Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine最新文献_第6页

Inter-laboratory method validation of CD34+ flow-cytometry assay: the experience of Turin Metropolitan Transplant Centre. CD34+流式细胞仪检测的实验室间方法验证：都灵大都会移植中心的经验。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-10-16 eCollection Date: 2023-10-01

I F Ivana Ferrero, D R Deborah Rustichelli, S C Sara Castiglia, L G Loretta Gammaitoni, A P Alessandra Polo, M P Marisa Pautasso, M G Massimo Geuna, F F Franca Fagioli

{"title":"Inter-laboratory method validation of CD34+ flow-cytometry assay: the experience of Turin Metropolitan Transplant Centre.","authors":"I F Ivana Ferrero, D R Deborah Rustichelli, S C Sara Castiglia, L G Loretta Gammaitoni, A P Alessandra Polo, M P Marisa Pautasso, M G Massimo Geuna, F F Franca Fagioli","doi":"","DOIUrl":"","url":null,"abstract":"The Turin Metropolitan Transplant Centre (CIC 305) includes four flow-cytometry laboratories assessing quality control on hematopoietic stem cells (HSC) with different instruments and operators. Therefore, the CD34+ enumeration assay should be validated on a regular basis. We describe here the validation plan to test the inter-laboratory reproducibility of CD34+ enumeration assay, based on the risk analysis. Stabilized blood samples were analysed using Stem-Kit reagent according to manufacturer's instructions and acquired using the Beckman Coulter Navios at Regina Margherita Children's' Hospital (305-1), Beckman Coulter FC500 at Candiolo Cancer Institute FPO-IRCCS (305-2), BD Biosciences FACSLyric™ at S. Luigi Hospital (305-3), and Beckman Coulter Navios EX at Mauriziano Hospital (305-4). The ISHAGE guidelines were followed for estimating % and absolute number of CD34+ cells in single-platform method. For each sample repeatability limit (r), reproducibility error, uncertainty of reproducibility error and coefficient of variation (CV) were reported. The repeated measurements from each laboratory or instrument have a variability, expressed as reproducibility error, lower than the repeatability limit for that single parameter. The corrected reproducibility error is always lower than the repeatability limit except for the percentage value of the \"low\" count. The analysis of inter-laboratory variance is within the maximum acceptable variance value, and the CV of all measurements for each parameter is less than 8%, indicating low measurement variability among laboratories. Evaluating the overall data, we can conclude that the four laboratories are perfectly aligned and the results are reproducible.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 3","pages":"220-227"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4e/58/ejifcc-34-220.PMC10588076.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49692769","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

Monoclonal Light Chains with alpha 2 mobility on Serum Protein Electrophoresis. 血清蛋白电泳上具有α2迁移率的单克隆轻链。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-10-16 eCollection Date: 2023-10-01

S Danalakshmi

引用次数: 0

CA125, Galectin-3 and FGF-23 are interrelated in heart failure with reduced ejection fraction. CA125、Galectin-3 和 FGF-23 在射血分数降低的心力衰竭中相互关联。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-07-10 eCollection Date: 2023-07-01

Damien Gruson, Diane Maisin, Anne-Catherine Pouleur, Sylvie A Ann, Michel F Rousseau

{"title":"CA125, Galectin-3 and FGF-23 are interrelated in heart failure with reduced ejection fraction.","authors":"Damien Gruson, Diane Maisin, Anne-Catherine Pouleur, Sylvie A Ann, Michel F Rousseau","doi":"","DOIUrl":"","url":null,"abstract":"Background: Carbohydrate Antigen 125 (CA125) is the most widely used biomarker in ovarian cancer screening. In patients with heart failure (HF), increased levels of CA125 have been observed and related to disease severity. Our objective was to determine the association of CA125 levels with two biomarkers of adverse remodeling in HF patients with reduced ejection fraction (HFrEF).Methods: CA125 circulating levels were determined with an electrochemiluminscent immunoassay. Concentrations of B-type natriuretic peptide (BNP), N-terminal proBNP (Nt-proBNP), Galectin-3 and Fibroblast Growth Factor 23 (FGF23) were also measured by immunoassays.Results: CA125 levels were increased in HFrEF, were associated to disease severity according NYHA classes. Median CA125 concentration was also significantly related to cardiovascular mortality. CA125 concentrations were positively and significantly associated to Galectin-3 and FGF23.Conclusions: Concentrations of CA125 are increased in patients with HFrEF, associated to disease severity and adverse cardiovascular outcomes. CA125 levels are also correlated to Galectin-3 and FGF-23, two biomarkers related to fibrosis and cardiovascular remodeling.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 2","pages":"103-109"},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c0/4c/ejifcc-34-103.PMC10349309.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10201125","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

Basics of laboratory statistics. 实验室统计学基础。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-07-01

Vivek Pant, Santosh Pradhan, Keyoor Gautam

引用次数: 0

Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA) Quidel Sofia SARS抗原荧光免疫分析（FIA）仪器诊断性能的汇总分析

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-07-01 DOI: 10.21203/rs.3.rs-2746356/v1

G. Lippi, B. Henry, M. Plebani

{"title":"Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA)","authors":"G. Lippi, B. Henry, M. Plebani","doi":"10.21203/rs.3.rs-2746356/v1","DOIUrl":"https://doi.org/10.21203/rs.3.rs-2746356/v1","url":null,"abstract":"Background This article presents a critical literature review and meta-analysis of diagnostic performance of Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA), a rapid diagnostic antigen test (RDT-Ag) adapted for automatic reading with portable instruments, thus potentially combining the advantages of point-of-care testing with those of a laboratory-based immunoassay. Methods We conducted an electronic search in PubMed and Scopus with the keywords “Quidel” OR “SOFIA” AND “Antigen” AND “SARS-CoV-2” OR “COVID-19” up to March 24, 2023, for identifying articles containing data on accuracy of Quidel Sofia SARS antigen FIA for diagnosing acute SARS-CoV-2 infections. We selected those where test accuracy was compared to that of a reference SARS-CoV-2 molecular assay, and with sufficient information for constructing a 2×2 table. Results A total number of 18 articles (48165 samples; 9.8% positive at molecular testing) were included in this meta-analysis, averaging 24 sample cohorts. The diagnostic accuracy (summary area under the curve), sensitivity and specificity were 0.980, 0.76 and 1.00 in all samples, 0.981, 0.81 and 0.99 in samples collected from symptomatic patients, 0.931, 0.55 and 1.00 in those taken from asymptomatic patients, and 0.960, 0.77 and 0.99 in samples from mixed cohorts of patients, respectively. Minor and clinically negligible differences of accuracy could be found by comparing test results in nasal and nasopharyngeal swabs. Conclusion Quidel Sofia SARS Ag FIA meets the minimum performance criteria of accuracy for SARS-CoV-2 antigenic testing, thus combining satisfactory diagnostic performance with the advantages of being potentially used as a portable device.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 1","pages":"123 - 141"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42750656","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

Autoantibodies to intrinsic factor can jeopardize pernicious anemia diagnosis: a case report. 内在因子自身抗体可危及恶性贫血的诊断:1例报告。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-07-01

Lucía Fraile, Ana Sopena, Carlos E Chávez, Maria Font-Font, Aureli Esquerda

引用次数: 0

Utility of anti-GM-CSF antibodies in the diagnosis of pulmonary alveolar proteinosis: a case report. 抗gm - csf抗体诊断肺泡蛋白沉积症1例。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-07-01

Antonio Sierra-Rivera, Jorge Ferriz-Vivancos, Marta Fandos-Sánchez, Pilar Teresa Timoneda-Timoneda, Goitzane Marcaida-Benito

{"title":"Utility of anti-GM-CSF antibodies in the diagnosis of pulmonary alveolar proteinosis: a case report.","authors":"Antonio Sierra-Rivera, Jorge Ferriz-Vivancos, Marta Fandos-Sánchez, Pilar Teresa Timoneda-Timoneda, Goitzane Marcaida-Benito","doi":"","DOIUrl":"","url":null,"abstract":"Introduction: Pulmonary alveolar proteinosis (PAP) is a disease characterized by the accumulation of lipoprotein-aceous material in the alveoli as a consequence of deficient processing of pulmonary surfactant. It is classified into primary, secondary, and congenital forms. Primary PAP (autoimmune origin) is characterized by the presence of antibodies against granulocyte-macrophage colony-stimulating factor (GM-CSF), while secondary PAP is due to multiple causes such as exposure to certain environmental substances. We present a case of a patient with probable mixed PAP, primary and secondary, due to exposure at the patient's workplace.Case presentation: A 35-year-old male patient attends the outpatient clinic of pulmonology due to symptoms of exertional dyspnea for one year. Pulmonary function tests are performed, and the chest X-ray reveals diffuse bilateral lung involvement with a ground-glass pattern. Incision and excision lung biopsy show findings compatible with predominant PAP in the left lower lobe (LLL). Additionally, a positive anti-GM-CSF antibody result is obtained. The patient is treated with bronchoalveolar lavage (BAL) and nebulized sargramostim. The patient shows satisfactory progress.Discussion: The clinical, analytical, radiological, and histological manifestations were compatible with the diagnosis of autoimmune PAP, and there was suspicion of secondary PAP due to exposure to rock wool. The role of the laboratory, in this case, was essential for the diagnostic confirmation of PAP by performing the determination of anti-GM-CSF antibodies.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 2","pages":"174-180"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/59/31/ejifcc-34-174.PMC10349312.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10182949","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

Predictive Value of the Platelet Times Neutrophil-to-Lymphocyte Ratio (SII Index) for COVID-19 In-Hospital Mortality. 血小板次数中性粒细胞与淋巴细胞比值(SII指数)对COVID-19住院死亡率的预测价值

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-07-01

Santiago J Ballaz, Martha Fors

{"title":"Predictive Value of the Platelet Times Neutrophil-to-Lymphocyte Ratio (SII Index) for COVID-19 In-Hospital Mortality.","authors":"Santiago J Ballaz, Martha Fors","doi":"","DOIUrl":"","url":null,"abstract":"Objective: The performance of the platelet times neutrophil-to-lymphocyte ratio, namely systemic immune inflammation (SII) index, is an inflammatory index that shows controversial results as a predicting indicator of the poor outcomes of COVID-19. In this study, this indicator was analyzed in 3280 patients admitted at a COVID-19 reference hospital in Quito (Ecuador).Methods: The Receiver Operating Characteristic (ROC) curve analysis was conducted on SII values upon admission to identify the most appropriate cut-off values in discriminating COVID-19 severity and in-hospital mortality.Results: SII was higher in both severe patients and in those who finally died (cut-off points of 757.3 and 808.5 respectively). However, the AUC-ROC analysis (0.60-0.67) demonstrated a modest discriminating performance of SII for COVID-19 severity (61.2% sensitivity and 61.5% specificity), which sensibly improved for COVID-19 mortality (AUC-ROC: 0.73-0.83, sensitivity: 80.6% specificity; 63.6%).Conclusion: SII index may well be an indicator of inflammatory conditions secondary to COVID-19 leading to a higher mortality, rather than a predictor of severe forms of the disease.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 2","pages":"167-173"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d6/03/ejifcc-34-167.PMC10349308.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10182951","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

Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA). Quidel Sofia SARS抗原荧光免疫分析法(FIA)诊断性能的汇总分析。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-07-01

Giuseppe Lippi, Brandon M Henry, Mario Plebani

{"title":"Pooled analysis of diagnostic performance of the instrument-read Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA).","authors":"Giuseppe Lippi, Brandon M Henry, Mario Plebani","doi":"","DOIUrl":"","url":null,"abstract":"Background: This article presents a critical literature review and meta-analysis of diagnostic performance of Quidel Sofia SARS antigen Fluorescent Immunoassay (FIA), a rapid diagnostic antigen test (RDT-Ag) adapted for automatic reading with portable instruments, thus potentially combining the advantages of point-of-care testing with those of a laboratory-based immunoassay.Methods: We conducted an electronic search in PubMed and Scopus with the keywords \"Quidel\" OR \"SOFIA\" AND \"Antigen\" AND \"SARS-CoV-2\" OR \"COVID-19\" up to March 24, 2023, for identifying articles containing data on accuracy of Quidel Sofia SARS antigen FIA for diagnosing acute SARS-CoV-2 infections. We selected those where test accuracy was compared to that of a reference SARS-CoV-2 molecular assay, and with sufficient information for constructing a 2×2 table.Results: A total number of 18 articles (48165 samples; 9.8% positive at molecular testing) were included in this meta-analysis, averaging 24 sample cohorts. The diagnostic accuracy (summary area under the curve), sensitivity and specificity were 0.980, 0.76 and 1.00 in all samples, 0.981, 0.81 and 0.99 in samples collected from symptomatic patients, 0.931, 0.55 and 1.00 in those taken from asymptomatic patients, and 0.960, 0.77 and 0.99 in samples from mixed cohorts of patients, respectively. Minor and clinically negligible differences of accuracy could be found by comparing test results in nasal and nasopharyngeal swabs.Conclusion: Quidel Sofia SARS Ag FIA meets the minimum performance criteria of accuracy for SARS-CoV-2 antigenic testing, thus combining satisfactory diagnostic performance with the advantages of being potentially used as a portable device.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 2","pages":"123-141"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5a/fc/ejifcc-34-123.PMC10349315.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10182952","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

A framework for implementing best laboratory practices for non-integrated point of care tests in low resource settings. 在资源匮乏环境中实施非综合护理点检测最佳实验室做法的框架。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-07-01

Lena Jafri, Sibtain Ahmed, Hafsa Majid, Farooq Ghani, Tahir Pillay, Aysha Habib Khan, Imran Siddiqui, Shahid Shakeel, Shuja Ahmed, Saba Azeem, Adil Khan

{"title":"A framework for implementing best laboratory practices for non-integrated point of care tests in low resource settings.","authors":"Lena Jafri, Sibtain Ahmed, Hafsa Majid, Farooq Ghani, Tahir Pillay, Aysha Habib Khan, Imran Siddiqui, Shahid Shakeel, Shuja Ahmed, Saba Azeem, Adil Khan","doi":"","DOIUrl":"","url":null,"abstract":"The method we respond to pandemics is still inadequate for dealing with the point of care testing (POCT) requirements of the next large epidemic. The proposed framework highlights the importance of having defined policies and procedures in place for non-integrated POCT to protect patient safety. In the absence of a pathology laboratory, this paradigm may help in the supply of diagnostic services to low-resource centers. A review of the literature was used to construct this POCT framework for non-integrated and/or unconnected devices. It also sought professional advice from the Chemical Pathology faculty, quality assurance laboratory experts and international POCT experts from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Our concept presents a comprehensive integrated and networked approach to POCT with direct and indirect clinical laboratory supervision, particularly for outpatient and inpatient care in low-resource health care settings.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 2","pages":"110-122"},"PeriodicalIF":0.0,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/17/bf/ejifcc-34-110.PMC10349313.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10182953","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