Validation of rapid tests for SARS-CoV-2 in primary care emergency services
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity, specificity, positive and negative predictive values of the Abbott
PanBio antigen test in relation to the RT-PCR (reference test).
Secondary outcome
Not applicable
Background summary
To prevent exposure to SARS-CoV-2 in the healthcare setting, patients are
routinely categorized in *suspected COVID-19* and *not suspected COVID-19*.
This categorization follows a COVID-19-triage protocol. Patients who request a
consultation in primary care, are asked whether they experience symptoms that
are suspicious for an (underlying) SARS-CoV-2 infection. However, because these
symptoms are shared with common illnesses, many patients are expected to be
falsely classified as *suspected for COVID-19*. Examples include a suspicion of
appendicitis, or a fever complicating a urinary tract infection. With an
improved triaging process, these patients should be accurately categorized as
*not suspected COVID-19*, which can reduce the pressure on COVID-19-related
healthcare. Additionally, the risk for the patient of being exposed to
SARS-CoV-2 when referred to a *corona centre* should not be ignored *
especially in the midst of a second wave of infections. Rapid antigen tests
hold great potential of improving the triaging process. However, while these
rapid tests are in the process of being validated in hospital care, the
validity for population of patients in the primary care setting * the majority
of patients * is still unknown.
Study objective
Validation of rapid tests for SARS-CoV-2 in primary care emergency services
Study design
A diagnostic intervention study
Study burden and risks
A minor burden for participation in this study, is for the patient to have a
second nasopharyngeal-throat swab taken. There are however no risks associated
with the swab; at most a nosebleed can occur.
President Kennedylaan 15
Den Haag 2517 JK
NL
President Kennedylaan 15
Den Haag 2517 JK
NL
Listed location countries
Age
Inclusion criteria
All patients 18 years and older who visit the corona urgent primary care
facility of the HADOKS (location Haga, Leyweg, The Hague) or the SHR/DDDB
(location Alrijne, Leiderdorp).
Exclusion criteria
Children younger than 18 years of age.
Insufficient understanding of the Dutch language.
Recent (< 12 hours) intake of alcohol.
Administration of remdesivir and/or dexamethasone before study procedures.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL75741.058.20 |