Practical Laboratory Medicine最新文献

{"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":null,"pages":null},"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":null,"pages":null},"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":"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":null,"pages":null},"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":"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":null,"pages":null},"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":"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":null,"pages":null},"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":"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":null,"pages":null},"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}

{"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":null,"pages":null},"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":"Enzymatic detection of α-hydroxybutyrate, an important marker of insulin resistance, and comparison with LC-MS/MS detection","authors":"Beate Steiner ,&nbsp;Christian Leitner ,&nbsp;David Stadler ,&nbsp;Eva-Maria Prugger ,&nbsp;Christoph Magnes ,&nbsp;Peter L. Herzog","doi":"10.1016/j.plabm.2024.e00398","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00398","url":null,"abstract":"<div><h3>Aim</h3><p>The metabolite α-hydroxybutyrate (α-HB) is an important marker of insulin resistance and impaired glucose tolerance allowing to identify patients at risk of developing diabetes and related metabolic disorders before any symptoms become apparent. At present, its exact quantification requires mass spectrometry (LC-MS), which is not compatible with routine laboratory use. Accordingly, a simple enzymatic-based method was assessed and its applicability and measuring accuracy compared with LC-MS was investigated.</p></div><div><h3>Methods</h3><p>Standards, serum, and plasma samples containing α-HB were prepared with routine procedures and their α-HB contents measured with the XpressGT® enzymatic test kit photometrically or with LC-MS and multiple reaction monitoring.</p></div><div><h3>Results</h3><p>α-HB detection with XpressGT® yielded highly linear calibration curves and 102 % recovery of stocks added to commercial samples. Stability of the analyte in serum and plasma samples prepared with various anti-coagulants was &gt;90 % after 46 h for several widely used preparations and recovery after 3 freeze-thaw cycles was ≥95 % with these anti-coagulants. A direct comparison of 75 samples indicated very good agreement of α-HB levels determined by both methods, 86 % of XpressGT® samples being within ±20 % of LC-MS values and even 93 % within ±20 % considering only samples above 30 μM concentration.</p></div><div><h3>Conclusion</h3><p>XpressGT®-based detection of α-HB is an easily applicable method which can be used for accurate and reliable quantification of the metabolite in clinical practice. Routine α-HB determination in patients at risk of developing diabetes would allow early establishment of preventive measures or pharmacological intervention reducing the risk for the onset of serious diabetes-related health problems.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000441/pdfft?md5=f57563a55f17bbd1ce542cb6fe9fd18f&pid=1-s2.0-S2352551724000441-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140879997","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":"Performance evaluation of influenza a rapid antigen test and PCR among nasopharyngeal and oropharyngeal samples","authors":"Xiaosong Su ,&nbsp;Jiaye Zhou ,&nbsp;Ling Liu ,&nbsp;Hongzhi Gao ,&nbsp;Yan Lin ,&nbsp;Zhile Wang ,&nbsp;Xin Zhang ,&nbsp;Baishen Pan ,&nbsp;Beili Wang ,&nbsp;Chunyan Zhang ,&nbsp;Wei Guo","doi":"10.1016/j.plabm.2024.e00416","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00416","url":null,"abstract":"<div><h3>Objectives</h3><p>Rapid antigen test (RAT) and polymerase chain reaction (PCR) using nasopharyngeal (NP) or oropharyngeal (OP) swab specimens are the two main testing techniques used for laboratory diagnosis of influenza in clinical practice. However, performance variations have been observed not only between techniques, but also between different specimens. This study evaluated the differences in performance between specimens and testing techniques to identify the best combination in clinical practice.</p></div><div><h3>Methods</h3><p>Both NP and OP samples from suspected influenza patients collected in the 2023/4–2023/5 Flu-season in Xiamen, China, were tested for RAT and quantitative PCR. The testing performance of the different specimens and testing techniques were recorded and evaluated.</p></div><div><h3>Results</h3><p>Compared to PCR, RAT showed 58.9 % and 10.3 % sensitivity for NP and OP swabs, respectively. The Limit of Detection (LoD) was 28.71 the Median Tissue Culture Infectious Dose (TCID₅₀)/mL. Compared with PCR using NP swabs, PCR with OP swabs showed 89.5 % sensitivity and 95.4 % specificity.</p></div><div><h3>Conclusions</h3><p>There were no significant differences in performance between the specimens when PCR was used to test for influenza. However, a decrease in sensitivity was observed when the RAT was used, regardless of the specimen type. Therefore, to avoid false-negative results, PCR may be a better choice when OP swabs are used as specimens. In contrast, NP swabs should be the recommended specimens for RAT.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000623/pdfft?md5=efeafd52dcb04891c8f51ab8d9ce74d1&pid=1-s2.0-S2352551724000623-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141323512","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":"Unified calibration of D-dimer can improve the uniformity of different detection systems","authors":"Kun Wang ,&nbsp;Xinwei Zang ,&nbsp;Wenjie Zhang ,&nbsp;Xiangyu Cao ,&nbsp;Huiru Zhao ,&nbsp;Chunyan Li ,&nbsp;Cuiying Liang ,&nbsp;Jun Wu","doi":"10.1016/j.plabm.2024.e00413","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00413","url":null,"abstract":"<div><h3>Background</h3><p>D-dimer at a low level is important evidence for excluding the onset and progression of thrombosis. It is readily detectable and yields rapid results, although significant variability exists among different detection systems. Our study aims to enhance the consistency across various detection systems.</p></div><div><h3>Methods</h3><p>Twelve detection systems were included in our study. We sought to address this inconsistency by using various calibrators (two supplied by manufacturers and two comprising pooled human plasma diluted with different diluents) to standardize D-dimer measurements. We categorized the data into three groups according to D-dimer concentration levels: low (≤0.5 mg/L), medium (&gt;0.5 mg/L - &lt;3 mg/L), and high (≥3 mg/L). We then analyzed the data focusing on range, consistency, comparability, negative coincidence rate, and false negative rate.</p></div><div><h3>Results</h3><p>Calibrating with pooled human plasma led to narrower result ranges in the low and medium groups (P &lt; 0.05). In the low group, consistency improved from weak to strong (ICC 0.4–0.7, P﹤0.05), while it remained excellent in the other groups and overall (ICC﹥0.75, P﹤0.05). The percentage of pairwise comparability increased in both the low and high groups. Additionally, there was an increase in the negative coincidence rate.</p></div><div><h3>Conclusion</h3><p>These findings demonstrate that uniform calibration of D-dimer can significantly enhance the consistency of results across different detection systems.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000593/pdfft?md5=df6911df6a73af616b3526357832c179&pid=1-s2.0-S2352551724000593-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141314733","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}