Journal of laboratory and precision medicine最新文献_第8页

A current analysis of quality indicators in Chinese clinical laboratories 我国临床实验室质量指标现状分析

Journal of laboratory and precision medicine Pub Date : 2021-07-01 DOI: 10.21037/JLPM-21-19

M. Saleem, Wesley Wong, Xiantao Huang, T. Badrick

{"title":"A current analysis of quality indicators in Chinese clinical laboratories","authors":"M. Saleem, Wesley Wong, Xiantao Huang, T. Badrick","doi":"10.21037/JLPM-21-19","DOIUrl":"https://doi.org/10.21037/JLPM-21-19","url":null,"abstract":"Background: Improvements in patient safety and outcomes have been linked with systems-based approaches to reduce variation in laboratory testing cycle. Activities linked to laboratory accreditation are also known to improvement in the quality of laboratory testing. Benchmarking is a continuous improvement approach utilised in which errors are identified and outcome of any intervention are monitored against peers. Methods: Roche Diagnostics started benchmarking surveys of laboratory practice in the Asia-Pacific Region in 2011 by collecting feedback from clinical laboratory managers and directors on their laboratories’ operation and performance. The survey is carried every alternate year, and benchmarking report will be released to the participants for their reference. The latest survey was a new edition performed in 2019 via an online platform. Results: This Survey provides a comparison in selected performance indicators in many Chinese diagnostic laboratories with Asia-Pacific peers. Whilst the performance of Chinese laboratories is generally comparable to those of other Asia-Pacific laboratories, there are some differences with regards to how STAT urgent) samples are handled, enrolment in External Quality Assurance programs and certain turnaround time targets. Conclusions: The performance of Chinese Laboratories in the main is similar to the performance of Asia-Pacific countries. Some areas of practice identified as unique to Chinese laboratories may reflect laboratory practices that may be mandated or preferred by Chinese agencies.","PeriodicalId":92408,"journal":{"name":"Journal of laboratory and precision medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45054706","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

Predicting gestational age improves newborn screening for congenital adrenal hyperplasia: a retrospective cohort study 预测胎龄可改善新生儿先天性肾上腺增生筛查：一项回顾性队列研究

Journal of laboratory and precision medicine Pub Date : 2021-07-01 DOI: 10.21037/JLPM-21-18

Danny Jomaa, S. Hawken, S. Lawrence, P. Chakraborty, Matthew Henderson

{"title":"Predicting gestational age improves newborn screening for congenital adrenal hyperplasia: a retrospective cohort study","authors":"Danny Jomaa, S. Hawken, S. Lawrence, P. Chakraborty, Matthew Henderson","doi":"10.21037/JLPM-21-18","DOIUrl":"https://doi.org/10.21037/JLPM-21-18","url":null,"abstract":"Background: Newborn screening for congenital adrenal hyperplasia (CAH) is increasingly performed using a two-tiered approach; 17-hydroxyprogesterone by immunoassay followed by steroid panel by liquid chromatography mass spectrometry. The first tier uses gestational age (GA)-based 17-hydroxyprogesterone screening thresholds. GA is unreported in approximately 5% of births and, in these cases, birth weight (BW)-based screening thresholds are used. However, BW based thresholds have a lower specificity, resulting in more first tier false positives. combining newborn the screening analytes measured in the blood spot screen, a predictive model this predicted in newborns with an unreported GA. Newborns underwent subsequent GA-based screening to determine whether this method results in a higher positive predictive value (PPV) than current BW-based screening methods. Methods: Screening results were obtained from Newborn Screening Ontario for 702,020 infants that were born in Ontario, Canada between 2011 and 2015. Predicted GA was calculated using a model composed of demographic and screening analyte factors. Newborns with an unreported GA underwent screening using BW and predicted GA, and the PPV for each method was calculated and compared. Descriptive statistics were determined for newborns that screened positive and negative with each algorithm. Results: PPV of first-tier GA-based and BW-based screening and 0.82%, respectively. time PPV of GA-based GA-based PPV of first-tier screening newborns GA Sequential screenings lower false positive true CAH. immune system disorders,","PeriodicalId":92408,"journal":{"name":"Journal of laboratory and precision medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41415788","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

Literature review: drug and alcohol-induced hypoglycaemia 文献综述:药物和酒精引起的低血糖

Journal of laboratory and precision medicine Pub Date : 2021-07-01 DOI: 10.21037/JLPM-21-16

Tejaskumar Kalaria, Y. L. Ko, Kiran Issuree

{"title":"Literature review: drug and alcohol-induced hypoglycaemia","authors":"Tejaskumar Kalaria, Y. L. Ko, Kiran Issuree","doi":"10.21037/JLPM-21-16","DOIUrl":"https://doi.org/10.21037/JLPM-21-16","url":null,"abstract":"Objective: Narrative literature review of medication and alcohol related hypoglycaemia. Background: Drugs and alcohol are the commonest causes of hypoglycaemia and account for a significant number of emergency department attendances and hospital admissions. Methods: Hypoglycaemia risk with various drug classes and alcohol is discussed along with underlying mechanisms, characteristics and caveats around the diagnosis and management. Conclusions: Hypoglycaemia is most common with insulin treatment in type 1 diabetes but insulin in type 2 diabetes, sulphonylureas, other anti-hyperglycaemic medications and medications from other classes like beta-blockers, angiotensin converting enzyme inhibitors, fibrates, psychotropic medications, antimalarial drugs, antibiotics, anti-arrhythmic drugs, non-steroidal anti-inflammatory agents, and a few other classes of medications may also increase hypoglycaemia risk. The risk, depending on the drug class, may be as monotherapy or when used in combination with anti-hyperglycaemic medications and may either be in the therapeutic doses or only in overdose. Alcohol has profound effects on glucose metabolism. However, the incidence of alcohol-induced hypoglycaemia in healthy individuals with good glycogen reserve is low. Glycogenolysis plays an initial role in the defence against alcohol-induced hypoglycaemia and gluconeogenesis takes over later on to prevent profound hypoglycaemia. There are inconstancies in the literature about the role of counter-regulatory hormones in alcohol-induced hypoglycaemia. 16","PeriodicalId":92408,"journal":{"name":"Journal of laboratory and precision medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42179423","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: 3

Autoimmune hypoglycaemia: a narrative review from the laboratory perspective 自身免疫性低血糖:从实验室角度的叙述性回顾

Journal of laboratory and precision medicine Pub Date : 2021-07-01 DOI: 10.21037/JLPM-20-111

Lauren E Hughes, J. Fenn, C. Ford, R. Gama

{"title":"Autoimmune hypoglycaemia: a narrative review from the laboratory perspective","authors":"Lauren E Hughes, J. Fenn, C. Ford, R. Gama","doi":"10.21037/JLPM-20-111","DOIUrl":"https://doi.org/10.21037/JLPM-20-111","url":null,"abstract":": Whilst hypoglycaemia is common, autoimmune causes are relatively rare. Autoimmune causes of hypoglycaemia includes both insulin autoimmune syndrome (IAS), and type B insulin resistance syndrome (TBIR). IAS typically presents with post-prandial hypoglycaemia in adulthood and is characterised by inappropriately high plasma insulin, proinsulin and C-peptide concentrations during hypoglycaemia, with C-peptide:insulin molar ratios of <1, high insulin autoantibody titres and the presence of macroinsulin. TBIR typically presents with hyperglycaemia due to insulin resistance as a result of insulin receptor antibodies. TBIR may, however, also present with endogenous hyperinsulinaemic hypoglycaemia or hyperglycaemia-hypoglycaemia depending on the activating or inhibiting action of the insulin receptor antibodies. Very rarely, autoimmune hypoglycaemia may be due to insulin antibodies raised to therapeutic insulin or insulin-binding paraproteins with purported mechanisms similar to IAS in producing hypoglycaemia. This review summarises the pathophysiology and laboratory features of IAS and TBIR, and highlights the importance of considering these diagnoses in patients with hypoglycaemia associated with non-suppressed insulin levels, to prevent unnecessary pancreatic surgery.","PeriodicalId":92408,"journal":{"name":"Journal of laboratory and precision medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47541919","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: 4

Tumour-induced hypoglycaemia: a narrative review 肿瘤引起的低血糖症：叙述性综述

Journal of laboratory and precision medicine Pub Date : 2021-07-01 DOI: 10.21037/JLPM-20-110

T. Barber, C. Bannon, M. Weickert, I. Kyrou, H. Randeva

{"title":"Tumour-induced hypoglycaemia: a narrative review","authors":"T. Barber, C. Bannon, M. Weickert, I. Kyrou, H. Randeva","doi":"10.21037/JLPM-20-110","DOIUrl":"https://doi.org/10.21037/JLPM-20-110","url":null,"abstract":"Objective: To provide an overview of the pathogenesis and clinical features of tumour-induced hypoglycaemia (TIH), its effective diagnostic work-up and management strategies and the challenges involved. Background: Hypoglycaemia, defined by a plasma blood glucose level <3.0 mmol/L (<54 mg/dL), results from failure of glucose homeostasis. Although multiple scenarios contribute to the onset of hypoglycaemia, certain tumours represent an important, although relatively uncommon group of causative factors. In patients with unexplained hypoglycaemia, it is important to conduct a careful clinical assessment, with detailed investigations to ascertain the underlying cause(s), and initiate appropriate and effective therapies. TIH often presents a clinical challenge for both accurate and timely diagnosis and effective management. Methods: We performed a narrative literature review using PubMed and search-term “Tumour-Induced Hypoglycaemia”, with articles written in English. Conclusions: There are two main groups of TIH: insulinoma and non-islet cell tumours (NICTs). Insulinomas are the commonest form of pancreatic neuroendocrine tumour, and a well-recognised cause of hyperinsulinaemia associated with recurrent hypoglycaemia. Conversely, NICTs mediate hypoglycaemia through the excessive production of big insulin-like growth factor 2 (IGF2), that cross-reacts with the insulin receptor. Through careful biochemical assessment, accurate diagnosis of Insulinoma versus NICTs provides a rationale for effective and individually tailored management.","PeriodicalId":92408,"journal":{"name":"Journal of laboratory and precision medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48991393","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

Inherited metabolic disorders associated with hypoglycaemia in adulthood: a narrative review 成年期与低血糖相关的遗传性代谢紊乱：叙述性综述

Journal of laboratory and precision medicine Pub Date : 2021-06-16 DOI: 10.21037/JLPM-20-100

C. Dawson

{"title":"Inherited metabolic disorders associated with hypoglycaemia in adulthood: a narrative review","authors":"C. Dawson","doi":"10.21037/JLPM-20-100","DOIUrl":"https://doi.org/10.21037/JLPM-20-100","url":null,"abstract":": In health, blood glucose homeostasis is maintained by the action of pancreatic hormones on the metabolic pathways of glycogenolysis and gluconeogenesis. Inherited metabolic disorders (IMD) are caused by mutations in genes encoding enzymes or transporter proteins directly involved in these pathways or indirectly via the fatty acid oxidation pathway. The clue to an IMD diagnosis comes from determining whether hypoglycaemia occurs in the fasting or post-prandial state and whether ketones are absent or present. In adults, hypoglycaemia is milder than in children and other clinical features usually predominate providing additional clues to the diagnosis. Confirmatory tests include acylcarnitine profile, free carnitine, urine organic acid profile and mutation analysis. Non-ketotic hypoglycaemia is indicative of either a fatty acid oxidation disorder or glycogen storage disorder Type 1 (GSD I). The differential diagnosis of fasting ketotic hypoglycaemia is broader and includes endocrine causes which must be excluded first. IMDs in this category include other GSDs and the gluconeogenesis disorder, fructose 1,6 bisphosphatase deficiency. Postprandial hypoglycaemia also more commonly has a non-IMD aetiology, but is a feature of hereditary fructose intolerance (HFI) and three of the congenital disorders of glycosylation (CDG). In the last two decades, better lifelong holistic care and advances in gene sequencing technology have improved our understanding of how IMDs affect adults. Consequently, attenuated IMD phenotypes are increasingly being recognised. 13","PeriodicalId":92408,"journal":{"name":"Journal of laboratory and precision medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44313841","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: 1

Comparing the performance of two commercial assays for detection of SARS-CoV-2 in samples with low viral load 比较两种商业检测方法在低病毒载量样品中检测SARS-CoV-2的性能

Journal of laboratory and precision medicine Pub Date : 2021-06-10 DOI: 10.21037/JLPM-21-17

Kok Siong Poon, N. Tee

{"title":"Comparing the performance of two commercial assays for detection of SARS-CoV-2 in samples with low viral load","authors":"Kok Siong Poon, N. Tee","doi":"10.21037/JLPM-21-17","DOIUrl":"https://doi.org/10.21037/JLPM-21-17","url":null,"abstract":"be safely discharged from isolation. We recently reviewed the Ct values from 24 consecutive nasopharyngeal swab samples received between June and July 2020 by the laboratory with presumptive positive SARS-CoV-2 RNA by cobas ® (a positive result for the E gene target but a negative result for the ORF1a gene target). These are specimens with a borderline viral titre close to the assay’s limit of detection (LOD) (100 copies/mL) (3) as indicated by their high Ct values. These samples were re-tested within the same day using the Xpert ® Xpress SARS-Cov-2 assay. This assay detects the N2 and E gene targets. Similar to the reporting algorithm of the cobas ® test, samples with only detectable E gene by the Xpert ® assay are considered as presumptive positive with recommendation for re-testing (Xpert ® Xpress SARS-Cov-2 assay package insert). The LOD of Xpert ® assay was determined by Wolters et al. to be 8.26 copies/mL (4). 24 presumptive positive samples by cobas test, 17 E and N2 gene Ct value for E gene target Ct value for gene for both E and N2 gene they were tested using the Xpert ® assay. Close agreement between the Ct values of E gene target of the two assays observed, with a high standard Stochastic effect, which is a prominent observation due to random variations when examining low","PeriodicalId":92408,"journal":{"name":"Journal of laboratory and precision medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47762257","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

A narrative review about regulatory acceptability standards for clinical assays 关于临床检测的监管可接受性标准的叙述性回顾

Journal of laboratory and precision medicine Pub Date : 2021-05-19 DOI: 10.21037/JLPM-21-3

J. Krouwer

{"title":"A narrative review about regulatory acceptability standards for clinical assays","authors":"J. Krouwer","doi":"10.21037/JLPM-21-3","DOIUrl":"https://doi.org/10.21037/JLPM-21-3","url":null,"abstract":"Objective: To review acceptance standards, particularly those used by regulatory agencies to approve products. A hierarchy of standards is discussed ranging from regulatory (FDA), quasi-regulatory (CLSI, ISO 15189, ISO 15197), to academic standards (Milan conference). Background: Many clinical chemistry assays produce results that can be compared to reference. This allows regulatory bodies such as FDA to have acceptance protocols that require evaluation results between the candidate and reference assay to meet certain acceptability limits. Methods: This paper analyzes the problems arising from acceptability standards including: (I) a generic problem with the standards; (II) protocols used to evaluate the standards; (III) how the data are analyzed; (IV) how often results are observed that potentially can cause serious patient harm, and (V) why people do not pay more attention to dangerous results. Conclusions: Suggested recommendations include: (I) specifications should better reflect the harm when the magnitude of error increases; (II) results should be provided with and without pre- and post-analytical error; (III) more focus is needed on tools that prevent large errors, especially if pre- and post-analytical errors are detected. These include improved user training, Failure Mode Effects Analysis (FMEA), fault trees and Failure Reporting And Corrective Action System (FRACAS); (IV) for assays on the market, the MAUDE database should be examined for adverse events.","PeriodicalId":92408,"journal":{"name":"Journal of laboratory and precision medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47859189","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

Preanalytical phase in pleural fluid analysis 胸膜液分析的预分析阶段

Journal of laboratory and precision medicine Pub Date : 2021-05-14 DOI: 10.21037/JLPM-2021-02

L. M. Kopčinović, Jelena Culej

{"title":"Preanalytical phase in pleural fluid analysis","authors":"L. M. Kopčinović, Jelena Culej","doi":"10.21037/JLPM-2021-02","DOIUrl":"https://doi.org/10.21037/JLPM-2021-02","url":null,"abstract":": The total testing process for pleural fluid samples comprises a continuum of five phases, from the initial procedures of the pre-preanalytical phase to the final steps in the post-postanalytical phase. It can be assumed that the extra-analytical phases in laboratory testing of pleural fluid samples are equally susceptible to errors and that the error rate is comparable to (or even higher than) the corresponding phases in standard samples analysis. It is through harmonization of the preanalytical phase that the risk of errors might be reduced and patients’ safety improved. However, with the exception of a few documents from standard writing bodies and national societies, little evidence is available on harmonization of the preanalytical phase for pleural fluid testing. A thorough understanding of potential errors in the preanalytical phase of pleural fluid analysis enables laboratory professionals to ensure reliable testing results and to assist clinicians in the diagnostic evaluation of pleural effusion. In this review, we discuss the preanalytical phase of pleural fluid analysis, presenting variables potentially affecting the quality of pleural fluid samples and hence the analytical reliability of pleural fluid analysis.","PeriodicalId":92408,"journal":{"name":"Journal of laboratory and precision medicine","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43675899","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: 3

Emerging COVID-19 diagnostics in context—what about testing saliva? 新出现的新冠肺炎诊断——唾液检测如何？

Journal of laboratory and precision medicine Pub Date : 2021-04-21 DOI: 10.21037/JLPM-21-14

Kok Siong Poon, N. Tee

引用次数: 0