Ma H, Wang W, Dong N
… +7 more, Liu J, Yuan S, Zhang C, Zhang C, Zeng J, Yan Y, Wang Z
Ann Clin Biochem
· 2025 May · PMID 39439153
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BackgroundBlood lead test is widely conducted in Chinese laboratories, while the imprecision of blood lead measurement based on internal quality control (IQC) across China has not been comprehensively evaluated nowadays....BackgroundBlood lead test is widely conducted in Chinese laboratories, while the imprecision of blood lead measurement based on internal quality control (IQC) across China has not been comprehensively evaluated nowadays.MethodsUsing the IQC data of blood lead collected through a web-based external quality assessment (EQA) reporting system, we analysed current coefficients of variation (CVs) of blood lead from 2015 to 2023 among Chinese laboratories. Two allowable total error (TEa) imprecision levels from EQA were applied to calculate the pass rates, namely percentages of laboratories meeting precision quality specifications. Besides, CV values and pass rates by different subgroups were further performed to assess potential differences.ResultsGenerally, median CV values significantly declined year by year from 6.8% in February 2015 to 5.9% in March 2023. The pass rates based on 1/3 TEa showed upward trends increasing from 15.3% in February 2015 to 20.0% in March 2023, but these percentages were non-ideal with less than 25%. No significant differences in CVs were found between tertiary hospitals and non-tertiary hospitals and between accredited and non-accredited laboratories. Significant time trends were observed in tertiary hospitals and non-accredited laboratories. As for manufacturers, Bohui and self-made QC sample were most widely used with obvious interannual declining trends of CVs.ConclusionsThe CVs of blood lead demonstrated continuous overall improvements in the past twenty years. However, relatively lower pass rates indicated the non-ideal imprecision performance, and more proper performance specifications are warranted. Thus, imprecision improvement and ongoing investigation for blood lead IQC are still needed.
Zhang H, Sun J, Guo C
… +5 more, Feng Q, Li Y, Zhao X, Sun L, Xu C
Ann Clin Biochem
· 2025 Mar · PMID 39439152
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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, H...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) . 46.5% (46/99); = 4.84, < .001), while the SPRi chip methods present a significantly higher specificity (56.3% (9/16) . 14.5% (9/62); = 3.54, < .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.
Caravaggi E, Serana F, Carini M
… +7 more, Ferrari F, Tregambe D, Micheletti M, Martellosio G, Brugnoni D, Bresciani R, Biasiotto G
Ann Clin Biochem
· 2025 Mar · PMID 39415315
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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 i...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.
Soh SX, Loh TP, Saw S
… +4 more, Chong AT, Yap JS, Sethi SK, Ong L
Ann Clin Biochem
· 2025 Mar · PMID 39410661
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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...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 careUS 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.
Ahmed S, Elgizouli M, Kilpatrick ES
… +1 more, Morris TJ
Ann Clin Biochem
· 2025 Mar · PMID 39389087
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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...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.
Ann Clin Biochem
· 2025 Mar · PMID 39367570
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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...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.
Stephenson AA, Robinson CG, Marrington R
… +1 more, Hawley JM
Ann Clin Biochem
· 2025 Mar · PMID 39367537
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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...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.
Ann Clin Biochem
· 2025 Jan · PMID 39367523
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Vitamin B (cobalamin; B) is an essential micronutrient, but deficiency is common. The prompt diagnosis and treatment of B deficiency protects against megaloblastic anaemia, neuropathy and neuropsychiatric changes. Biomar...Vitamin B (cobalamin; B) is an essential micronutrient, but deficiency is common. The prompt diagnosis and treatment of B deficiency protects against megaloblastic anaemia, neuropathy and neuropsychiatric changes. Biomarkers of B status include the measurement of serum B (also known as total B or serum cobalamin), holotranscobalamin (holoTC or 'active B12'), methylmalonic acid (MMA) and total plasma homocysteine (Hcy). There is no 'gold standard' test for deficiency and the sensitivity and specificity of each biomarker for the evaluation of B status is affected by analytical and biological factors that may confer a high degree of diagnostic uncertainty. Limited access to technical and clinical expertise can lead to an over-reliance on the serum B test, which is readily available and highly automated. In some cases, the sequential use of different B status biomarkers or the calculation of a composite B status score, derived from a panel of B biomarkers and adjusted for folate status and age, can be used to detect deficient states that may otherwise be overlooked when using a single biomarker approach. This review summarizes the utility of B-related biomarkers and describes approaches to their application and interpretation.
Gong X, He S, Luo L
… +5 more, Ding C, Qin X, Yuan Y, Cai P, Yang L
Ann Clin Biochem
· 2025 Mar · PMID 39261111
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BackgroundTo determine delta check limits for immunoglobulins and complements in outpatients and inpatients based on patient data and biological variation due to the lack of relevant studies.MethodsPatient data for IgA,...BackgroundTo determine delta check limits for immunoglobulins and complements in outpatients and inpatients based on patient data and biological variation due to the lack of relevant studies.MethodsPatient data for IgA, IgG, IgM, IgE, C3, and C4 from 1 January 2022 to 31 December 2023 was collected from laboratory information system (LIS) in our clinical laboratory of Wuhan Union Hospital, which includes both outpatients and inpatients. The delta difference (DD), delta percent change (DPC), and reference change value (RCV) were calculated based on patient data and biological variation.ResultsFor DDs, there are significant differences between outpatients and inpatients in C4, IgE, IgG, and IgM. For DPCs, the corresponding analytes which are significantly different are C3, C4, IgE, IgG, and IgM. Two sources of CV to calculate the RCV of IgA, IgG, IgM, C3, and C4 were applied in this study, which revealed that two kinds of RCVs based on different biological variation databases are similar to each other, but both were smaller than delta check limits based on patient data, except for C4.ConclusionsThe delta check is a useful tool to monitor potential errors which may occur in total testing process. We hope our findings could be helpful for future studies focused on delta checks in immunological analytes.
Cao Dinh H, Doan DM, Tran KQ
… +2 more, Tran TT, Nguyen SL
Ann Clin Biochem
· 2025 Jan · PMID 39256357
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We introduce a 16-year-old female who presented with tender cervical lymphadenopathy, prolonged fever, and hypothyroidism. After excluding common causes of fever of unknown origin, a surgical biopsy of cervical lymph nod...We introduce a 16-year-old female who presented with tender cervical lymphadenopathy, prolonged fever, and hypothyroidism. After excluding common causes of fever of unknown origin, a surgical biopsy of cervical lymph nodes revealed Kikuchi-Fujimoto disease. The patient showed improvement with a short-term course of NSAIDs. An increased titre of thyroperoxidase antibody led to a diagnosis of Hashimoto's thyroiditis during stable condition. This report underscores the importance of considering Kikuchi-Fujimoto disease in the differential diagnosis of prolonged fever of unknown origin with lymphadenopathy and highlights the association with Hashimoto's thyroiditis, advocating for vigilance regarding hypothyroidism in long-term follow-up after Kikuchi-Fujimoto disease recovery.
Ann Clin Biochem
· 2025 Jan · PMID 39242085
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Rheumatoid arthritis (RA) is a chronic, systemic, autoimmune condition that primarily affects the joints and periarticular soft tissues. In the past two decades, the discovery of new biomarkers has contributed to advance...Rheumatoid arthritis (RA) is a chronic, systemic, autoimmune condition that primarily affects the joints and periarticular soft tissues. In the past two decades, the discovery of new biomarkers has contributed to advances in the understanding of the pathogenesis and natural history of RA. These biomarkers, including genetic, clinical, serological and imaging biomarkers, play a key role in the different stages and aspects of RA, from the so called 'pre-clinical RA', which is characterized by subclinical pathological events, such as autoimmunity and inflammation, to diagnosis (including differential diagnosis), treatment decision making and disease monitoring.This review will provide an overview on the current role of traditional and newer biomarkers in the main aspects of RA management, from the identification of individuals 'at-risk' of RA who are likely to progress to clinically evident disease, to 'early' diagnosis of RA, prognosis, precision medicine, and prediction of response to treatment.
Rojas LH, Pereira-Morales AJ, Amador W
… +3 more, Montenegro A, Buelvas W, de la Espriella V
Ann Clin Biochem
· 2025 Jan · PMID 39242084
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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...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 m) 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.
Ann Clin Biochem
· 2025 Jan · PMID 39196699
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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 diab...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 (R = 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.
Inoue N, Gowda SGB, Gowda D
… +7 more, Sakurai T, Ikeda-Araki A, Bamai YA, Ketema RM, Kishi R, Chiba H, Hui SP
Ann Clin Biochem
· 2025 Jan · PMID 39167494
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BACKGROUND: Lysophosphatidylethanolamines (lyso-PEs) are the partial hydrolysis products of phosphatidylethanolamine. Although lyso-PEs are important biomarkers in various diseases, their determination is limited by the...BACKGROUND: Lysophosphatidylethanolamines (lyso-PEs) are the partial hydrolysis products of phosphatidylethanolamine. Although lyso-PEs are important biomarkers in various diseases, their determination is limited by the lack of simple and efficient quantification methods. This study aims to develop an improved quantitative method for the determination of lyso-PEs and its application to an epidemiological study. METHODS: Single reaction monitoring channels by collision-induced dissociation for seven lyso-PEs were established using liquid chromatography-tandem mass spectrometry. Plasma lyso-PEs were extracted with a single-phase method using an isotopically labelled internal standard for quantification. The proposed method was adopted to define lyso-PEs in plasma samples of children aged 9-12 years living in Sapporo, Japan. RESULTS: The limit of detection and limit of quantification for each lyso-PE ranged between 0.001-0.015 and 0.002-0.031 pmol/L, respectively. Recoveries were found to be > 91% for all the species. The analysis results of children's plasma showed that the total lyso-PE concentrations in boys ( = 181) and girls ( = 161) were 11.53 and 11.00 pmol/L (median), respectively. Participants were further classified by the percentage of overweight and subgrouped as underweight ( = 12), normal range ( = 292), or overweight ( = 38). Interestingly, the reduction of lyso-PE 16:0 and increased lyso-PE 22:6 were observed in overweight children compared with normal range (Fold change: 0.909 and 1.174, respectively). CONCLUSIONS: This study successfully established a simple quantitative method to determine lyso-PE concentrations. Furthermore, our method revealed the possible relation between plasma lyso-PEs and overweight status.
Smith JD, Karlaftis V, Hearps S
… +5 more, Attard C, Savoia H, Campbell J, Monagle P, HAPPI Kids study team
Ann Clin Biochem
· 2024 Nov · PMID 39163146
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BACKGROUND: The detection of deficiencies in B and folate children is important. However, despite the availability of various markers to assess B and folate metabolism, there are limited studies describing the reference...BACKGROUND: The detection of deficiencies in B and folate children is important. However, despite the availability of various markers to assess B and folate metabolism, there are limited studies describing the reference intervals (RIs) and changes during growth and development for these markers in healthy children. METHODS: Using samples collected from 378 children aged 30 days-< 18 years, we derived continuous RIs for holotranscobalamin, homocysteine and red cell folate. RESULTS: The lower RI for holotranscobalamin was lowest at birth, rising during early childhood and then declining following ages 4-6 years whereas red cell folate was highest early in life and then declined steadily towards adulthood. Total homocysteine, reflective of both B and folate status was elevated early in life, reaching a nadir at age 2 and then increasing towards adulthood. CONCLUSIONS: Continuous central 95 percentile RI for holotranscobalamin, homocysteine and red cell folate for children ages 30 days to <18 years were established. Each marker shows dynamic changes throughout childhood and adolescence which will assist clinicians in more appropriately assessing B and folate status in this population.
Ibrahim A, Prasad G, Kilpatrick ES
… +1 more, Morris TJ
Ann Clin Biochem
· 2025 Jan · PMID 39099134
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This is a case of a 61-year-old lady who presented to the lipid clinic with possible familial hypercholesterolaemia (Simon Broome Criteria). She was commenced on atorvastatin; however, 4 weeks later, she developed hepati...This is a case of a 61-year-old lady who presented to the lipid clinic with possible familial hypercholesterolaemia (Simon Broome Criteria). She was commenced on atorvastatin; however, 4 weeks later, she developed hepatitis, and therefore her atorvastatin was discontinued. Following that, her liver function tests normalized, and she was diagnosed with statin-induced hepatitis. Three years later, she was seen again in the lipid clinic with an uncontrolled lipid profile, and she was commenced on alirocumab, a Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor. A few days later, she developed hepatitis, and subsequently, the alirocumab was discontinued. She underwent a liver biopsy, which confirmed that she had Autoimmune Hepatitis (AIH) with presumed superimposed drug injury. This is the first reported case of autoimmune hepatitis associated with alirocumab.
Ann Clin Biochem
· 2025 Jan · PMID 39093620
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BACKGROUND: Faecal calprotectin is an inflammatory marker used to triage patients for further investigation with suspected inflammatory bowel disease (IBD). Our current method requires faecal samples be sent to the labor...BACKGROUND: Faecal calprotectin is an inflammatory marker used to triage patients for further investigation with suspected inflammatory bowel disease (IBD). Our current method requires faecal samples be sent to the laboratory, where calprotectin is extracted before analysis. This is a time-consuming, potential bottleneck in the pathway. We have recently evaluated the OC-SENSOR PLEDIA fCAL method that uses the same sampling device as used in some bowel cancer screening and symptomatic colorectal cancer programmes that detect faecal haemoglobin. The below study is a comparison of the OC-FCa method with the BÜHLMANN fCAL Turbo which is used routinely within BSPS. METHOD: 150 homogenised and 110 non-homogenised faecal samples were loaded into OC-Sampling Bottle 3 and BÜHLMANN CALEX cap sampling devices. The samples were then analysed on their respective systems according to manufacturer's instructions. RESULTS: The OC-FCa assay had a mean positive bias of 67.3% (homogenised) and 88.4% (non-homogenised). Homogenised samples showed substantial agreement between the methods for normal (<50 µg/g) and elevated (150+µg/g) risk categories (k = 0.794, k = 0.788, respectively) and moderate agreement for borderline (51-150 µg/g) (k = 0.25) according to the current Berkshire and Surrey Pathology Service (BSPS) guidelines. Non-homogenised samples had none to slight agreement for normal and borderline values (k = 0.02 for both) and moderate agreement for elevated (k = 0.596). CONCLUSION: The OC-FCa method is a viable alternative for faecal calprotectin testing, but requires an adjustment to clinical cut-off values due to the lack of standardisation and strong positive bias. A clinical comparative study is required to assess the impact of patients collecting their own samples into the devices, as this may negate any potential degradation samples may exhibit during transit to the laboratory.
Mallikarjun DN, Jain S, Malo PK
… +5 more, Kahali B, Sundarakumar JS, Diwakar L, Ravindranath V, SANSCOG study team
Ann Clin Biochem
· 2024 Nov · PMID 39054723
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BACKGROUND: Examining the distribution of biochemical and haematological tests in different age groups of rural population is necessary to ensure that health care facilities are equipped to address the prevalent health c...BACKGROUND: Examining the distribution of biochemical and haematological tests in different age groups of rural population is necessary to ensure that health care facilities are equipped to address the prevalent health conditions and manage age-related illness effectively. Hence, this study is aimed at seeing the distributions of blood biochemical and haematological parameters in rural population. METHODS: This cross-sectional study investigated the distribution of 26 different haematological and biochemical parameters in longitudinal cohort study (Srinivaspura Aging, NeuoSenescence and COGnition - SANSCOG), from the villages of Srinivaspura, Kolar district, India. A total of 2592 participants (1240 males and 1352 females), aged ≥45 years who are cognitively healthy were included for the analysis. Mean, 2.5, 5, 25, 50, 75, 95 and 97.5 percentiles were calculated for the entire sample. Additionally, median and percentiles were determined for both gender and age categories (45-54, 55-64, 65-74, and ≥75 years). RESULTS: We observed the distinct distributions of various haematological and biochemical parameters, with elevated levels of glycaemic, lipid, liver, and thyroid parameters. CONCLUSION: Findings revealed the notable variations from the established reference ranges, indicating the potential undiagnosed cases and highlighting the gaps in health awareness and health seeking behaviour.