly used biomarkers. A novel diagnostic approach focuses on the host immune response. One of the approaches, the MMBV index, is based on measuring in a blood sample three parameters: (i) tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), (ii) interferon-γ-induced protein-10 (IP10), and (iii) CRP. This study aimed to evaluate the usefulness of MMBV as an infection biomarker in an ICU cohort.</p></div><div><h3>Patients and Methods</h3><p>Forty-six patients treated in the University Clinical Center in Gdansk ICU were enrolled in the study, and their clinical data were retrospectively analyzed. In total, 91 MMBV results were analyzed.</p></div><div><h3>Results</h3><p>Most of the patients had high MMBV values, suggesting bacterial etiology. A weak correlation between PCT and MMBV was observed, and no correlation between parameter changes was noted. There was a correlation between CRP/MMBV and between changes in CRP / changes in MMBV.</p></div><div><h3>Conclusion</h3><p>It seems that MMBV is not valuable for ICU patients neither in diagnosing nor monitoring infection. Higher MMBV values may predict unfavorable treatment outcomes.</p></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"126 ","pages":"Article 110748"},"PeriodicalIF":2.8,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140136570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Spironolactone metabolite causes falsely increased progesterone in the Abbott Architect immunoassay","authors":"Kwabena A.N. Sarpong ,&nbsp;Su Hee Kim ,&nbsp;Christopher R. McCartney ,&nbsp;Joesph R. Wiencek ,&nbsp;Lindsay A.L. Bazydlo","doi":"10.1016/j.clinbiochem.2024.110747","DOIUrl":"10.1016/j.clinbiochem.2024.110747","url":null,"abstract":"<div><h3>Background</h3><p>Immunoassays are important for routine clinical testing and medical diagnosis. However, they are limited by cross-reactivity especially at low analyte concentrations. There is a critical need to investigate compounds that can interfere with immunoassays. Herein, we describe the identification of canrenone, a spironolactone metabolite that falsely increases progesterone concentrations on the Abbott Architect i2000 Immunoassay.</p></div><div><h3>Methods</h3><p>Serum samples and assay diluents were spiked with spironolactone or canrenone and progesterone concentrations were measured on the Architect i2000 and Immulite XPi immunoassay platforms. Blood samples from patients taking spironolactone were analyzed with liquid chromatography-tandem mass spectrometry to evaluate the intrinsic response of progesterone concentrations to the presence of canrenone.</p></div><div><h3>Results</h3><p>We measured approximately 10-fold higher progesterone concentrations on the Abbott Architect i2000 compared to reference immunoassay analyzers (Siemens Immulite XPi and Roche Cobas e601/602), suggesting an analytical error which is unique to the Architect i2000 antibody and/or assay conditions. By measuring serum progesterone after addition of spironolactone or canrenone to serum samples, we found that canrenone falsely increased progesterone on the Architect i2000 immunoassay. However, this interference was more pronounced at low serum progesterone concentrations. Moreover, a strong positive correlation was seen between canrenone and measured serum progesterone concentrations.</p></div><div><h3>Conclusions</h3><p>Our investigations are important for individuals who require progesterone measurements using the Architect i2000 immunoassay, especially because it is unlikely for clinicians to order canrenone measurements alongside progesterone measurements for individuals taking spironolactone. Further research is needed to determine whether canrenone can influence progesterone measurements on other immunoassay systems.</p></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"126 ","pages":"Article 110747"},"PeriodicalIF":2.8,"publicationDate":"2024-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140130822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}