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Diagnostic accuracy of fresh drooled saliva for SARS-CoV-2 in travelers

Mohd Thabit AA 1 , Peariasamy KM 2 , Kuan PX 3 , Fern Ying DK 4 , Nheu N 5 , Cyncynatus C 5 Show all authors , Mu'iz Arifin MA 1 , Shamsuddin AN 1 , Yamin MA 6 , Mohd Padzil MA 1 , Rajasekaram G 5 , Giddy M 5 , Sivaneson S 5 , Lakhbeer Singh HK 5 , Azman A 5 , Hassan AH 6 , Chidambaram SK 1

Affiliations 

  • 1 Infectious Disease Department, Sungai Buloh Hospital, Ministry of Health Malaysia, Malaysia
  • 2 Institute for Clinical Research, National Institutes of Health Malaysia, Malaysia; Paediatric Dental Department, Sungai Buloh Hospital, Ministry of Health Malaysia, Malaysia; Faculty of Health and Medical Sciences, Taylor's University, Malaysia
  • 3 Digital Health Research and Innovation Unit, Institute for Clinical Research, National Institutes of Health Malaysia, Malaysia; Clinical Research Centre, Sungai Buloh Hospital, Ministry of Health Malaysia, Malaysia. Electronic address: pxkuan@gmail.com
  • 4 Paediatric Dental Department, Sungai Buloh Hospital, Ministry of Health Malaysia, Malaysia
  • 5 Gribbles Pathology (M) Sdn Bhd, Malaysia
  • 6 Pathology Department, Sungai Buloh Hospital, Ministry of Health Malaysia, Malaysia
Travel Med Infect Dis, 2021;43:102144.
PMID: 34302954 DOI: 10.1016/j.tmaid.2021.102144

Abstract

BACKGROUND: The standard for SARS-CoV-2 diagnosis is RT-PCR from nasopharyngeal or oropharyngeal swabs. Major airports require COVID-19 screening, and saliva has the potential as a substitute specimen for SARS-CoV-2 diagnosis. We investigated the utility of fresh drooled saliva against NPS for COVID-19 screening of travelers.

METHODS: We recruited 81 travelers and 15 non-travelers (including ten controls) prospectively within a mean of 3·22 days of RT-PCR confirmed COVID-19. Each study participant provided 2 mls of early morning fresh drooled whole saliva separately into a sterile plastic container and GeneFiX™ saliva collection kit. The saliva specimens were processed within 4 h and tested for SARS-CoV-2 genes (E, RdRP, and N2) and the results compared to paired NPS RT-PCR for diagnostic accuracy.

RESULTS: Majority of travellers were asymptomatic (75·0%) with a mean age of 34·26 years. 77 travelers were RT-PCR positive at the time of hospitalization whilst three travelers had positive contacts. In this group, the detection rate for SARS-CoV-2 with NPS, whole saliva, and GeneFiX™ were comparable (89·3%, 50/56; 87·8%, 43/49; 89·6%, 43/48). Both saliva collection methods were in good agreement (Kappa = 0·69). There was no statistical difference between the detection rates of saliva and NPS (p > 0·05). Detection was highest for the N2 gene whilst the E gene provided the highest viral load (mean = 27·96 to 30·10, SD = 3·14 to 3·85). Saliva specimens have high sensitivity (80·4%) and specificity (90·0%) with a high positive predictive value of 91·8% for SARS-CoV-2 diagnosis.

CONCLUSION: Saliva for SARS-CoV-2 screening is a simple accurate technique comparable with NPS RT-PCR.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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