Practical Laboratory Medicine最新文献

{"title":"Implementation of long-read sequencing for routine molecular diagnosis of familial mediterranean fever","authors":"X. Vanhoye,&nbsp;P. Mouty,&nbsp;S. Mouty,&nbsp;N. Bargues,&nbsp;N. Couprie,&nbsp;E. Fayolle,&nbsp;V. Géromel,&nbsp;M. Taoudi,&nbsp;L. Raymond,&nbsp;J.-F. Taly","doi":"10.1016/j.plabm.2024.e00423","DOIUrl":"10.1016/j.plabm.2024.e00423","url":null,"abstract":"<div><h3>Background</h3><p>Long-read sequencing technology, widely used in research, is proving useful in clinical diagnosis, especially for infectious diseases. Despite recent advances, it hasn't been routinely applied to constitutional human diseases. Long-read sequencing detects intronic variants and phases variants, crucial for identifying recessive diseases.</p></div><div><h3>Methods</h3><p>We integrated long-read sequencing into the clinical diagnostic workflow for the MEFV gene, responsible for familial Mediterranean fever (FMF), using a Nanopore-based workflow. This involved long-range PCR amplification, native barcoding kit library preparation, GridION sequencing, and in-house bioinformatics. We compared this new workflow against our validated method using 39 patient samples and 3 samples from an external quality assessment scheme to ensure compliance with ISO15189 standards.</p></div><div><h3>Results</h3><p>Our evaluation demonstrated excellent performance, meeting ISO15189 requirements for reproducibility, repeatability, sensitivity, and specificity. Since October 2022, 150 patient samples were successfully analyzed with no failures. Among these samples, we identified 13 heterozygous carriers of likely pathogenic (LP) or pathogenic (P) variants, 1 patient with a homozygous LP/P variant in MEFV, and 4 patients with compound heterozygous variants.</p></div><div><h3>Conclusion</h3><p>This study represents the first integration of long-read sequencing for FMF clinical diagnosis, achieving 100 % sensitivity and specificity. Our findings highlight its potential to identify pathogenic variants without parental segregation analysis, offering faster, cost-effective, and accurate clinical diagnosis. This successful implementation lays the groundwork for future applications in other constitutional human diseases, advancing precision medicine.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00423"},"PeriodicalIF":1.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000696/pdfft?md5=ef62fb79c08b487cc52051c4961e4d33&pid=1-s2.0-S2352551724000696-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141964663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A comparison of anti-cyclic citrullinated peptides (CCP3 and CCP3.1) autoantibody tests in rheumatoid arthritis","authors":"Heather A. Nelson ,&nbsp;Dipanwita Banerjee ,&nbsp;Camille L. Novis ,&nbsp;Kevin D. Deane ,&nbsp;Marie L. Feser ,&nbsp;Vijayalakshmi Nandakumar","doi":"10.1016/j.plabm.2024.e00420","DOIUrl":"10.1016/j.plabm.2024.e00420","url":null,"abstract":"<div><h3>Background</h3><p>Anti-citrullinated protein antibodies (ACPA) are a specific serological biomarker used in the diagnosis of rheumatoid arthritis (RA). In clinical practice ACPA can be identified using immunoassays targeting synthetic cyclic citrullinated peptides (CCP). The 3rd generation anti-CCP IgG antibody (CCP3) offers improved sensitivity compared to the earlier versions. Recently, CCP3.1, capable of detecting both IgG and IgA antibodies, was introduced to enhance sensitivity, especially in patients with early RA.</p></div><div><h3>Methods</h3><p>We assessed serum CCP3.1 against CCP3 in 331 subjects undergoing RA panel serology, comprising 136 patients with RA and 195 patients without RA. Sera were tested for anti-CCP IgG (CCP3) and anti-CCP IgG/IgA (CCP3.1) antibodies. Clinical performance of these tests was compared at manufacturer-suggested cutoffs. A separate set of 81 patients with a diagnosis of RA by 2010 criteria and whose samples were obtained from within 1-year of RA diagnosis was similarly assessed to evaluate assay performance in an independent clinical RA cohort.</p></div><div><h3>Results</h3><p>Overall diagnostic accuracy was similar; CCP3 had an area under the curve (AUC) of 0.88, CCP3.1 had an AUC of 0.89. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for CCP3 were 79 %, 91 %, 86 %, and 86 %, respectively. For CCP3.1, sensitivity was 78 %, specificity 93 %, PPV 89 %, NPV 86 %. Both assays demonstrated excellent agreement; positive percent agreement of 94 % and negative percent agreement of 99 %.</p></div><div><h3>Conclusion</h3><p>Our findings indicate comparable diagnostic accuracy between CCP3 and CCP3.1 assays in these clinical cohorts.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00420"},"PeriodicalIF":1.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000660/pdfft?md5=583223d3ab9f7125ac49d9b57141b8d5&pid=1-s2.0-S2352551724000660-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141844296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Longevity of Schistosoma mansoni circulating cathodic antigens in filter paper dried urine spots","authors":"Abdallah Zacharia ,&nbsp;Clemence Kinabo ,&nbsp;Twilumba Makene ,&nbsp;Huda Omary ,&nbsp;George Ogweno ,&nbsp;Faraja Lyamuya ,&nbsp;Billy Ngasala","doi":"10.1016/j.plabm.2024.e00426","DOIUrl":"10.1016/j.plabm.2024.e00426","url":null,"abstract":"<div><h3>Objectives</h3><p>This study aims to determine the temporal stability of <em>Schistosoma mansoni</em> circulating cathodic antigens (CCA) in filter paper-based dried urine spot (FP-DUS) samples under varying temperatures condition.</p></div><div><h3>Methods</h3><p>Urine from 20 children confirmed to have <em>S. mansoni</em> infection using Kato-Katz (at least 1 egg per gram of stool) and Schisto POC-CCA (2+ and 3+) methods were stored in form of FP-DUS and urine at room temperature (RT), 4 °C and −20 °C. Standard urine and FP-DUS Schisto POC-CCA methods were employed to detect CCA in urine and FP-DUS samples respectively, at weeks 4, 8 and 12. The results were reported as negative or positive (trace, 1+. 2+, and 3+).</p></div><div><h3>Results</h3><p>In FP-DUS samples, POC-CCA scores initially increase after 4–8 weeks, but then showed a decrease in intensity while still remaining positive, independent of temperature condition. From week 4 to week 12, at least 80 % of urine samples had POC-CCA score of 3+, independent of temperature condition. However, 2 urine samples at RT tested negative at weeks 8 and 12.</p></div><div><h3>Conclusions</h3><p>Despite the decrease in the intensity of test line in many samples, <em>S. mansoni</em> CCA remains stable and detectable in urine samples stored in FP-DUS.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00426"},"PeriodicalIF":1.7,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000726/pdfft?md5=77180d3825dd578393d89f20ea9d8e51&pid=1-s2.0-S2352551724000726-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142117526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Choosing the right equation for calculating indirect LDL-Cholesterol (LDL-C) in adult Pakistani population: Evaluation of seven equations using big data analytics","authors":"Syed Bilal Hashmi ,&nbsp;Sibtain Ahmed ,&nbsp;Shiraz Hashmi ,&nbsp;Rasool Bux ,&nbsp;Imran Siddiqui","doi":"10.1016/j.plabm.2024.e00418","DOIUrl":"10.1016/j.plabm.2024.e00418","url":null,"abstract":"<div><h3>Objective</h3><p>Cardiovascular diseases (CVDs) are a leading cause of mortality worldwide. Low density lipoprotein cholesterol (LDL-C) contributes to the atherogenic process. However, direct LDL-C (d-LDL) has rarely been estimated by the gold standard method because it is cumbersome and expensive. We aim to evaluate calculated low density lipoprotein (LDL-c) by various equations with reference to directly measured LDL-C in the Pakistani adult population as a cost-effective alternative.</p></div><div><h3>Methods</h3><p>We retrospectively evaluated the validity of seven equations for estimating calculated LDL-C by computing correlation coefficients (r) and Bland Altman plots to assess agreement (mean %) for (d-LDL) and calculated (LDL-c) on all seven equations. Statistical analysis was performed in Stata Statistical Software: Release 17, College Station, TX: StataCorp LLC.</p></div><div><h3>Results</h3><p>We analyzed 247082 direct assays of lipid profiles of adults aged ≥18 years. The mean LDL-C levels computed on Friedewald, de Cordova, Chen, Hattori, Vujovic, Teerakanchana, Sampson equations were 106.8 ± 31.4, 103.7 ± 25.0, 108.6 ± 28.2, 100.1 ± 29.5, 115.2 ± 31.2, 113.1 ± 28.3 and 110.3 ± 30.6 respectively. Friedewald and Hattori equations correlated strongly with direct LDL-C (r = 0.937) for each followed by Sampson (r = 0.935) and Vujovic (r = 0.931). However, the median bias was least for the Friedwald equation (−1.6) compared to the other equations.</p></div><div><h3>Conclusion</h3><p>In contrast to the global literature advocating for the use of newer equations, although the conventional and widely utilized Friedewald equation remains the best alternative for calculated LDL-C estimation in adult Pakistani population.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"41 ","pages":"Article e00418"},"PeriodicalIF":1.7,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000647/pdfft?md5=f5fe030419edb50a321dead65c9ec4d1&pid=1-s2.0-S2352551724000647-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141622681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum levels of the N-terminal fragment of connective tissue growth factor is a novel biomarker for chronic pancreatitis","authors":"Naoki Morishima ,&nbsp;Yoshihiro Kamada ,&nbsp;Hiyori Ota,&nbsp;Yoshifumi Iwagami,&nbsp;Hidenori Takahashi,&nbsp;Munefumi Shimosaka,&nbsp;Daisuke Sakon,&nbsp;Jumpei Kondo,&nbsp;Makoto Yamada,&nbsp;Takashi Kumada,&nbsp;Hidetoshi Eguchi,&nbsp;Eiji Miyoshi","doi":"10.1016/j.plabm.2024.e00402","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00402","url":null,"abstract":"<div><p>Chronic inflammation of the pancreas is considered to be one of the causes of pancreatic cancer. However, the diagnosis of chronic pancreatitis (CP) is very difficult in the pancreas, where biopsies are difficult to perform. The prevalence of CP is estimated to be many times more common than in patients with actual symptomatic CP. In recent years, abnormal cleavage of certain proteins has attracted attention as a biomarker for CP other than pancreatic enzymes. Connective tissue growth factor (CTGF) is one of the growth factors involved in tissue repair and other processes and is increased by stimulation of transforming growth factor-β, suggesting a relationship of CTGF with fibrosis. In this study, we measured the total length of CTGF in blood and <em>N</em>-terminal fragment CTGF in 48 cases of chronic pancreatitis, 64 cases of pancreatic cancer and 45 healthy volunteers (HV). Interestingly, we found that blood <em>N</em>-terminal fragment CTGF level was significantly increased in CP and pancreatic cancer patients. Multiple logistic regression analysis showed serum levels of <em>N</em>-terminal fragment CTGF, CRP and amylase were significant and independent variables for the differential diagnosis of CP from HV. Receiver operating characteristic analysis showed that area under the curve (AUC) value of serum <em>N</em>-terminal fragment CTGF level was 0.933, which can differentiate between CP and HV. Several factors would be involved in the increase in serum <em>N</em>-terminal fragment CTGF level. In conclusion, serum <em>N</em>-terminal fragment CTGF level is a promising new biomarker for CP.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"40 ","pages":"Article e00402"},"PeriodicalIF":1.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000489/pdfft?md5=da21e15253b52b50970c50300de3c612&pid=1-s2.0-S2352551724000489-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141083661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Genetic study of the CDKN2A and CDKN2B genes in renal cell carcinoma patients","authors":"Nattaradee Kiatprungvech ,&nbsp;Premsant Sangkum ,&nbsp;Rozita Malinee ,&nbsp;Suchada Sommaluan ,&nbsp;Veerawat Korkiatsakul ,&nbsp;Suchin Worawichawong ,&nbsp;Budsaba Rerkamnuaychoke ,&nbsp;Adcharee Kongruang ,&nbsp;Suraida Aeesoa ,&nbsp;Panuwat Lertsithichai ,&nbsp;Kittinut Kijvikai ,&nbsp;Wisoot Kongchareonsombat ,&nbsp;Teerapong Siriboonpiputtana","doi":"10.1016/j.plabm.2024.e00410","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00410","url":null,"abstract":"<div><h3>Objectives</h3><p>While recent studies have demonstrated several genetic alterations are associated with pathogenesis of RCC, the significance of cyclin-dependent kinase inhibitor 2A <em>(CDKN2A)</em> and cyclin-dependent kinase inhibitor 2B <em>(CDKN2B)</em> in tumorigenesis of RCC is less clear. We investigate the distribution of <em>CDKN2A</em> and <em>CDKN2B</em> mutations in patients with RCC and analyze the impact of <em>CDKN2A</em> and <em>CDKN2B</em> mutations on RCC.</p></div><div><h3>Methods</h3><p>A pathological examination was conducted using thirty fresh renal tissue samples with renal masses that had undergone partial or radical nephrectomy. Multiplex ligation-dependent probe amplification (MLPA) was used to detect genetic aberrations of <em>CDKN2A</em> and <em>CDKN2B</em> in genomic DNA isolated from samples. Subsequently, <em>CDKN2A</em> and <em>CDKN2B</em> mutations were confirmed using chromosomal microarray technique.</p></div><div><h3>Results</h3><p>Twenty-one patients were diagnosed with RCC, eight with benign diseases, including angiomyolipoma (AML) and oncocytoma, and one with mucinous adenocarcinoma of renal pelvis. Two of twenty-one patients (9.5 %) with clear-cell RCC were positive for <em>CDKN2A</em> and <em>CDKN2B</em> gene deletions. Interestingly, patients with <em>CDKN2A</em> and <em>CDKN2B</em> mutations were associated with sarcomatoid patterns of RCC (2 out of 4, 50 %). In contrast, no <em>CDKN2A</em> or <em>CDKN2B</em> deletions were detected in samples from benign renal tumors, papillary RCC, or other kidney cancers.</p></div><div><h3>Conclusions</h3><p>This study demonstrated the potential use of <em>CDKN2A</em> and <em>CDKN2B</em> as biomarkers for the prognostic and molecular classification of renal cancer. <em>CDKN2A</em> and <em>CDKN2B</em> mutations may be associated with RCC development and sarcomatoid changes. Further research is needed to understand the underlying molecular mechanisms of <em>CDKN2A</em> and <em>CDKN2B</em> in the pathogenesis of RCC.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"40 ","pages":"Article e00410"},"PeriodicalIF":1.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000568/pdfft?md5=249646e4fe2ff3861b7952c26d5e0ef3&pid=1-s2.0-S2352551724000568-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141239117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Detection of CDH1 gene promoter hypermethylation in gastric cancer and chronic gastritis","authors":"Mitra Bayat ,&nbsp;Amir Shirgir ,&nbsp;Arash Kazemi Veisari ,&nbsp;Rouhallah Najjar Sadeghi","doi":"10.1016/j.plabm.2024.e00406","DOIUrl":"10.1016/j.plabm.2024.e00406","url":null,"abstract":"<div><h3>Aim</h3><p>The current study aimed to assess the frequency of <em>CDH1</em> promoter gene hypermethylation in gastric cancer and chronic gastritis and its correlation with clinicopathological aspects.</p></div><div><h3>Methods</h3><p>Methylation-specific PCR was used to detect CDH1 promoter gene hypermethylation in 53 chronic gastritis patients and 40 gastric cancer patients along with normal adjacent tissues.</p></div><div><h3>Results</h3><p>The chronic gastritis group comprised 29 males and 24 females with a mean age of 51.8 ± 12.96 years, and 49.1 % of them were positive for H. pylori infection. The frequency of <em>CDH1</em> hypermethylation in gastritis lesions was 18.8 %. <em>CDH1</em> hypermethylation showed a significant correlation with H. pylori infection (p = 0.039), but no significant association was observed with other clinical features. The gastric cancer group consisted of individuals with a mean age of 65.4 ± 10.6, among them, 77.5 % were male and 22.5 % were female, 62.5 % had PT3 tumors, 40 % had PN1 lymph node involvement, and the majority (47.5 %) of samples were obtained from body segment. <em>CDH1</em> hypermethylation was significantly associated with depth of invasion (p = 0.017) and nodal invasion (p = 0.041) in this group. In both groups, normal adjacent specimens lacked CDH1 hypermethylation, and there was no statistically significant correlation between CDH1 hypermethylation and age at which the tumor was diagnosed, gender, activity level, or tumor location.</p></div><div><h3>Conclusion</h3><p>This study demonstrates that E-cadherin methylation is associated with some characteristics of chronic gastritis and gastric cancer. These findings support previous research indicating that CDH1 hypermethylation may play a significant role in the development of gastric cancer.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"40 ","pages":"Article e00406"},"PeriodicalIF":1.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000520/pdfft?md5=8c6ac4ad32e9fc2fa93d69467d9c5744&pid=1-s2.0-S2352551724000520-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141140015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The US FDA's proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing","authors":"Leslie Smith ,&nbsp;Lisa A. Carricaburu ,&nbsp;Jonathan R. Genzen","doi":"10.1016/j.plabm.2024.e00407","DOIUrl":"10.1016/j.plabm.2024.e00407","url":null,"abstract":"<div><h3>Objectives</h3><p>To solicit quantifiable feedback from clinical laboratorians on the U.S. Food and Drug Administration (FDA) proposed rule to regulate laboratory-developed tests (LDTs) as medical devices.</p></div><div><h3>Design and Methods</h3><p>A ten-item questionnaire was developed and submitted to clinical laboratory customers of ARUP Laboratories, a national nonprofit clinical laboratory of the University of Utah Department of Pathology.</p></div><div><h3>Results</h3><p>Of 503 clinical laboratory respondents, only 41 (8 %) support the FDA's proposed rule. 67 % of respondents work in laboratories that perform LDTs and were therefore asked additional questions regarding the proposed rule. 84 % of these respondents believe that the proposed rule will negatively impact their laboratories, while only 3 % believe that they have the financial resources to pay for FDA user fees. 61 % of respondents anticipate removing tests from their laboratory menus if the proposed rule is enacted, while an additional 33 % indicated that they do not yet know. Only 11 % of respondents believe that they would pursue FDA submissions for all of their existing LDTs if the final rule is enacted. The vast majority of respondents (&gt;80 %) were either ‘extremely concerned’ or ‘very concerned’ about the impact of the proposed rule on patient access to essential testing, financial and personnel resources to comply, innovation, the FDA's ability to implement the rule, and send-out costs and test prices.</p></div><div><h3>Conclusions</h3><p>The majority of clinical laboratorians surveyed do not support the FDA's proposed rule on LDTs and report having insufficient resources to comply with the rule if it is enacted.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"40 ","pages":"Article e00407"},"PeriodicalIF":1.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000532/pdfft?md5=bc55bcefd759e5695d2abc8c336ddfb6&pid=1-s2.0-S2352551724000532-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141130914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the diagnostic performance of an immunochromatographic test for Chlamydia trachomatis","authors":"Shu-Lian Li ,&nbsp;Hui-Ling Lin ,&nbsp;Hong-Fei Mi ,&nbsp;Qing-Qi Meng ,&nbsp;Ya Yan ,&nbsp;Xiao-Luo Zhang ,&nbsp;Wei-Ming Gu ,&nbsp;Yao Xiao","doi":"10.1016/j.plabm.2024.e00412","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00412","url":null,"abstract":"<div><h3>Objectives</h3><p>To evaluate the diagnostic performance of different brands of immunochromatographic test (ICT) reagents for <em>Chlamydia trachomatis</em> using homogenized samples to provide a reference for reagent quality control.</p></div><div><h3>Methods</h3><p>Eight commercially available ICT reagents were evaluated, of which three used the latex method and five used the colloidal gold method. Analytical performance evaluation using a pure culture broth of <em>C. trachomatis</em>, as well as clinical application validation using cervical epithelial cell samples acquired from the research subjects, were conducted. The concentration of <em>C. trachomatis</em> was quantified using a nucleic acid amplification test.</p></div><div><h3>Results</h3><p>The limit of detection (LOD) of different ICT reagents in the analytical performance evaluation varied from 9.5 × 10³ to 1 × 10⁵ IFU/mL, and only one reagent met the LOD specified in the manufacturer's instructions. Likewise, only one reagent in the clinical application validation achieved the analytical LOD, four reagents were 2.1–4.2-fold of the analytical LODs, and three reagents failed to detect positive results in clinical samples.</p></div><div><h3>Conclusions</h3><p>The diagnostic performance of different methods and different brands of ICT reagents in clinical practice was different from the manufacturer's instructions and the results of laboratory evaluation. The diagnostic performance of reagents should be evaluated before they are actually used in clinical practice.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"40 ","pages":"Article e00412"},"PeriodicalIF":1.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000581/pdfft?md5=80e4a58215dd1f948a6dbedf49b565ca&pid=1-s2.0-S2352551724000581-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141239035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Management of refined and personalized newborn blood specimen collection","authors":"Hui-Bin Huang ,&nbsp;Yu-Bin Lin ,&nbsp;Jin-Hua Chen ,&nbsp;Min Zhu ,&nbsp;Li-Jin Chen ,&nbsp;Wang Ye ,&nbsp;Lin-Hua Luo ,&nbsp;Hui-ming Ye","doi":"10.1016/j.plabm.2024.e00408","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00408","url":null,"abstract":"<div><h3>Background</h3><p>Iatrogenic blood loss is an important cause of neonatal anemia. In this study, a spreadsheet tool was developed to reduce blood collection, providing a new idea for the prevention of iatrogenic blood loss in newborns.</p></div><div><h3>Methods</h3><p>Based on hematocrit, minimum test volume and dead volume, a new tool was to calculate the minimum blood collection volume and the number of containers required for the test portfolio. We collected data from October 2022 to October 2023 from Xiamen Maternal and Child Health Hospital for analysis and validation.</p></div><div><h3>Results</h3><p>During this year, there were 16,434 patients and 13,696 plasma/serological samples in the neonatology department. Among them, there were 8 test combinations of greater than 1%, and 9490 samples in total. According to the hospital manual, the recommended amount of blood collection is 27,534 ml and 9490 containers. Through the analysis of this tool, total blood collection was 8864.77 ml, marked qnantity of upward containers (closest level to the calculated blood collection volume) was 10301 ml, and the amount of containers was 8835, which decreased by 67.8%, 62.58% and 6.9% respectively. Besides, if the hematocrit information cannot be obtained in advance and the high hematocrit is calculated as 0.8, the recommended amount of blood collection is 14334.3 ml, and the marked amount of the upward container markering is 17340 ml, decreasing by 47.9% and 37.02% respectively.</p></div><div><h3>Conclusion</h3><p>We have developed an auxiliary tool that can manage neonatal blood specimen collection in a fine and personalized way and can be applied among different laboratory instruments by parameters modification.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"40 ","pages":"Article e00408"},"PeriodicalIF":1.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000544/pdfft?md5=a8b4c6a26fc621181e559c650bf3000f&pid=1-s2.0-S2352551724000544-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141239116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}