This study is a comparison of the ID Now COVID-19 (Abbott) assay to the Accula SARS-CoV-2 (Mesa Biotech) assay to assist in the identification of infection with COVID-19. The tests will be compared for sensitivity, specificity, positive predictive value and negative predictive value.
In response to the pandemic, the Food and Drug Administration (FDA) approved several
platforms under emergency use authorization (EUA). These platforms do not have full FDA
approval and may be used for COVID-19 testing temporarily in a clinical laboratory until the
manufacturer receives full FDA clearance for use in the U.S.
Two point of care (POC) platforms with current EUA approval are the ID NOW COVID-19 (Abbott)
and the Accula SARS-CoV-2 tests (Mesa Biotech). Both tests are designated as clinical
laboratory improvement amendments (CLIA) waived complexity. POCs play a vital role in the
diagnosis of COVID-19, especially in laboratories and clinics where testing including
molecular assays and serology is not available.
The purpose of this study is to compare SARS-CoV-2 results from clinical specimens on the ID
NOW and the Accula systems. If the Accula system is comparable or demonstrates superior test
parameters including sensitivity, then this assay may potentially assist in improving
turnaround times for COVID-19 results and facilitate reinstating elective procedures.
Patients with orders for rapid Covid-19 testing and who have consented to participate will be
included. For these patients one additional clinical specimen, a nasal specimen will be
collected from the patient at the same time as the initial specimen for the ID NOW. If there
is a discrepancy between the ID NOW and Accula test results, an additional specimen (nasal)
will be collected from the patient, if possible (i.e. if the patient remains in-house) to
confirm the COVID-19 results. We will also include patients who did not have an initial swab
but tested positive by PCR. They will be swabbed by both systems.
This study will evaluate accuracy by comparing Accula results to the ID NOW, precision
(reproducibility) by repeating select specimens with different users and on different
analyzers, limit of detection by diluting commercial SARS-CoV-2 controls with a known
concentration and cross-reactivity by testing known respiratory viruses (including influenza
A, B and RSV) on the Accula.
Diagnostic Test: ID NOW vs. Accula
Comparison of the ID Now assay vs. the Accula assay in detecting Covid-19.
Inclusion Criteria:
- Covid-19 testing has been ordered in the Emergency Dept. or for inpatients in the
hospital or patient has already tested positive via PCR.
- Adult patients
- Consent obtained
Exclusion Criteria:
- Testing not ordered or tested negative via PCR.
- Children
- Do not consent
Ascension St. John Hospital
Detroit, Michigan, United States
Melphine Harriott, PhD, Principal Investigator
Ascension St. John Hospital, Detroit, Michigan