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Summary
This paper presents the validation results of a qPCR test that was developed at University of Illinois Urbana-Champaign (UIUC) for non-invasively detecting the SARS-CoV-2 virus in saliva and tested in Aotearoa New Zealand laboratory. We used saliva samples that were collected from individuals that had also had nasal swabs taken at the same time. The nasal swabs for just over a third of these people were positive for SARS-CoV-2. Our results showed that the UIUC qPCR test is highly accurate (99.1%) for detecting SARS-CoV-2 in saliva and can detect very low copy numbers of SARS-CoV-2 in saliva. This UIUC qPCR for SARS-CoV-2 is as accurate as the qPCR tests used for detecting SARS-CoV-2 in nasopharyngeal samples in New Zealand. These results confirmed that this reliable option for SARS-CoV-2 testing, including for diagnostic testing for asymptomatic people requiring regular screening.
Key Points
**The SARS-CoV-2 RT-qPCR assay developed at University of Illinois Urbana-Champaign (UIUC) was analytically and diagnostically validated in New Zealand using 33 positive and 114 negative saliva samples that were paired with contemporaneously collected nasal specimens, mostly of nasopharyngeal origin.
**Our local testing using the UIUC RT-qPCR found it to be an assay with high analytical and diagnostic sensitivity and an extremely low limit of detection.
**The accuracy of 99.1% of this UIUC SARS-CoV-2 RT-qPCR makes it an extremely reliable option for SARS-CoV-2 testing, including for asymptomatic people with low viral load.