Covid-19NCT04403035
Comparison of the ID NOW and Accula Point-of-Care Assays for Detection of COVID-19
An observational study of Covid-19, run by Henry Ford Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Covid-19
- What is being tested?
- ID NOW vs. Accula
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2020to 9 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Adult, Older adult
Study population: Adult patients with orders for rapid COVID-19 testing who have consented to participate will be included in the study.
Who may be able to join
- 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
Who cannot join
- Testing not ordered or tested negative via PCR.
- Children
- Do not consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ascension St. John Hospital
Detroit, Michigan, 48236
About this study
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)
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.
Read the 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.
- Conditions
- Covid-19
- Being tested
- ID NOW vs. Accula
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID NOW vs. AcculaDiagnostic test
Comparison of the ID Now assay vs. the Accula assay in detecting Covid-19.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ID NOW vs. Accula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test characteristics
Comparison of accuracy, sensitivity, specificity, and positive and negative predictive values between the two assays.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start10 May 2020
- Primary completion1 Jul 2020 (estimated)
- Study completion9 May 2021 (estimated)
Why it stopped: Unable to get adequate resources to do the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melphine Harriott, PhD, Principal investigator, Ascension St. John Hospital, Detroit, Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403035
- Sponsor's protocol ID
- 1599159
- Status last verified
- Aug 2026
- First submitted
- 21 May 2020
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04403035
- Acronym / sponsor ID
- 1599159
- Conditions
- Covid-19
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to get adequate resources to do the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 9 May 2021 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ID NOW vs. Acccula arm | – | Diagnostic Test: ID NOW vs. AcculaEach 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with orders for rapid COVID-19 testing who have consented to participate will be included in the study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Testing not ordered or tested negative via PCR.
- Children
- Do not consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ID NOW vs. AcculaComparison of the ID Now assay vs. the Accula assay in detecting Covid-19. | Diagnostic test | ID NOW vs. Acccula arm |
Primary outcome
Test characteristics
Time frame: 3 months
Comparison of accuracy, sensitivity, specificity, and positive and negative predictive values between the two assays.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Results publicationAccula SARS-CoV-2 Test IFU (EUA). Mesa Biotech, 2020.
- Results publicationID NOW COVID-19 Assay IFU (EUA). Abbott, 2020.
- Results publicationLaboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases: Interim guidance. World Health Organization. 19 March 2020.
- US Centers for Disease Control and Prevention (CDC) GuidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melphine Harriott, PhD principal investigator
Ascension St. John Hospital, Detroit, Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test characteristics (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04403035, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.