Practical Laboratory Medicine最新文献

{"title":"Liquid biopsy in cancer management: Integrating diagnostics and clinical applications.","authors":"Shashwat Pandey, Preeti Yadav","doi":"10.1016/j.plabm.2024.e00446","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00446","url":null,"abstract":"<p><p>Liquid biopsy is an innovative, minimally invasive diagnostic tool revolutionizing cancer management by enabling the detection and analysis of cancer-related biomarkers from bodily fluids such as blood, urine, or cerebrospinal fluid. Unlike traditional tissue biopsies, which require invasive procedures, liquid biopsy offers a more accessible and repeatable method for tracking cancer progression, detecting early-stage cancers, and monitoring therapeutic responses. The technology primarily focuses on analyzing circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and other cancer-derived genetic materials. These biomarkers provide critical information on tumor heterogeneity, mutation profiles, and potential drug resistance. In clinical practice, liquid biopsy has demonstrated its utility in identifying actionable mutations, guiding personalized treatment strategies, and assessing minimal residual disease (MRD). While liquid biopsy holds immense promise, challenges related to its sensitivity, specificity, and standardization remain. Efforts to optimize pre-analytical and analytical processes, along with the establishment of robust regulatory frameworks, are crucial for its widespread clinical adoption. This abstract highlights the transformative potential of liquid biopsy in cancer diagnosis, prognosis, and treatment monitoring, emphasizing its role in advancing personalized oncology. Further research, clinical trials, and regulatory harmonization will be vital in realizing its full potential in precision cancer care.</p>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"43 ","pages":"e00446"},"PeriodicalIF":1.7,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11743551/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143010566","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":"Development of a droplet digital PCR method for the detection of <i>Ureaplasma urealyticum</i>.","authors":"Yong-Zhuo Zhou, Yun-Hu Zhao, Yan-Lan Chen, Hua Luo, Yu-Lin Zhou, Bing Gu, Wei-Zhen Fang, Chao-Hui Duan, Xu-Guang Guo","doi":"10.1016/j.plabm.2024.e00443","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00443","url":null,"abstract":"<p><strong>Background: </strong>Human infection with <i>Ureaplasma urealyticum(UU)</i> is mainly manifested as non-gonococcal urethritis, where it can lead to cervicitis, premature rupture of membranes and abortion in women, as well as infertility in males, which becomes a major problem in clinical diagnosis and treatment. At present, real-time fluorescence quantitative PCR and culture are the two main methods for detecting UU. The real-time fluorescence quantitative PCR method is cumbersome and cannot accomplish absolute quantification on nucleic acids, while the cultivation method has limitations such as low sensitivity and being time-consuming. The aim of this study is to establish a more rapid and accurate droplet digital PCR(ddPCR) method for the detection of UU.</p><p><strong>Methods: </strong>Primers were designed for the ParC gene of UU. Nucleic acids from a standard strain of UU were extracted. Specificity, sensitivity, and repeatability detection was performed using ddPCR, and the detection performance of ddPCR was evaluated.</p><p><strong>Results: </strong>The detection process could be completed in 92 min. It has a high sensitivity of up to 3.8 pg/μL. With a high specificity, no positive microdrop were detected in eight negative control pathogens in this experiment. In addition, ddPCR detection of UU has good repeatability, and the calculated CV is 2.1 %.</p><p><strong>Conclusion: </strong>Our data indicated that ddPCR detection technology has the characteristics of absolute quantification, high stability, high specificity and high sensitivity of UU. It can promote the accurate detection of UU, providing a more scientific basis for clinical diagnosis and treatment.</p>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"43 ","pages":"e00443"},"PeriodicalIF":1.7,"publicationDate":"2024-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11743552/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143010564","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":"Assay precision, 99th percentile reference value and proportion of detected healthy european adults for VIDAS® high-sensitive troponin I.","authors":"Nathalie Auberger, Isabelle Coin, Laure Marillet, Frédérique Raymond, Sandrine Michel-Busseret, Pierre-Géraud Claret, Camille Pease","doi":"10.1016/j.plabm.2024.e00441","DOIUrl":"10.1016/j.plabm.2024.e00441","url":null,"abstract":"<p><strong>Introduction/objectives: </strong>Following the IFCC (The International Federation of Clinical Chemistry and Laboratory Medicine) guidelines concerning high-sensitivity cardiac troponin assays, we performed an assessment of the VIDAS® High-Sensitive Troponin I (TNHS) assay. The test was evaluated on its capacity to detect at least 50 % of healthy individuals and checked that the coefficient of variation was less than 10 % at the 99th percentile.</p><p><strong>Methods: </strong>High-sensitivity performance was assessed by examining the limits of detection, the determination of the 99th percentile value, the evaluated imprecision at said value and the detectable results above limit of detection (LoD) in a cohort of healthy European individuals. The capacity of detection on a healthy population of VIDAS® TNHS was validated on a total of 808 plasma samples.</p><p><strong>Results: </strong>One thousand six hundred and nineteen values (888 values for male samples and 731 values for female samples) were included in the analysis. The total imprecision of VIDAS® High-Sensitive Troponin I assay at the 99th percentile was 5.2 %, and 57.4 % of healthy individuals had troponin I values exceeding the LoD. Since the test detected more than 50 % of healthy individuals and had a coefficient of variation less than 10 % at the 99th percentile, it met the criteria of high-sensitivity cardiac troponin assays.</p><p><strong>Conclusion: </strong>VIDAS® High-Sensitive Troponin I assay is a high-sensitivity cardiac troponin assays meeting the definition provided by IFCC guidelines.</p>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"e00441"},"PeriodicalIF":1.7,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11665417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882823","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":"Corrigendum to \"Unified calibration of D-dimer can improve the uniformity of different detection systems\" [Practical Laboratory Medicine 40 (2024) e00413].","authors":"Kun Wang, Xinwei Zang, Wenjie Zhang, Xiangyu Cao, Huiru Zhao, Chunyan Li, Cuiying Liang, Jun Wu","doi":"10.1016/j.plabm.2024.e00442","DOIUrl":"https://doi.org/10.1016/j.plabm.2024.e00442","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1016/j.plabm.2024.e00413.].</p>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"e00442"},"PeriodicalIF":1.7,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11723222/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972046","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":"Development of a rapid LFA test based on direct RT-LAMP for diagnosis of SARS-CoV-2","authors":"Negar Sadeghi ,&nbsp;Neda Shirazi ,&nbsp;Moein Dehbashi ,&nbsp;Bahareh Maleki ,&nbsp;William C. Cho ,&nbsp;Zohreh Hojati","doi":"10.1016/j.plabm.2024.e00437","DOIUrl":"10.1016/j.plabm.2024.e00437","url":null,"abstract":"<div><h3>Introduction</h3><div>In response to the rapid spread of the SARS-CoV-2 virus, we developed a rapid molecular approach to diagnose COVID-19 without the need for RNA extraction.</div></div><div><h3>Methods</h3><div>The study utilized two molecular methods, RT-qPCR and colorimetric RT-LAMP, to diagnose the RdRp and ORF8 genes, respectively, in oro-nasopharyngeal swabs. Due to the high sequence diversity of ORF8 in SARS-CoV and SARS-CoV-2, it has been identified as a suitable target for virus detection. The RT-LAMP method was also carried out directly on heat-treated swab samples. The strip tests were made using gold nanoparticles and combined with the RT-LAMP for further analysis.</div></div><div><h3>Results</h3><div>The results showed that the isothermal amplification method had a sensitivity of 95 % (95 % C.I.: 86.08 %–98.96 %) and a specificity of 75 % (95 % C.I.: 19.41 %–99.37 %). The RT-LAMP-LFA method was able to distinguish positive and negative samples with 100 % sensitivity (95 % C.I.: 91.96–100) and 77.27 % specificity (95 % C.I.: 54.63–92.18). This method only required heating swab samples for 10 min at 65 °C before the RT-LAMP reaction.</div></div><div><h3>Conclusion</h3><div>By utilizing the RT-LAMP in combination with the LFA, it is possible to diagnose SARS-CoV-2 rapidly without the need for RNA extraction. The entire process from sample collection to test interpretation takes only 75–90 min, and the results can be interpreted by untrained individuals with the naked eye. By employing the ORF8 gene as a diagnostic target and eliminating the need for RNA extraction, the direct RT-LAMP-LFA method achieves a significant breakthrough that was not previously reported.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00437"},"PeriodicalIF":1.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142573233","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 measurement of immunosuppressive drugs by mass spectrometry and immunoassay in a South African transplant setting","authors":"Amy Strydom,&nbsp;Doreen Jacob,&nbsp;Taryn Pillay,&nbsp;Refeletse Malahlela,&nbsp;Sean Currin","doi":"10.1016/j.plabm.2024.e00440","DOIUrl":"10.1016/j.plabm.2024.e00440","url":null,"abstract":"<div><h3>Objectives</h3><div>Liquid chromatography tandem mass spectrometry (LC-MS/MS) is the gold standard for measurement of immunosuppressive drugs (ISDs), but is technically demanding and less accessible in resource-limited countries. Immunoassays can also measure ISD concentrations, but may be limited by cross-reactivity. We evaluated the performance of the Roche electrochemiluminescence immunoassay (ECLIA) for cyclosporine, everolimus and sirolimus against LC-MS/MS in an African population for the first time.</div></div><div><h3>Methods</h3><div>Bias for ECLIA was estimated by comparing ECLIA-measured ISD concentrations to those obtained by LC-MS/MS in 42, 43 and 47 patient samples for cyclosporine, everolimus and sirolimus, respectively. Precision was assessed by performing replicate measurements of quality control materials.</div></div><div><h3>Results</h3><div>Deming regression analysis for all ISDs showed strong correlation between ECLIA and LC-MS/MS with a Pearson's r of &gt;0.94. The slopes for cyclosporine, everolimus and sirolimus were 0.94 [95 % CI: 0.87–1.03], 1.35 [95 % CI: 1.23–1.44] and 0.96 [95 % CI: 0.85–1.15] with y-intercepts of 31.60 μg/L [95 % CI: 2.02–57.63], 0.23 μg/L [95 % CI: 0.21 – 0.72] and 2.61 μg/L [95 % CI: 1.30–3.56], respectively. Difference plots showed a median bias of 2.07 % [95 % CI: 1.42 – 6.99 %], 41.2 % [95 % CI: 34.9–51.8 %] and 34.9 % [95 % CI: 28.4–47.3 %] for cyclosporine, everolimus and sirolimus, respectively.</div></div><div><h3>Conclusions</h3><div>The cyclosporine ECLIA yielded results comparable to LC-MS/MS while poorly comparable results were obtained for everolimus and sirolimus, which may be explained by ISD metabolite cross-reactivity, amongst other factors. The poor comparability, although not unique, is noteworthy and the clinical consequences of these differences require further investigation.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00440"},"PeriodicalIF":1.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142657875","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":"Falsely abnormal serum protein electrophoresis after administration of intravenous immunoglobulins (IVIG): A retrospective cohort study","authors":"Andrew Sulaiman,&nbsp;Patrizio Caturegli","doi":"10.1016/j.plabm.2024.e00434","DOIUrl":"10.1016/j.plabm.2024.e00434","url":null,"abstract":"<div><div>Intravenous immunoglobulin (IVIG) therapy, used in several neurologic, hematologic, immunologic and dermatologic conditions, is known to interfere with the results of some serum laboratory tests. We analyzed the potential interference of IVIG on serum protein electrophoresis (SPEP) by reviewing more than a decade of SPEP studies performed by the clinical immunology laboratory of the Johns Hopkins Hospital. Of the total 100,350 SPEP performed between January 1, 2013 and December 31, 2023, 395 contained the keyword IVIG in the pathologist report, contributed by 348 patients confirmed to have received IVIG by chart review. Of the 348 patients, 20 (6 %) had a M-spike on SPEP suggestive of monoclonal gammopathy, while 328 (94 %) did not have it. Of the 20 patients, 14 received IVIG within 30 days from the SPEP collection date, while 6 received beyond 30 days. Serum immunofixation electrophoresis (SIFE) and clinical follow up showed no evidence of monoclonal gammopathy in 5 of the 14 patients. Overall, this 11-year retrospective cohort study showed that 5 of 348 (1.4 %) patients treated with IVIG and tested by SPEP had a false M-spike, that is a spike not confirmed to be caused by a monoclonal gammopathy by subsequent studies. Although small, the false positive rate of 1.4 % suggests that integrating knowledge of recent IVIG administration into the pathologist report would reduce SPEP misdiagnosis.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00434"},"PeriodicalIF":1.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142699313","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":"Glycated albumin in pregnancy correlates negatively with body mass index and contributes to the risk of gestational diabetes mellitus","authors":"Toril Ø. Osestad ,&nbsp;Kristin Lilleholt ,&nbsp;Øyvind Skadberg ,&nbsp;Linda R. Sagedal ,&nbsp;Ingvild Vistad ,&nbsp;Thomas Hundhausen","doi":"10.1016/j.plabm.2024.e00439","DOIUrl":"10.1016/j.plabm.2024.e00439","url":null,"abstract":"<div><h3>Objectives</h3><div>The aims of our study were to establish a reference interval for glycated albumin (GA) in gestational week 30, to investigate whether GA can replace or reduce the need for oral glucose tolerance test (OGTT) in pregnancy, and to reassess the usefulness of body mass-index (BMI), age and fasting glucose in detection of gestational diabetes (GDM).</div></div><div><h3>Design</h3><div>and methods: We measured GA in 486 healthy pregnant women. Reference interval was calculated using the central 95 % of the results. ROC curves were created to assess the ability of GA, fasting glucose and BMI separately to detect GDM, and logistic regression analysis was used to estimate risk of developing GDM given the level of the same markers. Finally, multiple logistic regression analysis based on GA, fasting glucose and BMI was used to find a strategy of predicting a patient's risk of GDM.</div></div><div><h3>Results</h3><div>The reference interval for GA at week 30 of gestation is 6.8–10.3 %. The analysis has a low AUC (0.53) with respect to detecting GDM. It increases slightly to 0.64 when corrected for BMI, as GA is inversely correlated to BMI. Combining GA with fasting glucose and BMI at gestational weeks 16–20 could raise the AUC to 0.80.</div></div><div><h3>Conclusion</h3><div>GA cannot be recommended to replace OGTT for the diagnosis of GDM. Nor can it be used to identify women at risk of developing GDM. GA combined with fasting glucose and BMI in early pregnancy could be a useful model to estimate risk of GDM.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00439"},"PeriodicalIF":1.7,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142533309","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 novel case of Hb Bart's hydrops fetalis following prenatal diagnosis: Case report from Huizhou, China","authors":"Zeyan Zhong ,&nbsp;Dina Chen ,&nbsp;Zhiyang Guan ,&nbsp;Guoxing Zhong ,&nbsp;Zhiyong Wu ,&nbsp;Jianmin Chen ,&nbsp;Jianhong Chen","doi":"10.1016/j.plabm.2024.e00438","DOIUrl":"10.1016/j.plabm.2024.e00438","url":null,"abstract":"<div><h3>Objective</h3><div>Presentation of a novel case of a patient with Hb Bart's hydrops fetalis, which was accurately identified by SMRT sequencing leading to expand the mutation spectrum of α-thalassemia.</div></div><div><h3>Case report</h3><div>A 26-year-old pregnant woman and her husband underwent molecular analysis of thalassemia due to abnormal hematological results. The molecular analysis showed that the pregnant woman carried -α^3.7/--^SEA, while her husband exhibited a negative result. Accordingly, the pregnant woman continued the pregnancy until the 19-week gestational age. She was subsequently referred to our department for genetic counseling due to abnormal ultrasound findings in the fetus. A novel deletional α-thal mutation was detected for the husband by MLPA, and the precise location of the mutation was determined through SMRT sequencing, which revealed a 45.2 kb deletion. Later, an interventional umbilical cord blood puncture was offered for the pregnant woman. The cord blood was subjected to capillary electrophoresis, which revealed apparent Hb Bart's and Hb Portland peaks associated with Hb Bart's hydrops fetalis syndrome.</div></div><div><h3>Conclusion</h3><div>It is imperative that Hb Bart's hydrops fetalis syndrome be diagnosed with the utmost expediency. If results of molecular analysis are not consistent with the clinical hematological findings, the presence of a novel thalassemia could be suspected. To identify the novel genotype, the SMRT sequencing represents an effective method for achieving an accurate diagnosis.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00438"},"PeriodicalIF":1.7,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142533310","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":"Comparison of qPCR and chromogenic culture methods for rapid detection of group B streptococcus colonization in Vietnamese pregnant women","authors":"Manh-Tuan Ha ,&nbsp;Huyen Tran-Thi-Bich ,&nbsp;Thao Bui-Thi-Kim ,&nbsp;My-Linh Nguyen-Thi ,&nbsp;Thanh Vu-Tri ,&nbsp;Thuy-Duong Ho-Huynh ,&nbsp;Tuan-Anh Nguyen","doi":"10.1016/j.plabm.2024.e00435","DOIUrl":"10.1016/j.plabm.2024.e00435","url":null,"abstract":"<div><h3>Introduction</h3><div>Neonatal infections can rapidly become severe, with delays in treatment often proving fatal. <em>Streptococcus agalactiae</em> (Group B <em>Streptococcus</em>, GBS) is a common cause, typically transmitted from colonized pregnant women to neonates during childbirth. In Vietnam, routine prenatal care lacks standardized GBS screening protocols. This study aims to compare enhanced qPCR methods with the culture method, evaluate the diagnostic accuracy of these qPCR procedures, and assess the frequency of GBS infection in pregnant Vietnamese women during their final trimester.</div></div><div><h3>Materials and methods</h3><div>Pregnant women aged 35 weeks gestation or more were recruited. Rectovaginal swabs were collected and analyzed for GBS using chromogenic culture, a commercial real-time PCR kit, and in-house real-time PCR assays targeting the <em>cfb</em> and <em>sip</em> genes. Clinical diagnostic values were calculated, and GBS prevalence was determined.</div></div><div><h3>Results</h3><div>The study included 259 pregnant women with a mean age of 30.2 ± 5.0 years. Of these, 96.6 % had gestational ages of 37 weeks or more at delivery. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the <em>cfb</em>-based and sip-based qPCR assays were 94.1/92.7, 99.0/99.5, 97.1/98.5, 97.8/97.3, and 97.6 %, respectively. The Kappa values were excellent (0.940 and 0.939), with results available in under 2 h. GBS prevalence was 24.7 % and 25.5 % by <em>cfb</em>-based and <em>sip</em>-based qPCR assays, aligning with the culture method (25.5 %).</div></div><div><h3>Conclusions</h3><div>Both direct real-time PCR assays demonstrated high accuracy and were comparable to chromogenic culture in diagnosing GBS. A significant prevalence of GBS colonization was found among Vietnamese pregnant women in their final trimester.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"42 ","pages":"Article e00435"},"PeriodicalIF":1.7,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142445068","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}