Evaluating the Feasibility and Performance of Two Diagnostic Platforms for SARS-COV-2 Detection in Saliva
Abstract
The SARS-COV-2 pandemic has had severe world-wide consequences on human and economic health. Rapid diagnosis is critical to prevent transmission. This study evaluates two fully integrated sample processing platforms for SARS-COV-2 detection in saliva. The Xpert (registered trademark) Xpress CoV-2/Flu/RSV plus cartridge is used on the laboratory-based Cepheid (registered trademark) platform, while the XCEL (trademark) Respiratory ISP cartridge is used on the portable Franklin (registered trademark) ISP system. SARS-COV-2 patient research saliva samples (150 negative; 124 positive) were collected the same day as the nasal swab sample for the official CLIA test allowing for direct comparison. The limit of detection in saliva for the Cepheid (registered trademark) cartridge was 8400 copies/mL, while the Franklin (registered trademark) ISP cartridge was over 42,000 copies/mL. The Cepheid (registered trademark) cartridge exhibited sensitivity/specificity of 56.56 percent /98.11 percent, while the Franklin ISP system was 28.72 percent/94.56 percent. While both systems had high specificity for SARS-COV-2 detection in saliva, the sensitivity was low, thus requiring further refinement of the systems for saliva detection.
Document Details
- Document Type
- Technical Report
- Publication Date
- Aug 24, 2023
- Accession Number
- AD1208989
Entities
People
- Alexander J. Burdette
- Brandie K. Goren
- Hector Lopez
- Susana N. Asin
Organizations
- 59th Medical Wing