Clinical trial NCT04403035: Comparison of the ID NOW and Accula Point-of-Care Assays for Detection of COVID-19
Official title: Comparison of the ID NOW and Accula Point-of-Care Assays for the Detection of Severe Acute Respiratory System CoV-2 (SARS-CoV-2)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Covid-19
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with orders for rapid COVID-19 testing who have consented to participate will be included in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Test characteristics
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
Study officials:
affiliation: Ascension St. John Hospital, Detroit, Michigan
name: Melphine Harriott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Accula SARS-CoV-2 Test IFU (EUA). Mesa Biotech, 2020.
citation: ID NOW COVID-19 Assay IFU (EUA). Abbott, 2020.
citation: Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases: Interim guidance. World Health Organization. 19 March 2020.