NCT04403035

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

May 21, 2020

Last Update Submit

July 19, 2021

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

  • Test characteristics

    Comparison of accuracy, sensitivity, specificity, and positive and negative predictive values between the two assays.

    3 months

Study Arms (1)

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

Interventions

ID NOW vs. AcculaDIAGNOSTIC_TEST

Comparison of the ID Now assay vs. the Accula assay in detecting Covid-19.

ID NOW vs. Acccula arm

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with orders for rapid COVID-19 testing who have consented to participate will be included in the study.

You may qualify if:

  • 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

You may not qualify if:

  • Testing not ordered or tested negative via PCR.
  • Children
  • Do not consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Related Publications (3)

  • Accula SARS-CoV-2 Test IFU (EUA). Mesa Biotech, 2020.

    RESULT

  • ID NOW COVID-19 Assay IFU (EUA). Abbott, 2020.

    RESULT

  • Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases: Interim guidance. World Health Organization. 19 March 2020.

    RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Melphine Harriott, PhD

    Ascension St. John Hospital, Detroit, Michigan

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

May 10, 2020

Primary Completion

July 1, 2020

Study Completion

May 9, 2021

Last Updated

July 23, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)