American journal of clinical pathology最新文献_第10页

TEG® 6s coagulation testing with a novel heparin neutralization cartridge: Technical validation and determination of normal reference ranges. 使用新型肝素中和试剂盒进行 TEG® 6s 凝血检测：技术验证和正常参考范围的确定。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2024-07-27 DOI: 10.1093/ajcp/aqae088

Jan Hartmann, Joao Dias, Alexandra Shilo, Yamini Bynagari, Brandon Garrett, Walter Jeske, Zorayr Manukyan, Karen Mkhitaryan, Dieter Adelmann, Kathirvel Subramaniam, Tetsuro Sakai

{"title":"TEG® 6s coagulation testing with a novel heparin neutralization cartridge: Technical validation and determination of normal reference ranges.","authors":"Jan Hartmann, Joao Dias, Alexandra Shilo, Yamini Bynagari, Brandon Garrett, Walter Jeske, Zorayr Manukyan, Karen Mkhitaryan, Dieter Adelmann, Kathirvel Subramaniam, Tetsuro Sakai","doi":"10.1093/ajcp/aqae088","DOIUrl":"https://doi.org/10.1093/ajcp/aqae088","url":null,"abstract":"Objectives: We sought to establish normal reference ranges (NRRs) for a novel TEG 6s cartridge (TEG 6s Citrated: K, KH, RTH, FFH [Global Hemostasis]) (Haemonetics Corporation, Boston, MA, US).Methods: Healthy volunteers (≥18 years of age) included in this single-arm study provided single samples of whole blood. Primary end points included TEG parameters in the citrated kaolin (CK), CK with heparinase (CKH), RapidTEG with heparinase (CRTH), and functional fibrinogen with heparinase (CFFH) assays.Results: Evaluable data were contributed by 164 volunteers (48.8% female; 62% White/Caucasian). The following NRRs were established: CK maximum amplitude (MA), 51.0 to 67.6 mm; CKH-MA, 51.8 to 67.9 mm; CRTH-MA, 53.0 to 68.9 mm; CFFH-MA, 15.3 to 34.4 mm; CK reaction time, 5.0 to 9.1 minutes; CKH reaction time, 4.9 to 9.4 minutes; CKH lysis 30 minutes after MA, 0% to 3.2%. Duplicate measurements demonstrated high reproducibility. CFFH-MA correlated with Clauss fibrinogen concentration (Pearson correlation coefficient, 0.74). Laboratory-based studies demonstrated maintenance of the relationship between CFFH-MA and fibrinogen up to 1344 mg/dL (hyperfibrinogenemic samples) and acceptability of heparin neutralization up to concentrations of low molecular weight and unfractionated heparin of 1.3 IU/mL and 5 IU/mL, respectively.Conclusions: This study established NRRs for the Global Hemostasis cartridge and serves as a proof of concept for the validity of results obtained using this cartridge.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141791607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Assessing knowledge gaps and educational needs in urine drug test interpretation among health care professionals. 评估医护人员在尿液药物检测解读方面的知识差距和教育需求。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2024-07-26 DOI: 10.1093/ajcp/aqae095

Christine L H Snozek, Claire I Yee, Janetta Bryksin, Rejwi Dahal, Benjamin Gerson, Carmen Gherasim, Kristin D Hauff, Nicholas Heger, Marilyn A Huestis, Kamisha L Johnson-Davis, Claire E Knezevic, Sara A Love, Stacy E F Melanson, Jaime H Noguez, Michael Pikulski, Stephen Roper, Manoj Tyagi, Jill S Warrington, He Sarina Yang, Yifei K Yang

{"title":"Assessing knowledge gaps and educational needs in urine drug test interpretation among health care professionals.","authors":"Christine L H Snozek, Claire I Yee, Janetta Bryksin, Rejwi Dahal, Benjamin Gerson, Carmen Gherasim, Kristin D Hauff, Nicholas Heger, Marilyn A Huestis, Kamisha L Johnson-Davis, Claire E Knezevic, Sara A Love, Stacy E F Melanson, Jaime H Noguez, Michael Pikulski, Stephen Roper, Manoj Tyagi, Jill S Warrington, He Sarina Yang, Yifei K Yang","doi":"10.1093/ajcp/aqae095","DOIUrl":"10.1093/ajcp/aqae095","url":null,"abstract":"Objectives: Urine drug testing (UDT) is a critical tool used in medical, forensic, and occupational settings, but interpreting results can be challenging. We performed a study to assess the ability of health care professionals to interpret UDT results accurately.Methods: In total, 911 clinical and laboratory professionals in the United States and Canada responded to a survey with questions gauging expertise in UDT interpretation. Responses were analyzed to identify knowledge gaps.Results: Toxicologists and laboratory PhD scientists performed well, with means of 4.82 and 4.63 questions answered correctly (out of 6 possible), respectively. Physicians specializing in pathology, emergency medicine, primary care, and internal medicine, however, displayed concerning knowledge gaps, as did laboratorians with nondoctoral degrees. Experience and training correlated with interpretation accuracy. Identification of simulated compliance as well as understanding opioid exposure, metabolism, and immunoassay cross-reactivity were among the most clinically significant knowledge gaps. More than 30% of survey respondents indicated that they would seek UDT information from the internet or peers rather than clinical or laboratory experts.Conclusions: The study highlighted the need for targeted education and better collaboration between clinical and laboratory experts and other health care professionals to ensure that when physicians order UDT, they can accurately interpret results and reduce harm.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141764814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Do errors in requesting and interpreting drug screens harm patients? 申请和解释药物筛查中的错误是否会对患者造成伤害？

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2024-07-24 DOI: 10.1093/ajcp/aqae092

Roger L Bertholf

引用次数: 0

Umbilical cord blood as a substitute for neonatal blood in measuring serum albumin and immunoglobulin G levels. 用脐带血替代新生儿血液测量血清白蛋白和免疫球蛋白 G 水平。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2024-07-23 DOI: 10.1093/ajcp/aqae089

Toshihiko Ikuta, Sota Iwatani, Seiji Yoshimoto

{"title":"Umbilical cord blood as a substitute for neonatal blood in measuring serum albumin and immunoglobulin G levels.","authors":"Toshihiko Ikuta, Sota Iwatani, Seiji Yoshimoto","doi":"10.1093/ajcp/aqae089","DOIUrl":"https://doi.org/10.1093/ajcp/aqae089","url":null,"abstract":"Objectives: In this study, we investigated the clinical feasibility of using umbilical cord blood as an alternative to neonatal blood for measuring serum albumin and immunoglobulin G (IgG) levels in newborns, including preterm newborns.Methods: Serum levels of albumin and IgG were measured in cord and neonatal blood from singleton newborns. We analyzed correlations and systematic errors between cord and neonatal blood measurements, stratifying the results for very preterm newborns (VPNs) born at a gestational age of less than 32 weeks and non-VPNs born at a gestational age of 32 weeks or later.Results: Among all 494 newborns (78 VPNs and 416 non-VPNs), serum albumin and IgG levels were determined for 95.7% and 88.7% of them, respectively. Strong correlations between cord and neonatal blood were observed for the serum albumin and IgG levels (rs = 0.864 and 0.966, respectively). Moreover, the measurement errors between cord and neonatal blood were small for all newborns (0.2 g/dL and 65 mg/dL, respectively). These findings were consistent with both VPNs and non-VPNs.Conclusions: Umbilical cord blood is a suitable substitute for neonatal blood in measuring serum albumin and IgG levels in newborns, even in premature newborns.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141750877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

HbA2 levels in children with β-thalassemia trait associated with iron deficiency: A perspective for pediatricians. 缺铁性β地中海贫血患儿的 HbA2 水平：儿科医生的视角。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2024-07-23 DOI: 10.1093/ajcp/aqae085

Şeyda Değermenci, Deniz Aslan

{"title":"HbA2 levels in children with β-thalassemia trait associated with iron deficiency: A perspective for pediatricians.","authors":"Şeyda Değermenci, Deniz Aslan","doi":"10.1093/ajcp/aqae085","DOIUrl":"https://doi.org/10.1093/ajcp/aqae085","url":null,"abstract":"Objectives: A critical factor in β-thalassemia trait screening is a hemoglobin A2 (HbA2) level of 3.5% or higher. In children with iron deficiency, HbA2 levels decrease, and diagnosis may be missed. Studies with adult carriers have yielded conflicting results on this issue. The effectiveness of HbA2-based thalassemia screening in carrier children with iron deficiency has not been studied before.Methods: In this study, among 213 children with β-thalassemia trait, those with iron deficiency were determined based on ferritin value (<15 ng/mL), and their HbA2 levels were examined. We compared HbA2 levels of iron-deficient and iron-sufficient carriers and examined the correlation between low HbA2 levels and ferritin level. Because ferritin is an acute-phase reactant, similar evaluations were made by using transferrin saturation as the criterion for iron deficiency.Results: The median HbA2 value of iron-deficient carrier children was 4.1% and within the diagnostic range (≥3.5%) in the majority of children. Median HbA2 levels in iron-deficient carriers differed from levels in iron-sufficient carriers (4.1% vs 4.9%, P < .007). No correlation was present between low HbA2 levels and ferritin levels (0.226). Furthermore, among children without iron deficiency, there were individuals with low HbA2 levels (26.9%). Similar results were obtained when transferrin saturation was used.Conclusions: Hemoglobin A2 can be used as a screening test in children with β-thalassemia trait, despite accompanying iron deficiency. Low HbA2 levels in these children may be the result of underlying thalassemia mutation, not the result of accompanying iron deficiency. Therefore, in suspected cases of β-thalassemia trait, evaluation should continue, regardless of iron status or treatment.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141750876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Evaluating pathologist practices in peripheral blood smear review: A comprehensive practice survey. 评估病理学家在外周血涂片审查中的做法：综合实践调查。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2024-07-22 DOI: 10.1093/ajcp/aqae091

Margaret Moore, Xueyan Chen, Sam Sadigh, Robert Seifert, Andres E Mindiola Romero, Olga Pozdnyakova, Elizabeth L Courville

{"title":"Evaluating pathologist practices in peripheral blood smear review: A comprehensive practice survey.","authors":"Margaret Moore, Xueyan Chen, Sam Sadigh, Robert Seifert, Andres E Mindiola Romero, Olga Pozdnyakova, Elizabeth L Courville","doi":"10.1093/ajcp/aqae091","DOIUrl":"https://doi.org/10.1093/ajcp/aqae091","url":null,"abstract":"Objectives: Widely accepted standardized criteria for peripheral blood (PB) smear review do not exist. The aim of this study was to collect data regarding PB smear review practices across multiple institutions, with a focus on pathologist review.Methods: A 23-question survey was developed by members of the Society for Hematopathology (SH) Education Committee and distributed to SH members. The survey included questions on practice environment and PB smear review practices, including trainee involvement.Results: Of 725 members contacted, 137 (19%) completed the entire survey. Over half of practices examined 5 to 20 smears a day. All respondents reported using complete blood count/differential leukocyte count data and clinical history as part of smear review. The reported proportion of laboratory-initiated vs clinician-requested reviews varied across respondents. Clinician-requested smear reviews were more likely to be billed and issued as a separate pathology report. Glass slide review (as opposed to digital microscopy) was used by most respondents. All respondents affirmed that PB smear review is an essential component of pathology training programs. Numerous free-text comments were submitted by respondents regarding their own experiences with PB smear review and suggested improvements.Conclusions: This survey elucidated the spectrum of practice patterns for pathologist review of blood smears and identified potential areas for process improvement.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141733253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Persistent cytopenias after anti-BCMA CAR T-cell therapy are associated with reduced hematopoietic activity in posttreatment bone marrows. 抗BCMA CAR T细胞治疗后的持续细胞减少症与治疗后骨髓中造血活性降低有关。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2024-07-20 DOI: 10.1093/ajcp/aqae083

Pranav Pramod Patwardhan, Joseph Franz, Mounzer Agha, Bryan Rea

{"title":"Persistent cytopenias after anti-BCMA CAR T-cell therapy are associated with reduced hematopoietic activity in posttreatment bone marrows.","authors":"Pranav Pramod Patwardhan, Joseph Franz, Mounzer Agha, Bryan Rea","doi":"10.1093/ajcp/aqae083","DOIUrl":"https://doi.org/10.1093/ajcp/aqae083","url":null,"abstract":"Objectives: We attempt to analyze bone marrow findings and correlation with cytopenia(s) after anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell infusion in this study.Methods: Relevant clinicopathologic data, including complete blood counts, neutrophil counts, relevant therapy history, and pre- and posttherapy bone marrow evaluations, were studied in 12 patients who received anti-BCMA CAR T-cell therapy.Results: Bone marrow findings after CAR T-cell therapy were available in 6 of 12 cases, 3 of which showed markedly hypocellular marrow with either markedly reduced or essentially absent hematopoiesis. One case showed a hypocellular marrow with trilineage hematopoiesis, while the remaining 2 cases showed persistent involvement by plasma cell myeloma. Reticulin stains did not reveal significant fibrosis. Ten patients had anemia, and 8 patients had leukopenia and thrombocytopenia at day 90 posttherapy. Long-term follow-up showed persistent disease in 10 of 12 cases.Conclusions: Prolonged cytopenias occur in most patients after BCMA CAR T-cell therapy with bone marrow evaluations demonstrating associated marked hypocellularity with minimal or no hematopoiesis without an increase in fibrosis.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141730954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Evaluating the Sysmex DI-60 Integrated Slide Processing System's impact on hematology differential turnaround times and patient care: Real-world implementation experience in a large Veterans Affairs hospital. 评估 Sysmex DI-60 集成切片处理系统对血液学鉴别周转时间和患者护理的影响：一家大型退伍军人事务医院的实际实施经验。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2024-07-19 DOI: 10.1093/ajcp/aqae084

Cory R Lundgren

{"title":"Evaluating the Sysmex DI-60 Integrated Slide Processing System's impact on hematology differential turnaround times and patient care: Real-world implementation experience in a large Veterans Affairs hospital.","authors":"Cory R Lundgren","doi":"10.1093/ajcp/aqae084","DOIUrl":"https://doi.org/10.1093/ajcp/aqae084","url":null,"abstract":"Objectives: This quality improvement study conducted at the Kansas City VA Medical Center in Kansas City, Missouri, investigated the Sysmex DI-60 Integrated Slide Processing System's ability to improve hematology turnaround times when integrated into daily practices. It further addressed potential patient care factors associated with changes in turnaround times.Methods: Three months of manual and Sysmex DI-60 patient data were examined between May 2022 and February 2023. White blood cell (WBC) ranges, turnaround times, working hours, and study months were analyzed using 2-tailed unpaired t testing and percentage change. The number of specimens in these categories was further analyzed using 2-tailed, 2-sample proportion testing.Results: This quality improvement study indicated that the Sysmex DI-60 system produced a statisitcally significant reduction in turnaround times overall and for various ranges of WBCs plus work shifts. The most statistically significant improvement in turnaround times occurred for WBC concentrations less than 2.0 × 103/µL and concentrations within the reference range. In addition, the off shifts experienced a notable improvement in turnaround times.Conclusions: The Sysmex DI-60 system substantially decreases turnaround times for differentials, thus potentially benefiting patient care by providing prompt results. It is possible that reducing turnaround times could expedite emergency department admissions and discharges as well as enhance care for the oncology department's patients. It could also lead to more timely results for patients with false-positive flags by the Sysmex analyzer, which may also help with clinician decision-making.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141726736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Thinking like a pathologist: Morphologic approach to hepatobiliary tumors by ChatGPT. 像病理学家一样思考：通过 ChatGPT 学习肝胆肿瘤的形态学方法。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2024-07-19 DOI: 10.1093/ajcp/aqae087

Thiyaphat Laohawetwanit, Sompon Apornvirat, Chutimon Namboonlue

{"title":"Thinking like a pathologist: Morphologic approach to hepatobiliary tumors by ChatGPT.","authors":"Thiyaphat Laohawetwanit, Sompon Apornvirat, Chutimon Namboonlue","doi":"10.1093/ajcp/aqae087","DOIUrl":"https://doi.org/10.1093/ajcp/aqae087","url":null,"abstract":"Objectives: This research aimed to evaluate the effectiveness of ChatGPT in accurately diagnosing hepatobiliary tumors using histopathologic images.Methods: The study compared the diagnostic accuracies of the GPT-4 model, providing the same set of images and 2 different input prompts. The first prompt, the morphologic approach, was designed to mimic pathologists' approach to analyzing tissue morphology. In contrast, the second prompt functioned without incorporating this morphologic analysis feature. Diagnostic accuracy and consistency were analyzed.Results: A total of 120 photomicrographs, composed of 60 images of each hepatobiliary tumor and nonneoplastic liver tissue, were used. The findings revealed that the morphologic approach significantly enhanced the diagnostic accuracy and consistency of the artificial intelligence (AI). This version was particularly more accurate in identifying hepatocellular carcinoma (mean accuracy: 62.0% vs 27.3%), bile duct adenoma (10.7% vs 3.3%), and cholangiocarcinoma (68.7% vs 16.0%), as well as in distinguishing nonneoplastic liver tissues (77.3% vs 37.5%) (Ps ≤ .01). It also demonstrated higher diagnostic consistency than the other model without a morphologic analysis (κ: 0.46 vs 0.27).Conclusions: This research emphasizes the importance of incorporating pathologists' diagnostic approaches into AI to enhance accuracy and consistency in medical diagnostics. It mainly showcases the AI's histopathologic promise when replicating expert diagnostic processes.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141726737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Continued harmonization of the international normalized ratio across a large laboratory network: Evidence of sustained low interlaboratory variation and bias after a change in instrumentation. 在一个大型实验室网络中继续统一国际标准化比值：仪器更换后实验室间差异和偏差持续降低的证据。

IF 2.3 4区医学

American journal of clinical pathology Pub Date : 2024-07-18 DOI: 10.1093/ajcp/aqae090

Emmanuel J Favaloro, Sandya Arunachalam, Kent Chapman, Leonardo Pasalic

{"title":"Continued harmonization of the international normalized ratio across a large laboratory network: Evidence of sustained low interlaboratory variation and bias after a change in instrumentation.","authors":"Emmanuel J Favaloro, Sandya Arunachalam, Kent Chapman, Leonardo Pasalic","doi":"10.1093/ajcp/aqae090","DOIUrl":"https://doi.org/10.1093/ajcp/aqae090","url":null,"abstract":"Objectives: Our objective was to maintain low interlaboratory variation and bias in international normalized ratio (INR) results following a network change in instrumentation and reagents, using a process of ongoing standardization and harmonization.Methods: Network-wide standardization to new common instrument and reagent platforms followed by network-wide application of a simple novel process of verification of international sensitive index and mean normal prothrombin time values for each new lot of prothrombin time (PT) reagent that does not require use of World Health Organization reference thromboplastin or INR calibration/certified plasma.Results: The network transitioned from mechanical hemostasis detection instruments with associated PT reagent (Diagnostica Stago; NeoPTimal) to optical detection (ACL TOPs) with associated PT reagent (Werfen; RecombiPlasTin 2G). Comparing 3 years of data for each situation, the network (n = 27 laboratories) maintained low INR variability and bias relative to general mechanical and optical groups and other laboratories.Conclusions: Harmonized support for patient management of vitamin K antagonists such as warfarin was continuously maintained in our geography, with potentially positive implications for other coagulation laboratories and geographies. For the United States in particular, paucity of US Food and Drug Administration-cleared INR certified plasmas potentially compromises INR test accuracy; our novel approach may provide workable alternatives for other laboratories/networks.","PeriodicalId":7506,"journal":{"name":"American journal of clinical pathology","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141722858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0