We evaluated saliva (SAL) specimens for SARS-CoV-2 reverse transcriptase PCR (RT-PCR) testing by comparison of 459 prospectively paired nasopharyngeal (NP) or midturbinate (MT) swabs from 449 individuals with the aim of using saliva for asymptomatic screening. Samples were collected in a drive-through car line for symptomatic individuals (n = 380) and in the emergency department (ED) (n = 69). The percentages of positive and negative agreement of saliva compared to nasopharyngeal swab were 81.1% (95% confidence interval [CI], 65.8% to 90.5%) and 99.8% (95% CI, 98.7% to 100%), respectively. The percent positive agreement increased to 90.0% (95% CI, 74.4% to 96.5%) when considering only samples with moderate to high viral load (cycle threshold [C_T] for the NP, ≤34). Pools of five saliva specimens were also evaluated on three platforms, bioMérieux NucliSENS easyMAG with ABI 7500Fast (CDC assay), Hologic Panther Fusion, and Roche Cobas 6800. The average loss of signal upon pooling was 2 to 3 C_T values across the platforms. The sensitivities of detecting a positive specimen in a pool compared with testing individually were 94%, 90%, and 94% for the CDC 2019-nCoV real-time RT-PCR, Panther Fusion SARS-CoV-2 assay, and Cobas SARS-CoV-2 test, respectively, with decreased sample detection trending with lower viral load. We conclude that although pooled saliva testing, as collected in this study, is not quite as sensitive as NP/MT testing, saliva testing is adequate to detect individuals with higher viral loads in an asymptomatic screening program, does not require swabs or viral transport medium for collection, and may help to improve voluntary screening compliance for those individuals averse to various forms of nasal collections.

中文翻译：

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用于 SARS-CoV-2 检测的汇集唾液样本

我们通过比较 449 名个体的 459 份前瞻性配对鼻咽 (NP) 或中鼻甲 (MT) 拭子，评估了唾液 (SAL) 样本是否适用于 SARS-CoV-2 逆转录酶 PCR (RT-PCR) 检测，目的是使用唾液进行无症状筛查。样本是在有症状个体的免下车通道（n = 380）和急诊科（ED）（n = 69）中收集的。与鼻咽拭子相比，唾液的阳性和阴性一致性百分比分别为 81.1%（95% 置信区间 [CI]，65.8% 至 90.5%）和 99.8%（95% CI，98.7% 至 100%）。当仅考虑具有中度至高病毒载量的样本（NP 的循环阈值 [ CT _{] ，≤34）时，阳性一致性百分比增加至 90.0%（95% CI，74.4% 至 96.5%）。}还在三个平台上对五个唾液样本池进行了评估：bioMérieux NucliSENS easyMAG with ABI 7500Fast（CDC 检测）、Hologic Panther Fusion 和 Roche Cobas 6800。整个平台上池中信号的平均损失为 2 至 3 个C T_值。与单独检测相比，CDC 2019-nCoV 实时 RT-PCR、Panther Fusion SARS-CoV-2 检测和 Cobas SARS 检测在池中检测阳性样本的灵敏度分别为 94%、90% 和 94%。分别进行 CoV-2 检测，样本检测呈随着病毒载量降低而减少的趋势。我们的结论是，虽然本研究中收集的汇总唾液检测不如 NP/MT 检测那么敏感，但唾液检测足以在无症状筛查计划中检测病毒载量较高的个体，不需要拭子或病毒运输介质收集，并可能有助于提高那些厌恶各种形式的鼻腔收集的人的自愿筛查依从性。