Fatima Rodriguez-Alvarez, Paulina Moctezuma-Velázquez, Blanca Zuleyma Mota-Ayala, Paul Alonso Pamila-Tecuautzin, Ignacio García-Juárez, Carlos Moctezuma-Velázquez
{"title":"Different serum sodium assay, different model for end stage liver disease - sodium scores in patients awaiting liver transplant: A cross-sectional study.","authors":"Fatima Rodriguez-Alvarez, Paulina Moctezuma-Velázquez, Blanca Zuleyma Mota-Ayala, Paul Alonso Pamila-Tecuautzin, Ignacio García-Juárez, Carlos Moctezuma-Velázquez","doi":"10.1177/00045632231196052","DOIUrl":"10.1177/00045632231196052","url":null,"abstract":"<p><strong>Introduction and aims: </strong>Sodium can be measured with direct or indirect methods; abnormal plasma total protein concentration can impact on sodium measured by indirect ion-selective electrodes (ISE). Serum sodium is an important item to determine the Model for End Stage Liver Disease Sodium (MELD-Na) score, commonly used for liver graft allocation. Patients with cirrhosis usually have hypoproteinemia. The aim of this study was to determine if there was a significant difference between the MELD-Na scores calculated based on the results of two different serum sodium ISE: indirect and direct.</p><p><strong>Methods: </strong>This was a retrospective study; we included 166 patients that underwent liver transplant assessment, and that had paired (<i>i.e.</i> same date and time) direct and indirect sodium determinations. We calculated the MELD-Na scores with both sodium determinations, and we compared them.</p><p><strong>Results: </strong>There was a significant difference between MELD-Na scores; the mean difference was 0.4±1.3. If MELD-Na score had been determined by the sodium measured by the direct ISE, 69 patients (42%) would have stayed in the same place on the waiting list, 67 patients (40%) would have moved up, and 30 patients (18%) would have moved down.</p><p><strong>Conclusions: </strong>There was a statistically significant difference between the MELD-Na scores calculated based on the two different sodium concentrations, which would theoretically result in changes in the order of the waiting list. This finding should prompt studies to assess if MELD-Na calculated based on direct methods has a better performance to predict clinically relevant outcomes.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"115-121"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10938476/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10030471","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ömer Özcan, Joanna Ae van Wijk, Annet M Bosch, Wendy Pj den Elzen, Annemieke C Heijboer, Johan C Fischer
{"title":"Case report: Skin protective barrier cream interference in benzethonium chloride method for urine protein measurement in a 6-month-old girl.","authors":"Ömer Özcan, Joanna Ae van Wijk, Annet M Bosch, Wendy Pj den Elzen, Annemieke C Heijboer, Johan C Fischer","doi":"10.1177/00045632231218833","DOIUrl":"10.1177/00045632231218833","url":null,"abstract":"<p><p>This case report describes the positive interference of the commonly used skin protective barrier cream used together with urine collection bags on the benzethonium chloride method for urine protein measurements in a 6-month-old female baby, leading to falsely elevated results. The interference was identified by both artificially mixing urine samples with this cream and comparing the results obtained using the benzethonium chloride method with those obtained using the pyrogallol red method.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"150-153"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138440131","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}
{"title":"Current practice and recommendations for managing transgender patient data in clinical laboratories in the United Kingdom and Republic of Ireland.","authors":"Sophie Hepburn, Devon Buchanan, Seán J Costelloe","doi":"10.1177/00045632231195484","DOIUrl":"10.1177/00045632231195484","url":null,"abstract":"<p><strong>Background: </strong>Transgender people may avoid seeking medical care due to previous negative experiences and fear of discrimination. Clinical laboratories can contribute to a poor patient experience and clinical outcome when the design and functionality of laboratory information management systems (LIMS) do not consider the needs of transgender patients. This survey aimed to capture current practices in United Kingdom and Republic of Ireland clinical laboratories concerning how transgender patient data and test requests are managed throughout the total testing process.</p><p><strong>Methods: </strong>An anonymous survey was distributed to clinical laboratory professionals in November 2021. Thirty-three questions covered how gender variables are recorded for transgender patients and used to inform gender-specific calculations, test access, and reference intervals (RIs).</p><p><strong>Results: </strong>Of the 66 respondents, 70% were based in laboratories in England, with a majority of laboratories having ISO 15189 accreditation and processing 1000-10,000 blood samples daily. Eighty-five percent stated that their LIMS had a single field recording sex or gender information. Forty-three percent did not limit test access based on gender, but 68% did not append RIs for patients with unknown or indeterminate gender.</p><p><strong>Conclusions: </strong>This survey was the first to quantify how clinical laboratories manage sex and gender information and report results for transgender and non-binary patients, and details several key recommendations based on the survey responses.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"98-106"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10173094","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}
{"title":"Closed analyser lids do not reduce the measurement uncertainty of serum total carbon dioxide.","authors":"Francesca Borrillo, Alessia Capoferri, Leila Rovegno, Mauro Panteghini","doi":"10.1177/00045632231216598","DOIUrl":"10.1177/00045632231216598","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"154-155"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136395930","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}
Rouvick Gama, Javeria Peracha, Kate Bramham, Paul Cockwell
{"title":"Removal of ethnicity adjustment for creatinine-based estimated glomerular filtration rate equations.","authors":"Rouvick Gama, Javeria Peracha, Kate Bramham, Paul Cockwell","doi":"10.1177/00045632221149660","DOIUrl":"10.1177/00045632221149660","url":null,"abstract":"<p><p>Creatinine-based estimated glomerular filtration rate equations (eGFRcreatinine) are used to measure excretory kidney function in clinical practice. Despite inter and intra-patient variability, eGFRcreatinine has excellent clinical utility and provides the basis for the classification system for chronic kidney disease (CKD), for kidney function monitoring, treatment interventions and referral pathways. The 4-variable modification of diet in renal disease (MDRD) eGFRcreatinine equation was introduced in 2000 and recommended by the National Institute for Health and Care Excellence (NICE) in 2008. Subsequently, the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFRcreatinine equation was introduced in 2009 and is more accurate than MDRD in patients with mild and moderate CKD. In 2014, NICE recommended that CKD-EPI eGFRcreatinine replace MDRD eGFRcreatinine in routine clinical practice across England. Both equations originally incorporated adjustments for age, gender and ethnicity. However, the evidence for ethnicity adjustment has been increasingly questioned, and in 2021 NICE recommended that kidney function should be estimated by CKD-EPI eGFRcreatinine without using ethnicity adjustment. Recently, a CKD-EPI equation has been presented without ethnicity adjustment; however, this has not been validated outside of North America and NICE continues to recommend CKD-EPI 2009. We review the status of eGFRcreatinine in clinical practice, including the limitations of eGFRcreatinine and the rationale for removal of ethnicity adjustment and the potential impact of this change on clinical care for patients with kidney disease.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"8-18"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10558800","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}
{"title":"Example of use of clock time-dependent targets for patient-based quality control.","authors":"Douglas F Stickle","doi":"10.1177/00045632231185472","DOIUrl":"10.1177/00045632231185472","url":null,"abstract":"<p><strong>Background: </strong>Running means for total calcium (Ca) results at our laboratory exhibit a stable time-of-day (TOD) periodic pattern. We examined use of TOD-dependent targets for running means in patient-based quality control (PBQC) for Ca.</p><p><strong>Methods: </strong>Primary data were Ca results over a 3 month interval, restricted to weekday data within the Ca reference interval (8.5-10.3 mg/dL; 2.12-2.57 mmol/L). Running means were evaluated as sliding averages of 20 samples (20-mers).</p><p><strong>Results: </strong>Data comprised 39,629 consecutive Ca measurements (75.3% inpatient (IP)) for which Ca was 9.29±0.47 mg/dL. The all data average for 20-mers was 9.29 ± 0.18 mg/dL. When parsed in 1 h TOD intervals, however, averages among 20-mers ranged from 9.1 to 9.5 mg/dL, with blocs of contiguous results above (0800-2300 h; 53.3% of results; IP = 75.3%) and below (2300-0800 h; 46.7% of results; IP = 99.9%) the all-data mean. There was thus an inherent TOD-dependent pattern of deviation of means from target when using a fixed PBQC target. Using Fourier series analysis as an example approach, characterization of the pattern to produce TOD-dependent PBQC targets eliminated this inherent inaccuracy.</p><p><strong>Conclusions: </strong>In circumstances of periodic variation in running means, simple characterization of that variation can reduce the probability of both false positive and false negative flags in PBQC.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"39-47"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9667730","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}
David Metsu, Daphné Mille, Carole Pailly, Valerica G Oancea, Luc Essemilaire, Dominique Coppin
{"title":"Analytical assays and bootstrap resampling method to validate performance of the Roche Elecsys STAT highly sensitive troponin T assay and its application for the 'rule-out' part of ESC guidelines for NTSTEMI.","authors":"David Metsu, Daphné Mille, Carole Pailly, Valerica G Oancea, Luc Essemilaire, Dominique Coppin","doi":"10.1177/00045632231194449","DOIUrl":"10.1177/00045632231194449","url":null,"abstract":"<p><strong>Background: </strong>The European Society of Cardiology (ESC) guidelines recommend a dynamic (0-1h) cardiac troponin (cTn) determination for non-ST elevation myocardial infarction diagnosis. For patients with low cTn levels, a discharge from emergency can be considered. Nevertheless, cTn cutoffs for discharge are lower than the limits of quantification proposed by laboratory reagent suppliers.</p><p><strong>Aim: </strong>Validate cTn assay on the Elecsys STAT kit.</p><p><strong>Materials and methods: </strong>Precision, trueness, repeatability and within-laboratory variability were calculated from internal quality control and plasma pooled at 5.78 and 10.73 ng/L. Accuracy was calculated from external quality control. Uncertainty of measurement was calculated from (i) the uncertainty of the standard and control values and (ii) by precision from pooled plasma. Distribution of precision results from pooled plasma has been evaluated by bootstrap simulations. Dilution linearity tests with patient plasma were performed to evaluate the method for values near 5 ng/L.</p><p><strong>Results: </strong>Precision and trueness ranged from 1.35 to 4.45% and from 0.14 to -3.74%, respectively. Accuracy results ranged from 101.40 to 104.90%. Within laboratory variability was 2.91%. Uncertainty ranged from 3.66% to 19.90% for higher (2188) to lower values (5.78 ng/L). Bootstrap simulations allowed utilization of precision data from pooled plasma to evaluate cTn assay. The method was linear from 4.48 to 39.80 ng/L. A linear regression model best described the data.</p><p><strong>Conclusion: </strong>Elecsys STAT method provides accurate cTn results, including patients with cTn results categorizing them as 'rule-out' in the ESC guidelines.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"63-69"},"PeriodicalIF":2.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9948031","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}
{"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":"<p><strong>Introduction: </strong>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.</p><p><strong>Objectives: </strong>Our study aimed to evaluate the Roche Elecsys® AVB12 immunoassay performance versus Roche Elecsys® TVB12 competition assay.</p><p><strong>Design: </strong>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.</p><p><strong>Results: </strong>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%.</p><p><strong>Conclusions: </strong>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.</p>","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}
{"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}
{"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}