Annals of Clinical Biochemistry最新文献

{"title":"Reference ranges of thyroid hormones during the first trimester in Catalan women using the Atellica^® IM Solution Immunoassay Analyzer.","authors":"Marina Giralt, Noelia Díaz-Troyano, Immaculada Comas, Albert Blanco, Laura Conesa, Manel Mendoza, Carles Zafon, María Goya, Roser Ferrer","doi":"10.1177/00045632231219387","DOIUrl":"10.1177/00045632231219387","url":null,"abstract":"<p><strong>Background: </strong>Gestational hypothyroidism has been shown to be associated with adverse pregnancy outcomes as well as adverse outcomes for the child. Thyroid hormones concentrations change in gestation, especially within the first trimester, so the results of thyroid function test often are outside non-pregnant reference ranges. The objective of this study was to establish the first trimester reference ranges for thyroid stimulating hormone (TSH) and free thyroxine (FT4) for pregnant women in Barcelona (Spain).</p><p><strong>Methods: </strong>It was a prospective study in which 673 women were recruited during their first trimester of gestation (8-13 weeks). Serum TSH, FT4 and antithyroid peroxidase antibodies (TPOAb) were measured with Atellica^® IM 1600 (Siemens Healthineers). After excluding 418 women, the reference ranges for TSH and FT4 were calculated by the 2.5th and 97.5th percentiles. Potential variables examined in this study were age, body mass index (BMI), ethnicity, iodine supplementation and smoking habit.</p><p><strong>Results: </strong>The reference ranges established on the Atellica^® IM 1600 for the first trimester pregnancy in our population were 0.111 to 4.291 mIU/L for TSH and 11.45 to 17.76 pmol/L for FT4. No significant differences were found in thyroid hormones concentrations regarding maternal age (≤30 years vs >30 years) (<i>p</i> = .117), iodine supplementation (<i>p</i> = .683) and smoking habit (<i>p</i> = .363). The prevalence of TPOAb was estimated at 10.0%.</p><p><strong>Conclusions: </strong>We found that in our local population, the optimal TSH upper reference limit in the first trimester of gestation was 4.3 mIU/L, similar to that proposed by de ATA-2017 guideline (4.0 mIU/L).</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"284-290"},"PeriodicalIF":2.1,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138298179","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":"Development of a plasma maltose assay method as a screening test for upper gastrointestinal disorders.","authors":"Tetsuya Komene, Kotoko Kai, Kiyoko Kinpara, Tomoaki Sato, Eisaku Hokazono, Tatsuo Shimosawa, Susumu Osawa, Masanori Seimiya","doi":"10.1177/00045632231224218","DOIUrl":"10.1177/00045632231224218","url":null,"abstract":"<p><strong>Background and objective: </strong>The disaccharide loading test is a method to assess gastric mucosal damage. Since Trelan-G75, which is used for the sugar tolerance test, contains disaccharide maltose, if maltose is detected at a high sensitivity in the sample blood used in the sugar tolerance test, screening for upper gastrointestinal mucosal damage can be made simultaneously with the sugar tolerance test for the diagnosis of diabetes.</p><p><strong>Methods: </strong>Glucose-6-phosphate is generated by treating maltose with maltose phosphorylase, β-phosphoglucomutase, and glucose-1,6-bisphosphate. Then, change in the absorbance at 405 nm is measured by the enzymatic cycling method using Thio-NADP, β-NADPH, and Glucose-6-phosphate dehydrogenase. After evaluating the optimal condition for this method, it is mounted on an automatic biochemical analyzer, and samples after the sugar tolerance test were assayed.</p><p><strong>Results: </strong>Regarding the performance of this method, the repeatability was 10-50 μmol/L with a CV of ≤1.1%. Concerning the assay range, a curve passing the origin with a range of linearity up to 120 μmol/L was obtained. No effect of dyes or sugars in the blood was noted. As a result of application to patients with gastric mucosal disorders (those who had a health checkup), significant differences were observed depending on the stage of atrophic gastritis.</p><p><strong>Discussion: </strong>This method has a high sensitivity and a high precision and can be used for high-speed analysis on an automatic analyzer. It has the potential to be used as a screening test for gastric mucosal damage.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"303-308"},"PeriodicalIF":2.1,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138797177","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":"Isoelectric focusing followed by affinity immunoblotting to detect monoclonal free light chains in monoclonal gammopathies: Comparison with immunofixation electrophoresis and free light chain ratio.","authors":"David Zeman, Martin Štork, Lenka Švancarová, Marek Borský, Michaela Pospíšilová, Zdeněk Adam, Miroslava Beňovská, Luděk Pour","doi":"10.1177/00045632231221439","DOIUrl":"10.1177/00045632231221439","url":null,"abstract":"<p><strong>Background: </strong>Isoelectric focusing (IEF) is a method with an exquisite resolution, and coupled with affinity immunoblotting (AIB), it can provide superior sensitivity to detect monoclonal free light chains (FLC).</p><p><strong>Methods: </strong>We tested the hypothesis that IEF/AIB is more sensitive and specific for monoclonal FLC detection in serum and urine samples than conventional methods, that is, electrophoresis (ELP), immunofixation (IF) and serum FLC ratio assessment. Investigation included 107 samples of 68 patients, among which 21 multiple myeloma patients were recently tested for minimal residual disease and 18 patients with AL amyloidosis.</p><p><strong>Results: </strong>Monoclonal FLC were detected by IEF/AIB in 37% of serum samples negative for monoclonal FLC on ELP/IF. As for urine samples, significant advantage of the IEF/AIB over ELP/IF was not demonstrated. Considering both serum and urine results, IEF/AIB definitely revealed monoclonal FLC in 20/83 (24%) of ELP/IF-negative samples. FLC ratio was abnormally high (>1.65) in all 11 patients definitely positive for monoclonal FLC kappa by IEF/AIB but also in 16/47 (34%) IEF/AIB-negative samples. Abnormally low values (<0.26) were found only in 10/28 samples (36%) positive for monoclonal FLC lambda. Appropriate use of renal FLC ratio reference range reduced the number of presumably false positives (6/47, i.e. 13%) but not false negatives (17/28, i.e. 61%).</p><p><strong>Conclusions: </strong>The IEF/AIB method is more sensitive than IF and might be used in patients with negative IF results before deciding whether to proceed to minimal residual disease testing.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"291-302"},"PeriodicalIF":2.1,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138797180","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":"Cardiac troponin in hospitalized COVID-19 patients: Incidence, predictors, and outcomes.","authors":"Praveen Gupta, Anunay Gupta, Sandeep Bansal, Ira Balakrishnan","doi":"10.1177/00045632231216599","DOIUrl":"10.1177/00045632231216599","url":null,"abstract":"<p><strong>Background: </strong>The incidence, predictors, and association of cardiac troponin with mortality in hospitalized COVID-19 were not adequately studied in the past and were also not reported from an Indian hospital.</p><p><strong>Methods: </strong>In this retrospective cohort study, the cardiac troponin of 240 hospitalized COVID-19 patients was measured. The incidence, predictors, and association of elevated cardiac troponin with in-hospital mortality were determined among hospitalized COVID-19 patients.</p><p><strong>Results: </strong>The cardiac troponin was elevated in 12.9% (31/240) of the patients. The troponin was elevated in the patients in the older age group (64 years vs. 55 years, <i>p</i> = .002), severe COVID-19 illness (SpO2 < 90%) (93.5% vs. 60.8%, <i>p</i> < .001), low arterial oxygen saturation (SpO2) (80% vs. 88%, <i>p</i> = .001), and low PaO2/FiO2 ratio (<i>p</i> < .0001). The patients with elevated cardiac troponin had elevated total leukocyte counts (TLC) (<i>p</i> = .001), liver enzyme (<i>p</i> = .025), serum creatinine (<i>p</i> = .011), N-terminal-Pro Brain natriuretic peptide (<i>p</i> < .0001), and d-dimer (<i>p</i> < .0001). The majority of the patients with elevated cardiac troponin were admitted to the intensive care unit (90.3% vs. 51.2%; <i>p</i> < .0001), were on a ventilator (61.3% vs. 21.5%; <i>p</i> < .0001), and had higher mortality (64.5% vs. 19.6%; <i>p</i> < .0001). The Kaplan-Meir survival analysis showed that the patients with elevated troponin had worse survival (<i>p</i> log-rank<.0001). Age, NT-ProBNP, d-dimer, and ventilator were the predictors of elevated troponin in multivariate logistic regression analysis. The Cox-regression analysis showed a significant association between elevated cardiac troponin and in-hospital mortality (adjusted hazard ratio 2.13; 95% confidence interval [CI] 1.145-3.97; <i>p</i> = .017). Two-thirds (65%) of patients with elevated cardiac troponin died during their hospital stay.</p><p><strong>Conclusions: </strong>COVID-19 patients with elevated cardiac troponin had severe COVID illness, were more commonly admitted to an intensive care unit, were on a ventilator, and had high in-hospital mortality.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"255-264"},"PeriodicalIF":2.1,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72013208","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":"Implementation of point-of-care HbA1C instruments into community pharmacies: Initial development of a pathway for robust community testing.","authors":"Andrew Radley, Lewis Beer, Danya Rushdi, Hazel Close, Stephen McBurney, Adrian Mackenzie, Anna Gourlay, Anna Barnett, Alison Grant, Neil Greig, Ellie Dow, Calum Sutherland","doi":"10.1177/00045632231219380","DOIUrl":"10.1177/00045632231219380","url":null,"abstract":"<p><strong>Background: </strong>Point-of-care (POC) analysers in community settings can provide opportunistic and regular HbA1c monitoring. Community pharmacies in NHS Scotland are utilised by populations at greatest risk of type two diabetes (T2D). This study describes initial development of an HbA1c pathway using a POC analyser in community pharmacies.</p><p><strong>Methods: </strong>The Abbott Afinion analyser was compared in (i) NHS Tayside's Blood Sciences Service and (ii) community pharmacies from four Scottish Health Boards. A side by side comparison with standard operating procedures for HbA1c quantification using 80 T2D patient venous samples. The machine was implemented into 11 community pharmacies and 144 samples obtained from patients for comparison to their recent laboratory HbA1c. Four focus groups examined themes around the intervention and an exit questionnaire was administered.</p><p><strong>Results: </strong>Laboratory assessment verified the efficacy of the POC test machine. The value for level 1 quality control was 44 mmol/mol and the mean during testing 42.7 mmol/mol. The greatest percent coefficient of variation (cv) was within-run for both levels of quality control material, at a value of 1.63% and 1.62%, respectively. The analyser performed robustly within the pharmacy assessment, with a mean difference of 1.68 and a standard deviation of 0.71 (CV 0.423). Patients with T2D reported positive experiences of using a pharmacy. The focus groups identified an appreciation of the convenience of pharmacies and of the longitudinal relationships with pharmacy staff.</p><p><strong>Conclusion: </strong>POC HbA1c analysers can be successfully established in community pharmacies. The target patient group responded positively to the opportunity to use a pharmacy service.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"273-283"},"PeriodicalIF":2.1,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11337724/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138298178","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}

{"title":"Establishment of CA19-9 reference intervals in an apparently healthy adult population in Singapore.","authors":"Joanne Mee Yin Lee, Pearline Teo, Leslie Choong Weng Lam","doi":"10.1177/00045632231224216","DOIUrl":"10.1177/00045632231224216","url":null,"abstract":"<p><strong>Background: </strong>CA19-9 is elevated in pancreatic cancer and other malignancies, and commonly used in clinical practice. Unfortunately, CA19-9 immunoassays are not harmonized, and reference intervals may differ between assays. The aim of this study was to establish the reference interval of the ADVIA Centaur/Atellica IM CA19-9 assay in an apparently healthy Singapore adult population.</p><p><strong>Methods: </strong>This is a retrospective cross-sectional study. De-identified data from Health Screening participants were extracted from our database. Subjects with biochemical results suggesting anaemia, diabetes mellitus, viral hepatitis or abnormal liver, and renal and tumour markers were excluded. Outlier and subclass analyses by age and sex were performed. CA19-9 reference limits and 90% confidence intervals were then determined for candidate subclasses.</p><p><strong>Results: </strong>Data from 12,174 subjects (5846 males and 6328 females) were available after exclusion criteria were applied. CA19-9 results did not follow a normal distribution and were higher in females compared to males (<i>P</i> < .001). Although CA19-9 means were statistically different between certain age groups, the evaluable 99th percentile reference limits were not statistically different. The overall 99th percentile reference limits for the Centaur/Atellica CA19-9 assay was 37 U/mL for males 21-80 years, and 60 U/mL for females 21-80 years.</p><p><strong>Conclusions: </strong>Our results suggest that separate CA19-9 reference intervals should be applied for males and females.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"265-272"},"PeriodicalIF":2.1,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138797179","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 CELTIC ranges project (comprehensive and effective laboratory test reference intervals for Irish children) methodology and results for renal profile tests in plasma on the Roche modular^TM system.","authors":"Ann Leonard, Turlough Bolger, Eleanor Molloy, Gerard Boran","doi":"10.1177/00045632231202330","DOIUrl":"10.1177/00045632231202330","url":null,"abstract":"<p><strong>Background: </strong>The CELTIC ranges project aims to deliver a comprehensive range of reference intervals for commonly ordered laboratory investigations suitable for use in an Irish population as well as enabling comparison with relevant international studies. In this paper, we describe our methodology used throughout the entire project and present paediatric reference intervals for renal profile tests in plasma (sodium, potassium, urea and creatinine).</p><p><strong>Methods: </strong>1023 children aged up to 17 years were recruited from our hospital's general practitioner paediatric phlebotomy clinic. Clinical chemistry analyses were performed on the Roche modular system and statistical analysis was completed in line with CLSI guideline EP28-A3c.</p><p><strong>Results: </strong>The plasma reference interval for sodium for ages 0.45-16.99 years was 137-143 mmol/L in 1000 subjects (combined genders). For plasma potassium, the corresponding ranges between 1 and 16.99 years (combined genders) were 3.6-4.8 mmol/L. Apart from neonates and in keeping with other studies, age partitioning for electrolytes was not required. Data for plasma creatinine (enzymatic methodology) and urea is also presented and, as anticipated, required partitioning for both age and gender.</p><p><strong>Conclusions: </strong>Our renal profile findings are broadly consistent with those of international studies, for example, CALIPER, HAPPI, NORDIC, PRINCE and KiGGs. Moreover, the CELTIC ranges study is also based on over 1000 subjects whose samples were analysed on the widely used Roche modular analytics system. We also expect the findings will improve knowledge of children's metabolic health in Ireland.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"163-172"},"PeriodicalIF":2.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10533837","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":"Acceptability of plasma ammonia results when samples are not transported and processed under ideal conditions.","authors":"Ann Bowron, Victoria Osgood","doi":"10.1177/00045632241232931","DOIUrl":"10.1177/00045632241232931","url":null,"abstract":"<p><strong>Background: </strong>It is recommended that samples for plasma ammonia analysis are kept chilled and processed promptly as <i>in vitro</i> metabolism causes falsely elevated results. Rejection of unsuitable samples can cause delayed diagnosis and treatment of hyperammonaemia with potentially serious clinical consequences. The Metabolic Biochemistry Network (MetBioNet) hyperammonaemia guideline recommends analysis of samples not collected under ideal conditions and reporting with appropriate comments. An audit found that some laboratories did not follow this guidance. An investigation was performed into whether storage at controlled room temperature and delayed sample processing affected interpretation of plasma ammonia results.</p><p><strong>Methods: </strong>Eleven healthy volunteers provided informed consent. Blood was taken from each into 14 paediatric EDTA blood sample tubes, one placed immediately on ice, the others in a rack at room temperature. The chilled and baseline room temperature samples were centrifuged and plasma analysed by the Roche Ammonia (NH3L2) method. Samples stored at room temperature were analysed at 10-min intervals up to 2 h.</p><p><strong>Results: </strong>Baseline room temperature ammonia was higher than in the chilled sample (19 ± 6.6 µmol/L [mean ± standard deviation] and 18 ± 6.6 µmol/L, respectively). Ammonia increased further by 0.09 ± 0.02 µmol/L per minute to 30 ± 8.4 µmol/L at 2 h. No result was above the reference range (50 µmol/L). No healthy subject with normal baseline ammonia would have been erroneously identified as having hyperammonaemia.</p><p><strong>Conclusions: </strong>Results support MetBioNet guidance that laboratories accept blood samples for ammonia analysis which are not processed under ideal conditions.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"230-232"},"PeriodicalIF":2.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139650177","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":"Long term stability of lactate in uncentrifuged sodium fluoride/potassium oxalate blood collection tubes.","authors":"Ivan Stevic, Jade Bolsover, Rick Moore, Vipin Bhayana","doi":"10.1177/00045632231213746","DOIUrl":"10.1177/00045632231213746","url":null,"abstract":"<p><strong>Background: </strong>Delayed time from collection to centrifugation may cause erroneously high lactate levels in vitro (from continued blood cell metabolism under anaerobic conditions in the collection tube) if not collected in appropriate collection devices, consequently increasing the risk for inappropriate patient care or harm. We undertook a study to determine the turnaround time for lactate testing in a tertiary care setting and also performed short- and long-term lactate stability studies in blood collected in sodium fluoride/potassium oxalate (NaF/KOx) collection tubes.</p><p><strong>Methods: </strong>The hospital lab information system was mined for 6 months to determine patient samples that may have exceeded the time from collection-to-receival in lab of 15-min. Lactate stability was evaluated in unspun NaF/KOx collection tubes at 15 min intervals for to 2 h; and separately at 2, 6, 12, 24, and 48-h post-collection.</p><p><strong>Results: </strong>A total of 8,929 plasma samples were collected in 6 months, and 1/3 were not received in the lab within 15 min from collection. In NaF/KOx additive, lactate levels had minor increases over 2 h, and incremental increases at an average rate of 0.0035 mmol/L/h over 48 h with maximum increase of 9.8% at 48 h. However, the average change across all time points were within local allowable performance goals (at ≤4 mmol/L ± 0.5 mmol/L; at >4 mmol/L ± 12%).</p><p><strong>Conclusion: </strong>A small proportion of lactate specimens may experience delay in processing. Although lactate levels may incrementally increase over 48-h at room temperature in unspun NaF/KOx collection tubes, the changes may not be clinically impactful.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"204-209"},"PeriodicalIF":2.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71410324","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":"Validation of the Randox colorimetric assays for serum copper and zinc.","authors":"Simon A Handley, Troy Wanandy, Louise Prentice","doi":"10.1177/00045632231208337","DOIUrl":"10.1177/00045632231208337","url":null,"abstract":"<p><strong>Background: </strong>Serum copper and zinc are measured to assess deficiency and toxicity. Atomic absorption spectrophotometry and mass spectrometry methods are expensive and require highly trained staff. Colorimetric assays are available from Randox which are inexpensive and can be automated. We validated serum copper and zinc colorimetric assays on the Binding Site Optilite analyser including comparison with flame atomic absorption spectrophotometry (FAAS) and inductively coupled plasma-mass spectrometry (ICP-MS).</p><p><strong>Methods: </strong>Accuracy, imprecision, lower limit of quantitation, and linearity were ascertained. The impact of triglycerides, bilirubin, nickel, and iron on assay performance was also investigated. Comparison of results from colorimetric analysis of patient and external quality assurance samples with those obtained by FAAS and ICP-MS was undertaken.</p><p><strong>Results: </strong>Intra-, and inter-assay imprecision was <9%. Serum copper and zinc assays were linear between 1.8-35.6 and 2.3-45.7 µmol/L, respectively. Agreement was good between colorimetry and FAAS (intercept = -0.7, slope = 1.04) and ICP-MS (intercept = 0.6, slope = 0.99) for serum copper in patients' samples. For serum zinc, agreement was poor between colorimetry and FAAS (intercept = 2.2, slope = 0.87) and ICP-MS (intercept = 1.9, slope = 0.98) in patients' samples. There was a poor concordance in assessment of hypozincaemia between colorimetry and FAAS/ICP-MS.</p><p><strong>Conclusion: </strong>The Randox colorimetric assay for serum copper on the Optilite is simple to perform, has a short analysis time, and measured concentrations compare well with FAAS and ICP-MS. Due to poor agreement with FAAS and ICP-MS, colorimetry is not suitable for the measurement of serum zinc.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"182-194"},"PeriodicalIF":2.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41091879","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}