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唾液和鼻咽拭子标本 RT-PCR 检测 SARS-CoV-2 的诊断性能和耐受性。

Diagnostic Performance and Tolerability of Saliva and Nasopharyngeal Swab Specimens in the Detection of SARS-CoV-2 by RT-PCR.

机构信息

Department of Paediatrics and Adolescent Medicine, University of Turku, Turku, Finland.

Department of Paediatrics and Adolescent Medicine, Turku University Hospital, Turku, Finland.

出版信息

Microbiol Spectr. 2023 Jun 15;11(3):e0532422. doi: 10.1128/spectrum.05324-22. Epub 2023 Apr 24.

Abstract

Saliva is a promising alternative for a nasopharyngeal swab (NPS) in specimen collection to detect SARS-CoV-2. We compared the diagnostic performance and tolerability of saliva collection versus NPS in a clinical setting. Paired NPS and saliva specimens were collected sequentially from participants ( = 250) at the Turku University Hospital drive-in coronavirus testing station in the spring of 2022, with Omicron BA.2 as the dominant SARS-CoV-2 variant. Discomfort and preference for the sampling method were assessed. The specimens were analyzed for SARS-CoV-2 using real-time multiplex reverse transcriptase PCR (RT-PCR) with a laboratory-developed test (LDT) and two commercial kits (PerkinElmer SARS-CoV-2 and PerkinElmer SARS-CoV-2 Plus) for several target genes. Among the 250 participants, 246 had respiratory symptoms. With LDT, SARS-CoV-2 was detected in 135 and 134 participants from NPS and saliva, respectively. Of the 250 specimens, 11 gave a discordant outcome, resulting in excellent agreement between the specimen types (Cohen's kappa coefficient of 0.911; = 0.763). The cycle threshold () values of LDT and commercial kit target genes were significantly lower from NPS than from saliva. A total of 172 (69%) participants assessed saliva sampling as more tolerable than NPS ( < 0.0001). Our findings present saliva as an applicable alternative for SARS-CoV-2 diagnostics. However, the lower values obtained from NPS indicate that NPS may be a slightly more sensitive specimen type. Participants preferred saliva sampling, although delivering an adequate volume of saliva was challenging for some participants. The extensive testing of SARS-CoV-2 is vital in controlling the spread of COVID-19. The reference standard for specimen collection is a nasopharyngeal swab (NPS). However, the discomfort of NPS sampling, the risk of nosocomial infections, and global material shortages have accelerated the development of alternative testing methods. Our study demonstrates that patients tolerate saliva sampling better than NPS. Of importance, although the RT-PCR qualitative test results seem to correspond between NPS and saliva, we show significantly lower values for NPS, compared to saliva, thus contradicting the suggested superiority of the saliva specimen over NPS in the detection of the Omicron variants of SARS-CoV-2. Future research is still required to enable individual planning for specimen collection and to determine the effects of different SARS-CoV-2 variants on the sensitivity of the saliva matrix.

摘要

唾液是一种很有前途的替代鼻咽拭子(NPS)的标本采集方法,可用于检测 SARS-CoV-2。我们在临床环境中比较了唾液采集和 NPS 采集的诊断性能和耐受性。2022 年春季,在图尔库大学医院的 Drive-in 冠状病毒检测站,我们连续采集了 250 名参与者的 NPS 和唾液样本,当时主要的 SARS-CoV-2 变异株是奥密克戎 BA.2。我们评估了采样方法的不适程度和参与者的偏好。使用实验室开发的检测(LDT)和两种商业试剂盒(PerkinElmer SARS-CoV-2 和 PerkinElmer SARS-CoV-2 Plus)对实时多重逆转录酶 PCR(RT-PCR)检测的 SARS-CoV-2 进行了分析,这些试剂盒针对多个目标基因。在 250 名参与者中,有 246 名有呼吸道症状。使用 LDT,分别从 NPS 和唾液中检测到 135 名和 134 名参与者的 SARS-CoV-2。在 250 个标本中,有 11 个结果不一致,这表明两种标本类型的一致性非常好(Cohen 的 κ系数为 0.911; = 0.763)。LDT 和商业试剂盒靶基因的循环阈值(Ct)值从 NPS 显著低于唾液。共有 172 名(69%)参与者认为唾液采样比 NPS 更耐受(<0.0001)。我们的研究结果表明唾液是一种适用于 SARS-CoV-2 诊断的替代方法。然而,NPS 获得的较低 Ct 值表明 NPS 可能是一种稍敏感的标本类型。参与者更喜欢唾液采样,尽管对一些参与者来说,获得足够量的唾液是有挑战的。广泛检测 SARS-CoV-2 对于控制 COVID-19 的传播至关重要。标本采集的参考标准是鼻咽拭子(NPS)。然而,NPS 采样的不适、医院感染的风险以及全球材料短缺加速了替代检测方法的发展。我们的研究表明,患者对唾液采样的耐受性优于 NPS。重要的是,尽管 NPS 和唾液的 RT-PCR 定性检测结果似乎一致,但我们发现 NPS 的 Ct 值明显低于唾液,这与唾液标本在检测 SARS-CoV-2 奥密克戎变异株方面优于 NPS 的说法相矛盾。未来仍需要进行研究,以便能够针对标本采集进行个体化规划,并确定不同 SARS-CoV-2 变异株对唾液基质敏感性的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46f6/10269602/018bdbef9ac7/spectrum.05324-22-f001.jpg

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