Kristine M Erlandson, Linda N Geng, Caitlin A Selvaggi, Tanayott Thaweethai, Peter Chen, Nathan B Erdmann, Jason D Goldman, Timothy J Henrich, Mady Hornig, Elizabeth W Karlson, Stuart D Katz, C Kim, Sushma K Cribbs, Adeyinka O Laiyemo, Rebecca Letts, Janet Y Lin, Jai Marathe, Sairam Parthasarathy, Thomas F Patterson, Brittany D Taylor, Elizabeth R Duffy, Monika Haack, Boris Julg, Gabrielle Maranga, Carla Hernandez, Nora G Singer, Jenny Han, Priscilla Pemu, Hassan Brim, Hassan Ashktorab, Alexander W Charney, Juan Wisnivesky, Jenny J Lin, Helen Y Chu, Minjoung Go, Upinder Singh, Emily B Levitan, Paul A Goepfert, Janko Ž Nikolich, Harvey Hsu, Michael J Peluso, J Daniel Kelly, Megumi J Okumura, Valerie J Flaherman, John G Quigley, Jerry A Krishnan, Mary Beth Scholand, Rachel Hess, Torri D Metz, Maged M Costantine, Dwight J Rouse, Barbara S Taylor, Mark P Goldberg, Gailen D Marshall, Jeremy Wood, David Warren, Leora Horwitz, Andrea S Foulkes, Grace A McComsey
{"title":"Differentiation of Prior SARS-CoV-2 Infection and Postacute Sequelae by Standard Clinical Laboratory Measurements in the RECOVER Cohort.","authors":"Kristine M Erlandson, Linda N Geng, Caitlin A Selvaggi, Tanayott Thaweethai, Peter Chen, Nathan B Erdmann, Jason D Goldman, Timothy J Henrich, Mady Hornig, Elizabeth W Karlson, Stuart D Katz, C Kim, Sushma K Cribbs, Adeyinka O Laiyemo, Rebecca Letts, Janet Y Lin, Jai Marathe, Sairam Parthasarathy, Thomas F Patterson, Brittany D Taylor, Elizabeth R Duffy, Monika Haack, Boris Julg, Gabrielle Maranga, Carla Hernandez, Nora G Singer, Jenny Han, Priscilla Pemu, Hassan Brim, Hassan Ashktorab, Alexander W Charney, Juan Wisnivesky, Jenny J Lin, Helen Y Chu, Minjoung Go, Upinder Singh, Emily B Levitan, Paul A Goepfert, Janko Ž Nikolich, Harvey Hsu, Michael J Peluso, J Daniel Kelly, Megumi J Okumura, Valerie J Flaherman, John G Quigley, Jerry A Krishnan, Mary Beth Scholand, Rachel Hess, Torri D Metz, Maged M Costantine, Dwight J Rouse, Barbara S Taylor, Mark P Goldberg, Gailen D Marshall, Jeremy Wood, David Warren, Leora Horwitz, Andrea S Foulkes, Grace A McComsey","doi":"10.7326/M24-0737","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>There are currently no validated clinical biomarkers of postacute sequelae of SARS-CoV-2 infection (PASC).</p><p><strong>Objective: </strong>To investigate clinical laboratory markers of SARS-CoV-2 and PASC.</p><p><strong>Design: </strong>Propensity score-weighted linear regression models were fitted to evaluate differences in mean laboratory measures by prior infection and PASC index (≥12 vs. 0). (ClinicalTrials.gov: NCT05172024).</p><p><strong>Setting: </strong>83 enrolling sites.</p><p><strong>Participants: </strong>RECOVER-Adult cohort participants with or without SARS-CoV-2 infection with a study visit and laboratory measures 6 months after the index date (or at enrollment if >6 months after the index date). Participants were excluded if the 6-month visit occurred within 30 days of reinfection.</p><p><strong>Measurements: </strong>Participants completed questionnaires and standard clinical laboratory tests.</p><p><strong>Results: </strong>Among 10 094 participants, 8746 had prior SARS-CoV-2 infection, 1348 were uninfected, 1880 had a PASC index of 12 or higher, and 3351 had a PASC index of zero. After propensity score adjustment, participants with prior infection had a lower mean platelet count (265.9 × 10<sup>9</sup> cells/L [95% CI, 264.5 to 267.4 × 10<sup>9</sup> cells/L]) than participants without known prior infection (275.2 × 10<sup>9</sup> cells/L [CI, 268.5 to 282.0 × 10<sup>9</sup> cells/L]), as well as higher mean hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) level (5.58% [CI, 5.56% to 5.60%] vs. 5.46% [CI, 5.40% to 5.51%]) and urinary albumin-creatinine ratio (81.9 mg/g [CI, 67.5 to 96.2 mg/g] vs. 43.0 mg/g [CI, 25.4 to 60.6 mg/g]), although differences were of modest clinical significance. The difference in HbA<sub>1c</sub> levels was attenuated after participants with preexisting diabetes were excluded. Among participants with prior infection, no meaningful differences in mean laboratory values were found between those with a PASC index of 12 or higher and those with a PASC index of zero.</p><p><strong>Limitation: </strong>Whether differences in laboratory markers represent consequences of or risk factors for SARS-CoV-2 infection could not be determined.</p><p><strong>Conclusion: </strong>Overall, no evidence was found that any of the 25 routine clinical laboratory values assessed in this study could serve as a clinically useful biomarker of PASC.</p><p><strong>Primary funding source: </strong>National Institutes of Health.</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":null,"pages":null},"PeriodicalIF":19.6000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11408082/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Internal Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.7326/M24-0737","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/13 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: There are currently no validated clinical biomarkers of postacute sequelae of SARS-CoV-2 infection (PASC).
Objective: To investigate clinical laboratory markers of SARS-CoV-2 and PASC.
Design: Propensity score-weighted linear regression models were fitted to evaluate differences in mean laboratory measures by prior infection and PASC index (≥12 vs. 0). (ClinicalTrials.gov: NCT05172024).
Setting: 83 enrolling sites.
Participants: RECOVER-Adult cohort participants with or without SARS-CoV-2 infection with a study visit and laboratory measures 6 months after the index date (or at enrollment if >6 months after the index date). Participants were excluded if the 6-month visit occurred within 30 days of reinfection.
Measurements: Participants completed questionnaires and standard clinical laboratory tests.
Results: Among 10 094 participants, 8746 had prior SARS-CoV-2 infection, 1348 were uninfected, 1880 had a PASC index of 12 or higher, and 3351 had a PASC index of zero. After propensity score adjustment, participants with prior infection had a lower mean platelet count (265.9 × 109 cells/L [95% CI, 264.5 to 267.4 × 109 cells/L]) than participants without known prior infection (275.2 × 109 cells/L [CI, 268.5 to 282.0 × 109 cells/L]), as well as higher mean hemoglobin A1c (HbA1c) level (5.58% [CI, 5.56% to 5.60%] vs. 5.46% [CI, 5.40% to 5.51%]) and urinary albumin-creatinine ratio (81.9 mg/g [CI, 67.5 to 96.2 mg/g] vs. 43.0 mg/g [CI, 25.4 to 60.6 mg/g]), although differences were of modest clinical significance. The difference in HbA1c levels was attenuated after participants with preexisting diabetes were excluded. Among participants with prior infection, no meaningful differences in mean laboratory values were found between those with a PASC index of 12 or higher and those with a PASC index of zero.
Limitation: Whether differences in laboratory markers represent consequences of or risk factors for SARS-CoV-2 infection could not be determined.
Conclusion: Overall, no evidence was found that any of the 25 routine clinical laboratory values assessed in this study could serve as a clinically useful biomarker of PASC.
Primary funding source: National Institutes of Health.
期刊介绍：
Established in 1927 by the American College of Physicians (ACP), Annals of Internal Medicine is the premier internal medicine journal. Annals of Internal Medicine’s mission is to promote excellence in medicine, enable physicians and other health care professionals to be well informed members of the medical community and society, advance standards in the conduct and reporting of medical research, and contribute to improving the health of people worldwide. To achieve this mission, the journal publishes a wide variety of original research, review articles, practice guidelines, and commentary relevant to clinical practice, health care delivery, public health, health care policy, medical education, ethics, and research methodology. In addition, the journal publishes personal narratives that convey the feeling and the art of medicine.
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