Department of Medicine, Division of Infectious Diseases, University of Colorado, Anschutz Medical Campus, Aurora, Colorado (K.M.E.).
Department of Medicine, Stanford University, Stanford, California (L.N.G., M.G., U.S.).
Ann Intern Med. 2024 Sep;177(9):1209-1221. doi: 10.7326/M24-0737. Epub 2024 Aug 13.
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 × 10 cells/L [95% CI, 264.5 to 267.4 × 10 cells/L]) than participants without known prior infection (275.2 × 10 cells/L [CI, 268.5 to 282.0 × 10 cells/L]), as well as higher mean hemoglobin A (HbA) 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 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.
背景：目前尚无 SARS-CoV-2 感染后急性后遗症（PASC）的经临床验证的生物标志物。
目的：调查 SARS-CoV-2 和 PASC 的临床实验室标志物。
设计：采用倾向评分加权线性回归模型来评估既往感染和 PASC 指数（≥12 与 0）对实验室测量均值的差异。（ClinicalTrials.gov：NCT05172024）。
设置：83 个入组地点。
参与者：RECOVER-成人队列参与者，无论是否存在 SARS-CoV-2 感染，均在指数日期后 6 个月（或如果指数日期后超过 6 个月，则在入组时）进行研究就诊和实验室检查。如果 6 个月就诊发生在再感染后 30 天内，则排除参与者。
测量：参与者完成问卷调查和标准临床实验室检查。
结果：在 10094 名参与者中，8746 名有既往 SARS-CoV-2 感染史，1348 名无感染史，1880 名 PASC 指数为 12 或更高，3351 名 PASC 指数为 0。在进行倾向评分调整后，与无已知既往感染的参与者相比，既往感染的参与者的平均血小板计数（265.9×10 细胞/L [95%CI，264.5 至 267.4×10 细胞/L]）较低，血红蛋白 A（HbA）水平（5.58% [CI，5.56% 至 5.60%]）和尿白蛋白/肌酐比值（81.9mg/g [CI，67.5 至 96.2mg/g]）较高，尽管差异具有中等的临床意义。排除患有糖尿病的参与者后，HbA 水平的差异减弱。在既往感染的参与者中，PASC 指数为 12 或更高的参与者与 PASC 指数为 0 的参与者之间，在平均实验室值方面未发现有意义的差异。
局限性：实验室标志物的差异是否代表 SARS-CoV-2 感染的后果或危险因素尚无法确定。
结论：总体而言，本研究评估的 25 项常规临床实验室值中，没有任何一项可作为 PASC 的临床有用生物标志物。
主要资金来源：美国国立卫生研究院。
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