Coronavirus Infections
Conditions
Keywords
COVID-19, IgM Test, IgG Test
Brief summary
This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak. Patients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.
Detailed description
This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak in patients with no symptoms and with no known exposure to the COVID-19. Patients are tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test at day 0, day 7 and day 14. The investigators expect test to be negative on all the measurements in those patients that do not develop symptoms and that continue to have no known history of exposure to COVID-19 Patients that develop symptoms (cough, fever or respiratory distress) and a possible contact with people positive for COVID-19 OR patients that show a positive VivaDiag test during the time frame of the test are asked to attend the COVID-19 RT - PCR &CT. Subsequently, the investigators will continue, repeating two tests seven days apart every 30 days (predefined times 0-7-14, then 30-37, 60-67) for the next six months. The investigators can evaluate to stop the test however before the six months if there are no new cases of COVID-19 for at least 21 days in the region where the enrolled patients live. The test in use is the VivaDiag ™ COVID-19 lgM / IgG Procedure (as per the protocol in use for the administration of the test) 1. take out the test kit and leave it at least 30 minutes in the room where the test will be performed. 2. place the test equipment on a clean and dust-free surface 3. First insert 10µL of whole blood or serum or plasma in the area reserved for blood (in the well) present on the test, then apply 2 drops of buffer. 4. read the result after 15 minutes Interpretation of test results Positive result 1. The anti-COVID-19 lgM antibody is detected if: the quality control band C and the lgM band are both colored and the lgG band does not stain. This means that the anti-COVID-19 lgM antibody is positive. 2. The anti-COVID-19 lgG antibody is detected if: the quality control band C and the lgG band are both colored and the lgM band does not stain. This means that the COVID-19 lgG antibody is positive. 3. The lgG and lgM anti-COVID-19 antibodies are detected if: the C band, the lgG band and the lgM band are all three colored. This means that the anti-COVID-19 lgG and lgM antibodies are both positive. Negative result The anti-COVID-19 lgG and lgM antibodies are not detected if only the quality control C band is stained but the lgG and lgM bands are not colored, this means that the test is negative. Invalid result If the quality control band C does not color, regardless of whether the lgG and lgM bands are colored or not, the result is invalid and the test must be started again. Specs of the test Product Name VivaDiag™ COVID-19 IgM/IgG Rapid Test Test Principle Colloidal gold Sample Type Whole blood (from vein or fingertip), serum or plasma Sample Volume 10 μL Test Time 15 min Operation Temperature 18-25ºC Storage Temperature 2-30ºC Shelf Life (Unopened) 12 months
Interventions
DEVICEVivaDiag™ COVID-19 lgM/IgG Rapid Test
VivaDiag™ COVID-19 lgM/IgG Rapid Test is an in vitro diagnostic for the qualitative determination of COVID-19 IgM and IgG antibodies in human whole blood (from vein or fingertip), serum or plasma
Sponsors
VivaChek Laboratories, Inc.
Centro Studi Internazionali, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults healthcare workers (HCW) OR * Chronic patients with at least 2 chronic medical conditions
Exclusion criteria
* People that have been in contact with people positive for COVID-19 in the previous 14 days * People with body temperature \>37.5°C * People with Dry cough * People with Respiratory distress (Respiratory Rate \>25/min or O2 Saturation \<92%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with contrasting results | 30 days | Where available, number of patients positive for COVID-19 IgG and IgM and negative for COVID-19 PCR, or negative for COVID-19 IgG and IgM and positive for COVID-19 PCR |
| Number of patients with positive test with a positive PCR for COVID-19 | 30 days | Number of patients that present at least one positive VivaDiag test that when subsequently tested with PCR remain positive |
| Overall Number of patients positive for COVID-19 | six months | Where available, number of patients positive for COVID-19 IgG and IgM and positive for COVID-19 PCR |
| Overall Number of patients negative for COVID-19 | six months | Where available, number of patients negative for COVID-19 IgG and IgM and negative for COVID-19 PCR |
| Number of patients with constant negative results | 30 days | Number of patients with negative results in the three measurements, compared to the number of patients with at least one positive test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive HCW | 60 days | Number of healthcare workers that become positive for COVID-19 IgM or IgG |
| Number of Chronic Patients | 60 days | Number of Chronic Patients that become positive for COVID-19 IgM or IgG |
| Reliability of the test | 30 days | Number of Invalid results |
Countries
Italy
Contacts
Primary ContactAntonio V Gaddi, MD, MSc
Backup ContactFabio V Capello, MD, PhD
Outcome results
None listed