A diagnostic study comparing different tests for the diagnosis of COVID-19

Sensitivity, specificity and predictive values of molecular and serological tests for COVID-19: a longitudinal study in the emergency room

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13990999

Enrollment

400

Registered

2020-06-24

Start date

2020-04-03

Completion date

Unknown

Last updated

2021-03-30

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

Conditions

COVID-19 (SARS-CoV-2 infection) Respiratory COVID-19 (SARS-CoV-2 infection)

Interventions

Current interventions as of 25/06/2020: Patients will be recruited at the participating centre emergency room. They will have nasopharyngeal swabs for PCR and blood taken for serologic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Clinical suspicion of COVID-19 3. Consent to participate in the study and to the donation of biological samples given

Exclusion criteria

Exclusion criteria: 1. Missing or invalid samples

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 25/06/2020: Test accuracy for the diagnosis of SARS-CoV-2 infection assessed through comparison against a patient classification made using all the molecular tests and selected clinical variables, using the statistical technique of Latent Class Analysis (LCA) and with clinical reassessment of uncertain cases; the standard molecular test is performed at baseline (upon patient recruitment), while the six serological and two additional molecular (Rt-PCR) tests will be performed on cryopreserved swabs (Rt PCR) and serum specimens (serological tests), after completion of patient recruitment. Previous primary outcome measure: Test accuracy for the diagnosis of SARS-CoV-2 infection assessed through comparison against a patient classification using the standard molecular test, performed at baseline (upon patient recruitment) and with clinical reassessment of uncertain cases; and the six serological and three molecular (Rt-PCR) tests, performed on cryopreserved swabs (Rt PCR) and serum specimens (serological tests), after completion of patient recruitment (within 1 h)	—

Measure

Time frame

Current primary outcome measure as of 25/06/2020: Test accuracy for the diagnosis of SARS-CoV-2 infection assessed through comparison against a patient classification made using all the molecular tests and selected clinical variables, using the statistical technique of Latent Class Analysis (LCA) and with clinical reassessment of uncertain cases; the standard molecular test is performed at baseline (upon patient recruitment), while the six serological and two additional molecular (Rt-PCR) tests will be performed on cryopreserved swabs (Rt PCR) and serum specimens (serological tests), after completion of patient recruitment. Previous primary outcome measure: Test accuracy for the diagnosis of SARS-CoV-2 infection assessed through comparison against a patient classification using the standard molecular test, performed at baseline (upon patient recruitment) and with clinical reassessment of uncertain cases; and the six serological and three molecular (Rt-PCR) tests, performed on cryopreserved swabs (Rt PCR) and serum specimens (serological tests), after completion of patient recruitment (within 1 h)

—

Secondary

Measure	Time frame
Current secondary outcome measures as of 25/06/2020: Test accuracy of the six serological tests in the subset of patients reporting symptom duration =7 days assessed using the standard molecular test, performed at baseline (upon patient recruitment). Previous secondary outcome measures: Test accuracy in the subset of patients reporting symptom duration =7 days assessed using the standard molecular test, performed at baseline (upon patient recruitment); and the six serological and three molecular (Rt-PCR) tests, performed on cryopreserved swabs (Rt PCR) and serum specimens (serological tests), after completion of patient recruitment (within 1 h)	—

Measure

Time frame

Current secondary outcome measures as of 25/06/2020: Test accuracy of the six serological tests in the subset of patients reporting symptom duration =7 days assessed using the standard molecular test, performed at baseline (upon patient recruitment). Previous secondary outcome measures: Test accuracy in the subset of patients reporting symptom duration =7 days assessed using the standard molecular test, performed at baseline (upon patient recruitment); and the six serological and three molecular (Rt-PCR) tests, performed on cryopreserved swabs (Rt PCR) and serum specimens (serological tests), after completion of patient recruitment (within 1 h)

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026