Comparison of Next Generation Diagnostic Systems (NGDS) for the Detection of SARS-CoV-2

Abstract

Diagnostic testing for infectious diseases is essential for force health protection and mission readiness and is consequently a high priority for the United States Department of Defense. The World Health Organization declared Coronavirus Disease 2019 (COVID-19) a pandemic in March 2020. Early in the pandemic, testing procedures for COVID-19 relied heavily on the use of nasopharyngeal (NP) swabs and real-time polymerase chain reaction (RT-PCR) assays targeting SARS-CoV-2, the virus that causes COVID-19. In addition, there were supply chain disruptions coupled with increased demand that led to shortages of essential laboratory supplies like viral transport media (VTM). The overlap of clinical symptoms between COVID-19 and illness caused by other respiratory pathogens underscores the need for specific and accurate multi-target detection assays. Furthermore, the discomfort of procuring nasopharyngeal swabs highlights the necessity to expand the types of biological specimens that can be used for diagnostic testing. In this study we 1) compared the sensitivity and specificity of Cepheid GeneXpert IV and the BioFire FilmArray 2.0 systems, Next Generation Detection Systems (NGDS) with integrated sample processing, to detect SARS-CoV-2, 2) evaluated the performance of these NGDS using different sample types, and 3) assessed saline as an alternative to VTM for sample storage and shipping. Limit of detection testing indicated that the Cepheid GeneXpert IV is more sensitive than the BioFire FilmArray 2.0. Comparative testing using 1) nasopharyngeal swabs in VTM, 2) nasopharyngeal swabs in saline, 3) nasal swabs, and 4) oropharyngeal swabs from 216 study participants are consistent with the Cepheid GeneXpert being more sensitive than the BioFire FilmArray RP2.1. Conversely, testing saliva on the Cepheid GeneXpert IV demonstrated statistically significant lower sensitivity compared to the BioFire FilmArray RP2.1, counter to other results in this study.

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Document Details

Document Type
Technical Report
Publication Date
Apr 18, 2022
Accession Number
AD1174188

Entities

People

  • Anna R. Ochoa
  • Antonio O. Sanchez
  • August Blackburn
  • Chet R. Voelker
  • Jennifer S. McDaniel
  • Rachel E. Mahoney
  • Sallie L. Hall
  • Susana N. Asin
  • Tony T. Yuan

Organizations

  • 59th Medical Wing

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Air Force
  • Chain Reactions
  • Chemical Reactions
  • Covid-19
  • Detection
  • Disease Outbreaks
  • Governments
  • Hygiene
  • Infectious Diseases
  • Information Science
  • Institutional Review Board
  • Medical Personnel
  • Military Medicine
  • Military Personnel
  • Pcr Testing
  • Polymerase Chain Reaction
  • Public Health
  • Risk Analysis
  • Sars
  • Social Distancing
  • Test Methods
  • United States
  • Virus Diseases
  • Viruses

Fields of Study

  • Biology

Readers

  • Infectious Disease/Epidemiology
  • Oncology and Biomarker-Based Cancer Detection.