{"title":"Evaluation of a laboratory reflex testing protocol to detect hypopituitarism in primary care presenting as hypothyroxinaemia.","authors":"Colleen Flannery, Ana Rakovac, Gerard Boran","doi":"10.1177/00045632241298891","DOIUrl":"10.1177/00045632241298891","url":null,"abstract":"<p><p>BackgroundThyroid function tests (TFTs) are routinely requested by general practitioners (GPs) in the clinical biochemistry laboratory. Hypothyroxinaemia (low fT4) accompanied by TSH within the reference interval (RI) is a discordant pattern which is seen commonly in non-thyroidal illness and also as result of medications. Hypopituitarism is a lot rarer, but a serious condition the laboratory does not want to miss.MethodsAll thyroid hormone samples from primary care meeting the discordant case definition under investigation [fT4<10 pmol/L and TSH within RI (0.3-4.2 mU/L)] had partial anterior pituitary profiles [PAPP (cortisol, oestradiol/testosterone, prolactin, gonadotrophins)] added as reflex tests and results interpreted by a chemical pathologist. From January to June 2023, we conducted structured interviews with the requesting GPs, and, where indicated, requested repeat samples for full anterior pituitary profile [FAPP (PAPP, growth hormone (GH) and insulin-like growth factor 1 (IGF-1)]. We also reviewed the laboratory records of patients with previously known hypopituitarism to determine their fT4 and TSH values at diagnosis.ResultsOver the 6 months 41,487 GP TFTs were requested; 54 (0.13%) fitted the discordant case definition and had PAPP reflexed. 13 FAPPs were requested. We identified 3 cases of hypopituitarism. The number of additional tests required to diagnose 1 case of hypopituitarism was 129. In 74% of reflex-tested cases, there was a plausible explanation for the TFT pattern (medications, known thyroid dysfunction, non-thyroidal illness, pregnancy).ConclusionThis study highlights the importance of medical liaison and early intervention in a biochemistry laboratory in identifying cases of unsuspected hypopituitarism.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"118-125"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142563854","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}
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":"<p><p>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.</p>","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}
{"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":"<p><p>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.</p>","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}
{"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":"<p><p>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.</p>","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}
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":"<p><p>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.</p>","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}
{"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":"<p><p>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) <i>vs</i>. 46.5% (46/99); <i>z</i> = 4.84, <i>P</i> < .001), while the SPRi chip methods present a significantly higher specificity (56.3% (9/16) <i>vs</i>. 14.5% (9/62); <i>z</i> = 3.54, <i>P</i> < .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.</p>","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}
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":"<p><p>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<sup>TM</sup> 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.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"148-152"},"PeriodicalIF":2.1,"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}
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":"<p><p>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.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"143-147"},"PeriodicalIF":2.1,"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}
{"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":"<p><p>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.</p>","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}
Jemima M Curran, Katherine Onions, Jessica Watts, Arnab Rana, Emma Hughes, James Allison, Jamie G Cooper
{"title":"Ubiquitin C-terminal hydrolase-L1 and glial fibrillary acidic protein tandem brain biomarker test in the prediction of CT evident brain injury: A prospective evaluation in the emergency department.","authors":"Jemima M Curran, Katherine Onions, Jessica Watts, Arnab Rana, Emma Hughes, James Allison, Jamie G Cooper","doi":"10.1177/00045632251326483","DOIUrl":"10.1177/00045632251326483","url":null,"abstract":"<p><p><b>Background:</b> Patients with features of mild traumatic brain injury (mTBI) frequently present to the emergency department (ED) and often meet recognized criteria for CT head imaging. Observational studies suggest that use of a tandem ubiquitin C-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) brain biomarker test may significantly reduce need for CT scanning in this population, though data on patient flow are lacking.<b>Methods:</b> A prospective cohort evaluation of adult ED patients (≥18 years) with features of mTBI who met criteria for CT imaging within 12 hours of head injury had blood drawn for laboratory UCH-L1/GFAP testing. The diagnostic performance for CT-evident brain injury was expressed through the calculation of sensitivity and negative predictive value (NPV) with 95% confidence intervals (95% CI). Times from venepuncture to biomarker result availability, and from CT request to result availability were compared.<b>Results:</b> A laboratory UCH-L1/GFAP test identified 21 of 89 (24%) patients as low-risk for CT-evident TBI with a sensitivity of 100% (95% CI 76%-100%) and NPV of 100% (95% CI 85%-100%). The median time to biomarker and CT results were 88 minutes and 89 minutes, respectively. However, 68 (76%) of patients with a positive biomarker test would then progress to CT imaging, significantly prolonging ED length of stay, and restricting usefulness in adoption into clinical pathways.<b>Conclusion:</b> Evaluation of a laboratory UCH-L1/GFAP test in a UK population with mTBI demonstrates excellent performance for the exclusion of CT-evident brain injury. However, adoption into clinical patient pathways is likely to be limited until the test is available in whole blood at the point-of-care, and evidence of safe rationalization of CT imaging confirmed in randomized studies.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251326483"},"PeriodicalIF":2.1,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531189","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}