Covid19NCT04894760
Evaluation of a COVID-19 Rapid Diagnostic Test in ER Departments in Mexico: a Multi-center Study
An observational study of Covid19, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
Trial summary
An observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Rapid Antigen Test (PanBio Ag test)
- How many people
- 567 participants
- Where
- 1 siteMexico
- Study dates
- 30 Dec 2020to 31 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that arrive to the ER department of each reference center.
Who may be able to join
- At least 18 years of age
- Signed Informed consent
- Emergency room visit or screening site with respiratory symptoms consistent with COVID-19 / influenza.
Who cannot join
- Positive pregnancy test
- Lactation
- Decision of the responsible physician to remove patient from the study.
- Transfer of the patient to another hospital unit
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Mexico City, 14080
About this study
Official title: Evaluation of a Rapid Diagnostic Test of SARS-COV-2 Carried Out in the Emergency Units of Reference Hospitals in Mexico and in Primary Care: Multi-center Study
An observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in the 2020-2021 winter season, performed on site, compared to the gold standard (RT-qPCR).
Read the detailed description
This study aims to analyze the usefulness of rapid tests, especially: a) as a diagnostic test in people attending care for nonspecific, respiratory symptoms, in emergency services of referral hospitals b) as a diagnostic test in contacts of known patients. c) as a diagnostic test to differentiate influenza from COVID-19 in the circumstance of an overlap of both viruses in the community. d) In the 3 cases, the gold standard would be the RT-PCR test for influenza and for SARS-COV-2 performed in the usual laboratory following the officially approved technique in Mexico. If the test were in saliva, it would also be much more accepted and could come close to performing a test at home that would greatly facilitate the diagnosis. So it is important to see the performance of a saliva test.
As an observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in the 2020-2021 winter season, performed on site, compared to the gold standard (RT-qPCR).
- Conditions
- Covid19
- Being tested
- Rapid Antigen Test (PanBio Ag test)
- Keywords
- rapid test, diagnosis, antigen test
- Medical subject headings
- COVID-19, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Antigen Test (PanBio Ag test)Diagnostic test
Rapid Antigen Test (PanBio Ag test)
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Compared with gold standard RT-PCR
Measured: At 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start30 Dec 2020
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894760
- Sponsor's protocol ID
- Rapid Test COVID
- Status last verified
- Jan 2022
- First submitted
- 12 Apr 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: No plan yet
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Rapid Diagnostic Test of SARS-COV-2 Carried Out in the Emergency Units of Reference Hospitals in Mexico and in Primary Care: Multi-center Study
- ClinicalTrials.gov ID
- NCT04894760
- Acronym / sponsor ID
- Rapid Test COVID
- Conditions
- Covid19
- Keywords
- rapid test, diagnosis, antigen test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 20 May 2021 (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.
An observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in the 2020-2021 winter season, performed on site, compared to the gold standard (RT-qPCR).
Detailed description
This study aims to analyze the usefulness of rapid tests, especially: a) as a diagnostic test in people attending care for nonspecific, respiratory symptoms, in emergency services of referral hospitals b) as a diagnostic test in contacts of known patients. c) as a diagnostic test to differentiate influenza from COVID-19 in the circumstance of an overlap of both viruses in the community. d) In the 3 cases, the gold standard would be the RT-PCR test for influenza and for SARS-COV-2 performed in the usual laboratory following the officially approved technique in Mexico. If the test were in saliva, it would also be much more accepted and could come close to performing a test at home that would greatly facilitate the diagnosis. So it is important to see the performance of a saliva test.
As an observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in the 2020-2021 winter season, performed on site, compared to the gold standard (RT-qPCR).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that arrive to the ER department of each reference center.
Key inclusion criteria (3 listed)
- At least 18 years of age
- Signed Informed consent
- Emergency room visit or screening site with respiratory symptoms consistent with COVID-19 / influenza.
Key exclusion criteria (4 listed)
- Positive pregnancy test
- Lactation
- Decision of the responsible physician to remove patient from the study.
- Transfer of the patient to another hospital unit
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 |
|---|---|---|
| Rapid Antigen Test (PanBio Ag test)Rapid Antigen Test (PanBio Ag test) | Diagnostic test | – |
Primary outcome
Diagnostic accuracy
Time frame: At 24 hours
Compared with gold standard RT-PCR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: Undecided. No plan yet
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
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 4 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: finished, as of the sponsor's last update on 19 Jan 2022. 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 Mexico. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy (time frame: At 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2022.