首页 > 最新文献

Annals of Clinical Biochemistry最新文献

英文 中文
A service evaluation of the use of faecal immunochemical tests in symptomatic patients aged under 50 years presenting to primary care. 对 50 岁以下有症状的初级保健患者使用粪便免疫化学检验的服务评估。
IF 2.2 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-01-01 Epub Date: 2023-07-16 DOI: 10.1177/00045632231189386
Rebecca E Tibbs, Sally C Benton

Background: Most colorectal cancers (CRCs) occur in individuals aged over 50 years; however, the incidence in younger age groups is increasing. Diagnosis in younger patients is frequently delayed due to non-specific symptoms and the relative frequency of benign disease. There is a need to identify patients who warrant further investigation for CRC. This study reviewed whether a faecal haemoglobin (f-Hb) ≥10 μg Hb/g faeces measured by the faecal immunochemical test for f-Hb (FIT) was associated with CRC in a local primary care population aged under 50 years.

Methods: f-Hb results from symptomatic patients aged 18-49 years presenting to primary care during a 17-month period were extracted from local laboratory information systems. Colonoscopy lists were obtained from three local trusts. The Somerset Cancer Registry was searched to identify CRCs. f-Hb and outcomes were matched using NHS numbers.

Results: A total of 3119 patients were included (median age 41 years); 313 of 2682 patients with f-Hb <10 μg/g (11.7%) and 305 of 437 patients with f-Hb ≥10 μg/g (69.8%) underwent colonoscopy. Twelve CRCs were detected. At a cut-off of 10 μg/g, the positivity rate was 14.0%, sensitivity was 100% (75.8-100%), specificity was 86.3% (85.1-87.5%), positive predictive value (PPV) was 2.7% (2.5-3.0%) and negative predictive value (NPV) was 100%. At a cut-off of 150 μg/g, sensitivity was 83.3% (55.2-95.3%), specificity was 95.2% (94.4-95.9%), PPV was 6.2% (4.7-8.2%) and NPV was 99.9% (99.8-100%).

Conclusion: Our data supports the use of FIT to triage patients aged under 50 years presenting to primary care with symptoms suggestive of CRCs.

背景:大多数结肠直肠癌(CRC)发生在 50 岁以上的人群中;然而,年轻群体的发病率正在上升。由于非特异性症状和良性疾病相对较多,年轻患者的诊断常常被延误。有必要确定哪些患者需要进一步检查是否患有 CRC。本研究对当地 50 岁以下初级保健人群中通过粪便血红蛋白免疫化学检验(FIT)测得的粪便血红蛋白(f-Hb)≥10 μg Hb/g粪便是否与 CRC 相关进行了回顾。从当地三家信托机构获得结肠镜检查名单。使用 NHS 编号对 f-Hb 和结果进行匹配:结果:共纳入 3119 名患者(中位年龄 41 岁);2682 名患者中有 313 名患者有 f-Hb 结论:我们的数据支持使用 FIT 来检测 CRC:我们的数据支持使用 FIT 对 50 岁以下、因症状提示有 CRC 的初级保健患者进行分流。
{"title":"A service evaluation of the use of faecal immunochemical tests in symptomatic patients aged under 50 years presenting to primary care.","authors":"Rebecca E Tibbs, Sally C Benton","doi":"10.1177/00045632231189386","DOIUrl":"10.1177/00045632231189386","url":null,"abstract":"<p><strong>Background: </strong>Most colorectal cancers (CRCs) occur in individuals aged over 50 years; however, the incidence in younger age groups is increasing. Diagnosis in younger patients is frequently delayed due to non-specific symptoms and the relative frequency of benign disease. There is a need to identify patients who warrant further investigation for CRC. This study reviewed whether a faecal haemoglobin (f-Hb) ≥10 μg Hb/g faeces measured by the faecal immunochemical test for f-Hb (FIT) was associated with CRC in a local primary care population aged under 50 years.</p><p><strong>Methods: </strong>f-Hb results from symptomatic patients aged 18-49 years presenting to primary care during a 17-month period were extracted from local laboratory information systems. Colonoscopy lists were obtained from three local trusts. The Somerset Cancer Registry was searched to identify CRCs. f-Hb and outcomes were matched using NHS numbers.</p><p><strong>Results: </strong>A total of 3119 patients were included (median age 41 years); 313 of 2682 patients with f-Hb <10 μg/g (11.7%) and 305 of 437 patients with f-Hb ≥10 μg/g (69.8%) underwent colonoscopy. Twelve CRCs were detected. At a cut-off of 10 μg/g, the positivity rate was 14.0%, sensitivity was 100% (75.8-100%), specificity was 86.3% (85.1-87.5%), positive predictive value (PPV) was 2.7% (2.5-3.0%) and negative predictive value (NPV) was 100%. At a cut-off of 150 μg/g, sensitivity was 83.3% (55.2-95.3%), specificity was 95.2% (94.4-95.9%), PPV was 6.2% (4.7-8.2%) and NPV was 99.9% (99.8-100%).</p><p><strong>Conclusion: </strong>Our data supports the use of FIT to triage patients aged under 50 years presenting to primary care with symptoms suggestive of CRCs.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"48-54"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9778315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The laboratory investigation of diabetes insipidus: A review. 糖尿病性尿崩症的实验室检查:综述。
IF 2.2 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-01-01 Epub Date: 2023-02-06 DOI: 10.1177/00045632231154391
Christopher Boot

Diabetes insipidus (DI) is a group of disorders that lead to inappropriate production of large volumes of dilute urine. The three main forms are central DI (CDI), nephrogenic DI (NDI) and primary polydipsia (PP). Differentiating CDI/NDI from PP is important as patients with true DI are at risk of severe dehydration without treatment. Biochemical testing is key in the diagnosis of DI. The indirect water deprivation test (WDT) is commonly used in the investigation of DI but has drawbacks including being cumbersome and sometimes producing equivocal results. Direct measurement of AVP has theoretical advantages but has generally only been used in specialist centres. Disadvantages include the requirement to measure AVP under hypertonic stimulation and pre-analytical/analytical challenges. Copeptin (CT-proAVP) is a proxy marker for AVP that is more stable, easier to measure and has been studied more widely in recent years. Historically, the evidence supporting the diagnostic performance of these tests has been relatively poor, being based on a few small, usually single-centre studies. However more recent, well-designed prospective studies are improving the evidence base for investigation of DI. These studies have focused on the utility of copeptin measurements during stimulation tests. There is evidence that measurement of copeptin under stimulation offers improved diagnostic performance compared to the WDT. There is currently a lack of systematic, evidence-based guidelines on the diagnosis of DI, but as the quality of the evidence defining the diagnostic performance of tests for DI continues to improve, a clearer consensus on the optimal approach should become achievable.

糖尿病性尿崩症(DI)是一组导致不适当地产生大量稀释尿液的疾病。主要有三种形式:中枢性尿崩症(CDI)、肾源性尿崩症(NDI)和原发性多尿症(PP)。将 CDI/NDI 与 PP 区分开来非常重要,因为真正的 DI 患者如果不接受治疗,就会面临严重脱水的风险。生化检测是诊断 DI 的关键。间接缺水试验(WDT)常用于 DI 的检查,但其缺点是操作繁琐,有时结果不明确。直接测量 AVP 具有理论上的优势,但通常只在专科中心使用。其缺点包括需要在高渗刺激下测量 AVP 以及分析前/分析中的难题。谷丙肽(CT-proAVP)是 AVP 的替代标记物,它更稳定、更容易测量,近年来得到了更广泛的研究。从历史上看,支持这些检测诊断性能的证据相对较少,主要基于一些小型的、通常是单中心的研究。然而,最近更多精心设计的前瞻性研究正在改善 DI 调查的证据基础。这些研究的重点是在刺激试验中测量 copeptin 的效用。有证据表明,与 WDT 相比,在刺激下测量 copeptin 可提高诊断性能。目前还缺乏系统的、以证据为基础的 DI 诊断指南,但随着定义 DI 检测诊断性能的证据质量不断提高,应该可以就最佳方法达成更明确的共识。
{"title":"The laboratory investigation of diabetes insipidus: A review.","authors":"Christopher Boot","doi":"10.1177/00045632231154391","DOIUrl":"10.1177/00045632231154391","url":null,"abstract":"<p><p>Diabetes insipidus (DI) is a group of disorders that lead to inappropriate production of large volumes of dilute urine. The three main forms are central DI (CDI), nephrogenic DI (NDI) and primary polydipsia (PP). Differentiating CDI/NDI from PP is important as patients with true DI are at risk of severe dehydration without treatment. Biochemical testing is key in the diagnosis of DI. The indirect water deprivation test (WDT) is commonly used in the investigation of DI but has drawbacks including being cumbersome and sometimes producing equivocal results. Direct measurement of AVP has theoretical advantages but has generally only been used in specialist centres. Disadvantages include the requirement to measure AVP under hypertonic stimulation and pre-analytical/analytical challenges. Copeptin (CT-proAVP) is a proxy marker for AVP that is more stable, easier to measure and has been studied more widely in recent years. Historically, the evidence supporting the diagnostic performance of these tests has been relatively poor, being based on a few small, usually single-centre studies. However more recent, well-designed prospective studies are improving the evidence base for investigation of DI. These studies have focused on the utility of copeptin measurements during stimulation tests. There is evidence that measurement of copeptin under stimulation offers improved diagnostic performance compared to the WDT. There is currently a lack of systematic, evidence-based guidelines on the diagnosis of DI, but as the quality of the evidence defining the diagnostic performance of tests for DI continues to improve, a clearer consensus on the optimal approach should become achievable.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"19-31"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10652246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Artificially raised creatinine concentrations due to analytical interference for samples contaminated with total parenteral nutrition fluid. 受全胃肠外营养液污染的样本因分析干扰而导致肌酐浓度人为升高。
IF 2.2 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-01-01 Epub Date: 2023-07-11 DOI: 10.1177/00045632231186058
Jinny Jeffery, Helen Millar, Rachel Marrington, Finlay MacKenzie, Roanna George

Background: A sample received in the laboratory from a patient receiving total parenteral nutrition (TPN) indicated that the patient may have renal dysfunction, but the results were not considered to be reliable enough to report. Investigations using a reference method for measurement of creatinine confirmed positive interference in the creatinine assay and distribution of samples via an External Quality Assessment (EQA) Scheme showed that this positive interference was method dependent.

Methods: Residual TPN fluid (Nutriflex Lipid Special) left in the bag after the patient had completed the infusion was collected and added to a patient serum pool in increasing amounts and distributed to different laboratories for analysis of creatinine and glucose through an EQA Scheme.

Results: Positive interference in a number of different creatinine assays was identified as a result of a component in the TPN fluid. Positive interference from high concentrations of glucose has been demonstrated to be a cause for falsely high results in Jaffe creatinine assays.

Conclusions: The concern would be that a sample contaminated with TPN fluid would have both abnormal electrolytes and creatinine concentrations and give the impression that the patient was in renal failure due to analytical interference in the creatinine assay and laboratory staff need to be aware of this problem.

背景:实验室从一名接受全肠外营养(TPN)的病人身上采集到的样本显示,该病人可能存在肾功能障碍,但结果被认为不够可靠,无法报告。使用测量肌酐的参考方法进行的调查证实了肌酐测定中的阳性干扰,而通过外部质量评估(EQA)计划对样本进行的分配表明,这种阳性干扰与方法有关:方法:收集病人输完液后留在输液袋中的残留 TPN 液(Nutriflex 脂质专用液),并按递增的量加入病人血清池中,然后通过 EQA 计划将样本分发到不同的实验室进行肌酐和葡萄糖分析:结果:在一些不同的肌酐检测中发现,TPN 液中的一种成分会造成阳性干扰。高浓度葡萄糖的阳性干扰已被证明是造成贾菲肌酐测定结果偏高的一个原因:令人担忧的是,被 TPN 液污染的样本会同时出现电解质和肌酐浓度异常,并由于肌酐测定中的分析干扰而给人造成患者肾衰竭的印象,因此实验室工作人员需要意识到这一问题。
{"title":"Artificially raised creatinine concentrations due to analytical interference for samples contaminated with total parenteral nutrition fluid.","authors":"Jinny Jeffery, Helen Millar, Rachel Marrington, Finlay MacKenzie, Roanna George","doi":"10.1177/00045632231186058","DOIUrl":"10.1177/00045632231186058","url":null,"abstract":"<p><strong>Background: </strong>A sample received in the laboratory from a patient receiving total parenteral nutrition (TPN) indicated that the patient may have renal dysfunction, but the results were not considered to be reliable enough to report. Investigations using a reference method for measurement of creatinine confirmed positive interference in the creatinine assay and distribution of samples via an External Quality Assessment (EQA) Scheme showed that this positive interference was method dependent.</p><p><strong>Methods: </strong>Residual TPN fluid (Nutriflex Lipid Special) left in the bag after the patient had completed the infusion was collected and added to a patient serum pool in increasing amounts and distributed to different laboratories for analysis of creatinine and glucose through an EQA Scheme.</p><p><strong>Results: </strong>Positive interference in a number of different creatinine assays was identified as a result of a component in the TPN fluid. Positive interference from high concentrations of glucose has been demonstrated to be a cause for falsely high results in Jaffe creatinine assays.</p><p><strong>Conclusions: </strong>The concern would be that a sample contaminated with TPN fluid would have both abnormal electrolytes and creatinine concentrations and give the impression that the patient was in renal failure due to analytical interference in the creatinine assay and laboratory staff need to be aware of this problem.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"32-38"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9767174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Sample viscosity as a source of analytical error: The role of protein structure and mass concentration. 样品粘度是分析误差的来源:蛋白质结构和质量浓度的作用。
IF 2.2 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-01-01 Epub Date: 2023-09-29 DOI: 10.1177/00045632231205106
Charlton Agius
{"title":"Sample viscosity as a source of analytical error: The role of protein structure and mass concentration.","authors":"Charlton Agius","doi":"10.1177/00045632231205106","DOIUrl":"10.1177/00045632231205106","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"74-75"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41105463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of multiple loading FIT sample collection devices on faecal haemoglobin concentration. 多重装载FIT样本采集装置对粪便血红蛋白浓度的影响。
IF 2.2 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-01-01 Epub Date: 2023-10-06 DOI: 10.1177/00045632231183850
Cerin John, Carolyn Piggott, Sally C Benton

Background: Faecal immunochemical tests (FIT) are routinely used in colorectal cancer (CRC) screening programmes around the world. More recently, quantitative FIT has been recommended to help triage patients presenting to primary care with symptoms suggestive of CRC. Participants collect faecal samples using sampling probes which are inserted into sample collection devices (SCDs) containing preservative buffer. The SCDs have an internal collar designed to remove excess sample. The aim of this study was to investigate the impact of multiple loading on faecal haemoglobin concentration (f-Hb) using SCDs of four FIT systems.

Methods: Pools of f-Hb negative samples were spiked with blood, homogenised and loaded into SCDs 1, 3 and 5 times, with insertion of the sampling probes into the SCDs with and without mixing between loads. The f-Hb was measured using the relevant FIT system. The percentage change in f-Hb for multiple loads was compared with a single load for each system for the mixed and unmixed groups.

Results: The p values show a significant difference (p < 0.05) in the mass and f-Hb for the mixed and unmixed group, for 1-3 and 1-5 loads for all systems. The median percentage change in f-Hb for the mixed is higher than the unmixed group.

Conclusion: This study showed that multiple loading does significantly increase the f-Hb in the SCDs.

背景:Faecal免疫化学测试(FIT)在世界各地的结直肠癌(CRC)筛查计划中被常规使用。最近,定量FIT被建议帮助对出现CRC症状的初级保健患者进行分类。参与者使用插入含有防腐剂缓冲液的样本采集装置(SCD)的采样探针采集粪便样本。SCD有一个内部轴环,用于去除多余的样本。本研究的目的是使用四种FIT系统的SCD来研究多重负荷对粪便血红蛋白浓度(f-Hb)的影响。方法:将f-Hb阴性样本池掺入血液,匀浆并装载到SCD中1、3和5次,将采样探针插入SCD中,负载之间混合或不混合。使用相关的FIT系统测量f-Hb。将混合组和未混合组的多个负荷的f-Hb的百分比变化与每个系统的单个负荷进行比较。结果:对于所有系统的1-3和1-5负荷,混合组和未混合组的p值显示出质量和f-Hb的显著差异(p<0.05)。混合组f-Hb的中位百分比变化高于未混合组。结论:本研究表明,多次负荷确实显著增加SCDs中的f-Hb。
{"title":"Effect of multiple loading FIT sample collection devices on faecal haemoglobin concentration.","authors":"Cerin John, Carolyn Piggott, Sally C Benton","doi":"10.1177/00045632231183850","DOIUrl":"10.1177/00045632231183850","url":null,"abstract":"<p><strong>Background: </strong>Faecal immunochemical tests (FIT) are routinely used in colorectal cancer (CRC) screening programmes around the world. More recently, quantitative FIT has been recommended to help triage patients presenting to primary care with symptoms suggestive of CRC. Participants collect faecal samples using sampling probes which are inserted into sample collection devices (SCDs) containing preservative buffer. The SCDs have an internal collar designed to remove excess sample. The aim of this study was to investigate the impact of multiple loading on faecal haemoglobin concentration (f-Hb) using SCDs of four FIT systems.</p><p><strong>Methods: </strong>Pools of f-Hb negative samples were spiked with blood, homogenised and loaded into SCDs 1, 3 and 5 times, with insertion of the sampling probes into the SCDs with and without mixing between loads. The f-Hb was measured using the relevant FIT system. The percentage change in f-Hb for multiple loads was compared with a single load for each system for the mixed and unmixed groups.</p><p><strong>Results: </strong>The <i>p</i> values show a significant difference (<i>p</i> < 0.05) in the mass and f-Hb for the mixed and unmixed group, for 1-3 and 1-5 loads for all systems. The median percentage change in f-Hb for the mixed is higher than the unmixed group.</p><p><strong>Conclusion: </strong>This study showed that multiple loading does significantly increase the f-Hb in the SCDs.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"70-73"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9593211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures. LEAP检查表,用于临床测量程序的实验室评估和分析性能特征报告。
IF 2.2 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-01-01 Epub Date: 2023-10-15 DOI: 10.1177/00045632231206029
Tze Ping Loh, Brian R Cooke, Thi Chi Mai Tran, Corey Markus, Rosita Zakaria, Chung Shun Ho, Elvar Theodorsson, Ronda F Greaves

Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the LEAP checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.

在同行评审期刊上报告方法评估后的测量程序及其分析性能是临床实验室从业者分享他们的发现的重要手段。它也是一个重要的证据基础来源,可以帮助其他人对自己的做法做出明智的决定。目前,实验室医学期刊出版物中描述测量程序分析性能的信息存在显著差异。这些变化也对作者、读者、审稿人和编辑在决定提交稿件的质量方面提出了挑战。国际临床化学和实验医学联合会方法评估协议工作组(IFCC WG-MEP)制定了一份检查表,并建议采用该检查表,以便在实验医学期刊上报告方法评估和测量程序的分析性能特征。据设想,LEAP检查表将提高描述方法评估和分析性能特征的期刊出版物的标准化,提高从业者所依赖的证据库的质量。
{"title":"The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures.","authors":"Tze Ping Loh, Brian R Cooke, Thi Chi Mai Tran, Corey Markus, Rosita Zakaria, Chung Shun Ho, Elvar Theodorsson, Ronda F Greaves","doi":"10.1177/00045632231206029","DOIUrl":"10.1177/00045632231206029","url":null,"abstract":"<p><p>Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the LEAP checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"3-7"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41189238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Determination of in vitro stability of routine haematinics tests using EFLM standards and the CRESS checklist. 用EFLM标准和CRESS检查表测定常规血液学试验的体外稳定性。
IF 2.2 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-11-01 Epub Date: 2023-05-25 DOI: 10.1177/00045632231177247
Robert D Williams, Christopher J Duff, Alexandra Yates

Background: Laboratories should be aware of the stability of the analytes they are testing in order to avoid incorrect reporting and patient management. Stability studies are difficult to interpret and reproduce, with little guidance on how to determine appropriate clinical cut off values. Here we describe a standardised approach to determining stability for routine haematinics tests using published EFLM guidelines.

Methods: The haematinics panel at UHNM contains vitamin B12, folate, ferritin, iron and transferrin. Blood tubes included were serum separator tubes, gel-free serum and lithium-heparin plasma. Conditions tested were room temperature, 2-8°C and -20°C. For each condition and tube, three samples were analysed in duplicate at 0, 24, 48, 72, 96 and 120 h using the Siemens Atellica platform.

Results: The percentage difference was calculated for each respective blood tube and storage condition, in addition to individual analyte maximum permissible instability scores. The majority of analytes for all blood tubes were stable for 5 days or more when stored at 4-8°C and -20°C. Ferritin (excluding gel-free), iron and transferrin further showed stability >5 days when stored at room temperature. However, vitamin B12 and folate demonstrated poor stability data for all tube types tested.

Conclusions: Here we describe a stability study for the haematinics panel on the Siemens Atellica platform using the standardised EFLM Checklist for Reporting Stability Studies (CRESS). The checklist was used in order to promote a standardised and transferable scientific approach to what has previously been lacking in the literature when performing stability experiments.

背景:实验室应该意识到他们正在测试的分析物的稳定性,以避免不正确的报告和患者管理。稳定性研究很难解释和重现,很少有关于如何确定适当的临床临界值的指导。在这里,我们描述了一种标准化的方法来确定常规血液学测试的稳定性,使用已出版的EFLM指南。方法:UHNM血液学组含有维生素B12、叶酸、铁蛋白、铁和转铁蛋白。血管包括血清分离管、无凝胶血清和锂肝素血浆。测试条件为室温、2-8°C和-20°C。对于每种条件和试管,使用西门子Atellica平台在0、24、48、72、96和120 h时重复分析三个样本。结果:除了个别分析物最大允许不稳定性评分外,还计算了每个各自的血管和储存条件的百分比差异。在4-8°C和-20°C保存时,所有血管的大多数分析物在5天或更长时间内稳定。铁蛋白(不含无凝胶)、铁和转铁蛋白在室温下保存50天后表现出稳定性。然而,维生素B12和叶酸在所有试管类型的测试中显示出较差的稳定性数据。结论:在这里,我们描述了西门子Atellica平台上使用标准化EFLM报告稳定性研究清单(CRESS)的血液学面板的稳定性研究。使用清单是为了促进标准化和可转移的科学方法,以解决以前在进行稳定性实验时文献中所缺乏的问题。
{"title":"Determination of in vitro stability of routine haematinics tests using EFLM standards and the CRESS checklist.","authors":"Robert D Williams, Christopher J Duff, Alexandra Yates","doi":"10.1177/00045632231177247","DOIUrl":"10.1177/00045632231177247","url":null,"abstract":"<p><strong>Background: </strong>Laboratories should be aware of the stability of the analytes they are testing in order to avoid incorrect reporting and patient management. Stability studies are difficult to interpret and reproduce, with little guidance on how to determine appropriate clinical cut off values. Here we describe a standardised approach to determining stability for routine haematinics tests using published EFLM guidelines.</p><p><strong>Methods: </strong>The haematinics panel at UHNM contains vitamin B12, folate, ferritin, iron and transferrin. Blood tubes included were serum separator tubes, gel-free serum and lithium-heparin plasma. Conditions tested were room temperature, 2-8°C and -20°C. For each condition and tube, three samples were analysed in duplicate at 0, 24, 48, 72, 96 and 120 h using the Siemens Atellica platform.</p><p><strong>Results: </strong>The percentage difference was calculated for each respective blood tube and storage condition, in addition to individual analyte maximum permissible instability scores. The majority of analytes for all blood tubes were stable for 5 days or more when stored at 4-8°C and -20°C. Ferritin (excluding gel-free), iron and transferrin further showed stability >5 days when stored at room temperature. However, vitamin B12 and folate demonstrated poor stability data for all tube types tested.</p><p><strong>Conclusions: </strong>Here we describe a stability study for the haematinics panel on the Siemens Atellica platform using the standardised EFLM Checklist for Reporting Stability Studies (CRESS). The checklist was used in order to promote a standardised and transferable scientific approach to what has previously been lacking in the literature when performing stability experiments.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"367-373"},"PeriodicalIF":2.2,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9507923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
National recommendations to standardise acute kidney injury detection and alerting. 国家对急性肾损伤检测和报警标准化的建议。
IF 2.2 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-11-01 Epub Date: 2023-06-14 DOI: 10.1177/00045632231180403
Rachel Marrington, Anna L Barton, Alexandra Yates, William McKane, Nicholas M Selby, Jonathan S Murray, James F Medcalf, Finlay MacKenzie, Martin Myers

Background: National Health Service England issued a Patient Safety Alert in 2014 mandating all acute Trusts in England to implement Acute Kidney Injury (AKI) warning stage results and to do so using a standardised algorithm. In 2021, the Renal and Pathology Getting It Right First Time (GIRFT) teams found significant variation in AKI reporting across the UK. A survey was designed to capture information on the entire AKI detection and alerting process to investigate the potential sources of this unwarranted variation.

Methods: In August 2021, an online survey consisting of 54 questions was made available to all UK laboratories. The questions covered creatinine assays, laboratory information management systems (LIMS), the AKI algorithm and AKI reporting.

Results: We received 101 responses from laboratories. Data were reviewed for England only - 91 laboratories. Findings included that 72% used enzymatic creatinine. In addition, 7 manufacturer-analytical platforms, 15 different LIMS and a wide range of creatinine reference ranges were in use. In 68% of laboratories, the AKI algorithm was installed by the LIMS provider. Marked variation was found in the minimum age of AKI reporting with only 18% starting at the recommended 1 month/28-days. Some 89% phoned all new AKI2s and AKI3s, as per AKI guidance while 76% provided comments/hyperlinks in reports.

Conclusions: The national survey has identified laboratory practices that potentially contribute to unwarranted variation in the reporting of AKI in the England. This has formed the basis for improvement work to remedy the situation, including national recommendations, included within this article.

背景:2014年,英国国家卫生服务发布了患者安全警报,要求英格兰所有急性信托机构实施急性肾损伤(AKI)预警阶段结果,并使用标准化算法。2021年,肾脏和病理学第一次正确(GIRFT)团队发现英国各地AKI报告的差异很大。一项调查旨在获取整个AKI检测和警报过程的信息,以调查这种无根据变异的潜在来源。方法:2021年8月,向所有英国实验室提供了一份包含54个问题的在线调查。问题包括肌酐测定、实验室信息管理系统(LIMS)、AKI算法和AKI报告。结果:共收到101份实验室反馈。我们只对英国91个实验室的数据进行了审查。结果包括72%的人使用酶促肌酐。此外,还使用了7个制造商分析平台,15种不同的LIMS和广泛的肌酐参考范围。在68%的实验室中,LIMS提供商安装了AKI算法。在AKI报告的最低年龄上发现了明显的差异,只有18%的人从推荐的1个月/28天开始。根据AKI指南,大约89%的人打电话给所有新的aki2和aki3, 76%的人在报告中提供评论/超链接。结论:全国调查已经确定了实验室操作可能导致英国AKI报告的不合理变化。这构成了改善工作的基础,以纠正这种情况,包括本条所载的国家建议。
{"title":"National recommendations to standardise acute kidney injury detection and alerting.","authors":"Rachel Marrington, Anna L Barton, Alexandra Yates, William McKane, Nicholas M Selby, Jonathan S Murray, James F Medcalf, Finlay MacKenzie, Martin Myers","doi":"10.1177/00045632231180403","DOIUrl":"10.1177/00045632231180403","url":null,"abstract":"<p><strong>Background: </strong>National Health Service England issued a Patient Safety Alert in 2014 mandating all acute Trusts in England to implement Acute Kidney Injury (AKI) warning stage results and to do so using a standardised algorithm. In 2021, the Renal and Pathology Getting It Right First Time (GIRFT) teams found significant variation in AKI reporting across the UK. A survey was designed to capture information on the entire AKI detection and alerting process to investigate the potential sources of this unwarranted variation.</p><p><strong>Methods: </strong>In August 2021, an online survey consisting of 54 questions was made available to all UK laboratories. The questions covered creatinine assays, laboratory information management systems (LIMS), the AKI algorithm and AKI reporting.</p><p><strong>Results: </strong>We received 101 responses from laboratories. Data were reviewed for England only - 91 laboratories. Findings included that 72% used enzymatic creatinine. In addition, 7 manufacturer-analytical platforms, 15 different LIMS and a wide range of creatinine reference ranges were in use. In 68% of laboratories, the AKI algorithm was installed by the LIMS provider. Marked variation was found in the minimum age of AKI reporting with only 18% starting at the recommended 1 month/28-days. Some 89% phoned all new AKI2s and AKI3s, as per AKI guidance while 76% provided comments/hyperlinks in reports.</p><p><strong>Conclusions: </strong>The national survey has identified laboratory practices that potentially contribute to unwarranted variation in the reporting of AKI in the England. This has formed the basis for improvement work to remedy the situation, including national recommendations, included within this article.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"406-416"},"PeriodicalIF":2.2,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10003330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Interference by paraproteins is an infrequent finding in nine Roche c702 assays. 副蛋白的干扰在9个罗氏c702试验中是一个罕见的发现。
IF 2.2 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-11-01 Epub Date: 2023-08-10 DOI: 10.1177/00045632231194435
Alison M Jones, Stuart J Wilkinson
{"title":"Interference by paraproteins is an infrequent finding in nine Roche c702 assays.","authors":"Alison M Jones, Stuart J Wilkinson","doi":"10.1177/00045632231194435","DOIUrl":"10.1177/00045632231194435","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"429-431"},"PeriodicalIF":2.2,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10028122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A further monoclonal antibody-based immunoturbidimetry option for measuring faecal elastase on the Optilite analyser. 另一种基于单克隆抗体的免疫比浊法选择,用于在Optilite分析仪上测量粪便弹性蛋白酶。
IF 2.2 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-11-01 Epub Date: 2023-07-20 DOI: 10.1177/00045632231190516
Alessia Capoferri, Ilenia Infusino, Mauro Panteghini
{"title":"A further monoclonal antibody-based immunoturbidimetry option for measuring faecal elastase on the Optilite analyser.","authors":"Alessia Capoferri, Ilenia Infusino, Mauro Panteghini","doi":"10.1177/00045632231190516","DOIUrl":"10.1177/00045632231190516","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"428-429"},"PeriodicalIF":2.2,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10221951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Annals of Clinical Biochemistry
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1