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

Completed

• Conditions: COVID
• Interventions: Device: 2019-nCoV IgG/IgM Rapid Test Cassette

• Registration Number: NCT04434417
• Lead Sponsor: European Institute of Oncology

Brief 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.

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 Timeline

• Study Start: 2020-04-15
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-16
• Primary Completion: 2021-07-31
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort tested	2019-nCoV IgG/IgM Rapid Test Cassette	The cohort will include patients or health professionals who patients who were suspected of being infected with 2019-nCoV

Primary Outcome Measures

Name	Time	Method
Tumor Necrosis Factor (TNF) quantification	3 months	Multiplex immunoassay
Evaluation of the rate of SARS-CoV-2 positive cancer patients and health professionals in a comprehensive cancer center or in a cancer setting.	6 months	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.
Evaluation of test accuracy	3 months	The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was compared with a leading commercial Polymerase Chain Reaction
Interleukin-6 quantification	3 months	Multiplex immunoassay
Interleukin-2 quantification	3 months	Multiplex immunoassay
Interleukin-1 quantification	6 months	Multiplex immunoassay
Interferon gamma quantification	3 months	Multiplex immunoassay

Trial Locations

Locations (5)

Azienda Socio-Sanitaria Territoriale di Cremona; 🇮🇹 Cremona, Italy

Papa Giovanni XXIII Hospital; 🇮🇹 Bergamo, Italy

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta; 🇮🇹 Milano, Italy

European IO, Division of Early Drug Development for Innovative Therapies; 🇮🇹 Milan, Italy

Azienda Ospedaliera Niguarda Cà Granda; 🇮🇹 Milano, Italy