Validation of a molecular assay to detect SARS-CoV-2 in saliva
New Zealand Medical Journal
; 134(1547):14, 2021.
Article
in English
| Web of Science | ID: covidwho-1695516
ABSTRACT
AIM:
To validate a reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) assay to detect SARS-CoV-2 in saliva in two independent Aotearoa New Zealand laboratories.METHODS:
An RT-qPCR assay developed at University of Illinois Urbana-Champaign, USA, was validated in two New Zealand laboratories. Analytical measures, such as limit of detection (LOD) and cross-reactivity, were performed. One hundred and forty-seven saliva samples, each paired with a contemporaneously collected nasal swab, mainly of nasopharyngeal origin, were received. Positive (N=33) and negative (N=114) samples were tested blindly in each laboratory. Diagnostic sensitivity and specificity were then calculated.RESULTS:
The LOD was <0.75 copy per mu L and no cross-reactivity with MERS-CoV was detected. There was complete concordance between laboratories for all saliva samples with the quantification cycle values for all three genes in close agreement. Saliva had 98.7% concordance with paired nasal samples and a sensitivity, specificity and accuracy of 97.0%, 99.1% and 99.1%, respectively.CONCLUSION:
This saliva RT-qPCR assay produces reproducible results with a low LOD. High sensitivity and specificity make it a reliable option for SARS-CoV-2 testing, including for asymptomatic people requiring regular screening.
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Collection:
Databases of international organizations
Database:
Web of Science
Type of study:
Prognostic study
Language:
English
Journal:
New Zealand Medical Journal
Year:
2021
Document Type:
Article
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