Annals of Clinical Biochemistry最新文献_第9页

Investigation into the linearity of the Roche c 702 carbamazepine assay. 罗氏 c 702 卡马西平检测法线性度调查。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-03-01 Epub Date: 2024-10-17 DOI: 10.1177/00045632241292510

Alice A Stephenson, Chris G Robinson, Rachel Marrington, James M Hawley

{"title":"Investigation into the linearity of the Roche c 702 carbamazepine assay.","authors":"Alice A Stephenson, Chris G Robinson, Rachel Marrington, James M Hawley","doi":"10.1177/00045632241292510","DOIUrl":"10.1177/00045632241292510","url":null,"abstract":"BackgroundCarbamazepine is an anticonvulsant drug which is monitored in patients due to toxic side effects. At Manchester University NHS Foundation Trust (MFT), carbamazepine is measured using Roche's Kinetic Interaction of Microparticles in Solution (KIMS) method on the c 702 platform. The assay has an upper limit of linearity of 20 mg/L. Samples with concentrations above this limit should be identified and manually diluted. However, a poor EQA return from UK NEQAS for Tox and TDM Distribution 456 has highlighted an issue with the Roche KIMS assay. Sample A of the distribution had a carbamazepine concentration of 36 mg/L but was underreported by several Roche users. This indicated that the assay was not consistently identifying high concentration samples which required a dilution.MethodIn this investigation, fresh frozen plasma was spiked with carbamazepine concentrations ranging from 15 to 40 mg/L. The spiked samples and EQA material were analysed at two clinical laboratories using the Roche KIMS assay.ResultsSamples spiked with concentrations 20-30 mg/L were not consistently identified for dilution by the analyser. This was observed at both hospital sites. Spike samples and EQA with concentrations >30 mg/L were correctly identified at both sites.ConclusionThe manual dilution policy has been changed at MFT, so all samples with a carbamazepine level ≥15 mg/L will be manually diluted. The problem was reported to Roche who are investigating the issue further. We would suggest that other laboratories look at validating their dilution protocols.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"135-139"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142374911","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

Simultaneous quantification of serum symmetric dimethylarginine, asymmetric dimethylarginine and creatinine for use in a routine clinical laboratory. 用于常规临床实验室的血清对称二甲基精氨酸、非对称二甲基精氨酸和肌酐的同步定量。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-03-01 Epub Date: 2024-11-12 DOI: 10.1177/00045632241298161

David J Marshall, James M Hawley, Brian G Keevil

{"title":"Simultaneous quantification of serum symmetric dimethylarginine, asymmetric dimethylarginine and creatinine for use in a routine clinical laboratory.","authors":"David J Marshall, James M Hawley, Brian G Keevil","doi":"10.1177/00045632241298161","DOIUrl":"10.1177/00045632241298161","url":null,"abstract":"BackgroundSymmetric dimethylarginine (SDMA) and asymmetric dimethylarginine (ADMA) are naturally occurring amino acids classed as uraemic toxins by the European Uremic Toxins Work Group. SDMA is principally excreted through the kidneys and is a well-known renal function marker, and ADMA is a potent inhibitor of nitric oxide production. Here, we describe the development of a rapid and sensitive liquid chromatography tandem mass spectrometry method for simultaneous measurement of SDMA, ADMA and creatinine.MethodSerum samples were prepared by protein precipitation and dilution with acetonitrile prior to injection onto a Waters TQS-Micro. SDMA, ADMA, creatinine and their corresponding internal standard transitions were detected using multiple reaction monitoring after separation with a hydrophilic interaction liquid chromatography analytical column. Sample stability and intra-individual variation studies were also assessed following ethical approval.ResultsThe retention time for creatinine was 0.43, SDMA 1.10 and ADMA 1.14 min. Mean recovery for creatinine was 103%, SDMA was 100% and ADMA was 103%; matrix effects were minimal (<6%). Lower limit of quantitation for creatinine and SDMA/ADMA was 17.5 µmol/L and 0.1 µmol/L, respectively. Analytical imprecision showed a coefficient of variation <10% for all analytes across the working range of the assays. Intra-individual variation for creatinine was 4.7%, SDMA 7.5% and ADMA 7.6%.DiscussionWe have developed a rugged assay for measurement of SDMA, ADMA and creatinine by LC-MS/MS suitable for routine use. It is easy to perform owing to its simplicity and reproducibility. The stability of SDMA and ADMA pre- and post-centrifugation allows for their routine use without any special sample handling requirements.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"126-134"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493405","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

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-03-01 Epub Date: 2024-11-12 DOI: 10.1177/00045632241292514

Goce Dimeski, Amanda Holford, Katherine Isoardi

{"title":"Suggested guide to using lactate gap as a surrogate marker in the diagnosis of ethylene glycol overdose.","authors":"Goce Dimeski, Amanda Holford, Katherine Isoardi","doi":"10.1177/00045632241292514","DOIUrl":"10.1177/00045632241292514","url":null,"abstract":"BackgroundEthylene glycol (EG) poisoning, if not diagnosed rapidly, can lead to poor patient outcomes. Gas chromatography (GC) is primarily used for EG quantitation which is rarely available, and the turn-around time may be prolonged. Most lactate results from point-of-care (POCT) methods are falsely elevated in EG poisoning compared with automated chemistry analyser results. In combination, the lactate gap (POCT-Automated chemistry) can be used as surrogate marker in just about all laboratories to indicate likely EG toxicity and guide treatment.Case ReportA man presented by ambulance to hospital with severe agitation requiring mechanical ventilation to facilitate ongoing management. Venous blood gas analysis confirmed a high anion gap metabolic acidosis (HAGMA) with an elevated lactate. The lactate and osmolarity measured in the laboratory showed a normal lactate and high osmolarity, giving a large osmolar gap. The patient was immediately commenced on renal replacement therapy for presumed EG poisoning to minimize kidney injury, and the treatment continued for 19 hours. A very high EG concentration was confirmed by GC the next day.ConclusionAn elevated lactate gap along with a HAGMA and osmolar gap can provide rapid surrogate laboratory data indicating EG poisoning enabling timely treatment and better patient outcomes.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"140-142"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142374912","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

Diagnostic accuracy of bone marrow blood evaluation in haemophagocytic lymphohistiocytosis paediatric patients. 嗜血细胞淋巴组织细胞增多症儿科患者骨髓血评估的诊断准确性。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-03-01 Epub Date: 2024-10-24 DOI: 10.1177/00045632241295694

Elisa Caravaggi, Federico Serana, Mattia Carini, Fabiana Ferrari, Daniela Tregambe, Moira Micheletti, Giovanni Martellosio, Duilio Brugnoni, Roberto Bresciani, Giorgio Biasiotto

{"title":"Diagnostic accuracy of bone marrow blood evaluation in haemophagocytic lymphohistiocytosis paediatric patients.","authors":"Elisa Caravaggi, Federico Serana, Mattia Carini, Fabiana Ferrari, Daniela Tregambe, Moira Micheletti, Giovanni Martellosio, Duilio Brugnoni, Roberto Bresciani, Giorgio Biasiotto","doi":"10.1177/00045632241295694","DOIUrl":"10.1177/00045632241295694","url":null,"abstract":"IntroductionHaemophagocytic lymphohistiocytosis (HLH) is a rare and serious immunological syndrome that involves a strong activation of cytotoxic T lymphocytes and macrophages. HLH determines a cytokine-mediated tissue injury with a contemporary multi-organ failure and a high fatality rate.Material and methodsA retrospective study was performed considering the medical records of paediatric patients who underwent a bone marrow aspirate for suspect HLH. The biomarkers evaluated were among those included in the HLH-2004. Lactate dehydrogenase (LD) was also evaluated. Haemophagocytosis was evaluated in bone marrow blood smear slides.ResultsEnrolled were 11 patients included in the HLH group and 8 patients as controls. Haemoglobin and fibrinogen resulted lower in HLH patients than in controls, while blood triglycerides, serum ferritin and LD resulted increased. Blood triglycerides and fibrinogen discriminated HLH cases perfectly, with a sensitivity and specificity of 100%. Ferritin had a sensitivity of 100% and a specificity of 83% (cut off ≥3,721 µg/L) and LD of 73% and of 100% (the cut off ≥1,903 U/L). Haemoglobin was found to have a sensitivity of 75% and a specificity of 100% (cut off ≤ 96 g/L). Total haemophagocytes cell counts were not different between patients and controls. Only the increased number of phagocytized nucleated red blood cells (NRBC) was found to be significantly increased in the patients. Erythrocytes phagocytosis (≥4/1,000 cells) only tended towards significance.ConclusionsThe blood biomarkers showed better diagnostic performance than the morphological evaluation. Among the different cell lineages engulfed by haemophagocytes, the best diagnostic performance was obtained by phagocytosed mature erythrocytes and immature nucleated erythrocytes.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"91-100"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456545","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

Application of surface Plasmon resonance imaging in the high-throughput detection of influenza virus. 表面等离子体共振成像在流感病毒高通量检测中的应用。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-03-01 Epub Date: 2024-11-06 DOI: 10.1177/00045632241297819

Haixiang Zhang, Jingying Sun, Chunyan Guo, Qing Feng, Yan Li, Xiangrong Zhao, Lijun Sun, Cuixiang Xu

{"title":"Application of surface Plasmon resonance imaging in the high-throughput detection of influenza virus.","authors":"Haixiang Zhang, Jingying Sun, Chunyan Guo, Qing Feng, Yan Li, Xiangrong Zhao, Lijun Sun, Cuixiang Xu","doi":"10.1177/00045632241297819","DOIUrl":"10.1177/00045632241297819","url":null,"abstract":"ObjectiveTo evaluate the application effect of SPRi monoclonal antibody (mAb) chip in the detection of influenza virus antigen in complex mixtures.MethodsA total of 115 strains of mAbs against different subtypes (H1N1, H5N1, A1, A3, B, H7N9, H9N2, and H3N2) of influenza virus were prepared. The chip of mAbs against influenza virus was prepared by surface plasmonic resonance imaging (SPRi) technology, which was used for the detection of influenza virus supernatant, and compared with the traditional antigen capture ELISA method.ResultsComparative studies have shown that traditional antigen capture ELISA methods have a higher sensitivity (86.8% (46/53) vs. 46.5% (46/99); z = 4.84, P < .001), while the SPRi chip methods present a significantly higher specificity (56.3% (9/16) vs. 14.5% (9/62); z = 3.54, P < .001). The SPRi chip detection method for influenza virus antibodies can well reflect the specific binding characteristics of influenza virus antigens and antibodies.ConclusionThe SPRi mAb chip can be used for the detection of specific pathogenic microorganisms or viral proteins in complex mixtures such as influenza virus supernatant. It has significant advantages of label free, real-time, high-throughput, and good specificity, and can play an important role in disease diagnosis and infectious disease prevention and control.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"101-108"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493392","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

Usefulness of the 3-hydroxykynurenine/kynurenic acid ratio as a diagnostic biomarker for diffuse larger B-cell lymphoma. 3-hydroxykynurenine/kynurenic acid 比率作为弥漫性大 B 细胞淋巴瘤诊断生物标志物的实用性。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-03-01 Epub Date: 2024-11-11 DOI: 10.1177/00045632241297873

Yasuko Yamamoto, Naoe Goto, Kengo Kambara, Suwako Fujigaki, Hidetsugu Fujigaki, Masao Takemura, Toshitaka Nabeshima, Akihiro Tomita, Kuniaki Saito

{"title":"Usefulness of the 3-hydroxykynurenine/kynurenic acid ratio as a diagnostic biomarker for diffuse larger B-cell lymphoma.","authors":"Yasuko Yamamoto, Naoe Goto, Kengo Kambara, Suwako Fujigaki, Hidetsugu Fujigaki, Masao Takemura, Toshitaka Nabeshima, Akihiro Tomita, Kuniaki Saito","doi":"10.1177/00045632241297873","DOIUrl":"10.1177/00045632241297873","url":null,"abstract":"ObjectivesReports have shown that the kynurenine pathway, one of the pathways by which tryptophan is metabolized, is activated in patients with diffuse large B-cell lymphoma (DLBCL). Activation of the kynurenine pathway triggers the production of various metabolites, such as kynurenine (Kyn), 3-hydroxykynurenine (3-HK), 3-hydroxyanthranilic acid (3-HAA), kynurenic acid (KA), and anthranilic acid (AA), which contribute to immune tolerance. The current study aimed to investigate the changes in metabolites of kynurenine pathway in DLBCL patients and evaluate their performance predicting DLBCL.MethodsChanges in metabolites of kynurenine pathway were examined using high-performance liquid chromatography in 35 DLBCL patients (age 61.2 ± 13.5 years) and 44 healthy controls (age 58.5 ± 12.5 years).ResultsDLBCL patients had significantly higher levels of 3-HK, AA, and 3-HAA but lower levels of tryptophan (Trp) and KA compared to healthy controls. Given that the ratio of each metabolite represents the change in the Kyn pathway, the 3-HK/KA ratio was examined. Notably, DLBCL patients had a significantly higher 3-HK/KA ratio compared to healthy controls. In DLBCL, the area under the receiver operative characteristic (ROC) curve for 3-HK/KA (0.999) was higher than that for lactate dehydrogenase (0.885) and comparable to that for soluble interleukin-2 receptor (sIL-2R) (0.997). Based on ROC curve analysis, the 3-HK/KA ratio was found to be useful biomarker for the diagnosis of DLBCL.ConclusionOur results suggest that the 3-HK/KA ratio is a clinically useful biomarker of DLBCL. Moreover, its combination with existing markers, such as sIL-2R, can improve its effectiveness of diagnosing DLBCL.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"109-117"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493406","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 curious case of a negative control line on a dengue duo assay due to interference - A case report. 登革热二重奏检测阴性对照线受干扰的奇特病例--病例报告。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-03-01 Epub Date: 2024-10-15 DOI: 10.1177/00045632241292430

Sheila X Soh, Tze Ping Loh, Sharon Saw, Ai Teng Chong, Jia Sing Yap, Sunil K Sethi, Lizhen Ong

{"title":"A curious case of a negative control line on a dengue duo assay due to interference - A case report.","authors":"Sheila X Soh, Tze Ping Loh, Sharon Saw, Ai Teng Chong, Jia Sing Yap, Sunil K Sethi, Lizhen Ong","doi":"10.1177/00045632241292430","DOIUrl":"10.1177/00045632241292430","url":null,"abstract":"An elderly patient who presented with 1 week of fever and respiratory symptoms was tested for dengue infection with an Abbott Bioline™ Dengue Duo immunochromatographic assay. Unexpectedly, the control line of the dengue non-structural protein 1 (NS1) component was absent, necessitating result invalidation. It remained absent when the test was repeated on the SD Biosensor Standard™ Q Dengue Duo, but present on the Wells Bio careUSTM Dengue Combo and Asan Easy Test® Dengue DUO assays, suggesting potential interference. Dilution, polyethylene glycol (PEG) precipitation and centrifugation with a 100 kDa filter were performed to reduce/remove the potential interferent. Sera from other patients that showed a control line, and a test line that was either positive or negative for NS1, were used as controls. Upon dilution with negative control serum, a faint control line emerged. PEG precipitation resulted in disappearance of control and test lines in the positive control. Filtration led to emergence of the control line for the patient's serum but caused the test line for the positive control serum to disappear. Overall, investigations suggested the presence of a high molecular weight (>100 kDa) substance which interferes with chicken IgY-anti-chicken IgY binding at the control line of affected assays. Our results highlight two important points: firstly, some commonly used laboratory procedures (e.g. PEG or filtration) may inadvertently remove the target biomarker (e.g. multimeric NS1) and should be interpreted with appropriate controls. Secondly, alternative kits that use a different antigen-antibody combination for the control line can be considered when similar patients are encountered in future.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"148-152"},"PeriodicalIF":1.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456544","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

Familial hypercholesterolaemia with high triglycerides: A diagnostic challenge. 伴有高甘油三酯的家族性高胆固醇血症：诊断难题。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-03-01 Epub Date: 2024-10-10 DOI: 10.1177/00045632241289275

Suha Ahmed, Marwa Elgizouli, Eric S Kilpatrick, Timothy J Morris

{"title":"Familial hypercholesterolaemia with high triglycerides: A diagnostic challenge.","authors":"Suha Ahmed, Marwa Elgizouli, Eric S Kilpatrick, Timothy J Morris","doi":"10.1177/00045632241289275","DOIUrl":"10.1177/00045632241289275","url":null,"abstract":"Combined or mixed hyperlipidaemia is characterised by hypercholesterolaemia together with high triglyceride concentrations. It is found in approximately 1 in 100 people in the United Kingdom. Most cases are secondary to an underlying condition such as the metabolic syndrome, diabetes mellitus (especially poorly controlled) or individuals with a high alcohol intake. Mixed hyperlipidaemia is also a feature of some primary hyperlipidaemia conditions such familial combined hyperlipidaemia (FCH) or type III hyperlipidaemia (dysbetalipoproteinaemia). One differential diagnosis for mixed hyperlipidaemia that can easily be overlooked is a patient with an underlying diagnosis of familial hypercholesterolaemia (FH) who also has a hypertriglyceridaemia due to any other cause. Those patients may have very high total and low-density lipoprotein cholesterol concentrations (LDL-C) with a moderately elevated triglyceride concentration. In this article, we report 4 cases of familial hypercholesterolaemia, confirmed by genetic testing, in patients initially presenting with hypertriglyceridaemia in addition to high total cholesterol and LDL-C. This article discusses the diagnostic challenges associated with this presentation and highlights the key role of directly measuring LDL-C to aid diagnosis in these specific situations.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"143-147"},"PeriodicalIF":1.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142399193","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

Analytical performance evaluation of the GreenCare A1c and Cera-Stat HbA1c point-of-care testing assays. GreenCare A1c 和 Cera-Stat HbA1c 床旁检测试剂盒的分析性能评估。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-01 Epub Date: 2024-09-23 DOI: 10.1177/00045632241282580

Joon Hee Lee, Sun-Hee Jun, Jikyo Lee, Sang Hoon Song, Kyunghoon Lee

{"title":"Analytical performance evaluation of the GreenCare A1c and Cera-Stat HbA1c point-of-care testing assays.","authors":"Joon Hee Lee, Sun-Hee Jun, Jikyo Lee, Sang Hoon Song, Kyunghoon Lee","doi":"10.1177/00045632241282580","DOIUrl":"10.1177/00045632241282580","url":null,"abstract":"Background: The escalating prevalence of diabetes underscores the need for precise diagnostic tools to facilitate effective management. Hemoglobin A1c (HbA1c) is a crucial biomarker for long-term glycemic control in diabetic patients. Point-of-care testing (POCT) for HbA1c offers rapid, accessible alternatives to conventional laboratory methods, but uncertainties persist regarding the accuracy and reliability of POCT assays.Methods: This study evaluates the analytical performance of two boronate-affinity based HbA1c POCT assays, the GreenCare A1c and Cera-Stat HbA1c. Various analytical parameters including precision, linearity, comparison, and accuracy are assessed following guidelines from Clinical and Laboratory Standards Institute (CLSI), with results applied to certification criteria from the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Furthermore, 52 and 13 frozen EDTA whole blood samples were respectively used for additional evaluation of accuracy and interference due to Hb variants for the GreenCare A1c assay.Results: Both GreenCare and Cera-Stat demonstrated good precision (repeatability CV% 1.5-1.9 and total imprecision CV% 1.6-2.2), linearity (R2 = 0.9996 & 0.9990), and correlation (r = 0.982 & 0.978) with an established HbA1c analyzer, the Bio-Rad D100. The GreenCare also exhibited good accuracy with frozen EDTA samples with known HbA1c values. Both assays met the certification criteria from NGSP and IFCC, classifying them as \"standard\" according to IFCC model for quality targets for HbA1c.Conclusions: This evaluation affirms the reliability of GreenCare and Cera-Stat POCT assays for HbA1c measurements, which can potentially reduce unnecessary referrals and enhance the overall quality of diabetes diagnosis and treatment.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"46-56"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142085884","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

Development and validation of interpretable machine learning models to predict glomerular filtration rate in chronic kidney disease Colombian patients. 开发和验证可解释的机器学习模型，以预测哥伦比亚慢性肾病患者的肾小球滤过率。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-01 Epub Date: 2024-09-21 DOI: 10.1177/00045632241285528

Luis H Rojas, Angela J Pereira-Morales, William Amador, Albert Montenegro, Walberto Buelvas, Víctor de la Espriella

{"title":"Development and validation of interpretable machine learning models to predict glomerular filtration rate in chronic kidney disease Colombian patients.","authors":"Luis H Rojas, Angela J Pereira-Morales, William Amador, Albert Montenegro, Walberto Buelvas, Víctor de la Espriella","doi":"10.1177/00045632241285528","DOIUrl":"10.1177/00045632241285528","url":null,"abstract":"Background: ML predictive models have shown their capability to improve risk prediction and assist medical decision-making, nevertheless, there is a lack of accuracy systems to early identify future rapid CKD progressors in Colombia and even in South America.Objective: The purpose of this study was to develop a series of interpretable machine learning models that predict GFR at 6-months, 9-months, and 12-months.Study design and setting: Over 29,000 CKD patients stage 1 to 3b (estimated GFR, <60 mL/min/1.73 m2) with an average of 3-year follow-up data were included. We used the machine learning extreme gradient boosting (XGBoost) to build three models to predict the next eGFR. Models were internally and externally validated. In addition, we included SHapley Additive exPlanation (SHAP) values to offer interpretable global and local prediction models.Results: All models showed a good performance in development and external validation. However, the 6-months XGBoost prediction model showed the best performance in internal (MAE average = 6.07; RSME = 78.87), and in external validation (MAE average = 6.45, RSME = 18.94). The top 3 most influential features that pushed the predicted eGFR value to lower values were the interpolated values for eGFR and creatinine, and eGFR at baseline.Conclusion: In the current study we have developed and validated machine learning models to predict the next eGFR value at different intervals. Furthermore, we attempted to approach the need for prediction explanation by offering transparent predictions.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"57-66"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144993","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