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

Covid-19 Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04403035
• Other study ID #: 1599159
• Status: Withdrawn
• Start date: May 10, 2020
• Est. completion date: May 9, 2021

Study information

• Verified date: July 2020
• Source: Ascension South East Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 9, 2021
• Est. primary completion date: July 1, 2020
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid-19

Intervention

Diagnostic Test:
• ID NOW vs. Accula
Comparison of the ID Now assay vs. the Accula assay in detecting Covid-19.

Locations

Country	Name	City	State
United States	Ascension St. John Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascension South East Michigan

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test characteristics	Comparison of accuracy, sensitivity, specificity, and positive and negative predictive values between the two assays.	3 months

External Links

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