Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-03-04 @ 2:54 PM
Study NCT ID:
NCT04403035
Status:
WITHDRAWN
Last Update Posted:
2021-07-23
First Post:
2020-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the ID NOW and Accula Point-of-Care Assays for Detection of COVID-19
Sponsor:
Henry Ford Health System
Organization:
Study Overview
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)
Status:
WITHDRAWN
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to get adequate resources to do the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: