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