{"title":"Direct-to-Consumer Testing: Benefits and Concerns of Commercially Accessed Laboratory Tests.","authors":"Matthias Orth, Sverre Sandberg, Patti Shih","doi":"10.1093/clinchem/hvaf004","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf004","url":null,"abstract":"<p><strong>Background: </strong>Promoting self-empowerment of patients and of healthy persons in contemporary health cultures shifts the imperative for initiating laboratory tests from the healthcare professionals (HCP) to the patients themselves.</p><p><strong>Content: </strong>Laboratory testing requested directly by patients without interaction by HCP is called DTCT (direct-to-consumer testing). DTCT is not conducted within traditional healthcare systems, and the regulations that protect the patients in healthcare are not necessarily present in DTCT. Aggressive marketing of DTCT may mislead the consumer, resulting in psychological, physical, and financial harm. The benefit of laboratory testing is dependent on being used on selected persons, with samples collected and stored appropriately, measured with an adequate technique and the test results interpreted properly. DTCT can empower patients, but consumer knowledge varies and currently, there is a lack of reliable resources for consumers to consult. In the absence of healthcare protection rules for DTCT, the concept of informing consumers concurrently with marketing DTCT by the vendors is not in place.</p><p><strong>Summary: </strong>DTCT might be advantageous over traditional testing settings in a few selected situations but has a substantial risk of medicalization of healthy persons and damaging the trust in the reliability of healthcare laboratory testing.</p>","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":""},"PeriodicalIF":7.1,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440245","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}
Leslie J Donato, Kyla M Lara-Breitinger, Allan S Jaffe
{"title":"The Slow Progress in Developing Better Long-Term Cardiovascular Risk Assessment in Women Continues.","authors":"Leslie J Donato, Kyla M Lara-Breitinger, Allan S Jaffe","doi":"10.1093/clinchem/hvaf003","DOIUrl":"https://doi.org/10.1093/clinchem/hvaf003","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":""},"PeriodicalIF":7.1,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381822","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}
Blanca Fabre-Estremera, Antonio Buño-Soto, Mercedes Sotos-Prieto, Adrián Carballo-Casla, Samara Palma Milla, Fernando Rodríguez-Artalejo, Rosario Ortolá
{"title":"Cardiac Biomarkers and Malnutrition Incidence in Community-Dwelling Older Adults without Cardiovascular Disease: The Seniors-ENRICA-2 Cohort.","authors":"Blanca Fabre-Estremera, Antonio Buño-Soto, Mercedes Sotos-Prieto, Adrián Carballo-Casla, Samara Palma Milla, Fernando Rodríguez-Artalejo, Rosario Ortolá","doi":"10.1093/clinchem/hvae221","DOIUrl":"https://doi.org/10.1093/clinchem/hvae221","url":null,"abstract":"<p><strong>Background: </strong>Given the close relationship between cardiovascular disease (CVD) and malnutrition, we examined whether higher concentrations of high-sensitivity cardiac troponin T (hs-cTnT) and N-terminal pro-brain natriuretic peptide (NT-proBNP), which indicate CVD risk in the general population, were prospectively associated with malnutrition incidence in community-dwelling older adults without CVD.</p><p><strong>Methods: </strong>We used data from 1490 individuals ≥65 years from the Seniors-ENRICA-2 cohort followed up for 2.2 years. Malnutrition was evaluated by the screening Mini Nutritional Assessment-Short Form (MNA-SF) score, which consists of a short questionnaire, and a complete nutritional assessment according to the Global Leadership Initiative on Malnutrition (GLIM) criteria. Associations were summarized with odds ratios (OR) and their 95% confidence interval (CI), obtained from logistic regression and adjusted for the main confounders.</p><p><strong>Results: </strong>NT-proBNP was associated with higher malnutrition incidence assessed by the MNA-SF score and the GLIM criteria, with OR (95% CI) of 1.51 (1.09-2.09) and 1.43 (1.04-1.96) per one logarithmic-unit increment, respectively. Malnutrition incidence according to the GLIM criteria was also higher in participants who had elevated NT-proBNP (heart stress age-specific rule-in cutoffs) vs those who did not, with OR (95% CI) of 1.84 (1.05-3.22). hs-cTnT was not associated with higher malnutrition incidence.</p><p><strong>Conclusions: </strong>In this cohort of older adults without CVD, NT-proBNP was associated with higher malnutrition incidence. Further research is needed to validate our findings, uncover the underlying biological mechanisms, and assess whether preventive interventions can reduce NT-proBNP concentrations and, consequently, reduce the risk of malnutrition.</p>","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":""},"PeriodicalIF":7.1,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364155","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":"Glomerular Filtration Rate (GFR) Estimation with Cystatin C—Past, Present, and Future","authors":"Amy B Karger, Michael G Shlipak","doi":"10.1093/clinchem/hvae226","DOIUrl":"https://doi.org/10.1093/clinchem/hvae226","url":null,"abstract":"Background Cystatin C is a long-established filtration marker which can be used to assess kidney function, but it has been sparingly used for clinical care due to creatinine’s role as the primary biomarker for kidney function assessment based on estimated glomerular filtration rate (eGFR). Content This review summarizes the evolution of cystatin C’s role in kidney disease assessment and highlights new guidelines promoting more widespread use. Specifically, the 2021 National Kidney Foundation and American Society of Nephrology Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease report, and the 2024 Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD), recommend increased use of cystatin C as an alternative and complementary biomarker for kidney function assessment, since it does not differ by race like creatinine, correlates better with adverse outcomes compared to creatinine, and provides a more accurate eGFR when used in combination with creatinine. Summary While robust literature demonstrates improved accuracy with cystatin C-based eGFR (eGFRcys) in certain clinical subpopulations, future research is needed to better understand its performance relative to creatinine-based eGFR (eGFRcr) and measured glomerular filtration rate (mGFR) in additional diverse cohorts, and to achieve assay standardization to match the performance of creatinine assays. Additionally, cystatin C testing availability will need to be broadened from primarily reference laboratories to local laboratories, and partnerships will need to be developed between clinical stakeholders and the laboratory to promote cystatin C’s clinical use, to achieve widespread adoption of guideline-recommended eGFR equations.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"39 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143125104","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 Unexpectedly High IgE Level during Allergic Exploration.","authors":"Louis Nevejan, Xavier Bossuyt","doi":"10.1093/clinchem/hvae175","DOIUrl":"https://doi.org/10.1093/clinchem/hvae175","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"71 2","pages":"245-246"},"PeriodicalIF":7.1,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122272","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 Hiding in Plain Sight: Protein Electrophoresis Profile Inconsistent with Patient's Diagnosis.","authors":"Melissa R Snyder","doi":"10.1093/clinchem/hvae162","DOIUrl":"https://doi.org/10.1093/clinchem/hvae162","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"71 2","pages":"253"},"PeriodicalIF":7.1,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122367","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":"New Insights into Xylazine Pharmacokinetics in Humans.","authors":"Kara L Lynch","doi":"10.1093/clinchem/hvae201","DOIUrl":"10.1093/clinchem/hvae201","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":" ","pages":"230-231"},"PeriodicalIF":7.1,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142806001","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 Hiding in Plain Sight: Protein Electrophoresis Profile Inconsistent with Patient's Diagnosis.","authors":"Jing Cao","doi":"10.1093/clinchem/hvae161","DOIUrl":"https://doi.org/10.1093/clinchem/hvae161","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"71 2","pages":"252"},"PeriodicalIF":7.1,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143122366","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}