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 | Unknown

• 1 other identifier: 2021 A00515 36
• Study Type: interventional
• Target: 1,467
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COVID-19 diagnostic

Outcome Measures

Primary Outcomes (1)

• evaluation of the sensitivity of detection of SARS-CoV-2 N antigen

  The sensitivity corresponds to the number of patients with a positive detection of SARS-CoV-2 antigenemia and a positive SARS-CoV-2 nasopharyngeal PCR / Number of patients with a positive SARS-CoV-2 nasopharyngeal PCR

  1 day

Study Arms (1)

Venous and Capillary blood sampling

EXPERIMENTAL

Venous and Capillary blood sampling

Diagnostic Test: Venous and Capillary blood sampling

Interventions

Venous and Capillary blood sampling DIAGNOSTIC_TEST

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

Venous and Capillary blood sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject informed and having signed the consent
• Age ≥ 18 years old
• Affiliation to a social security
• Indication for carrying out a screening or diagnostic test for COVID-19
• For the study of diagnostic performance in symptomatic hospitalized patients, at least one of the following criteria (HAS recommendations - June 2020):
• Respiratory rate\> 25 / min
• Pulse\> 100 / mn
• SpO2 \<94%
• Dyspnea
• For the study of diagnostic performance in asymptomatic patients:
• ● No symptoms of respiratory infection present (fever, chills, sweating, headache, myalgia, feeling sick, cough, rhinorrhea or sputum, sore throat, chest pain)
• For the study of diagnostic performance in symptomatic or pauci-symptomatic patients who are not hospitalized:
• ● None of the criteria of the two previous populations

You may not qualify if:

• Contraindication to performing a nasopharyngeal sample or inability to perform the nasopharyngeal sample
• Subject who has already participated in the study
• All categories of persons protected according to the CSP (minor subject, pregnant, deprived of liberty, under measure of legal protection, guardianship or curators)
• Lack of social security affiliation, CMU (or equivalent)
• Subject under AME
• Lack of signed informed consent
• For the study of diagnostic performance in pauci-symptomatic patients
• Need for nasal oxygen therapy
• For the study of diagnostic performance in asymptomatic patients
• Presence of respiratory symptoms suggestive of viral infection of the upper respiratory tract
• Need for nasal oxygen therapy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat Hospital

Paris, 75018, France

RECRUITING

Study Officials

• VISSEAUX BENOIT

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VISSEAUX BENOIT

CONTACT

01 40 25 61 52; benoit.visseaux@aphp.fr

GHOSN Jade

CONTACT

jade.ghosn@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 267 Symptomatic hospitalized patients 400 Symptomatic or symptomatic patients not hospitalized 800 asymptomatic patients
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional study

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 25, 2021
• Study Start: July 15, 2021
• Primary Completion: June 15, 2022
• Study Completion: December 30, 2022
• Last Updated: April 21, 2022

Record last verified: 2021-09

Locations

FR (1)