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Performance evaluation of a sars-cov-2 rapid antigentest: test performance in the community in the netherlands

Performance evaluation of a sars-cov-2 rapid antigentest: test performance in the community in the netherlands

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22075
Enrollment
1000
Registered
2020-10-19
Start date
2020-09-26
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

COVID-19

Interventions

None listed

Sponsors

Amphia Hospital Breda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to evaluate clinical specificity, symptomatic adults (=18 years) who present at a participating GGD test centre for a COVID- 19 test will be included. In order to evaluate clinical sensitivity, symptomatic adults (=18 years) who were tested positive with qRT-PCR in a participating GGD test centre will be included.

Exclusion criteria

Exclusion criteria: Age <18 years

Design outcomes

Primary

MeasureTime frame
For part one of the study the primary outcome was the VRD clinical sensitivity and specificity compared to qRT-PCR. For the second part of the study the primary outcome was VRD clinical sensitivity compared to qRT-PCR stratified by Ct-value category (Ct<20, Ct20-25, Ct25-30 and Ct=30) and time since symptom onset (< 7 days, = 7 days).

Secondary

MeasureTime frame
Furthermore, overall positive predictive value (PPV) and negative predictive value (NPV) were calculated for a range of population prevalence (0.1%, 1.0%, 5%, 10%). In both parts of the study concordance between VRD analysis with the VA and visual interpretation were evaluated and compared with qRT-PCR results. Furthermore the practical applicability will be evaluated.

Contacts

Public ContactNathalie Van der Moeren

Microvida Amphia Hospital Breda

n.vdmoeren@gmail.com0032470888849

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)