EJIFCCPub Date : 2021-10-18eCollection Date: 2021-10-01
T Scott Isbell, Elaine Colwell, Elizabeth L Frank, Brad S Karon, Veronica Luzzi, Lou Ann Wyer
{"title":"Professional Certification in Point-of-Care Testing.","authors":"T Scott Isbell, Elaine Colwell, Elizabeth L Frank, Brad S Karon, Veronica Luzzi, Lou Ann Wyer","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Professional certification is affirmation and documentation that the certified individual has the knowledge, training, and skills necessary to practice some aspect of medicine or other profession. Herein is a description of the genesis of a professional certification in point of care testing (POCT), inclusive of rationale and goals. A distinction between professional certification and certificate training programs is made. Details regarding eligibility to sit for the board exam are provided along with a list exam content areas. Finally, successes of this professional certification program are highlighted.</p>","PeriodicalId":193105,"journal":{"name":"EJIFCC","volume":"32 3","pages":"303-310"},"PeriodicalIF":0.0,"publicationDate":"2021-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/93/31/ejifcc-32-303.PMC8592634.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39768224","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}
EJIFCCPub Date : 2021-10-18eCollection Date: 2021-10-01
Tommaso Trenti
{"title":"Synergy Between Point-of-Care Testing and Laboratory Consolidations.","authors":"Tommaso Trenti","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Central or area laboratories will offer an improved number of diagnostic testing services, where drivers for change will involve chronic disease clinical care for an increasingly older population, new emerging diagnostic technologies and personalized medicine. Higher automation quality and ever more diagnostic field integration will lead to higher productivity by means of an improved throughput. At the same time Point of Care Testing (POCT) site of patient care allows for timely medical assessment, which can lead to improved patient outcomes, more effectiveness and patient satisfaction. POCT test introduction in clinical practice should be assessed by an outcome-based policy to avoid adverse events, failure to diagnose providing appropriate timed treatment. The use of POCT devices does not only require technological considerations for the production and management of acceptable tests possibly managed by central laboratory, but also implicates a shift in diagnostic practice across all health organizations. The interaction between laboratory professionals and clinicians will be enriched with new methods of evaluation of patient needs in the internet of things and mobile Health worlds, where boundaries between POCT and central laboratory or hospital and primary healthcare will no longer exist and where all data can be shared and disseminated among stakeholders in the healthcare system.</p>","PeriodicalId":193105,"journal":{"name":"EJIFCC","volume":"32 3","pages":"328-336"},"PeriodicalIF":0.0,"publicationDate":"2021-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6a/94/ejifcc-32-328.PMC8592627.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39655859","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}
{"title":"A Combined Analysis of Serum Growth Differentiation Factor-15 and Cancer Antigen 15-3 Enhances the Diagnostic Efficiency in Breast Cancer.","authors":"Anupama Modi, Purvi Purohit, Ashita Gadwal, Dipayan Roy, Sujoy Fernandes, Jeewan Ram Vishnoi, Puneet Pareek, Poonam Elhence, Sanjeev Misra, Praveen Sharma","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Introduction: </strong>Existing diagnostic biomarkers of breast cancer (BC) are limited by poor sensitivity. In this study, we evaluated the role of serum GDF-15 in early BC diagnosis, independently and in combination with CA15-3, a known blood biomarker of BC.</p><p><strong>Material and methods: </strong>A total of 113 diagnosed, pre-therapy BC patients and 54 healthy controls were recruited. Clinical characteristics, TNM staging, and hormone receptor status of the patients were recorded. Serum GDF-15 and serum CA15-3 were measured by sandwich ELISA and chemiluminescence assay, respectively.</p><p><strong>Results: </strong>The serum GDF-15 levels were significantly (p<0.001) elevated in BC patients compared to healthy controls and in patients with larger tumor size, advanced disease stage, and distant metastasis. ROC analysis revealed that at the cut-off of 525.77 pg/mL, GDF-15 had greater sensitivity than CA15-3. GDF-15 and CA15-3 performed better in combination than individually, with the combined test having an AUC of 0.85 and sensitivity and specificity of 0.63 and 0.98, respectively.Further, serum GDF-15 had a better predictive ability for early-stage BC compared to CA15-3. GDF-15 could independently diagnose BC patients after adjusting for age.</p><p><strong>Conclusion: </strong>We conclude that serum GDF-15 is a promising, robust marker for detecting early-stage BC. However, larger prospective studies are necessary to validate this claim.</p>","PeriodicalId":193105,"journal":{"name":"EJIFCC","volume":"32 3","pages":"363-376"},"PeriodicalIF":0.0,"publicationDate":"2021-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/29/e0/ejifcc-32-363.PMC8592631.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39655862","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}
EJIFCCPub Date : 2021-10-18eCollection Date: 2021-10-01
Giuseppe Lippi, Fabian Sanchis-Gomar, Brandon Michael Henry, Carl J Lavie
{"title":"Cardiac Biomarkers in COVID-19: A Narrative Review.","authors":"Giuseppe Lippi, Fabian Sanchis-Gomar, Brandon Michael Henry, Carl J Lavie","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The diagnosis and risk stratification of coronavirus disease 2019 (COVID-19) is primarily based on discretionary use of laboratory resources. Several lines of evidence now attest that cardiovascular disease not only is a frequent complication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, but its pre-existence may increase the risk of morbidity, disability, and death in patients with COVID-19. To this end, routine assessment of biomarkers of cardiac injury (i.e., cardiac troponin I or T) and dysfunction (e.g., natriuretic peptides) has emerged as an almost essential practice in patients with moderate, severe, and critical COVID-19 illness. Therefore, this narrative review aims to provide an overview of cardiac involvement in patients with SARS-CoV-2 infection as well as the clinical background for including cardiac biomarkers within specific panels of laboratory tests for managing COVID-19 patients.</p>","PeriodicalId":193105,"journal":{"name":"EJIFCC","volume":"32 3","pages":"337-346"},"PeriodicalIF":0.0,"publicationDate":"2021-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d6/d4/ejifcc-32-337.PMC8592630.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39655860","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}
{"title":"In-House Algorithm for Reporting Discrepant HbA1c Result and Troubleshooting a Case of False Low HbA1c.","authors":"Vivek Pant, Abha Shrestha, Devish Pyakurel, Keyoor Gautam, Santosh Pradhan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>We report an unusual case of a patient having low glycosylated hemoglobin (HbA1c) below the reportable range, despite having borderline fasting blood glucose. The patient had decreased erythrocytes count and elevated reticulocyte count, with no evidence of hemoglobinopathy. He reported taking multidrug therapy for borderline lepromatous leprosy. Dapsone induced hemolysis was identified as the cause for the discordant HbA1c. Thus, it is important to be aware of medications and conditions that may lead to a falsely low HbA1c level so that incorrect treatment decisions are not made. In such situations, alternative measure of glycemic control, such as fructosamine is recommended. Further it is also recommended that clinical laboratories have standard protocol to troubleshoot any discrepant HbA1c result.</p>","PeriodicalId":193105,"journal":{"name":"EJIFCC","volume":"32 3","pages":"377-384"},"PeriodicalIF":0.0,"publicationDate":"2021-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ec/0e/ejifcc-32-377.PMC8592636.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39655863","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}
EJIFCCPub Date : 2021-10-18eCollection Date: 2021-10-01
Nina Maria Fanaropoulou
{"title":"Hope Injections: The Promises of Regenerative Medicine in Curing Type 1 Diabetes Mellitus.","authors":"Nina Maria Fanaropoulou","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":193105,"journal":{"name":"EJIFCC","volume":"32 3","pages":"392-397"},"PeriodicalIF":0.0,"publicationDate":"2021-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5d/81/ejifcc-32-392.PMC8592635.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39655865","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}
EJIFCCPub Date : 2021-06-29eCollection Date: 2021-06-01
Zoe Brooks, Saswati Das, Tom Pliura
{"title":"Clinicians' Probability Calculator to Convert Pre-Test to Post-Test Probability of SARS-CoV-2 Infection Based on Method Validation from Each Laboratory.","authors":"Zoe Brooks, Saswati Das, Tom Pliura","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Despite best efforts, false positive and false negative test results for SARS-CoV-2 are unavoidable. Likelihood ratios convert a clinical opinion of pre-test probability to post-test probability, independently of prevalence of disease in the test population.</p><p><strong>Methods: </strong>The authors examined results of PPA (Positive Percent Agreement, sensitivity) and NPA (Negative Percent Agreement, specificity) from 73 laboratory experiments for molecular tests for SARS-CoV-2 as reported to the FIND database, and for two manufacturers' claims in FDA EUA submissions.PPA and NPA were converted to likelihood ratios to calculate post-test probability of disease based on clinical opinion of pre-test probability. Confidence intervals were based on the number of samples tested. An online calculator was created to help clinicians identify false-positive, or false-negative SARS-CoV-2 test results for COVID-19 disease.</p><p><strong>Results: </strong>Laboratory results from the same test methods did not mirror each other or the manufacturer. Laboratory studies showed PPA from 17% to 100% and NPA from 70.4% to 100%. The number of known samples varied 8 to 675 known patient samples, which greatly impacted confidence intervals.</p><p><strong>Conclusion: </strong>Post-test probability of the presence of disease (true-positive or false-negative tests) varies with clinical pre-test probability, likelihood ratios and confidence intervals.The Clinician's Probability Calculator creates reports to help clinicians estimate post-test probability of COVID-19 based on the testing laboratory's verified PPA and NPA.</p>","PeriodicalId":193105,"journal":{"name":"EJIFCC","volume":"32 2","pages":"265-279"},"PeriodicalIF":0.0,"publicationDate":"2021-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/66/dc/ejifcc-32-265.PMC8343041.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39334136","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}
EJIFCCPub Date : 2021-06-29eCollection Date: 2021-06-01
Sergio Bernardini
{"title":"Foreword: Introducing the eJIFCC Special Issue on \"POCT - Making the Point\".","authors":"Sergio Bernardini","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":193105,"journal":{"name":"EJIFCC","volume":"32 2","pages":"116-117"},"PeriodicalIF":0.0,"publicationDate":"2021-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e5/ed/ejifcc-32-116.PMC8343047.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39333765","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}
EJIFCCPub Date : 2021-06-29eCollection Date: 2021-06-01
Sedef Yenice
{"title":"Training and Competency Strategies for Point-of-Care Testing.","authors":"Sedef Yenice","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The increased availability and use of POCT are being influenced by many factors, such as; industry trends to move towards patient-centered care and healthcare decentralization, the increasing prevalence of infectious diseases also including the current use of Rapid SARS-CoV-2 Testing, a growing incidence of lifestyle diseases such as diabetes, heart disease, and hypertension, as well as advances in in-vitro diagnostic medical technologies. The use of POCT can increase the efficiency of services and improve outcomes for patients. However, the variability of the testing environment and conditions as well as the competency of staff performing the tests may have a significant impact on the quality and accuracy of POCT results. A majority of the staff who perform POCT are not trained laboratory staff and may not be as knowledgeable about the processes involved in testing, such as patient preparation, sample collection, management of equipment and supplies, instrument calibration and maintenance, the performance of the test, quality control, interpretation of the results, and reporting/documentation of results in each patient's context. Therefore, staff performing POCT must have the proper training and experience to ensure test results are accurate and reliable. This short communication outlines the specific requirements for staff training based on international standards which need to be considered to ensure the quality of test results and describes competency criteria required for compliance with POCT.</p>","PeriodicalId":193105,"journal":{"name":"EJIFCC","volume":"32 2","pages":"167-178"},"PeriodicalIF":0.0,"publicationDate":"2021-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/07/a0/ejifcc-32-167.PMC8343045.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39336223","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}
EJIFCCPub Date : 2021-06-29eCollection Date: 2021-06-01
Edward W Randell, Vinita Thakur
{"title":"Leading POCT Networks: Operating POCT Programs Across Multiple Sites Involving Vast Geographical Areas and Rural Communities.","authors":"Edward W Randell, Vinita Thakur","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Few peer-reviewed publications provide laboratory leaders with useful strategies on which to develop and implement point of care testing (POCT) programs to support delivery of acute care services to remote rural communities, with or without trained laboratory staff on site. This mini review discusses common challenges faced by laboratory leaders poised to implement and operate POCT programs at multiple remote and rural sites. It identifies areas for consideration during the initial program planning phases and provides areas for focus during evaluation and for continued improvement of POCT services at remote locations. Finally, it discusses a potential oversight framework for governance and leadership of multisite POCT programs servicing remote and rural communities.</p>","PeriodicalId":193105,"journal":{"name":"EJIFCC","volume":"32 2","pages":"179-189"},"PeriodicalIF":0.0,"publicationDate":"2021-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/21/c7/ejifcc-32-179.PMC8343053.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39336224","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}