Laboratory medicine最新文献

筛选
英文 中文
Preanalytical stability of hemoglobin H inclusion body detection using rapid brilliant cresyl blue staining: a genotype-stratified stability study in EDTA blood stored at 4 °C. 快速亮甲酰蓝染色检测血红蛋白H包涵体的分析前稳定性:4°C保存EDTA血液的基因型分层稳定性研究。
IF 1
Laboratory medicine Pub Date : 2026-08-04 DOI: 10.1093/labmed/lmag057
Ekkapong Boriboonwong, Thanyaphat Lengkhanyuen, Phonchita Kaewjaem, Plubplueng Sansai, Sitthichai Panyasai
{"title":"Preanalytical stability of hemoglobin H inclusion body detection using rapid brilliant cresyl blue staining: a genotype-stratified stability study in EDTA blood stored at 4 °C.","authors":"Ekkapong Boriboonwong, Thanyaphat Lengkhanyuen, Phonchita Kaewjaem, Plubplueng Sansai, Sitthichai Panyasai","doi":"10.1093/labmed/lmag057","DOIUrl":"https://doi.org/10.1093/labmed/lmag057","url":null,"abstract":"<p><strong>Introduction: </strong>No evidence-based preanalytical guideline exists for EDTA blood storage before hemoglobin H (HbH) inclusion body detection. We evaluated the stability of rapid (30-minute) brilliant cresyl blue staining across α-globin and β-globin genotypes in blood stored at 4 °C.</p><p><strong>Methods: </strong>Residual EDTA blood from 322 patients with microcytic hypochromic anemia was stored at 4 °C and tested on days 0, 2, 4, and 7 by 3 blinded medical technologists. Hemoglobin typing and genotyping followed inclusion body counting. Wilcoxon and Mann-Whitney U tests as well as intraclass correlation coefficient(2,1) were applied.</p><p><strong>Results: </strong>Six α-globin genotype groups were identified, including HbH disease (n = 103), by β-globin genotype background. Non-HbH groups showed no meaningful inclusion bodies, confirming stable specificity. In HbH disease with a normal β-globin gene, 100% qualitative concordance was maintained at day 7, with no statistically significant quantitative change from day 0 (P = .28); the intraclass correlation coefficient(2,1) was 0.858. A transient increase at day 2 (P < .001) may have reflected in vitro HbH autoxidation during cold storage. Hemoglobin H disease co-inheriting HbE showed stable but markedly reduced counts throughout storage; a consistent pattern was observed in isolated cases co-inheriting β-thalassemia.</p><p><strong>Discussion: </strong>EDTA blood stored at 4 °C maintains qualitative stability for HbH inclusion body detection for up to 7 days; HbE co-inheritance substantially reduces diagnostic sensitivity, with a similar pattern observed in isolated β-thalassemia co-inheritance.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 5","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148868792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The U-shaped association between serum fibrinogen level and poststroke epilepsy within 1 year of acute ischemic stroke. 急性缺血性脑卒中1年内血清纤维蛋白原水平与脑卒中后癫痫的u型关系。
IF 1
Laboratory medicine Pub Date : 2026-08-04 DOI: 10.1093/labmed/lmag046
Ying Zheng, Zhiguo Yuan, Chenju Zhan, Qixi Liu, Chengsheng Chen
{"title":"The U-shaped association between serum fibrinogen level and poststroke epilepsy within 1 year of acute ischemic stroke.","authors":"Ying Zheng, Zhiguo Yuan, Chenju Zhan, Qixi Liu, Chengsheng Chen","doi":"10.1093/labmed/lmag046","DOIUrl":"https://doi.org/10.1093/labmed/lmag046","url":null,"abstract":"<p><strong>Introduction: </strong>As an indicator of coagulation function, the effect of circulating fibrinogen on cardiovascular and cerebrovascular diseases has been well studied, but the association between fibrinogen and poststroke epilepsy (PSE) has not. We explored the relationship between circulating serum fibrinogen levels and PSE events in a large sample of patients who had had an acute ischemic stroke in the past year.</p><p><strong>Methods: </strong>We obtained from the Dryad database the medical records of 21 459 patients who had experienced an ischemic stroke to analyze the association between circulating fibrinogen level and PSE risk.</p><p><strong>Results: </strong>Smooth curve analysis showed a U-shaped association between circulating fibrinogen level and PSE risk in the patients analyzed. The fold point of the circulating fibrinogen level for the association was 2.9 g/L. When fibrinogen levels were less than 2.9 g/L, an increase in fibrinogen contributed to a statistically significantly reduced risk of PSE events (odds ratio, 0.1 [95% CI, 0.1-0.2]; P < .001). In contrast, when fibrinogen levels were higher than 2.9 g/L, an increase in fibrinogen level was related to a higher risk of PSE events (odds ratio, 1.4 [95% CI, 1.2-1.7]; P < .001).</p><p><strong>Discussion: </strong>Circulating serum fibrinogen level had a potential U-shaped association with PSE risk in a large-scale population of individuals who had had an acute ischemic stroke in the previous year.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 5","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148763899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A blended problem-based learning/case-based learning/artificial intelligence teaching model for medical laboratory technology interns: a quasi-experimental study. 基于问题的学习/基于案例的学习/人工智能的医学实验室实习生混合教学模式:准实验研究
IF 1
Laboratory medicine Pub Date : 2026-08-04 DOI: 10.1093/labmed/lmag065
Qin Lu, Chunmei Li, Ning Feng, Fanting Zeng, Shoukun Wang, Guangshun Ma
{"title":"A blended problem-based learning/case-based learning/artificial intelligence teaching model for medical laboratory technology interns: a quasi-experimental study.","authors":"Qin Lu, Chunmei Li, Ning Feng, Fanting Zeng, Shoukun Wang, Guangshun Ma","doi":"10.1093/labmed/lmag065","DOIUrl":"https://doi.org/10.1093/labmed/lmag065","url":null,"abstract":"<p><strong>Introduction: </strong>The 1-year clinical practicum in China's 4-year medical laboratory technology (MLT) program often fails to bridge the gap between theoretical knowledge and clinical practice. This study evaluated the effect of a blended learning model that integrated problem-based learning (PBL), case-based learning (CBL), and artificial intelligence (AI) on clinical training outcomes among MLT interns.</p><p><strong>Methods: </strong>A total of 77 MLT interns (August 2024-April 2026) were assigned to a control group (traditional lecture-based teaching, n = 38) or an intervention group (blended PBL/CBL/AI teaching, n = 39). Objective outcomes were measured by phased theoretical and practical skills tests; subjective outcomes were collected through questionnaires.</p><p><strong>Results: </strong>No baseline differences were found between groups (all P > .05). The intervention group scored statistically significantly higher in theoretical knowledge (mean [SD], 77.15 [8.51] vs 71.55 [8.12]; P = .004) and practical skills (mean [SD], 70.38 [12.27] vs. 64.08 [9.58]; P = .02) and reported higher satisfaction across all 12 teaching dimensions (P < .05). In AI-integrated teaching, the intervention group showed higher satisfaction in 5 of 6 dimensions, particularly in ease of use (P < .001), except for question-posing ability (P = .40).</p><p><strong>Discussion: </strong>The blended PBL/CBL/AI internship model substantially enhanced theoretical knowledge, practical skills, and student satisfaction. Despite the limitations of its single-center design and small sample size, this model provides a valuable reference for internship reform.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 5","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149032391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Combined total error in calculated clinical chemistry tests: component analytical error is magnified and decision threshold gray zones widen. 计算临床化学试验的综合总误差:成分分析误差放大,决策阈值灰色地带扩大。
IF 1
Laboratory medicine Pub Date : 2026-08-04 DOI: 10.1093/labmed/lmag068
Alper Gümüş
{"title":"Combined total error in calculated clinical chemistry tests: component analytical error is magnified and decision threshold gray zones widen.","authors":"Alper Gümüş","doi":"10.1093/labmed/lmag068","DOIUrl":"https://doi.org/10.1093/labmed/lmag068","url":null,"abstract":"<p><strong>Introduction: </strong>Calculated tests propagate component analytical errors, yet laboratories monitor only the measured components, rarely the calculated quantity.</p><p><strong>Methods: </strong>Using analytical performance specifications (APSs) from the European Federation of Clinical Chemistry and Laboratory Medicine Biological Variation Database, we propagated bias and imprecision through 5 calculated tests (low-density lipoprotein cholesterol [LDL-C], anion gap, albumin-corrected calcium, the Homeostatic Model Assessment of Insulin Resistance [HOMA-IR], and the De Ritis ratio), representing difference, linear correction, product, and ratio structures. Difference-based and linear-based tests were assessed across clinical scenarios; the ratio was validated by Monte Carlo simulation.</p><p><strong>Results: </strong>At desirable component APSs, the combined total error was 2.1% to 2.8% for albumin-corrected calcium, 25.9% for the De Ritis ratio, and 34% for the HOMA-IR. At typical values, combined errors for LDL-C and the anion gap were 18.5% and 20.8%, respectively, exceeding their respective allowable total error targets (12.0% and 11.3%). Error was concentration dependent: the anion-gap error decreased to 7.4% at 28 mmol/L but increased to 43.0% at 6 mmol/L; the LDL-C error reached 28.6% at 60 mg/dL. The allowable total error-based estimate closely matched the quadrature-bias estimate but underestimated worst-case error.</p><p><strong>Discussion: </strong>Acceptable component performance does not ensure acceptable performance of calculated tests. Derived quantities require specific APSs, and results near clinical decision limits should be interpreted within concentration-dependent analytical gray zones.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 5","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149032383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A rare case of naturally occurring anti-Jka antibody detected in a 6-month-old infant. 一例罕见的自然发生的抗jka抗体检测在一个6个月大的婴儿。
IF 1
Laboratory medicine Pub Date : 2026-08-04 DOI: 10.1093/labmed/lmag050
Dong Hyeok Lee, Suk Won Seo, Han Joo Kim, Sang-Hyun Hwang, Heung-Bum Oh, Dae-Hyun Ko
{"title":"A rare case of naturally occurring anti-Jka antibody detected in a 6-month-old infant.","authors":"Dong Hyeok Lee, Suk Won Seo, Han Joo Kim, Sang-Hyun Hwang, Heung-Bum Oh, Dae-Hyun Ko","doi":"10.1093/labmed/lmag050","DOIUrl":"https://doi.org/10.1093/labmed/lmag050","url":null,"abstract":"<p><strong>Introduction: </strong>Antibodies of the Kidd blood group system are associated with hemolytic transfusion reactions and, less commonly, hemolytic disease of the fetus and newborn. Naturally occurring antibodies against Kidd antigens are exceedingly rare, with a limited number of cases reported worldwide. We report a case of a naturally occurring anti-Jka antibody detected in a 6-month-old male infant.</p><p><strong>Methods: </strong>The patient was admitted with a high fever after routine age-appropriate vaccinations. He had no history of blood transfusion, underlying disease, or perinatal complications. Blood, urine, and cerebrospinal fluid cultures were negative, while respiratory viral polymerase chain reaction was positive for human coronavirus 229E.</p><p><strong>Results: </strong>As part of the routine admission protocol, blood grouping and antibody screening were performed, and subsequent antibody identification confirmed the presence of anti-Jka. Serologic testing showed a partial reduction in antibody titer after dithiothreitol treatment, consistent with a predominantly immunoglobulin M antibody, with a possible immunoglobulin G component. The infant and his mother shared the Jk(a - b+) red blood cell phenotype, and maternal antibody screening was negative. In the absence of prior red blood cell exposure or maternal alloimmunization, the antibody was interpreted as naturally occurring.</p><p><strong>Discussion: </strong>This case highlights the importance of recognizing naturally occurring Kidd antibodies in infants to ensure transfusion safety.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 5","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148803823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Penile blood gas determination for the evaluation of priapism. 评价阴茎勃起的阴茎血气测定。
IF 1
Laboratory medicine Pub Date : 2026-08-04 DOI: 10.1093/labmed/lmag056
Jingcai Wang, Abraham Bailey, Amy L Pyle-Eilola
{"title":"Penile blood gas determination for the evaluation of priapism.","authors":"Jingcai Wang, Abraham Bailey, Amy L Pyle-Eilola","doi":"10.1093/labmed/lmag056","DOIUrl":"https://doi.org/10.1093/labmed/lmag056","url":null,"abstract":"<p><strong>Introduction: </strong>Priapism is a penile erection that is sustained beyond or is unrelated to sexual stimulation. Depending on the etiology of the priapism, there may be low blood flow to the tissue, causing ischemic priapism, or high blood flow, called nonischemic priapism. Ischemic priapism is assessed in part by corporal blood gas analysis and should be treated emergently to preserve tissue health and function. Ischemic priapism is a common morbidity associated with sickle cell disease (SCD).</p><p><strong>Methods: </strong>A 16-year-old male individual presented at the emergency department with priapism. His medical history was clinically significant for SCD and prior episodes of priapism. He was not on medications to manage SCD at that time. Corporal blood aspiration was performed to attempt detumescence, and an aliquot of that blood was sent to the laboratory for blood gas analysis.</p><p><strong>Results: </strong>The blood submitted for analysis was deep red, and blood gas results revealed acidosis, hypercarbia, and hypoxemia. These results were consistent with ischemic priapism and prompted more aggressive treatment and patient monitoring.</p><p><strong>Discussion: </strong>This case illustrates the role of blood gas analysis in the evaluation of priapism. Laboratorians should be aware of this rare sample type that may present with extreme values.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 5","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148868766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction to: Medical laboratory science course performance and grade point average as indicators of ASCP certification success: a 10-year review from an NAACLS-accredited program. 医学实验室科学课程成绩和平均绩点作为ASCP认证成功的指标:来自naacls认证项目的10年回顾。
IF 1
Laboratory medicine Pub Date : 2026-08-04 DOI: 10.1093/labmed/lmag066
{"title":"Correction to: Medical laboratory science course performance and grade point average as indicators of ASCP certification success: a 10-year review from an NAACLS-accredited program.","authors":"","doi":"10.1093/labmed/lmag066","DOIUrl":"10.1093/labmed/lmag066","url":null,"abstract":"","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 5","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13569926/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148957766","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}
引用次数: 0
Effect of structured, simulation-based education on nurses' knowledge and self-reported safe blood transfusion practices. 结构化模拟教育对护士知识和自我报告的安全输血实践的影响。
IF 1
Laboratory medicine Pub Date : 2026-08-04 DOI: 10.1093/labmed/lmag051
Akshaya Tomar, Ranjana Bhandari, Anoop Sharma
{"title":"Effect of structured, simulation-based education on nurses' knowledge and self-reported safe blood transfusion practices.","authors":"Akshaya Tomar, Ranjana Bhandari, Anoop Sharma","doi":"10.1093/labmed/lmag051","DOIUrl":"https://doi.org/10.1093/labmed/lmag051","url":null,"abstract":"<p><strong>Introduction: </strong>Errors during blood transfusion continue to contribute to preventable adverse events, and nurses often have gaps in their transfusion-related knowledge and practices. This study evaluated the effect of simulation-based education on nurses' knowledge and practices regarding blood transfusion.</p><p><strong>Methods: </strong>A quasiexperimental, single-group, pretest/post-test study was conducted among 227 registered nurses at a tertiary-care hospital. A structured questionnaire was used to assess knowledge (23 items, maximum score = 30) and self-reported practices (15 items, maximum score = 75) before and after 4-hour simulation-based education. The intervention consisted of didactic review, hands-on skills stations, and high-fidelity simulation scenarios. Data were analyzed using paired t tests, independent t tests, and 1-way analysis of variance.</p><p><strong>Results: </strong>The mean (SD) postintervention total score (54.8 [7.1]) demonstrated a statistically significant increase of 20.0 points from the preintervention score (34.8 [10.5]) (t226 = -61.5; P < .001], with a large effect size (Cohen d = 2.24). Statistically significant improvements were observed in both the knowledge and practice domains (P < .001). Analysis revealed that nurses with less than 5 years of clinical experience and those in the 20 to 29 years of age group had statistically significantly lower baseline scores but showed the greatest magnitude of improvement (P < .001). Prior formal training showed no statistically significant association with baseline knowledge or improvement.</p><p><strong>Discussion: </strong>Simulation-based education substantially improved nurses' transfusion-related knowledge and practices.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 5","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148803746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correlation and categorical discrepancies of platelet function assays across diverse clinical settings: an exploratory analysis. 血小板功能测定在不同临床环境中的相关性和分类差异:一项探索性分析。
IF 1
Laboratory medicine Pub Date : 2026-08-04 DOI: 10.1093/labmed/lmag067
Liqin Ling, Yujie Liu, Chaonan Liu, Xunbei Huang, Shuang Wang, Zhiyu Yu, Jing Zhou
{"title":"Correlation and categorical discrepancies of platelet function assays across diverse clinical settings: an exploratory analysis.","authors":"Liqin Ling, Yujie Liu, Chaonan Liu, Xunbei Huang, Shuang Wang, Zhiyu Yu, Jing Zhou","doi":"10.1093/labmed/lmag067","DOIUrl":"https://doi.org/10.1093/labmed/lmag067","url":null,"abstract":"<p><strong>Introduction: </strong>Inconsistent results among platelet function assays complicate clinical interpretation. This study evaluated clinical agreement among light transmission aggregometry (LTA), thromboelastography (TEG)-platelet mapping, and the INNOVANCE Platelet Function Analyzer 200 system across diverse clinical settings.</p><p><strong>Methods: </strong>Platelet function assays were performed in 3 cohorts, generating 4 datasets: 22 patients with aneurysm who were on dual antiplatelet therapy, 20 pregnant women on aspirin monotherapy, and 21 patients with an intracranial space-occupying lesion not on antiplatelet therapy allocated to a preoperative or postoperative cohort as appropriate.</p><p><strong>Results: </strong>For the cyclooxygenase 1 pathway, no statistically significant correlations were found among any assay pairs in any dataset. For the adenosine diphosphate pathway, statistically significant correlations were observed only in dataset 1 between LTA and TEG (r = ‒0.80, 95% CI = ‒0.91 to ‒0.55; P < .001) and between PFA-200 and TEG (r = 0.44, 95%CI = 0.009 to 0.73; P = .04). In dataset 2, detection rates of aspirin responsiveness of PFA-200 (30%) were lower than with LTA (95%) and TEG (100%) (P < .001). In dataset 4, detection rates of platelet hyporesponsiveness (adenosine diphosphate pathway) were 61.9% (LTA), 100% (TEG), and 4.8% (PFA-200), with all pairwise comparisons statistically significantly different (P < .001). No statistically significant differences among assays were observed in other comparisons.</p><p><strong>Discussion: </strong>No single assay can be recommended over the others. Assay selection should be guided by the specific clinical setting.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 5","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149066929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Operationalizing accreditation standards for laboratory-developed next-generation sequencing validation of CFTR amplicon-based assays. 实施实验室开发的基于CFTR扩增子的新一代测序验证的认可标准。
IF 1
Laboratory medicine Pub Date : 2026-08-04 DOI: 10.1093/labmed/lmag049
Muhammad Fareeduddin, Muhammad Usama, Shakir Hussain, Rukhsana Syed Aamir Zahir, Nada Sikander, Javeria Aijaz
{"title":"Operationalizing accreditation standards for laboratory-developed next-generation sequencing validation of CFTR amplicon-based assays.","authors":"Muhammad Fareeduddin, Muhammad Usama, Shakir Hussain, Rukhsana Syed Aamir Zahir, Nada Sikander, Javeria Aijaz","doi":"10.1093/labmed/lmag049","DOIUrl":"https://doi.org/10.1093/labmed/lmag049","url":null,"abstract":"<p><strong>Introduction: </strong>Application of College of American Pathologists (CAP) standards for molecular next-generation sequencing assays, typically high-complexity laboratory-developed tests, requires assay-specific, principled translation. We sought to systematically apply CAP laboratory-developed test validation requirements for next-generating sequencing to targeted CFTR gene sequencing on an Illumina iSeq100 Sequencing System and to address assay-specific translational guidance gaps.</p><p><strong>Methods: </strong>We evaluated the analytic performance (accuracy, precision, analytic sensitivity, and specificity) and other requirements (eg, confirmatory testing, proficiency testing) in a CAP-accredited laboratory, including assessment of logistics (eg, turnaround time, cost), with particular attention to feasibility for smaller laboratories.</p><p><strong>Results: </strong>Variant calls showed complete concordance across analytic parameters but, as the sole outcome measure, obscured subthreshold effects of experimental variables and random variability. Critical site depth analysis was essential to reveal these effects.</p><p><strong>Discussion: </strong>Per-sample costs depend on batch size; smaller laboratories can reduce costs through centralization or sample pooling, although pooling requires longer turnaround (weeks to months), even on a iSeq100 system, potentially causing misalignment of CAP proficiency testing and batch schedules. This issue mandates self-evaluation and code 11 selection for CAP proficiency testing submissions. Real-time sample preparation, however, precludes running negative and internal controls with each processing run, necessitating process controls (eg, minor allele frequency, alternate allele determination) and an individualized quality control plan.</p>","PeriodicalId":94124,"journal":{"name":"Laboratory medicine","volume":"57 5","pages":""},"PeriodicalIF":1.0,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148803841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信
小红书