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

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1000
sponsor

European Institute of Oncology

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Updated on 19 February 2024

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Summary

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.

Details

Condition	COVID
Age	18-100 years
Treatment	2019-nCoV IgG/IgM Rapid Test Cassette
Clinical Study Identifier	NCT04434417
Sponsor	European Institute of Oncology
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Suspected cases who meet the following 2 criteria at the same time
	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
	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
	\. 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
	\. 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
	Ascertained influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human metapneumovirus, Severe Acute Respiratory Syndrome coronavirus, and other known other viral pneumonia
	Ascertained mycoplasma pneumoniae, chlamydia pneumonia, and bacterial pneumonia; non-infectious diseases such as vasculitis, dermatomyositis, and organizing pneumonia

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