Annals of Clinical Biochemistry最新文献_第9页

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

Annals of Clinical Biochemistry Pub Date : 2023-11-01 Epub Date: 2023-07-20 DOI: 10.1177/00045632231190516

Alessia Capoferri, Ilenia Infusino, Mauro Panteghini

引用次数: 0

Vitamin B12 reference intervals on Beckman, Roche and Siemens analytical platforms. 贝克曼，罗氏和西门子分析平台的维生素B12参考区间。

IF 2.2 4区医学

Annals of Clinical Biochemistry Pub Date : 2023-11-01 Epub Date: 2023-09-12 DOI: 10.1177/00045632231202211

Nuthar Jassam, Thomas Bancroft, Ahai Luvai, Wycliffe Mbagaya, Julian H Barth

{"title":"Vitamin B12 reference intervals on Beckman, Roche and Siemens analytical platforms.","authors":"Nuthar Jassam, Thomas Bancroft, Ahai Luvai, Wycliffe Mbagaya, Julian H Barth","doi":"10.1177/00045632231202211","DOIUrl":"10.1177/00045632231202211","url":null,"abstract":"Background: Vitamin B12 status is assessed primarily by measuring total serum B12 using competitive binding methods. The lack of availability of a standard material and high-level reference measurement procedure affect the trueness of B12 results; this results in variation between methods. This study aimed to determine the reference intervals for vitamin B12 on three routine analytical platforms.Method: A prospective reference population of healthy individuals was recruited according to the IFCC CRIDL criteria. Vitamin B12 samples were measured on Roche, Beckman and Siemens analytical platforms.Results: In total, 300 adult subjects were recruited; the central 95th centile values for B12 for Roche (190-678 ng/mL) and Siemens (181-562 ng/mL) analytical platforms were in a close agreement. Beckman DXi, however, showed a significantly lower reference limit (110-562 ng/mL). All reference intervals are in keeping with previously published data but some are not in agreement with manufacturer provided reference interval.Conclusion: As the quality of the reference intervals plays a significant role in clinical outcome, it is of great importance that laboratories use a method-specific reference interval and if possible, locally derived reference intervals until further method standardization occurs.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"417-422"},"PeriodicalIF":2.2,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10275007","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

Dataset dependency of low-density lipoprotein-cholesterol estimation by machine learning. 机器学习估计低密度脂蛋白-胆固醇的数据集依赖性。

IF 2.2 4区医学

Annals of Clinical Biochemistry Pub Date : 2023-11-01 Epub Date: 2023-06-05 DOI: 10.1177/00045632231180408

Ishida Hidekazu, Hiroki Nagasawa, Yasuko Yamamoto, Hiroki Doi, Midori Saito, Yuya Ishihara, Takashi Fujita, Mariko Ishida, Yohei Kato, Ryosuke Kikuchi, Hidetoshi Matsunami, Masao Takemura, Hiroyasu Ito, Kuniaki Saito

{"title":"Dataset dependency of low-density lipoprotein-cholesterol estimation by machine learning.","authors":"Ishida Hidekazu, Hiroki Nagasawa, Yasuko Yamamoto, Hiroki Doi, Midori Saito, Yuya Ishihara, Takashi Fujita, Mariko Ishida, Yohei Kato, Ryosuke Kikuchi, Hidetoshi Matsunami, Masao Takemura, Hiroyasu Ito, Kuniaki Saito","doi":"10.1177/00045632231180408","DOIUrl":"10.1177/00045632231180408","url":null,"abstract":"Objectives: We evaluated the applicability of a machine learning-based low-density lipoprotein-cholesterol (LDL-C) estimation method and the influence of the characteristics of the training datasets.Methods: Three training datasets were chosen from training datasets: health check-up participants at the Resource Center for Health Science (N = 2664), clinical patients at Gifu University Hospital (N = 7409), and clinical patients at Fujita Health University Hospital (N = 14,842). Nine different machine learning models were constructed through hyperparameter tuning and 10-fold cross-validation. Another test dataset of another 3711 clinical patients at Fujita Health University Hospital was selected as the test set used for comparing and validating the model against the Friedewald formula and the Martin method.Results: The coefficients of determination of the models trained on the health check-up dataset produced coefficients of determination that were equal to or inferior to those of the Martin method. In contrast, the coefficients of determination of several models trained on clinical patients exceeded those of the Martin method. The means of the differences and the convergences to the direct method were higher for the models trained on the clinical patients' dataset than for those trained on the health check-up participants' dataset. The models trained on the latter dataset tended to overestimate the 2019 ESC/EAS Guideline for LDL-cholesterol classification.Conclusion: Although machine learning models provide valuable method for LDL-C estimates, they should be trained on datasets with matched characteristics. The versatility of machine learning methods is another important consideration.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"396-405"},"PeriodicalIF":2.2,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9944734","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

Serum cortisol assay performance following the 1 mg overnight dexamethasone suppression test. 1 mg地塞米松夜间抑制试验后血清皮质醇测定性能。

IF 2.2 4区医学

Annals of Clinical Biochemistry Pub Date : 2023-11-01 Epub Date: 2023-06-30 DOI: 10.1177/00045632231179560

Jonathan S Atkins, James M Hawley, Laura J Owen, Jonathan Clayton, Jonathan Scargill, Brian G Keevil

{"title":"Serum cortisol assay performance following the 1 mg overnight dexamethasone suppression test.","authors":"Jonathan S Atkins, James M Hawley, Laura J Owen, Jonathan Clayton, Jonathan Scargill, Brian G Keevil","doi":"10.1177/00045632231179560","DOIUrl":"10.1177/00045632231179560","url":null,"abstract":"Background: The 1 mg overnight dexamethasone suppression test (ONDST) is recommended for the differential diagnosis of Cushing's syndrome and the investigation of adrenal incidentalomas. Despite documented variation in serum cortisol immunoassay performance, little has been published regarding its effect on the ONDST.Aims: Assess the performance of three immunoassay platforms (Roche Elecsys II, Abbott Alinity & Siemens Centaur) when compared to a liquid chromatography tandem mass spectrometry (LC-MS/MS) method.Methods: Samples (n = 77) sent to the laboratory as part of an ONDST were retrieved prior to disposal, anonymized, and analysed on all platforms. Samples with factors impacting immunoassay analysis quality were excluded. Results were statistically compared to an LC-MS/MS method that previously demonstrated excellent comparability to a candidate reference method.Results: The Roche gen II showed a mean bias of -2.4 nmol/L and a Passing-Bablok fit of y = -0.9 + 0.97x. This was not affected by sex. The Abbott showed a mean bias -18.8 nmol/L, and a fit of y = -11.3 + 0.88x. This bias was -20.7 nmol/L in females versus -17.2 nmol/L in males. The Siemens had a mean bias of 2.3 nmol/L and a fit of y = 1.4 + 1.07x. This bias was 5.7 nmol/L in males versus -1.0 nmol/L in females.Conclusions: Clinicians should be aware of the method-dependent variation that exists within serum cortisol analysis during the ONDSTs. Roche and Siemens aligned more closely with LC-MS/MS while the Abbot may cause a reduction in ONDST sensitivity. This data supports assay-specific cut-offs for the ONDST.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"386-395"},"PeriodicalIF":2.2,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9701122","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: 2

Measurement of cholesterol levels of lipoprotein subclasses in human serum using anion-exchange high-performance liquid chromatography with a linear concentration gradient of sodium perchlorate. 高氯酸钠线性浓度梯度阴离子交换高效液相色谱法测定人血清中脂蛋白亚类胆固醇水平。

IF 2.2 4区医学

Annals of Clinical Biochemistry Pub Date : 2023-11-01 Epub Date: 2023-06-02 DOI: 10.1177/00045632231179082

Riku Ito, Daisuke Manita, Hidekatsu Yanai, Yuji Hirowatari

{"title":"Measurement of cholesterol levels of lipoprotein subclasses in human serum using anion-exchange high-performance liquid chromatography with a linear concentration gradient of sodium perchlorate.","authors":"Riku Ito, Daisuke Manita, Hidekatsu Yanai, Yuji Hirowatari","doi":"10.1177/00045632231179082","DOIUrl":"10.1177/00045632231179082","url":null,"abstract":"Background: Relationships between the subclasses of high-density lipoprotein (HDL) or low-density lipoprotein (LDL) and the risk of atherosclerotic cardiovascular disease have been studied, and using various methods, such as ultracentrifugation, electrophoresis, and nuclear magnetic resonance, for analysing lipoprotein subclasses. We established a method for HDL and LDL subclasses using anion-exchange high-performance liquid chromatography (AEX-HPLC) with a linear concentration gradient of sodium perchlorate (NaClO4).Method: In the AEX-HPLC, the subclasses of HDL and LDL were separated, and detected using a post-column reactor with an enzymatic cholesterol reagent, that contained cholesterol esterase, cholesterol oxidase, and peroxidase as major ingredients. LDL subclasses were divided based on the absolute value of first-derivative chromatogram.Result: Three HDL subclasses, HDL-P1, HDL-P2, and HDL-P3, and three LDL subclasses, LDL-P1, LDL-P2, and LDL-P3, were separated by AEX-HPLC, and detected in order. The major components of HDL-P2 and HDL-P3 were HDL3 and HDL2, respectively. The linearity was determined for each lipoprotein subclass. The coefficients of variation of cholesterol concentration of the subclasses for within-day assay (n = 10) and between-day assay (n = 10) ranged between 3.08-8.94% and 4.52-9.97%, respectively. Cholesterol levels in HDL-P1 of diabetic patients were positively correlated with oxidized LDL levels (r = 0.409, p = 0.002). Moreover, cholesterol levels in LDL-P2 and LDL-P3 were positively correlated with oxidized LDL levels (r = 0.393, p = 0.004 and r = 0.561, p < 0.001, respectively).Conclusion: AEX-HPLC may be highly suitable as an assay to clinically assess lipoprotein subclasses.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"374-385"},"PeriodicalIF":2.2,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9560430","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

Artefactually low creatinine by Beckman Coulter enzymatic method due to immunoglobulin M paraprotein interference. 免疫球蛋白M副蛋白干扰用贝克曼库尔特酶法人工降低肌酐。

IF 2.2 4区医学

Annals of Clinical Biochemistry Pub Date : 2023-11-01 Epub Date: 2023-07-23 DOI: 10.1177/00045632231190507

Bobby Li, Simon Thompson, Kareen Igot, Richard King, Matthew Doogue, Chris Florkowski

{"title":"Artefactually low creatinine by Beckman Coulter enzymatic method due to immunoglobulin M paraprotein interference.","authors":"Bobby Li, Simon Thompson, Kareen Igot, Richard King, Matthew Doogue, Chris Florkowski","doi":"10.1177/00045632231190507","DOIUrl":"10.1177/00045632231190507","url":null,"abstract":"An 81-year-old man was admitted to hospital with symptomatic coronavirus disease (COVID-19) infection. He had a background of progressive chronic inflammatory demyelinating polyneuropathy associated with Waldenstrom's macroglobulinaemia. His plasma creatinine on four separate samples was inconceivably low (all ≤13 μmol/L), as measured by a Beckman Coulter enzymatic assay) after being 72 μmol/L 3 months earlier. On further investigation, his serum immunoglobulin M (IgM) was 15.4 g/L and his plasma creatinine measured by Roche enzymatic and Roche Jaffe methods was 62 μmol/L and 64 μmol/L, respectively. This was consistent with results post dilution studies and polyethylene glycol (PEG) precipitation on the Beckman Coulter assay. There was no evidence of similar interference when reviewing creatinine results from 10 other patients with IgM paraproteinaemia who had been tested in our laboratory. Clinicians and laboratorians are reminded that enzymatic creatinine is not free from interferences. IgM paraprotein negative interference of enzymatic creatinine is rare and specific to a patient's IgM and assay combination, but should be considered in patients with an unexplained low enzymatic creatinine result. Useful investigations to identify an interference include dilution studies, PEG precipitation and measuring creatinine on an alternative method such as Jaffe, mass spectrometry or an enzymatic method from a different platform.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"423-427"},"PeriodicalIF":2.2,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9849305","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

Paediatric reference ranges for plasma chromogranin A. 血浆嗜铬粒蛋白A的儿科参考范围。

IF 2.2 4区医学

Annals of Clinical Biochemistry Pub Date : 2023-09-15 DOI: 10.1177/00045632231202652

Sofie Lieberoth, Frederik Friis-Hansen, Lennart Friis-Hansen

{"title":"Paediatric reference ranges for plasma chromogranin A.","authors":"Sofie Lieberoth, Frederik Friis-Hansen, Lennart Friis-Hansen","doi":"10.1177/00045632231202652","DOIUrl":"https://doi.org/10.1177/00045632231202652","url":null,"abstract":"Background: Neuroendocrine neoplasms (NENs) are a heterogeneous group of rare diseases with varied aggressiveness originating from endocrine cells belonging to the diffuse endocrine system and most often produce and secrete chromogranin A (CgA). CgA in plasma is therefore used to screen, diagnose, and monitor for NENs in both adults and children with sporadic or familial NENs.Methods: Plasma CgA was measured using the Brahms Kryptor assay in 268 healthy children/adolescents; 85 children were tested as part of a familial cancer screening program and 183 additional children younger than 20 years of age underwent screening for allergies. Repeated measurements (month - years) was used to calculate the intra-individual variation. The dataset was analysed in R using the referenceInterval package.Results: The plasma CgA concentration decreased with age and was 32-118 µg/L for children aged 0-3 years, 18-85 µg/L for children aged 4-13 years, and 6-79 µg/L for adolescents aged 14-19 years. Earlier reported CgA reference intervals for adults have upper limits from 88 to 102 µg/L while no lower limits have been reported. The median for the three groups were 78, 51, and 39 µg/L, respectively. The median intra-individual variation was 14% (25%-centile 9.4%/75%-centile 21%).Conclusions: The reference interval will be useful when screening, diagnosing, and monitoring children for NENs respecting the limitations plasma CgA has.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632231202652"},"PeriodicalIF":2.2,"publicationDate":"2023-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10240881","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

Evaluation of the two-point calibration bromocresol green method, showing reduced deviation from the bromocresol purple method in sera from patients with hypoalbuminemia. 评估两点校准溴甲酚绿法，显示低白蛋白血症患者血清中溴甲酚紫法的偏差减少。

IF 2.2 4区医学

Annals of Clinical Biochemistry Pub Date : 2023-09-01 Epub Date: 2023-04-15 DOI: 10.1177/00045632231170554

Tatsuya Iwasaki, Kazuki Nakajima, Yuji Hirowatari, Makoto Matsushita

{"title":"Evaluation of the two-point calibration bromocresol green method, showing reduced deviation from the bromocresol purple method in sera from patients with hypoalbuminemia.","authors":"Tatsuya Iwasaki, Kazuki Nakajima, Yuji Hirowatari, Makoto Matsushita","doi":"10.1177/00045632231170554","DOIUrl":"10.1177/00045632231170554","url":null,"abstract":"Background: The bromocresol green (BCG) and bromocresol purple (BCP) methods are widely used for albumin measurements in routine testing, but the BCG method is known to react with globulin fractions and to have low specificity for albumin. We evaluated a calibration method using different concentrations of human serum albumin standards (two-point calibration BCG method) with the aim of reducing the effect of globulin fractions on the BCG method in patients with hypoalbuminemia.Method: In the two-point calibration BCG method, two concentrations of standard solutions and their calibration values are set based on the difference in albumin concentrations measured by the BCG method (BCG-HSA method) and the modified BCP (modified BCP-HSA method) calibrated with human serum albumin standard solution (HSA). Albumin concentrations were measured in 136 patient serum samples (healthy group: 52, hypoalbuminemic group: 84) by the two-point calibrated BCG method and compared with those obtained using the modified BCP-HSA method.Results: The mean albumin concentrations obtained using the two-point calibrated BCG and modified BCP-HSA methods were 39.18 ± 3.42 g/L and 39.37 ± 3.14 g/L (healthy group) and 26.20 ± 6.23 g/L and 26.23 ± 5.67 g/L (hypoalbuminemia group), respectively. The results of the two-point calibration BCG method were in a close agreement over the entire concentration range tested compared to the modified BCP-HSA method.Conclusions: Based on these results, this calibration method reduces the influence of the globulin fraction on the BCG method. In the hypoalbuminemic group, the calibration method was shown to provide results consistent with the BCP method, which is highly specific for albumin.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"320-327"},"PeriodicalIF":2.2,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9300590","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 diagnostic utility of IgG index and oligoclonal bands for multiple sclerosis in a neurology hospital patient population. IgG指数和寡克隆带在神经科医院患者群体中对多发性硬化症的诊断作用。

IF 2.2 4区医学

Annals of Clinical Biochemistry Pub Date : 2023-09-01 Epub Date: 2023-06-05 DOI: 10.1177/00045632231179618

Francesca Shaw, Carrie Chadwick

{"title":"The diagnostic utility of IgG index and oligoclonal bands for multiple sclerosis in a neurology hospital patient population.","authors":"Francesca Shaw, Carrie Chadwick","doi":"10.1177/00045632231179618","DOIUrl":"10.1177/00045632231179618","url":null,"abstract":"Background: Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system. Diagnosis is based on the 2017 revised McDonald criteria. Unmatched oligoclonal bands (OCB) within the CSF (i.e. positive OCB) can substitute for dissemination in time by magnetic resonance imaging (MRI). Simonsen et al. (2020) claimed a raised (>0.7) immunoglobulin G (IgG) index could replace OCB status. This study aimed to establish the diagnostic utility of IgG index for MS in the population served by The Walton Centre NHS Foundation Trust (WCFT) a neurology and neurosurgery hospital, and to derive a population-based IgG index reference interval.Methods: OCB results from the laboratory information system (LIS) were collated from November 2018 to 2021. Final diagnosis and medication history was obtained from the electronic patient record. Exclusions were made based on age (<18 years) at the time of lumbar puncture (LP) disease-modifying treatment prior to LP, unknown IgG index and unclear OCB patterns.Results: 935 of 1101 results remained following exclusions. 226 (24.2%) had a diagnosis of MS, 212 (93.8%) were OCB positive and 165 (73.0%) had a raised IgG index. The diagnostic specificity of a raised IgG index was calculated at 90.3% compared to 86.9% for positive OCB. 386 results with negative OCB were used to establish the IgG index reference interval (0.36-0.68) at 95th percentiles.Conclusion: This study provides evidence that IgG index should not replace OCB in the diagnosis of MS. >0.7 is an appropriate cut-off to define a raised IgG index for the patient population.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"353-355"},"PeriodicalIF":2.2,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9576499","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

EQA: There's not a glitch in the matrix. Investigation of CRP bias on the Roche Cobas c701. EQA：矩阵中没有任何故障。罗氏Cobas c701的CRP偏倚研究。

IF 2.2 4区医学

Annals of Clinical Biochemistry Pub Date : 2023-09-01 Epub Date: 2023-05-17 DOI: 10.1177/00045632231169151

Emma Stevenson, Chelsey Walsh, Sadie Thomas

{"title":"EQA: There's not a glitch in the matrix. Investigation of CRP bias on the Roche Cobas c701.","authors":"Emma Stevenson, Chelsey Walsh, Sadie Thomas","doi":"10.1177/00045632231169151","DOIUrl":"10.1177/00045632231169151","url":null,"abstract":"Background: The Roche Cobas c Tina-quant C-Reactive Protein (CRP) IV method has shown persistent, significant negative bias compared to other methodologies in the UK NEQAS external quality assurance (EQA) scheme. The aim of this study was to compare CRP concentrations determined by this restandardized 4th generation assay with another commercially available method to assess the extent of any bias and impact on clinical cut-offs.Methods: CRP concentrations in 38 anonymized patient serum samples were determined by a particle-enhanced immunoturbidimetric assay on the Roche Cobas c701 module and a latex assay on the Beckman Coulter AU5800 analyser over a concentration range of 1-308 mg/L.Results: 97.4% samples analysed by the Roche Tina-quant CRP IV method demonstrated a negative bias compared to the Beckman AU latex method. The mean absolute bias was -4.12 mg/L (range: -19.13-10.93 mg/L; 95% CI: -17.25-9.01 mg/L). The mean relative difference was -15.5% (range: -40-4%; 95% CI: -33.03-1.94%). This bias was seen across the range of samples assayed, including at clinically significant cut-offs of 5 mg/L (-24% bias), 20 mg/L (-5%) and 100 mg/L (-13%).Conclusion: The negative bias of the Roche method demonstrated in the EQA scheme appears to reflect genuine differences in patient results, rather than an EQA matrix effect, despite re-standardization of the CRP assay. This report indicates that clinical cut-offs and reference ranges may be method-dependent, which should be reflected in published guidance and interpretation provided by laboratories.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"349-352"},"PeriodicalIF":2.2,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9475072","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