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Validation of an Immunochromatographic Assay for IgG/IgM Antibodies to 2019- nCoV

NCT04434417 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-05-13

No results posted yet for this study

Summary

In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of SARS-CoV-2. The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the detection of immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies to SARS-CoV-2 in whole blood, serum or plasma specimen. Clinical specimens from patients who were suspected of being infected with 2019-nCoV will be used to evaluate the performance of the assay.

Conditions

Interventions

DEVICE

2019-nCoV IgG/IgM Rapid Test Cassette

The specimen (whole blood, serum, plasma) will be loaded into the cassette and will migrate via capillary action along the membrane to react with the gold conjugate. The result will be available in 10 minutes

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale di Cremona

    collaborator OTHER

  • Azienda Ospedaliera Niguarda Cà Granda

    collaborator OTHER

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    collaborator OTHER

  • Papa Giovanni XXIII Hospital

    collaborator OTHER

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Giuseppe Curigliano, MD · European IO

  • Antonio Marra, MD · European IO

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2021-07-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT04434417 on ClinicalTrials.gov