Validation of an Immunochromatographic Assay for IgG/IgM Antibodies to 2019- nCoV (I-GLOBAL)

Clinical Validation of a Simple and Fast Immunochromatographic Assay for Qualitative Determination of Specific ImmunoGLObulin IgG/IgM Antibodies to 2019- nCoV in Whole bLood, Serum or Plasma Specimen

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.

Study Overview

• Status: Completed
• Conditions: COVID
• Intervention / Treatment: Device: 2019-nCoV IgG/IgM Rapid Test Cassette

Detailed Description

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-2in whole blood, serum or plasma specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with 2019-nCoV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to SARS-CoV-2. The study aims to validate in a real life study a self diagnostic assay for SARS-CoV-2 with the advantages of high speed, simple operation and low cost, and overcomes the shortcomings of the existing molecular detection methods. Clinical specimens from patients who were suspected of being infected with 2019-nCoV will be used to evaluate the performance of the assay. In parallel, we will also use molecular assays for the detection of the presence of the viral RNA from nasopharyngeal swabs since Polymerase Chain Reaction is currently the gold standard.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • Papa Giovanni XXIII Hospital
  • Cremona, Italy
    • Azienda Socio-Sanitaria Territoriale di Cremona
  • Milan, Italy, 20141
    • European IO, Division of Early Drug Development for Innovative Therapies
  • Milano, Italy, 20133
    • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
  • Milano, Italy, 20162
    • Azienda Ospedaliera Niguarda Cà Granda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population includes:

• Patients or health professionals already tested positive for the viral RNA from nasopharyngeal swabs by RT-PCR
• Patients or health professional who are suspected of being infected with SARS-CoV-2 in the hospital
• Patients who are considered at high risk for infection and eligible for active therapy and major surgery.

Description

Inclusion Criteria:

1. Suspected cases who meet the following 2 criteria at the same time:

   1. Epidemiological history: There was a history of contact with confirmed cases before the onset of illness; or subjects with at least one symptom in the last week before accrual in the trial. Subjects who have been in contact with people positive for SARS-CoV-2 in the previous 14 days.
   2. Clinical manifestations are defined as :

   Fever >37.5°; dry cough, muscle pain and/or fatigue, anosmia, subjects with respiratory distress (Respiratory Rate >25/min or O2 Saturation <92%) or imaging characteristics of pneumonia; or the total number of white blood cells is normal or decreased with the lymphocyte count decreased in the early stage of onset or there is an abnormal C-Reactive protein. Other symptoms that clinical investigator will relate to SARS-CoV-2 infection. Subject or cancer patients who have been quarantined for suspect symptoms and have access to hospital to continue therapy or to receive major surgery

2. Confirmed cases, namely patients or subjects with positive Reverse Transcription-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2. On the basis of meeting the criteria for suspected cases, sputum, throat swabs, lower respiratory tract secretions, and other specimens are tested by realtime RT-PCR for positive nucleic acid detection of new coronavirus; or viral gene sequencing is highly homologous with known new coronaviruses. Patients positive are serially tested with SARS-CoV-2 lgM / IgG Rapid Test to evaluate the immune response in IgG negative patients and the reliability of the test in those patients who develop clinical signs of SARS-CoV-2 during the trial.

3. Patients who are considered at high risk for infection and eligible for active therapy and major surgery

   • Frailty (age and multiple comorbidities) planned to receive a standard systemic anticancer treatment comprising chemotherapy and/or immunotherapy and/or radiation therapy or to receive an experimental treatment
   • Major surgery or surgery after neoadjuvant chemotherapy and or chemo/radiotherapy

Exclusion Criteria:

1. Ascertained influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human metapneumovirus, Severe Acute Respiratory Syndrome coronavirus, and other known other viral pneumonia;
2. Ascertained mycoplasma pneumoniae, chlamydia pneumonia, and bacterial pneumonia; non-infectious diseases such as vasculitis, dermatomyositis, and organizing pneumonia.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort tested; The cohort will include patients or health professionals who patients who were suspected of being infected with 2019-nCoV	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the rate of SARS-CoV-2 positive cancer patients and health professionals in a comprehensive cancer center or in a cancer setting.	Patients positive are serially tested with SARSCoV-2 lgM / IgG Rapid Test to evaluate the immune response in IgG negative patients and the reliability of the test in those patients who develop clinical signs of SARS-CoV-2 during the trial.	6 months
Evaluation of test accuracy	The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was compared with a leading commercial Polymerase Chain Reaction	3 months
Interleukin-6 quantification	Multiplex immunoassay	3 months
Interleukin-2 quantification	Multiplex immunoassay	3 months
Interleukin-1 quantification	Multiplex immunoassay	6 months
Tumor Necrosis Factor (TNF) quantification	Multiplex immunoassay	3 months
Interferon gamma quantification	Multiplex immunoassay	3 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Collaborators: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta; Azienda Ospedaliera Niguarda Cà Granda; Papa Giovanni XXIII Hospital; Azienda Socio Sanitaria Territoriale di Cremona
• Investigators: Principal Investigator: Giuseppe Curigliano, MD, European IO; Principal Investigator: Antonio Marra, MD, European IO

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: cancer; COVID; immunoassay; immunoglobulin IgM; immunoglobulin IgG
• Other Study ID Numbers: I-GLOBAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD will be available upon request
• IPD Sharing Time Frame: At the end of the study
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No