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Evaluation of the Detection Performance of the N Antigenemia of SARS-CoV-2 in the General Population for the Diagnosis and Screening of COVID-19

NCT05092607 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1467

Last updated 2022-04-21

No results posted yet for this study

Summary

SARS-CoV-2 is responsible for COVID-19. Today, RT-PCR performed on a nasopharyngeal sample remains the gold standard for diagnosing SARS-CoV-2 infection. However, several other assays have been developed to increase testing capabilities and provide rapid screening strategies such as antigenic lateral flow assays. Most recommended tests to date are based nasopharyngeal sampling that is often poorly tolerated by patients and associated with a significant risk of infection for the sampler. Saliva can be used but provide slightly lower sensitivities depending of the subsequent assay use with those samples. The detection of the N antigen of SARS-CoV-2, by ELISA or rapid immunochromatographic technique, on a serum or blood sample would make it possible to overcome these constraints and to provide a new testing alternative. ELISA tests are faster, cheaper and easier to automate than molecular biology approaches.

Blood sampling may be easier to perform in certain populations (in particular in hospitalized patients who already benefit from blood sampling, blood donors, etc.), require less equipment, and is better tolerated (immunocompromised patients subject to blood sampling repeated), and can be integrated more systematically into assessments carried out at the entrance to hospitals or in town, etc. If the N-antigen levels in blood are sufficient, rapid antigen assay on capillary blood could also provide useful testing alternatives.

In a pilot study conducted at Bichat Claude Bernard Hospital, the sensitivity of the first available commercial test was estimated at 93% (95% CI, 84.7-100), and its specificity at 98% (95% CI, 85.3-100).

The main objective of the current work is to evaluate the sensitivity of the SARS-CoV-2 N antigen detection in the serum compared to nasopharyngeal SARS-CoV-2 PCR in several populations such as symptomatic hospitalized patients, symptomatic non-hospitalized patients and asymptomatic subjects.

For each detection kit evaluated, the primary endpoint is the sensitivity (and its 95% confidence interval) of the detection of SARS-CoV-2 N antigen in serum overall and in those populations. The specificity will also be assess.

Conditions

  • Respiratory Viral Infection

Interventions

DIAGNOSTIC_TEST

Venous and Capillary blood sampling

Venous sample at the bend of the elbow (7mL) taken immediately after the nasopharyngeal sample. Capillary blood sampling, for patients included in participating centers

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • VISSEAUX BENOIT · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2022-06-15
Completion
2022-12-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05092607 on ClinicalTrials.gov