Sarrah Lahorewala, Zheng Yin, Jacob Kinskey, Shane A Bobart, Angelina Edwards, Paul Christensen, Roger L Bertholf, Xin Yi
{"title":"eGFR Inaccuracy in the Assessment of Living Kidney Transplant Donor Eligibility.","authors":"Sarrah Lahorewala, Zheng Yin, Jacob Kinskey, Shane A Bobart, Angelina Edwards, Paul Christensen, Roger L Bertholf, Xin Yi","doi":"10.1093/clinchem/hvaf071","DOIUrl":"10.1093/clinchem/hvaf071","url":null,"abstract":"<p><strong>Background: </strong>Accurate glomerular filtration rate (GFR) estimation is crucial for evaluating living kidney donors, especially when measured GFR (mGFR) is unavailable. This study compares the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), full age spectrum (FAS), and European Kidney Function Consortium (EKFC) creatinine- and/or cystatin C-based estimated GFR (eGFR) equations against iohexol mGFR to determine the optimal equation for donor eligibility assessment in a US population.</p><p><strong>Methods: </strong>1210 kidney donor candidates were retrospectively analyzed, comparing eGFR equations based on creatinine, cystatin C, or both against iohexol mGFR. Accuracy metrics (P10, P30, mean bias) and subgroup analyses for Black donors and age-based bias were evaluated. The classification performance of eGFR equations in donor eligibility was examined.</p><p><strong>Results: </strong>The 2021 CKD-EPIcr [AS (age, sex)] demonstrated the best accuracy across the overall cohort (P10 48.2%, P30 93.2%, mean bias -4.8 mL/min/1.73 m²). The 2021 CKD-EPIcr-cys (AS) excelled in Black donors (P10 60.3%, P30 95.4%, mean bias -3.6 mL/min/1.73 m²). Cystatin C-based equations showed higher negative bias, with the largest underestimation observed in older donors. All equations demonstrated <35% positive predictive value (PPV) for rejecting ineligible donors (<60 mL/min/1.73 m²) but >85% PPV in determining acceptable donors (≥90 mL/min/1.73 m²). Overall, 2021 CKD-EPIcr-cys (AS) was the most reliable for identifying acceptable donors (F1 score 83.9 at ≥90 mL/min/1.73 m²). Using age/sex-specific thresholds improved performance of all equations in donor eligibility classification compared to absolute thresholds.</p><p><strong>Conclusions: </strong>No eGFR equation reliably rejected ineligible donors. 2021 CKD-EPIcr-cys (AS) exhibited the best overall performance for donor eligibility assessment.</p>","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"870-883"},"PeriodicalIF":6.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rosalie M Sterner,Farha Sherani,Margaret A DiGuardo,Patricia T Greipp,Ann M Moyer
{"title":"An Ambiguous NUDT15 Signal in a Child with B-cell Acute Lymphoblastic Leukemia.","authors":"Rosalie M Sterner,Farha Sherani,Margaret A DiGuardo,Patricia T Greipp,Ann M Moyer","doi":"10.1093/clinchem/hvaf028","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf028","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"15 1","pages":"835-839"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144756083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Toward Improved Prostate Cancer Screening: Insights from the Göteborg-2 Trial.","authors":"Jacob E Tallman, Sigrid V Carlsson, Hans Lilja","doi":"10.1093/clinchem/hvaf032","DOIUrl":"10.1093/clinchem/hvaf032","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"832-834"},"PeriodicalIF":6.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Discordance between Cystatin C-Based and Creatinine-Based Estimated Glomerular Filtration Rate as a Measure of Health.","authors":"Sharanya Ramesh,Lesley A Inker","doi":"10.1093/clinchem/hvaf079","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf079","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"9 1","pages":"829-831"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144756157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction to: Challenges in Hb A1c Point-of-Care Testing: Only 5 of 19 Hb A1c Point-of-Care Devices Meet IFCC and NGSP Certification Criteria on Independent Evaluation.","authors":"","doi":"10.1093/clinchem/hvaf075","DOIUrl":"10.1093/clinchem/hvaf075","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"922"},"PeriodicalIF":6.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144552535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Commentary on An Ambiguous NUDT15 Signal in a Child with B-Cell Acute Lymphoblastic Leukemia.","authors":"Wanxia Gai","doi":"10.1093/clinchem/hvaf042","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf042","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"217 1","pages":"839-840"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144756159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Commentary on An Ambiguous NUDT15 Signal in a Child with B-Cell Acute Lymphoblastic Leukemia.","authors":"Reynold C Ly","doi":"10.1093/clinchem/hvaf069","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf069","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"11 1","pages":"840-841"},"PeriodicalIF":9.3,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144756126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"From Laptop to Laboratory: Development and Implementation of a Machine Learning Model for Detecting Iron-Deficiency Anemia.","authors":"Nicholas C Spies","doi":"10.1093/clinchem/hvaf083","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf083","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"14 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144720024","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nicola J Flowers, Clare J Love, Katrina L Scarff, Olivia Giouzeppos, Alison D Archibald, Martin B Delatycki, Mark D Pertile
{"title":"Assessment of Placental Chromosomal Mosaicism during Prenatal Cell-Free DNA Screening Refines Positive Predictive Values for Fetal Trisomy","authors":"Nicola J Flowers, Clare J Love, Katrina L Scarff, Olivia Giouzeppos, Alison D Archibald, Martin B Delatycki, Mark D Pertile","doi":"10.1093/clinchem/hvaf076","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf076","url":null,"abstract":"Background Confined placental mosaicism can cause false-positive prenatal cell-free DNA (cfDNA) screening results, thereby reducing the positive predictive value (PPV) of the test. We sought to investigate how PPVs for the common fetal trisomies can be refined based on the presence or absence of chromosomal mosaicism in cfDNA sequencing data. Methods The study cohort included singleton pregnancies tested between March 2019 and December 2021. Outcome data were requested for high-risk results. Mosaic ratio (MR) generated by VeriSeq NIPT Solution v2 was used to classify high-risk cfDNA results as mosaic trisomy (MR &lt; 0.7) or non-mosaic trisomy (MR ≥ 0.7) and the PPVs calculated. Results The cohort consisted of 821 high-risk results from 76 329 tests (1.08%). Prior to applying MR, PPVs for T21, T18 and T13 were 93.3% [95% CI 90.2–95.5], 81% [95% CI 73.1–87.0], and 55.3% [95% CI 44.7–65.4], respectively. After applying MR, PPVs for non-mosaic trisomy results were significantly higher (P &lt; 0.001) than the PPVs for mosaic trisomy results; T21: 99.3% and 50%, T18: 97.6% and 22.7%, T13: 93.9% and 0%, respectively. Conclusions Mosaic ratio can be used to calculate more specific PPVs for the common trisomies. There is currently limited guidance on the application of VeriSeq v2 MR. Our approach provides a framework for laboratories to consider using MRs to refine PPV estimates for the common trisomies. High-risk cfDNA screening results are distressing for tested individuals. A refined PPV incorporating the presence or absence of mosaicism provides patients with more accurate information on the likely outcome of the diagnostic testing result, helping guide genetic counseling, choice of prenatal procedure, and overall pregnancy management.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"710 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144719394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Isaiah K Mensah,Vahid Azimi,Christopher W Farnsworth
{"title":"Continuous Glucose Monitors Have Acceptable Accuracy but High Discordance at High and Low Glucose Concentrations in Pediatric Hospitalized Patients.","authors":"Isaiah K Mensah,Vahid Azimi,Christopher W Farnsworth","doi":"10.1093/clinchem/hvaf080","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf080","url":null,"abstract":"BACKGROUNDContinuous glucose monitors (CGMs) assess interstitial glucose concentrations and improve diabetes management in outpatient settings. However, limited studies have assessed CGM performance in hospitalized pediatric patients, especially at high and low glucose thresholds near clinical decision limits.METHODSThis retrospective study included 72 hospitalized pediatric patients with dysglycemia who used CGMs during hospitalization. Paired CGM results within 10 min of laboratory (Lab) and point-of-care (POC) glucose results were retrieved. The mean absolute relative difference (MARD) and percentage of glucose values in acceptable Parkes error zones were assessed. Concordance of CGM and POC results and the frequency that CGM results <70 mg/dL and >180 mg/dL were confirmed (-15 min to +30 min) using POC was assessed.RESULTSThere were 2228 paired CGM and Lab or POC glucose results with a MARD of 14.8%, and 99.2% of results were in Parkes zones A and B. The MARD was 20.2% and 13.6% in the hypoglycemic and hyperglycemic ranges. The MARD for POC glucose meters was 15.6% and 8.2% for the hypoglycemic and hyperglycemic ranges. The Cohen kappa between CGM and POC was 0.66 (95% CI, 0.63-0.69). CGM results in the hypoglycemic and hyperglycemic ranges were repeated 80.2% and 16.5% of the time, respectively, with POC methods.CONCLUSIONThe MARD of CGM in hospitalized pediatric patients is clinically acceptable but there is high discordance between CGM and POC. This implies a clinical need to confirm high and low glucose concentrations with Lab or POC methods but confirmatory testing is commonly not performed.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"55 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144701037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}