Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine最新文献_第9页

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

Development of Control Material for Exhaled Breath-Alcohol Testing and its Application. 呼气酒精检测控制材料的研制及其应用。

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

Krittin Chumsawat, Somsak Fongsupa, Sudawadee Kongkhum, Pramote Sriwanitchrak, Narisa K Bordeerat

{"title":"Development of Control Material for Exhaled Breath-Alcohol Testing and its Application.","authors":"Krittin Chumsawat, Somsak Fongsupa, Sudawadee Kongkhum, Pramote Sriwanitchrak, Narisa K Bordeerat","doi":"","DOIUrl":"","url":null,"abstract":"Background: Breath analyser tests are used worldwide to obtain proof of alcohol intoxication and often used in the conviction of traffic violators. These tests are conducted to quickly and painlessly determine the existing concentration of alcohol in arterial blood by measuring the amount of ethanol in exhaled breath, which can be identified with an electrochemical sensor.At present, the calibration and maintenance of analysers used for these tests are typically performed regularly but lack quality control. Consequently, test results may not be accurate because of calibration deterioration.The aim of this study was to develop and evaluate the uncertainty of control materials used in breath-alcohol testing at the Bangkok Metropolitan Police Station.Material and methods: Ethyl alcohol (99.99%; Certified Reference Material grade) diluted at three different concentrations was kept under design conditions. The concentrations were 28, 67, and 134 mg/dL, determined by performing headspace gas chromatography, and the uncertainty was set as ±1.3925, ±2.8736, and ±1.8231 mg/dL (±4.97%, ±4.29%, and ±2.72% for the concentrations, respectively), as per ISO Guide 35:2017.Results: The total error percentages of the developed control materials were 4.97%, 4.29%, and 2.72% for concentrations of 28, 67, and 134 mg/dL, respectively. Each concentration of the materials was tested by using measurements from 70 breath-alcohol analysers belonging to the Bangkok Metropolitan Police Station.Conclusion: These control materials are applicable to quality assurance and standards tests and may help to ensure the accuracy of breath-alcohol testing in the future.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 2","pages":"142-152"},"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/61/cd/ejifcc-34-142.PMC10349310.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10182956","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

Age-Stratified Lithium Therapeutic Ranges for Older Adults with Bipolar Disorder - from Awareness to an Action Plan. 老年人双相情感障碍的年龄分层锂治疗范围-从意识到行动计划。

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

Angela W S Fung, Kenneth I Shulman, Danijela Konforte, Hilde Vandenberghe, Julia Stemp, Victoria R Yuan, Paul M Yip, Lei Fu

{"title":"Age-Stratified Lithium Therapeutic Ranges for Older Adults with Bipolar Disorder - from Awareness to an Action Plan.","authors":"Angela W S Fung, Kenneth I Shulman, Danijela Konforte, Hilde Vandenberghe, Julia Stemp, Victoria R Yuan, Paul M Yip, Lei Fu","doi":"","DOIUrl":"","url":null,"abstract":"Lithium is the first-line treatment for maintenance therapy in bipolar disorder. It is an effective mood stabilizer agent, and may have potential benefits in neuroprotection and reducing the risk of suicide. Toxicity has been a concern in recent decades, particularly in older adults (≥60 years). In 2019, the Older Adults Task Force within the International Society for Bipolar Disorder (ISBD) published recommendations for age-stratified lithium therapeutic ranges for therapy of Older Age Bipolar Disorder (OABD), namely 0.4 - 0.8 mmol/L for ages 60 to 79 and 0.4 - 0.7 mmol/L for ages 80 and above. Clinical laboratory practice surveys in Canada indicated that adoption and implementation of the proposed ranges has been limited to date. In this article, we describe the approach and steps taken to evaluate and implement recommended lithium therapeutic ranges in Ontario and other provinces in Canada for laboratory quality improvement. Sources of variation in lithium reporting practices are discussed and shared here to highlight potential barriers to implementation. The overall goal of this article is to bring attention across the global laboratory community that lower lithium therapeutic target ranges in older patients are crucial for patient safety in OABD.","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 2","pages":"153-166"},"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/f8/6d/ejifcc-34-153.PMC10349314.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10201127","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

Dasatinib-Induced Chylothorax: A Clinical Laboratory's Perspective. 达沙替尼诱导乳糜胸:临床实验室的观点。

Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine Pub Date : 2023-04-01

Rafael J García Martínez, Clara Sanz Gea, Víctor Martin-Riera, Armando Raúl Guerra Ruiz, Rosanna Paciucci Barzanti, Roser Ferrer-Costa, Clara Ramirez-Serra

引用次数: 0