Annals of Clinical Biochemistry最新文献

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Thyroid Reference Ranges in Pregnancy Utilizing an Abbott Alinity Platform in a Multi-Ethnic Population in the UK.
IF 2.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-03-28 DOI: 10.1177/00045632251333286
Rebecca Scott, Mariana Abdel-Malek, Jun Zhu, Joanna Tan, Darmiga Thayabaran, Rajalakshmi Valaiyapathi, Pritpal Singh Padam, Emma Jackson, Sophie Barnes, Hanine Fourie, Maya Al-Memar, Christopher Kyriacou, Megumi Nimura, Thomas Bourne, Nicholas Martin, Rochan Agha-Jaffar, Bryony Jones, Bernard Khoo, Tricia Tan
{"title":"Thyroid Reference Ranges in Pregnancy Utilizing an Abbott Alinity Platform in a Multi-Ethnic Population in the UK.","authors":"Rebecca Scott, Mariana Abdel-Malek, Jun Zhu, Joanna Tan, Darmiga Thayabaran, Rajalakshmi Valaiyapathi, Pritpal Singh Padam, Emma Jackson, Sophie Barnes, Hanine Fourie, Maya Al-Memar, Christopher Kyriacou, Megumi Nimura, Thomas Bourne, Nicholas Martin, Rochan Agha-Jaffar, Bryony Jones, Bernard Khoo, Tricia Tan","doi":"10.1177/00045632251333286","DOIUrl":"https://doi.org/10.1177/00045632251333286","url":null,"abstract":"<p><p>Objective To establish new trimester-specific reference ranges for thyroid function tests - thyroid stimulating hormone (TSH), free thyroxine (fT4) and free triiodothyronine (fT3) - in a diverse multi-ethnic population using the Abbott Alinity analyser, in accordance with the 2017 American Thyroid Association Guidelines for the Diagnosis and Management of Thyroid disease during Pregnancy and the Postpartum. Design Reference ranges (defined as 2.5th-97.5th centile) were established for TSH, fT4 and fT3 from prospective samples from 663 iodine-replete healthy pregnant people with no history of thyroid dysfunction nor positive thyroid peroxidase antibodies, recruited from a large multi-ethnic urban maternity centre. Results The reference ranges for TSH were 0.06-2.73 mIU/l, 0.02-2.47 mIU/l and 0.41-2.80 mIU/l in the 1st, 2nd and 3rd trimesters. For fT4, the reference ranges were 9.9-15.3pmol/l, 8.5-14.4 pmol and 7.6-12.3 pmol/l in the 1st, 2nd and 3rd trimesters. For fT3, the reference ranges were 3.4-5.6 pmol/l, 3.3-5.5 pmol/l and 3.1-5.0 pmol/l in the 1st, 2nd and 3rd trimesters. There were no significant differences in reference ranges when the results from white and non-white participants were compared. Conclusions This study reports gestation- and trimester-specific reference ranges for thyroid function tests using the Abbott Alinity assay platform, to improve the care of pregnant people with thyroid dysfunction.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251333286"},"PeriodicalIF":2.1,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143741890","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
Comparison of three blood collection tubes for 16 biochemical analytes and stability assessment of selected analytes: VACUETTE® CAT serum Sep clot activator tube, VACUETTE® LH lithium heparin Sep tube, and VACUETTE® CAT serum fast separator tube.
IF 2.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-03-25 DOI: 10.1177/00045632251329272
Jong Do Seo, Yeon Jae Lee, Changhee Ha, Ju Hee Choi, Seon-Hyeon Shin, Hye Young Han, Hyun-Joong Kim, Sung Hea Kim, Bum Sung Kim, Hanah Kim, Hee-Won Moon, Mina Hur, Yeo-Min Yun
{"title":"Comparison of three blood collection tubes for 16 biochemical analytes and stability assessment of selected analytes: VACUETTE<sup>®</sup> CAT serum Sep clot activator tube, VACUETTE<sup>®</sup> LH lithium heparin Sep tube, and VACUETTE<sup>®</sup> CAT serum fast separator tube.","authors":"Jong Do Seo, Yeon Jae Lee, Changhee Ha, Ju Hee Choi, Seon-Hyeon Shin, Hye Young Han, Hyun-Joong Kim, Sung Hea Kim, Bum Sung Kim, Hanah Kim, Hee-Won Moon, Mina Hur, Yeo-Min Yun","doi":"10.1177/00045632251329272","DOIUrl":"https://doi.org/10.1177/00045632251329272","url":null,"abstract":"<p><p>BackgroundAnalytical performance of VACUETTE® CAT Serum Fast Separator Tube (SFT; Greiner Bio-One, Austria), recently developed quick-clotting serum separator, was evaluated for correlation and stability, comparing with VACUETTE® CAT Serum Sep Clot Activator Tube (SST; Greiner Bio-One) and VACUETTE® LH Lithium Heparin Sep Tube (LiHep Tube; Greiner Bio-One).MethodFor 107 paired samples, 16 analytes (glucose, potassium, LDH, CRP, creatinine, AST, ALT, ALP, GGT, AFP, PSA, TSH, free T4, iPTH, CK-MB, and cardiac troponin I[cTnI]) were measured. Correlations were assessed using Passing-Bablok regression and paired t-tests. Differences were evaluated by comparing the mean percentage difference and estimated difference at medical decision limits (MDLs), to the acceptable desirable difference. For six analytes - glucose, potassium, LDH, AST, iPTH, and cTnI - known for different stabilities between sample types, stability was evaluated by comparing changes over time with desirable differences.ResultsAcross the evaluated range, SFT showed clinically comparable differences to SST, except for CK-MB which showed significant positive bias. Plasma exhibited unacceptable biases: negative for potassium and positive for LDH and CK-MB. Estimated differences at MDLs were acceptable in SFT except for potassium and CK-MB, while plasma showed unacceptable differences in potassium, LDH, creatinine, and CK-MB. LiHep Tube showed reduced stability than SST for all analytes except for iPTH, impairing retest reliability. SFT showed comparable stability except for LDH and iPTH, which showed slightly shortened stability.ConclusionsThe SFT demonstrated high correlation and comparable stability to SST, making it a suitable replacement for the LiHep Tube, as an alternative to SST for rapid testing.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251329272"},"PeriodicalIF":2.1,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143707897","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
Underreporting of synthetic cathinone poisoning with clinical immunoassays: An experimental and observational study.
IF 2.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-03-21 DOI: 10.1177/00045632251331404
Théo Willeman, Mathis Laudet, Bruno Revol, Coralie Boudin, Hélène Eysseric-Guerin, Virginie Scolan, Françoise Stanke-Labesque
{"title":"Underreporting of synthetic cathinone poisoning with clinical immunoassays: An experimental and observational study.","authors":"Théo Willeman, Mathis Laudet, Bruno Revol, Coralie Boudin, Hélène Eysseric-Guerin, Virginie Scolan, Françoise Stanke-Labesque","doi":"10.1177/00045632251331404","DOIUrl":"10.1177/00045632251331404","url":null,"abstract":"<p><p>BackgroundThere is an increasing global concern about the use of synthetic cathinones (SCs). Detecting these drugs in human urine samples can be difficult, particularly in emergency settings. Cross-reactivity has been described for several immunoassays. We evaluated the analytical interference caused by common SCs in MDMA and amphetamine assays that use the EMIT® Atellica CH (Siemens Healthineers) with both clinical and in vitro experimental data.MethodsDrug-free urine samples were spiked with various concentrations (5 to 100 µg/mL) of 2-methylmethcathinone (MMC), 3-MMC, 4-MMC, 3-chloromethcathinone (CMC), methylone and alpha-PHP and tested using EMIT® assays. The percentage of false-positive results was determined in urine samples from patients above 18 years of age admitted to the ICU or emergency department who underwent routine toxicology screening and urine immunoassays over a 4-year period. Confirmatory analyses of SC were performed by mass spectrometry techniques.ResultsFalse-positive results occurred for the MDMA assay with methylone (10 µg/mL) and 3-CMC (100 µg/mL) and for the amphetamine test with 2-MMC (50 µg/mL). We studied 2033 urine samples from 1812 patients (mean age 39 years, 61.8% male), of which 49 tested positive for amphetamine and 76 for MDMA. SCs were responsible for a false-positive rate of 16.3% for the amphetamine tests and 17.1% for the MDMA tests. Most of the false-positive tests occurred among young male patients (mean age 38 years, 92.8% male).ConclusionsThis study demonstrates that SC intoxication may be underreported in immunoassay toxicology testing. Due to a lack of specificity of screening immunoassay methods, positive results for amphetamine-type stimulants should be confirmed by specific MS methods.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251331404"},"PeriodicalIF":2.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673195","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 five-year retrospective analysis of a national external quality assessment program for urinary organic acid analysis in newborn screening for inherited metabolic disorders in China.
IF 2.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-03-21 DOI: 10.1177/00045632251332460
Yuxuan Du, Wei Wang, Yanling Yang, Zhiguo Wang
{"title":"A five-year retrospective analysis of a national external quality assessment program for urinary organic acid analysis in newborn screening for inherited metabolic disorders in China.","authors":"Yuxuan Du, Wei Wang, Yanling Yang, Zhiguo Wang","doi":"10.1177/00045632251332460","DOIUrl":"10.1177/00045632251332460","url":null,"abstract":"<p><p>ObjectivesUrinary organic acid analysis is crucial for diagnosing inherited metabolic disorders (IMDs). This study assesses the impact of an external quality assessment (EQA) scheme on standardizing urinary organic acid detection in China from 2019 to 2023.MethodsThis retrospective longitudinal study analysed data from the NCCL-E-25 EQA scheme for urinary organic acid analysis using gas chromatography-mass spectrometry (GC-MS). Ten batches of EQA data over 5 years were included, focussing on eight key organic acid metabolites. Robust statistical methods were used to evaluate laboratory performance, including regional variations, sample preparation methods, and laboratory types.ResultsParticipating laboratories increased from 43 in 2019 to 76 in 2023, with high participation rates (median 94.74%). All eight target compounds showed significant reductions in robust coefficient of variation (CV) over time. Regional performance disparities narrowed, converging by 2022-2023. Extraction preparation methods generally outperformed non-extraction methods. Newborn Screening Centers (NBSCs) demonstrated lower robust CVs compared to non-NBSCs.ConclusionsThe EQA scheme effectively improved and standardized laboratory testing quality nationwide, particularly benefiting central and western regions. The study highlights the importance of standardized protocols and continuous improvement in enhancing IMD diagnostic accuracy. Future efforts should focus on encouraging wider participation, especially from underrepresented regions, and integrating quantitative and diagnostic capability assessments to comprehensively evaluate laboratory performance.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251332460"},"PeriodicalIF":2.1,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673194","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
Decrease in the internal quality control intermediate reproducibility imprecision of Cystatin C results in China in the years from 2014 to 2023.
IF 2.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-03-14 DOI: 10.1177/00045632251329182
Zhixin Zhang, Jie Zeng, Wei Wang, Yuxuan Du, Shuai Yuan, Na Dong, Chuanbao Zhang, Zhiguo Wang
{"title":"Decrease in the internal quality control intermediate reproducibility imprecision of Cystatin C results in China in the years from 2014 to 2023.","authors":"Zhixin Zhang, Jie Zeng, Wei Wang, Yuxuan Du, Shuai Yuan, Na Dong, Chuanbao Zhang, Zhiguo Wang","doi":"10.1177/00045632251329182","DOIUrl":"10.1177/00045632251329182","url":null,"abstract":"<p><p>ObjectivesWe evaluated the intermediate reproducibility imprecision of cystatin C results based on internal quality control (IQC) data.MethodsIQC data for cystatin C analyte were collected each year from 2014 to 2023. We used the coefficient of variation (CV) to evaluate the level of laboratory imprecision. Five performance specifications [1/3 total allowable error (TEa), 1/4TEa and three levels performance specifications based on biological variation] were used to calculate the proportion of laboratories with CVs less than or equal to the performance specifications, namely, the pass rate. Based on the reference interval of Chinese adult serum cystatin C (0.59-1.03 mg/L), the concentration of quality control materials was divided into two levels for CV analysis: Level 1 (≤1.03 mg/L) and Level 2 (>1.03 mg/L). Additionally, group analysis was conducted according to the reagent manufacturer. Peer groups were further divided based on instruments to study differences between instruments. Boxplots were drawn to analyze trends in CVs, and differences in CVs among different groups were assessed using the Kruskal-Wallis test and Mann-Whitney U test.ResultsThe number of participating laboratories increased significantly from 255 in 2014 to 1814 in 2023. The intermediate reproducibility imprecision of Cystatin C IQC results in China had decreased from 5.1% (CV%) in 2014 to 3.3% in 2023. The pass rates based on 1/3 TEa showed upward trends increasing from 67% in 2014 to 88% in 2023. The pass rates for the other four performance specifications were all below 80%. The CVs of two concentration levels showed significant differences in most years. Roche Diagnostics reagent manufacturer exhibited low intermediate reproducibility imprecision. The BSBE-Abbott Architect series platform achieved a 100% pass rate based on 1/3 TEa in 2023.ConclusionsThe intermediate reproducibility imprecision of cystatin C has been a continuous overall improvement in China. However, the performance specifications of Cystatin C based on BV are currently not applicable to some laboratories in China. In addition, attention should be paid to the differences in intermediate reproducibility imprecision between various analysis systems.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251329182"},"PeriodicalIF":2.1,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630069","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
Importance of the preanalytical phase: Elevation of protein levels in cerebrospinal fluid samples due to inappropriate containers.
IF 2.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-03-14 DOI: 10.1177/00045632251330749
Alberto Izquierdo-Martínez, Carmen Sánchez-Palacios
{"title":"Importance of the preanalytical phase: Elevation of protein levels in cerebrospinal fluid samples due to inappropriate containers.","authors":"Alberto Izquierdo-Martínez, Carmen Sánchez-Palacios","doi":"10.1177/00045632251330749","DOIUrl":"10.1177/00045632251330749","url":null,"abstract":"<p><p><b>Background:</b> Biomarkers in cerebrospinal fluid (CSF) are crucial for diagnosing, monitoring, and prognosing neurological disorders.<b>Purpose:</b> This study evaluates the impact of preanalytical variables, particularly container choice, on CSF protein measurements.<b>Analysis:</b> Using 30 CSF samples, we compared sterile, additive-free tubes and lithium heparin tubes without separator gel.<b>Results:</b> Protein levels were significantly elevated higher in heparin tubes (mean difference: 230.71 mg/dL, <i>P</i> < .001).<b>Conclusions:</b> This overestimation underscores the necessity of adhering to preanalytical protocols to avoid erroneous clinical interpretations and ensure accurate diagnostic outcomes.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251330749"},"PeriodicalIF":2.1,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630073","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 SIMPLER AND MORE SENSITIVE MODIFIED CATALYTIC (BLEOMYCIN DETECTABLE) IRON ASSAY.
IF 2.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-03-14 DOI: 10.1177/00045632251330176
Mohan M Rajapurkar, Banibrata Mukhopadhyay, Suhas S Lele, Sudhir V Shah
{"title":"A SIMPLER AND MORE SENSITIVE MODIFIED CATALYTIC (BLEOMYCIN DETECTABLE) IRON ASSAY.","authors":"Mohan M Rajapurkar, Banibrata Mukhopadhyay, Suhas S Lele, Sudhir V Shah","doi":"10.1177/00045632251330176","DOIUrl":"https://doi.org/10.1177/00045632251330176","url":null,"abstract":"<p><strong>Background: </strong>Iron is ubiquitously distributed in biology, only a miniscule amount exists as free is capable of catalysing production of highly toxic reactive hydroxyl radicle. This free iron also called; labile iron, non-transferrin bound iron or catalytic iron (CI). CI is measured by bleomycin-detectable iron assay. The assay as described originally was difficult to perform accurately and reproducibly due to variations of pH in the assay mixture and due to the lack of properly diluted iron standards.</p><p><strong>Methods: </strong>. In our laboratory we modified the assay for serum/plasma so that the variations of pH in assay medium were constantly between 7.4 to 7.6 using acid diluted iron standards by multiple treatments of Chelex resin which is alkaline.</p><p><strong>Results: </strong>Intra assay CV for low, medium, and high levels of catalytic iron was 0.05%, 0.61% and 0.68% whereas the interassay CV was 0.06%, 0.96% and .28% respectively. The modified assay is highly sensitive being able to detect levels as low as 0.1 μ mol/l. In patients on maintenance haemodialysis CI measured by the original assay failed to detect any catalytic iron in almost all of these samples whereas by modified method it was measurable in all patients with a mean of 0.66 ± 0.10 μ mol/l.. Normal values for catalytic iron in subjects having no comorbidities measured by modified method is 0.11± 0.06 µ moles/l.</p><p><strong>Conclusions: </strong>The modified assay is reproducible and more sensitive than original assay and has been validated in several clinical studies.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251330176"},"PeriodicalIF":2.1,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630066","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
'Tired all the time': What general practitioners request and find in patients with tiredness/fatigue - an audit against NICE clinical knowledge summary of tiredness/fatigue in adults.
IF 2.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-03-14 DOI: 10.1177/00045632251329175
Sava Handjiev, Jennifer Nobes, Michael J Murphy
{"title":"'Tired all the time': What general practitioners request and find in patients with tiredness/fatigue - an audit against NICE clinical knowledge summary of tiredness/fatigue in adults.","authors":"Sava Handjiev, Jennifer Nobes, Michael J Murphy","doi":"10.1177/00045632251329175","DOIUrl":"10.1177/00045632251329175","url":null,"abstract":"<p><p>BackgroundTiredness/fatigue is a common presenting complaint in primary care. Advice is available from the National Institute for Health and Care Excellence (NICE) Clinical Knowledge Summary (CKS) on its investigation. The application of this guidance has not been reported.AimTo audit the investigation of tiredness/fatigue in adults in primary care against NICE CKS recommendations.MethodsWe reviewed 16,889 primary care requests in 2019, where clinical details included: 'tired all the time' or 'TATT'; 'tired (ness)'; 'fatigue'. We report on how many first-line investigations recommended by the NICE CKS were requested, and, if they were, what the outcome was. We categorised outcomes as normal or abnormal, using relevant laboratory reference intervals.ResultsFirst-line investigations were requested, in decreasing order of frequency, as follows: full blood count (FBC) 89%, renal function (U&Es) 83%, liver function tests (LFTs) 80%, thyroid-stimulating hormone (TSH) 80%, bone profile 70%, C-reactive protein (CRP) 66%, plasma viscosity (PV) 46%, ferritin 9.4%, IgA tissue transglutaminase (TTG) 3.2%, and creatine kinase (CK) 1.4%. Likelihood of abnormal results was 37% for PV, 26% for ferritin, 25% for LFTs, 24% for bone profile, 23% for FBC, 15% for U&Es, 14% for CRP, 10% for TSH, 8% for CK, and 3% for TTG. (Requesting of diagnostic HbA1c (2.8%) was vetted in accordance with a local protocol; 59% of results were in the diabetic range).ConclusionThis is the first study to audit the application in primary care of NICE CKS advice on investigation of tiredness/fatigue in adults. Our findings provide an insight into 'real-world' primary care requesting behaviour, and outcomes of investigations.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251329175"},"PeriodicalIF":2.1,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630092","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
Sigma metrics for assessing the analytical performance of 14 biochemical analytes in Mansoura university children's hospital laboratories (MUCHLs) using CLIA LIMITS 1988 & 2024.
IF 2.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-03-14 DOI: 10.1177/00045632251330163
Nada Karam, Reham M El-Farahaty, Abdel-Hady El-Gilany, Nessma A Nosser
{"title":"Sigma metrics for assessing the analytical performance of 14 biochemical analytes in Mansoura university children's hospital laboratories (MUCHLs) using CLIA LIMITS 1988 & 2024.","authors":"Nada Karam, Reham M El-Farahaty, Abdel-Hady El-Gilany, Nessma A Nosser","doi":"10.1177/00045632251330163","DOIUrl":"10.1177/00045632251330163","url":null,"abstract":"<p><p>IntroductionAnalytical quality is a crucial prerequisite for best practice in medical laboratory. Six-Sigma Methodology (SM) is a quality measurement tool used to evaluate laboratory performance. This study aims to assess the analytical phase baseline performance using SM and compare results using TEa of CLIA 1988 and CLIA 2024.Materials and methodsCoefficient of variation and bias were determined for 14 analytes. The sigma level for each parameter was calculated using total allowable error (TEa) for CLIA 1988 and CLIA 2024. The quality goal index ratio was calculated for analytes with Sigma less than 3. Normalized method decision Charts were plotted for level 1 and 2 Bio-Rad internal quality control for both CLIA 1988 and 2024.ResultsUsing CLIA TEa 1988, HDL-C, triglycerides & uric acid for level 1 and ALT, AST, HDL-C, calcium, triglycerides & uric acid for level 2 had six Sigma world class performance, meanwhile, only BUN for level 1 and 2 performed less than 3. Using CLIA TEa 2024, HDL-C, GGT, and triglycerides for level 1 and ALT, AST, calcium, GGT, and triglycerides for level 2 had world class quality performance. Meanwhile, creatinine, glucose, BUN for level 1 and BUN and creatinine for level 2 performed less than 3.ConclusionEvaluation of baseline analytical performance using SM revealed lower sigma values with stringent CLIA TEa 2024 versus tolerant CLIA TEa 1988. Improvement in the methodology of analytes with poor performance on some assay platforms with stringent quality control regimes is recommended.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251330163"},"PeriodicalIF":2.1,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630089","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
Elevated lactate dehydrogenase and reflexive myeloproliferative neoplasm molecular diagnostics.
IF 2.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2025-03-11 DOI: 10.1177/00045632251324811
Stephen E Langabeer
{"title":"Elevated lactate dehydrogenase and reflexive myeloproliferative neoplasm molecular diagnostics.","authors":"Stephen E Langabeer","doi":"10.1177/00045632251324811","DOIUrl":"https://doi.org/10.1177/00045632251324811","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251324811"},"PeriodicalIF":2.1,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603713","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
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