Annals of Laboratory Medicine最新文献

{"title":"Performance Evaluation of the LabGenius C-CT/NG-BMX Assay for <i>Chlamydia trachomatis</i> and <i>Neisseria gonorrhoeae</i> Detection.","authors":"Yong Kwan Lim, Oh Joo Kweon, Ae Ja Park, Hongkyung Kim, Sumi Yoon, Tae-Hyoung Kim, Mi-Kyung Lee","doi":"10.3343/alm.2024.0118","DOIUrl":"10.3343/alm.2024.0118","url":null,"abstract":"<p><p>The LabGenius C-CT/NG-BMX assay (LabGenius CT/NG; BIOMEDUX, Gyeonggi, Republic of Korea) is a recently developed real-time PCR assay that can simultaneously detect the sexually transmitted pathogens <i>Chlamydia trachomatis</i> (CT) and <i>Neisseria gonorrhoeae</i> (NG) in genitourinary specimens. We evaluated the analytical performance of this assay in comparison with BD MAX CT/GC/TV (Becton Dickinson, Franklin Lakes, NJ, USA). The results of both assays were in nearly perfect agreement for the detection of CT and NG. LabGenius CT/NG demonstrated acceptable analytical performance, comparable with that of another commercially available kit, and provides a cost-effective option for detecting sexually transmitted pathogens in routine and follow-up testing.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"218-222"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142602922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Machine Learning Approach for Predicting In-Hospital Cardiac Arrest Using Single-Day Vital Signs, Laboratory Test Results, and International Classification of Disease-10 Block for Diagnosis.","authors":"Haeil Park, Chan Seok Park","doi":"10.3343/alm.2024.0315","DOIUrl":"10.3343/alm.2024.0315","url":null,"abstract":"<p><strong>Background: </strong>Predicting in-hospital cardiac arrest (IHCA) is crucial for potentially reducing mortality and improving patient outcomes. However, most models, which rely solely on vital signs, may not comprehensively capture the patients' risk profiles. We aimed to improve IHCA predictions by combining vital sign indicators with laboratory test results and, optionally, International Classification of Disease-10 block for diagnosis (ICD10BD).</p><p><strong>Methods: </strong>We conducted a retrospective cohort study in the general ward (GW) and intensive care unit (ICU) of a 680-bed secondary healthcare institution. We included 62,061 adults admitted to the Department of Internal Medicine from January 2010 to August 2022. IHCAs were identified based on cardiopulmonary resuscitation prescriptions. Patient-days within three days preceding IHCAs were labeled as case days; all others were control days. The eXtreme Gradient Boosting (XGBoost) model was trained using daily vital signs, 14 laboratory test results, and ICD10BD.</p><p><strong>Results: </strong>In the GW, among 1,299,448 patient-days from 62,038 patients, 1,367 days linked to 713 patients were cases. In the ICU, among 117,190 patient-days from 16,881 patients, 1,119 days from 444 patients were cases. The area under the ROC curve for IHCA prediction model was 0.934 and 0.896 in the GW and ICU, respectively, using the combination of vital signs, laboratory test results, and ICD10BD; 0.925 and 0.878, respectively, with vital signs and laboratory test results; and 0.839 and 0.828, respectively, with only vital signs.</p><p><strong>Conclusions: </strong>Incorporating laboratory test results or combining laboratory test results and ICD10BD with vital signs as predictor variables in the XGBoost model potentially enhances clinical decision-making and improves patient outcomes in hospital settings.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"209-217"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788698/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142816910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>TP53</i> Mutation Status in Myelodysplastic Neoplasm and Acute Myeloid Leukemia: Impact of Reclassification Based on the 5th WHO and International Consensus Classification Criteria: A Korean Multicenter Study.","authors":"Hyun-Young Kim, Saeam Shin, Jong-Mi Lee, In-Suk Kim, Boram Kim, Hee-Jin Kim, Yu Jeong Choi, Byunggyu Bae, Yonggoo Kim, Eunhui Ji, Hyerin Kim, Hyerim Kim, Jee-Soo Lee, Yoon Hwan Chang, Hyun Kyung Kim, Ja Young Lee, Shinae Yu, Miyoung Kim, Young-Uk Cho, Seongsoo Jang, Myungshin Kim","doi":"10.3343/alm.2024.0351","DOIUrl":"10.3343/alm.2024.0351","url":null,"abstract":"<p><strong>Background: </strong><i>TP53</i> mutations are associated with poor prognosis in myelodysplastic neoplasm (MDS) and AML. The updated 5th WHO classification and International Consensus Classification (ICC) categorize <i>TP53</i>-mutated MDS and AML as unique entities. We conducted a multicenter study in Korea to investigate the characteristics of <i>TP53</i>-mutated MDS and AML, focusing on diagnostic aspects based on updated classifications.</p><p><strong>Methods: </strong>This study included patients aged ≥ 18 yrs who were diagnosed as having MDS (N=1,244) or AML (N=2,115) at six institutions. The results of bone marrow examination, cytogenetic studies, and targeted next-generation sequencing, including <i>TP53</i>, were collected and analyzed.</p><p><strong>Results: </strong><i>TP53</i> mutations were detected in 9.3% and 9.2% of patients with MDS and AML, respectively. Missense mutation was the most common, with hotspot codons R248/R273/G245/Y220/R175/C238 accounting for 25.4% of <i>TP53</i> mutations. Ten percent of patients had multiple <i>TP53</i> mutations, and 78.4% had a complex karyotype. The median variant allele frequency (VAF) of <i>TP53</i> mutations was 41.5%, with a notable difference according to the presence of a complex karyotype. According to the 5th WHO classification and ICC, the multi-hit <i>TP53</i> mutation criteria were met in 58.6% and 75% of MDS patients, respectively, and the primary determinants were a <i>TP53</i> VAF >50% for the 5th WHO classification and the presence of a complex karyotype for the ICC.</p><p><strong>Conclusions: </strong>Collectively, we elucidated the molecular genetic characteristics of patients with <i>TP53</i>-mutated MDS and AML, highlighting key factors in applying <i>TP53</i> mutation-related criteria in updated classifications, which will aid in establishing diagnostic strategies.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"160-169"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788706/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reclassification of Acute Myeloid Leukemia According to the 2022 World Health Organization Classification and the International Consensus Classification Using Open-Source Data.","authors":"Jiwon Yun","doi":"10.3343/alm.2024.0194","DOIUrl":"10.3343/alm.2024.0194","url":null,"abstract":"<p><strong>Background: </strong>In 2022, the revised WHO classification and International Consensus Classification (ICC) for myeloid neoplasms were published. We examined the impact of these guidelines on AML diagnoses alongside the 2022 European LeukemiaNet (ELN) recommendations on risk stratification.</p><p><strong>Methods: </strong>We included 450 adult patients with newly diagnosed AML (non-acute promyelocytic leukemia) from the cBioPortal open-source dataset. Diagnoses and risk stratifications were revised based on the new guidelines and compared with the 2017 WHO classification. Survival analyses were performed using Cox regression.</p><p><strong>Results: </strong>Among the patients included, 190 (42.2%) had consistent diagnoses across the three classifications, whereas 225 (50.0%) had inconsistent diagnoses. The two major WHO 2017 subtypes, AML not otherwise specified (AML-NOS) and AML with myelodysplasia-related changes (AML-MRC), were further subdivided according to the WHO 2022 and ICC. The ICC had the highest prognostication power among the three classifications. Subgroup analysis according to the different definitions of myelodysplasia-related AML and the introduction of AML with mutated TP53 (AML-<i>TP53</i>) showed that the differentiation of AML-<i>TP53</i> was beneficial. The update from ELN 2017 to ELN 2022 resulted in significant transitions in a subset of patients. The updated diagnostic classification and ELN risk stratification (i.e., the ICC and ELN 2022) showed a straightforward relationship.</p><p><strong>Conclusions: </strong>This study presents an integrative comparative analysis of past and current guidelines for AML diagnosis and risk classification based on open-source data. The ICC diagnostic criteria are clinically significant for determining AML prognosis. In line with the changing treatment paradigm for AML, future research is needed to continuously validate diagnostic and risk stratification systems.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"170-177"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788709/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prognostic Value of Residual Circulating Tumor DNA in Metastatic Pancreatic Ductal Adenocarcinoma.","authors":"Hongkyung Kim, Jinho Lee, Mi Ri Park, Zisun Choi, Seung Jung Han, Dongha Kim, Saeam Shin, Seung-Tae Lee, Jong Rak Choi, Seung Woo Park","doi":"10.3343/alm.2024.0345","DOIUrl":"10.3343/alm.2024.0345","url":null,"abstract":"<p><strong>Background: </strong>Circulating tumor DNA (ctDNA) is a potential biomarker in pancreatic ductal adenocarcinoma (PDAC). However, studies on residual ctDNA in patients post-chemotherapy are limited. We assessed the prognostic value of residual ctDNA in metastatic PDAC relative to that of carbohydrate antigen 19-9 (CA19-9).</p><p><strong>Methods: </strong>ctDNA analysis using a targeted next-generation sequencing panel was performed at baseline and during chemotherapy response evaluation in 53 patients. Progression-free survival (PFS) and overall survival (OS) were first evaluated based on ctDNA positivity at baseline. For further comparison, patients testing ctDNA-positive at baseline were subdivided based on residual ctDNA into ctDNA responders (no residual ctDNA post-chemotherapy) and ctDNA non-responders (residual ctDNA post-chemotherapy). Additional survival analysis was performed based on CA19-9 levels.</p><p><strong>Results: </strong>The baseline ctDNA detection rate was 56.6%. Although clinical outcomes tended to be poorer in patients with baseline ctDNA positivity than in those without, the differences were not significant. Residual ctDNA post-chemotherapy was associated with reduced PFS and OS. The prognosis of ctDNA responders was better than that of non-responders but did not significantly differ from that of ctDNA-negative individuals (no ctDNA both at baseline and during post-chemotherapy). Compared with ctDNA responses to chemotherapy, a ≥ 50% decrease in the CA19-9 level had less effect on both PFS and OS based on hazard ratios and significance levels. ctDNA could be monitored in half of the patients whose baseline CA19-9 levels were within the reference range.</p><p><strong>Conclusions: </strong>Residual ctDNA analysis post-chemotherapy is a promising approach for predicting the clinical outcomes of patients with metastatic PDAC.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"199-208"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788705/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Pharmacogenetic Testing and Application: 2024 Updated Guidelines by the Korean Society for Laboratory Medicine.","authors":"John Hoon Rim, Young-Gon Kim, Sollip Kim, Rihwa Choi, Jee-Soo Lee, Seungman Park, Woochang Lee, Eun Young Song, Soo-Youn Lee, Sail Chun","doi":"10.3343/alm.2024.0572","DOIUrl":"10.3343/alm.2024.0572","url":null,"abstract":"<p><p>In the era of precision medicine, pharmacogenetics has substantial potential for addressing inter-individual variability in drug responses. Although pharmacogenetics has been a research focus for many years, resulting in the establishment of several formal guidelines, its clinical implementation remains limited to several gene-drug combinations in most countries, including Korea. The main causes of delayed implementation are technical challenges in genotyping and knowledge gaps among healthcare providers; therefore, clinical laboratories play a critical role in the timely implementation of pharmacogenetics. This paper presents an update of the Clinical Pharmacogenetic Testing and Application guidelines issued by the Korean Society for Laboratory Medicine and aims to provide the necessary information for clinical laboratories planning to implement or expand their pharmacogenetic testing. Current knowledge regarding nomenclature, gene-drug relationships, genotyping technologies, testing strategies, methods for clinically relevant information delivery, QC, and reimbursements has been curated and described in this guideline.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"121-132"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142833816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CD69 Expression is Negatively Associated With T-Cell Immunity and Predicts Antiviral Therapy Response in Chronic Hepatitis B.","authors":"Yurong Gu, Yanhua Bi, Zexuan Huang, Chunhong Liao, Xiaoyan Li, Hao Hu, Huaping Xie, Yuehua Huang","doi":"10.3343/alm.2024.0178","DOIUrl":"10.3343/alm.2024.0178","url":null,"abstract":"<p><strong>Background: </strong>The function of CD69 expressed on T cells in chronic hepatitis B (CHB) remains unclear. We aimed to elucidate the roles of CD69 on T cells in the disease process and in antiviral therapy for CHB.</p><p><strong>Methods: </strong>We enrolled 335 treatment-naive patients with CHB and 93 patients with CHB on antiviral therapy. CD69, antiviral cytokine production by T cells, T-helper (Th) cells, and inhibitory molecules of T cells were measured using flow cytometry, and clinical-virological characteristics were examined dynamically during antiviral therapy.</p><p><strong>Results: </strong>CD69 expression on CD3+, CD4+, and CD8+ T cells was the lowest in the immune-active phase and was negatively correlated with liver transaminase activity, fibrosis features, inflammatory cytokine production by T cells, and Th-cell frequencies but positively with inhibitory molecules on T cells. CD69 expression on CD3+, CD4+, and CD8+ T cells decreased after 48 weeks of antiviral therapy, and patients with hepatitis B e antigen (HBeAg) seroconversion in week 48 showed lower CD69 expression on T cells at baseline and week 48. The area under the ROC curve of CD69 expression on T cells at baseline for predicting HBeAg seroconversion in week 48 was 0.870, the sensitivity was 0.909, and the specificity was 0.714 (<i>P</i> =0.002).</p><p><strong>Conclusions: </strong>CD69 negatively regulates T-cell immunity during CHB, and its expression decreases with antiviral therapy. CD69 expression predicts HBeAg seroconversion in week 48. CD69 may play an important negative role in regulating T cells and affect the efficacy of antiviral therapy.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":"185-198"},"PeriodicalIF":4.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788699/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142862995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Implications of Circulating Tumor DNA in Multiple Myeloma and Its Precursor Diseases.","authors":"Sung-Soo Park, Na Yung Kim, Ji-Young Lim, Jung Yeon Lee, Sujin Yun, Yeun-Jun Chung, Seung-Hyun Jung, Chang-Ki Min","doi":"10.3343/alm.2024.0424","DOIUrl":"https://doi.org/10.3343/alm.2024.0424","url":null,"abstract":"<p><strong>Background: </strong>Genetic alterations play a pivotal role in multiple myeloma (MM) development and therapeutic resistance. Traditionally, the genetic profiling of MM requires invasive bone marrow (BM) procedures; however, these procedures are associated with patient discomfort and cannot fully capture the spatial and temporal heterogeneity of the disease. Therefore, we investigated the clinical implications of liquid biopsy using targeted deep sequencing.</p><p><strong>Methods: </strong>We analyzed the genetic profiles of circulating tumor DNA (ctDNA) by targeted deep sequencing from 102 patients, including those with monoclonal gammopathy of undetermined significance (MGUS, N=7), smoldering MM (N=6), and symptomatic MM (N=89).</p><p><strong>Results: </strong>The number of ctDNA mutations increased with disease progression from MGUS to MM, with averages of 1.0 mutations in MGUS, 1.8 mutations in smoldering MM, and 1.9 mutations in MM, respectively. Shared mutations between BM and ctDNA were more prevalent in MM (68.9%) than in MGUS (25.0%). RAS/RAF and <i>TP53</i> mutations were significantly enriched in MM ctDNA. Specific mutations were associated with clinical features in patients with MM: hypercalcemia and <i>TET2</i> (<i>P</i>=0.006), renal insufficiency and <i>NRAS</i> (<i>P</i>=0.012), paramedullary myeloma and <i>TP53</i> (<i>P</i>=0.02), and extramedullary myeloma and <i>NRAS</i> (<i>P</i>=0.007). <i>TET2</i> mutations significantly affected 2-yr progression-free survival (hazard ratio=7.11, <i>P</i>=0.003). Serial ctDNA profiling accurately predicted treatment response in patients with MM.</p><p><strong>Conclusions: </strong>Our findings highlight the potential of liquid biopsy for understanding MM progression and prognosis utilizing a minimally invasive approach, paving the way for its integration into personalized treatment strategies and real-time disease monitoring.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Complement Activation and Hemolysis in Non-Human Primates Following Transfusion of Genetically Modified Pig Red Blood Cells.","authors":"Hee Jung Kang, Juhye Roh, Haneulnari Lee, Eun Mi Park, Hye Won Lee, Ju Young Lee, Jeong Ho Hwang, Joohyun Shim, Kimyung Choi","doi":"10.3343/alm.2024.0443","DOIUrl":"https://doi.org/10.3343/alm.2024.0443","url":null,"abstract":"<p><strong>Background: </strong>Pig red blood cells (RBCs) are rapidly eliminated when transfused into nonhuman primates (NHPs) because of immune reactions involving antibody binding and complement activation. We assessed the relationship between post-transfusion hemolysis and complement activation.</p><p><strong>Methods: </strong>RBCs for transfusion were prepared from wild-type (WT) and genetically modified pigs and NHPs. After the withdrawal of 25% of the blood volume, NHPs received transfusions of WT (N=4), triple knockout (TKO, N=8), and TKO pig RBCs expressing human <i>CD55</i> and <i>CD39</i> (TKO/hCD55.hCD39, N=4). Additional groups received repeated xenotransfusions (ReXTf, N=3), NHP RBC transfusions (N=3), or a saline infusion (N=4). Blood samples were collected at multiple time points to measure Hb and complement fragment (C3a, C4a, and factor Bb) levels and agglutination titers.</p><p><strong>Results: </strong>Hb levels were restored by transfusions but not by saline infusion. The degree of complement activation varied with the type of transfused RBCs, with significant increases in C3a and factor Bb levels immediately after xenotransfusions but not allotransfusions. These increases were particularly notable in ReXTf and negatively correlated with Hb levels on post-transfusion day 1 (ρ=-0.547 and -0.556; <i>P</i> =0.0187 and 0.0165, respectively). In TKO/hCD55.hCD39 pig RBC transfusions, C3a and factor Bb peak levels were delayed until post-transfusion day 3, unlike in TKO pig RBC transfusions.</p><p><strong>Conclusions: </strong>Post-transfusion complement activation varies depending on prior sensitization and genetic modifications in pig RBCs. Monitoring complement activation can provide insight into the survival and compatibility of transfused RBCs in NHPs.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143397924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"XN-1000 Hematology Analyzer as an Alternative to Flow Cytometry for Measuring Residual Cells in Blood Components.","authors":"Anita Siller, Lisa Seekircher, Daniela Schmidt, Lena Tschiderer, Peter Willeit, Harald Schennach, Marco Amato","doi":"10.3343/alm.2024.0448","DOIUrl":"https://doi.org/10.3343/alm.2024.0448","url":null,"abstract":"<p><strong>Background: </strong>Measuring residual cells in blood products is legally required for monitoring the manufacturing process and ensuring recipient safety. We compared the accuracy and performance of the two methodologies.</p><p><strong>Methods: </strong>Residual white blood cells (rWBCs), red blood cells (rRBCs), and platelets (rPLTs) were measured in RBC concentrates (rWBCs), fresh frozen plasma (rWBCs, rRBCs, and rPLTs), and PLT concentrates (rWBCs and rRBCs) using the Sysmex XN-1000 hematology analyzer (Sysmex, Kobe, Japan) equipped with Blood Bank mode and standard flow cytometry (fluorescence-activated cell sorting; FACS).</p><p><strong>Results: </strong>rWBC counts in RBC concentrates and plasma were similar between XN-1000 and FACS. In pooled pathogen-inactivated PLT concentrates, XN-1000 yielded higher rWBC counts. Correlations between XN-1000 and FACS were moderate for rWBCs (0.42, 95% confidence interval: 0.15-0.69) in RBC inline-filtrated WBC-depleted RBC concentrates. In plasma, correlations were high for rWBC, rRBC, and rPLT counts, with Spearman correlation coefficients of 0.82-0.97. In pathogen-inactivated PLT concentrates, correlations were moderate for rWBCs (0.58, 0.33-0.84) and rRBCs (0.61, 0.35-0.87) in pooled samples but not significant in apheresis-derived samples. Median differences between FACS and XN-1000 were generally low, but XN-1000 overestimated residual cell counts in a subset of measurements. Residual cell cut-off values were surpassed in ⟩90% of RBC concentrates, plasma, and apheresis pathogen-inactivated PLT concentrates using both methods. In pooled pathogen-inactivated PLT concentrates, 91.2% and 70.6% surpassed the cut-off using FACS and XN-1000, respectively.</p><p><strong>Conclusions: </strong>Sysmex XN-1000 is suitable for residual cell measurements in RBC concentrates and plasma, with some limitations for PLT concentrates.</p>","PeriodicalId":8421,"journal":{"name":"Annals of Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143397926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}