Comparison of the ID NOW and Accula Point-of-Care Assays for Detection of COVID-19

Comparison of the ID NOW and Accula Point-of-Care Assays for the Detection of Severe Acute Respiratory System CoV-2 (SARS-CoV-2)

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.

Study Overview

• Status: Withdrawn
• Conditions: Covid-19
• Intervention / Treatment: Diagnostic test: ID NOW vs. Accula

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Ascension St. John Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ID NOW vs. Acccula arm; Each patient serves as his or her own control. The ID NOW test is the one that is being currently used (i.e. the control) and the Accula test is the newer test being evaluated.	Diagnostic test: ID NOW vs. Accula; Comparison of the ID Now assay vs. the Accula assay in detecting Covid-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test characteristics	Comparison of accuracy, sensitivity, specificity, and positive and negative predictive values between the two assays.	3 months

Collaborators and Investigators

• Sponsor: Ascension South East Michigan
• Investigators: Principal Investigator: Melphine Harriott, PhD, Ascension St. John Hospital, Detroit, Michigan

Publications and helpful links

General Publications

• Accula SARS-CoV-2 Test IFU (EUA). Mesa Biotech, 2020.
• ID NOW COVID-19 Assay IFU (EUA). Abbott, 2020.
• Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases: Interim guidance. World Health Organization. 19 March 2020.

Helpful Links

• US Centers for Disease Control and Prevention (CDC) Guidelines

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2020
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): May 9, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 1599159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes