Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire Hôtel-Dieu, 30 Bd. Jean Monnet, 44093, Nantes Cedex 1, France.
CRICS-TRIGGERSEP Network, Tours, France.
Sci Rep. 2021 Jan 27;11(1):2388. doi: 10.1038/s41598-021-82192-6.
Reverse transcriptase-polymerase chain reaction (RT-PCR) testing is an important tool for diagnosing coronavirus disease 2019 (COVID-19). However, performance concerns have emerged recently, notably regarding sensitivity. We hypothesized that the clinical, biological, and radiological characteristics of patients with a false-negative first RT-PCR test and a final diagnosis of COVID-19 might differ from those of patients with a positive first RT-PCR test. We conducted a multicenter matched case-control study in COVID-19 patients. Patients with a negative first RT-PCR test were matched to patients with a positive first RT-PCR test on age, sex, and initial admission unit (ward or intensive care). We included 80 cases and 80 controls between March 30, and June 22, 2020. Neither mortality at hospital discharge nor hospital stay length differed between the two groups (P = 0.80 and P = 0.54, respectively). By multivariate analysis, two factors were independently associated with a lower risk of a first false-negative test, namely, headache (adjusted OR [aOR], 0.07; 95% confidence interval [95% CI], 0.01-0.49]; P = 0.007) and fatigue/malaise (aOR, 0.16; 95% CI, 0.03-0.81; P = 0.027); two other factors were independently associated with a higher risk of a first false-negative test, namely, platelets > 207·10 mm (aOR, 3.81; 95% CI, 1.10-13.16]; P = 0.034) and C-reactive protein > 79.8 mg·L (aOR, 4.00; 95% CI, 1.21-13.19; P = 0.023). Patients with suspected COVID-19 whose laboratory tests indicating marked inflammation were at higher risk of a first false-negative RT-PCR test. Strategies involving serial RT-PCR testing must be rigorously evaluated.
逆转录-聚合酶链反应（RT-PCR）检测是诊断 2019 年冠状病毒病（COVID-19）的重要工具。然而，最近出现了性能方面的担忧，特别是在敏感性方面。我们假设，首次 RT-PCR 检测结果为阴性且最终诊断为 COVID-19 的患者与首次 RT-PCR 检测结果为阳性的患者的临床、生物学和影像学特征可能不同。我们在 COVID-19 患者中进行了一项多中心匹配病例对照研究。将首次 RT-PCR 检测结果为阴性的患者与首次 RT-PCR 检测结果为阳性的患者按年龄、性别和初始入院科室（病房或重症监护病房）进行匹配。我们在 2020 年 3 月 30 日至 6 月 22 日期间纳入了 80 例病例和 80 例对照。两组患者的出院时死亡率和住院时间长短均无差异（P=0.80 和 P=0.54）。多变量分析显示，有两个因素独立与首次假阴性检测的风险较低相关，即头痛（调整后的比值比 [aOR]，0.07；95%置信区间 [95%CI]，0.01-0.49；P=0.007）和疲劳/不适（aOR，0.16；95%CI，0.03-0.81；P=0.027）；有两个因素独立与首次假阴性检测的风险较高相关，即血小板计数>207·10mm（aOR，3.81；95%CI，1.10-13.16；P=0.034）和 C 反应蛋白>79.8mg·L（aOR，4.00；95%CI，1.21-13.19；P=0.023）。实验室检查显示炎症明显的疑似 COVID-19 患者首次 RT-PCR 检测假阴性的风险较高。必须严格评估涉及连续 RT-PCR 检测的策略。
