SARS-CoV-2 血清学检测在大流行期间提高了 CT 疑似、PCR 阴性 COVID-19 患者的诊断准确性。
SARS-CoV-2 serology increases diagnostic accuracy in CT-suspected, PCR-negative COVID-19 patients during pandemic.
机构信息
Department of Internal Medicine II, School of Medicine, Technical University of Munich, Munich, Germany.
German Center for Infection Research (DZIF), partner site Munich, Munich, Germany.
出版信息
Respir Res. 2021 Apr 23;22(1):119. doi: 10.1186/s12931-021-01717-9.
BACKGROUND
In the absence of PCR detection of SARS-CoV-2 RNA, accurate diagnosis of COVID-19 is challenging. Low-dose computed tomography (CT) detects pulmonary infiltrates with high sensitivity, but findings may be non-specific. This study assesses the diagnostic value of SARS-CoV-2 serology for patients with distinct CT features but negative PCR.
METHODS
IgM/IgG chemiluminescent immunoassay was performed for 107 patients with confirmed (group A: PCR + ; CT ±) and 46 patients with suspected (group B: repetitive PCR-; CT +) COVID-19, admitted to a German university hospital during the pandemic's first wave. A standardized, in-house CT classification of radiological signs of a viral pneumonia was used to assess the probability of COVID-19.
RESULTS
Seroconversion rates (SR) determined on day 5, 10, 15, 20 and 25 after symptom onset (SO) were 8%, 25%, 65%, 76% and 91% for group A, and 0%, 10%, 19%, 37% and 46% for group B, respectively; (p < 0.01). Compared to hospitalized patients with a non-complicated course (non-ICU patients), seroconversion tended to occur at lower frequency and delayed in patients on intensive care units. SR of patients with CT findings classified as high certainty for COVID-19 were 8%, 22%, 68%, 79% and 93% in group A, compared with 0%, 15%, 28%, 50% and 50% in group B (p < 0.01). SARS-CoV-2 serology established a definite diagnosis in 12/46 group B patients. In 88% (8/9) of patients with negative serology > 14 days after symptom onset (group B), clinico-radiological consensus reassessment revealed probable diagnoses other than COVID-19. Sensitivity of SARS-CoV-2 serology was superior to PCR > 17d after symptom onset.
CONCLUSIONS
Approximately one-third of patients with distinct COVID-19 CT findings are tested negative for SARS-CoV-2 RNA by PCR rendering correct diagnosis difficult. Implementation of SARS-CoV-2 serology testing alongside current CT/PCR-based diagnostic algorithms improves discrimination between COVID-19-related and non-related pulmonary infiltrates in PCR negative patients. However, sensitivity of SARS-CoV-2 serology strongly depends on the time of testing and becomes superior to PCR after the 2 week following symptom onset.
背景
在无法检测 SARS-CoV-2 RNA 的情况下，准确诊断 COVID-19 具有挑战性。低剂量计算机断层扫描（CT）具有高灵敏度，但发现可能是非特异性的。本研究评估了 SARS-CoV-2 血清学对具有不同 CT 特征但 PCR 阴性的患者的诊断价值。
方法
对一家德国大学医院在大流行第一波期间收治的 107 例确诊（A 组：PCR+；CT±）和 46 例疑似（B 组：重复 PCR-；CT+）COVID-19 患者进行 IgM/IgG 化学发光免疫分析。使用标准化的内部 CT 分类方法评估病毒性肺炎的放射学征象，以评估 COVID-19 的可能性。
结果
A 组第 5、10、15、20 和 25 天的血清转换率（SR）分别为 8%、25%、65%、76%和 91%，B 组分别为 0%、10%、19%、37%和 46%；（p<0.01）。与非 ICU 患者相比，住院治疗且病情不复杂的患者（非 ICU 患者）血清转换频率较低且延迟。A 组中 CT 结果高度确定为 COVID-19 的患者的 SR 分别为 8%、22%、68%、79%和 93%，B 组分别为 0%、15%、28%、50%和 50%（p<0.01）。SARS-CoV-2 血清学在 B 组的 12/46 例患者中建立了明确的诊断。在症状出现后 14 天以上（B 组）阴性血清学结果的 88%（8/9）患者中，临床放射学共识重新评估显示可能的诊断并非 COVID-19。SARS-CoV-2 血清学的敏感性优于症状出现后 17 天的 PCR。
结论
大约三分之一具有明显 COVID-19 CT 特征的患者通过 PCR 检测 SARS-CoV-2 RNA 呈阴性，这使得正确诊断变得困难。在当前基于 CT/PCR 的诊断算法中实施 SARS-CoV-2 血清学检测可提高对 PCR 阴性患者中 COVID-19 相关和非相关肺浸润的鉴别诊断能力。然而，SARS-CoV-2 血清学的敏感性在很大程度上取决于检测时间，在症状出现后 2 周后，其敏感性优于 PCR。
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