Dataset Information

Self-Collected Oral Fluid Saliva Is Insensitive Compared With Nasal-Oropharyngeal Swabs in the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Outpatients.

ABSTRACT:

Background

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic control will require widespread access to accurate diagnostics. Salivary sampling circumvents swab supply chain bottlenecks, is amenable to self-collection, and is less likely to create an aerosol during collection compared with the nasopharyngeal swab.

Methods

We compared real-time reverse-transcription polymerase chain reaction Abbott m2000 results from matched salivary oral fluid (gingival crevicular fluid collected in an Oracol device) and nasal-oropharyngeal (OP) self-collected specimens in viral transport media from a nonhospitalized, ambulatory cohort of coronavirus disease 2019 (COVID-19) patients at multiple time points. These 2 sentences should be at the beginning of the results.

Results

There were 171 matched specimen pairs. Compared with nasal-OP swabs, 41.6% of the oral fluid samples were positive. Adding spit to the oral fluid percent collection device increased the percent positive agreement from 37.2% (16 of 43) to 44.6% (29 of 65). The positive percent agreement was highest in the first 5 days after symptoms and decreased thereafter. All of the infectious nasal-OP samples (culture positive on VeroE6 TMPRSS2 cells) had a matched SARS-CoV-2 positive oral fluid sample.

Conclusions

In this study of nonhospitalized SARS-CoV-2-infected persons, we demonstrate lower diagnostic sensitivity of self-collected oral fluid compared with nasal-OP specimens, a difference that was especially prominent more than 5 days from symptom onset. These data do not justify the routine use of oral fluid collection for diagnosis of SARS-CoV-2 despite the greater ease of collection. It also underscores the importance of considering the method of saliva specimen collection and the time from symptom onset especially in outpatient populations.

SUBMITTER: Manabe YC

PROVIDER: S-EPMC7798743 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Abstract Background Anterior nasal swabs (ANS) are established specimen collection methods for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection detection. While saliva (SA) specimens provide an alternative, few studies have comprehensively characterized the performance of SA specimens in longitudinal studies. Methods We compared SARS-CoV-2 detections between paired self-collected ANS and SA specimens from a household transmission study. Participants recorded symptoms and paired ANS and SA specimens daily for 14 days. Specimens were tested using RT-PCR. We calculated the proportion of detections identified by each specimen type among the detections from both types combined. We computed percent agreement and Kappa statistics to assess concordance in detections. We also computed estimates stratified by presence of symptoms and examined the influence of traditional and inactivating transport media on the performance of ANS. Results We examined 2535 self-collected paired specimens from 216 participants. Among 1238 (49%) paired specimens with detections by either specimen type, ANS identified 77.1% (954; 95% CI, 74.6% to 79.3%) and SA 81.9% (1014; 95% CI, 79.7% to 84.0%), with a difference of 4.9% (95% CI, 1.4% to 8.5%). Overall agreement was 80.0%, and Kappa was 0.6 (95% CI, 0.5 to 0.6). Nevertheless, the difference in the proportion of detections identified by ANS and SA using traditional and inactivating transport media was 32.5% (95% CI, 26.8% to 38.0%) and –9.5% (95% CI, −13.7% to –5.2%), respectively. Among participants who remained asymptomatic, the difference in detections between SA and ANS was 51.2% (95% CI, 31.8% to 66.0%) and 26.1% (95% CI, 0% to 48.5%) using traditional and inactivating media, respectively. Conclusions Self-collected saliva specimens provide a noninvasive alternative to nasal swabs, especially to those collected in traditional transport media, for longitudinal field studies that aim to detect both symptomatic and asymptomatic SARS-CoV-2 infections.