View The Document

Accession Number:



Evaluating the Feasibility and Performance of Two Diagnostic Platforms for SARS-COV-2 Detection in Saliva


Author Organization(s):

Report Date:



The SARS-COV-2 pandemic has had severe world-wide consequences on human andeconomic health. Rapid diagnosis is critical to prevent transmission. This study evaluates twofully integrated sample processing platforms for SARS-COV-2 detection in saliva. The XpertXpress CoV-2/Flu/RSV plus cartridge is used on the laboratory-based Cepheid platform, whilethe XCEL Respiratory ISP cartridge is used on the portable Franklin ISP system. SARS-COV-2 patient research saliva samples (150 negative; 124 positive) were collected the same dayas the nasal swab sample for the official CLIA test allowing for direct comparison. The limit ofdetection in saliva for the Cepheid cartridge was 8400 copies/mL, while the Franklin ISPcartridge was over 42,000 copies/mL. The Cepheid cartridge exhibited sensitivity/specificityof 56.56 /98.11 , while the Franklin ISP system was 28.72 /94.56 . While both systemshad high specificity for SARS-COV-2 detection in saliva, the sensitivity was low, thus requiringfurther refinement of the systems for saliva detection.



File Size:



Distribution Statement:

Approved For Public Release

View The Document