Aetion, Inc, New York, New York.
HealthVerity, Philadelphia, Pennsylvania.
JAMA Intern Med. 2021 May 1;181(5):672-679. doi: 10.1001/jamainternmed.2021.0366.
Understanding the effect of serum antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on susceptibility to infection is important for identifying at-risk populations and could have implications for vaccine deployment.
The study purpose was to evaluate evidence of SARS-CoV-2 infection based on diagnostic nucleic acid amplification test (NAAT) among patients with positive vs negative test results for antibodies in an observational descriptive cohort study of clinical laboratory and linked claims data.
DESIGN, SETTING, AND PARTICIPANTS: The study created cohorts from a deidentified data set composed of commercial laboratory tests, medical and pharmacy claims, electronic health records, and hospital chargemaster data. Patients were categorized as antibody-positive or antibody-negative according to their first SARS-CoV-2 antibody test in the database.
Primary end points were post-index diagnostic NAAT results, with infection defined as a positive diagnostic test post-index, measured in 30-day intervals (0-30, 31-60, 61-90, >90 days). Additional measures included demographic, geographic, and clinical characteristics at the time of the index antibody test, including recorded signs and symptoms or prior evidence of coronavirus 2019 (COVID) diagnoses or positive NAAT results and recorded comorbidities.
The cohort included 3 257 478 unique patients with an index antibody test; 56% were female with a median (SD) age of 48 (20) years. Of these, 2 876 773 (88.3%) had a negative index antibody result, and 378 606 (11.6%) had a positive index antibody result. Patients with a negative antibody test result were older than those with a positive result (mean age 48 vs 44 years). Of index-positive patients, 18.4% converted to seronegative over the follow-up period. During the follow-up periods, the ratio (95% CI) of positive NAAT results among individuals who had a positive antibody test at index vs those with a negative antibody test at index was 2.85 (95% CI, 2.73-2.97) at 0 to 30 days, 0.67 (95% CI, 0.6-0.74) at 31 to 60 days, 0.29 (95% CI, 0.24-0.35) at 61 to 90 days, and 0.10 (95% CI, 0.05-0.19) at more than 90 days.
In this cohort study, patients with positive antibody test results were initially more likely to have positive NAAT results, consistent with prolonged RNA shedding, but became markedly less likely to have positive NAAT results over time, suggesting that seropositivity is associated with protection from infection. The duration of protection is unknown, and protection may wane over time.
了解针对严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的血清抗体对易感性的影响对于确定高危人群很重要，并且可能对疫苗部署有影响。
本研究旨在通过观察性描述性临床实验室和关联索赔数据队列研究，根据诊断核酸扩增试验 (NAAT) 检测结果评估抗体阳性患者的 SARS-CoV-2 感染证据。
设计、地点和参与者：该研究从由商业实验室检测、医疗和药房理赔、电子健康记录和医院计费主数据组成的去标识数据集创建队列。根据数据库中 SARS-CoV-2 抗体的首次检测，患者被分为抗体阳性或抗体阴性。
主要终点是索引后诊断性 NAAT 结果，以索引后阳性诊断性检测为感染，测量时间间隔为 30 天（0-30、31-60、61-90、>90 天）。其他措施包括索引抗体检测时的人口统计学、地理和临床特征，包括记录的体征和症状或以前的冠状病毒 2019 (COVID) 诊断或阳性 NAAT 结果以及记录的合并症。
该队列包括 3257478 名接受索引抗体检测的患者；56%为女性，中位（SD）年龄为 48（20）岁。其中，2876773 名（88.3%）患者的索引抗体检测结果为阴性，378606 名（11.6%）患者的索引抗体检测结果为阳性。与抗体阴性的患者相比，抗体检测阳性的患者年龄较大（平均年龄 48 岁比 44 岁）。在随访期间，18.4%的指数阳性患者转为血清阴性。在随访期间，与抗体阴性的患者相比，在索引时抗体检测阳性的个体中阳性 NAAT 结果的比值（95%CI）在 0 至 30 天为 2.85（95%CI，2.73-2.97），在 31 至 60 天为 0.67（95%CI，0.6-0.74），在 61 至 90 天为 0.29（95%CI，0.24-0.35），在 90 天以上为 0.10（95%CI，0.05-0.19）。
在这项队列研究中，抗体检测阳性的患者最初更有可能出现阳性 NAAT 结果，这与持续的 RNA 脱落一致，但随着时间的推移，他们出现阳性 NAAT 结果的可能性明显降低，表明血清阳性与感染保护有关。保护的持续时间未知，并且保护可能随时间减弱。
