Pooled Saliva Specimens for SARS-CoV-2 Testing.

Pooled Saliva Specimens for SARS-CoV-2 Testing.
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用于SARS-CoV-2检测的合并唾液标本。

DOI:
10.1128/jcm.02486-20
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发表时间:
2021-02-18
影响因子:
9.4
通讯作者:
Frank KM
Frank KM
中科院分区:
医学2区
文献类型:
--
作者:
Barat B;Das S;De Giorgi V;Henderson DK;Kopka S;Lau AF;Miller T;Moriarty T;Palmore TN;Sawney S;Spalding C;Tanjutco P;Wortmann G;Zelazny AM;Frank KM

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我们通过比较449人的459对鼻咽(NP)或中鼻甲(MT)拭子,对唾液(SAL)样本进行SARS-CoV-2逆转录聚合酶链式反应(RT-PCR)检测,目的是利用唾液进行无症状筛查。样本收集在有症状个体的免下车路线(n = 380)和急诊科(ED)(n = 69)。我们通过比较449人的459对鼻咽(NP)或中鼻甲(MT)拭子,对唾液(SAL)样本进行SARS-CoV-2逆转录聚合酶链式反应(RT-PCR)检测,目的是利用唾液进行无症状筛查。样本收集在有症状个体的免下车路线(n = 380)和急诊科(ED)(n = 69)。唾液和鼻咽拭子的阳性符合率和阴性符合率分别为81.1%(95%可信区间,65.8%~90.5%)和99.8%(95%可信区间,98.7%~100%)。当仅考虑中到高病毒载量(NP的循环阈值[CT],≤34)的样本时,阳性符合率增加到90.0%(95%CI,74.4%到96.5%)。还在三个平台上对五个唾液样本的池进行了评估,这三个平台是BioMérieux NucliSENS easyMAG with ABI 7500Fast(CDC试剂盒)、HOOGIC Panther Fusion和Roche Cobas 6800。所有平台合并后的平均信号损失为2至3个CT值。与单独检测相比,在CDC 2019-nCoV实时RT-PCR、Panther Fusion SARS-CoV-2检测和Cobas SARS-CoV-2检测中,在池中检测阳性样本的灵敏度分别为94%、90%和94%,随着病毒载量的降低,样品检测有减少的趋势。我们的结论是,尽管本研究收集的混合唾液检测不像NP/MT检测那样敏感,但唾液检测足以在无症状筛查计划中检测出病毒载量较高的个体,不需要拭子或病毒传输介质进行采集,并且可能有助于提高那些反对各种形式鼻腔采集的个体的自愿筛查依从性。
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). 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 [CT] 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 CT 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.