Annals of Clinical Biochemistry最新文献_第8页

Preliminary evaluation of the diagnostic performance of Roche Elecsys® active vitamin B12 versus total vitamin B12 for vitamin B12 deficiency screening. 初步评估罗氏 Elecsys® 活性维生素 B12 与维生素 B12 总含量在维生素 B12 缺乏症筛查中的诊断性能。

IF 2.2 4区医学

Annals of Clinical Biochemistry Pub Date : 2024-01-01 Epub Date: 2023-08-31 DOI: 10.1177/00045632231194157

Jennifer Guillerme, Guillaume Feugray, Hélène Girot, Valéry Brunel, Muriel Quillard Muraine

{"title":"Preliminary evaluation of the diagnostic performance of Roche Elecsys® active vitamin B12 versus total vitamin B12 for vitamin B12 deficiency screening.","authors":"Jennifer Guillerme, Guillaume Feugray, Hélène Girot, Valéry Brunel, Muriel Quillard Muraine","doi":"10.1177/00045632231194157","DOIUrl":"10.1177/00045632231194157","url":null,"abstract":"Introduction: The prevalence of vitamin B12 deficiency is high in at-risk populations with sometimes irreversible consequences. Beside total B12 (TVB12), active B12 (AVB12) is a promising first-line marker. Only Abbott AVB12 assays were largely evaluated and generally demonstrated benefit in clinical practice. More recently developed Roche AVB12 still requires some investigations.Objectives: Our study aimed to evaluate the Roche Elecsys® AVB12 immunoassay performance versus Roche Elecsys® TVB12 competition assay.Design: and Methods: We included 175 patients at Rouen University Hospital who had a TVB12 value <300 pmol/L. We evaluated performance of AVB12 by comparing the results with TVB12 and MMA values in case of disagreement.Results: Positive correlation was found between the AVB12 and TVB12. We found a disagreement between TVB12 and AVB12 in 18.8% of cases. Among 33 cases of disagreement, 76% had normal AVB12 but low TVB12, whereas 24% had low AVB12 and normal TVB12. Thirty-one MMA determinations were performed: 71% showed agreement between MMA and AVB12, versus 29% between MMA and TVB12. TVB12 reported a sensitivity (Se) at 66.7%, specificity (Sp) at 20%, positive predictive value (PPV) at 16.7% and negative predictive value (NPV) at 71.4% for the prediction of MMA elevation. We determined an optimized cut-off value of 45.5 pmol/L for AVB12, which reported a Se 66.7%, Sp 60%, PPV 30.7%, and NPV 88.9%.Conclusions: Our results provide preliminary evidence that Roche AVB12 may offer better discrimination than Roche TVB12 in the diagnosis of vitamin B12 deficiency. Further more detailed evaluation is warranted.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"55-62"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10119918","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 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

Annals of Clinical Biochemistry Pub Date : 2024-01-01 Epub Date: 2023-07-16 DOI: 10.1177/00045632231189386

Rebecca E Tibbs, Sally C Benton

{"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":"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.","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

Annals of Clinical Biochemistry Pub Date : 2024-01-01 Epub Date: 2023-02-06 DOI: 10.1177/00045632231154391

Christopher Boot

{"title":"The laboratory investigation of diabetes insipidus: A review.","authors":"Christopher Boot","doi":"10.1177/00045632231154391","DOIUrl":"10.1177/00045632231154391","url":null,"abstract":"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.","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

Annals of Clinical Biochemistry Pub Date : 2024-01-01 Epub Date: 2023-07-11 DOI: 10.1177/00045632231186058

Jinny Jeffery, Helen Millar, Rachel Marrington, Finlay MacKenzie, Roanna George

{"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":"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.","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

Annals of Clinical Biochemistry Pub Date : 2024-01-01 Epub Date: 2023-09-29 DOI: 10.1177/00045632231205106

Charlton Agius

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

Annals of Clinical Biochemistry Pub Date : 2024-01-01 Epub Date: 2023-10-06 DOI: 10.1177/00045632231183850

Cerin John, Carolyn Piggott, Sally C Benton

{"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":"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.","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

Annals of Clinical Biochemistry 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

{"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":"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.","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

Annals of Clinical Biochemistry Pub Date : 2023-11-01 Epub Date: 2023-05-25 DOI: 10.1177/00045632231177247

Robert D Williams, Christopher J Duff, Alexandra Yates

{"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":"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.","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

Annals of Clinical Biochemistry 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

{"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":"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.","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

Annals of Clinical Biochemistry Pub Date : 2023-11-01 Epub Date: 2023-08-10 DOI: 10.1177/00045632231194435

Alison M Jones, Stuart J Wilkinson

引用次数: 0