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Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

Use of Rapid Covid-19 Antibody Test Marketed by AAZ Laboratories in Healthcare Workers Presumably Being Infected by SARS-CoV-2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04525417
Enrollment
75
Registered
2020-08-25
Start date
2020-04-25
Completion date
2020-10-25
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19 Immune Status of Healthcare Workers

Brief summary

The study objectives were to assess 1/the immune status of healthcare professionals with suggestive symptomatology of Covid-19 infection and 2/the sensitivity and specificity of AAZ rapid test by comparing it with a serological ELISA test. An open-label, monocentric, prospective, non-randomized study, is conducted, including 50 hospital healthcare professionals and 50 private health professionals. Knowledge of serostatus will achieve the implementation of a strategy of management of patients according to specific immunity of health professionals

Interventions

DIAGNOSTIC_TESTAAZ Covid-19 rapid test

To assess the immune status

Sponsors

Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Lead SponsorNETWORK

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Monocentric, open-label, prospective, non-randomized study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Healthcare professionals with symptoms suggestive of Covid-19 infection

Exclusion criteria

* any other subject * pregnant women * protected adult

Design outcomes

Primary

MeasureTime frameDescription
To assess the predictive value of Covid-19 rapid testOne weekComparative study with Elisa Test
Compare the results of rapid tests on serum and capillary samplesone weekPerformance evaluation of rapid tests according to the samples used

Secondary

MeasureTime frameDescription
A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatologyone weekUse of rapid test
Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serologyOne weekAnalysis of clinical data

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026