Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in Early Detecting the Infection of COVID-19
NCT ID: NCT04316728
Last Updated: 2020-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-03-31
2020-11-30
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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negative Patients
Adult HCWs with no signs or symptom of coronavirus infection and no known previous history of contact with patients positive for COVID-19, working in a primary care setting and Adult patients with at least 2 chronic medical conditions routinely attending a General Practioner (GP) practice or an outpatients departments or a primary care facility
VivaDiag™ 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
Interventions
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VivaDiag™ 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
Eligibility Criteria
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Inclusion Criteria
* Chronic patients with at least 2 chronic medical conditions
Exclusion Criteria
* People with body temperature \>37.5°C
* People with Dry cough
* People with Respiratory distress (Respiratory Rate \>25/min or O2 Saturation \<92%)
18 Years
ALL
Yes
Sponsors
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VivaChek Laboratories, Inc.
UNKNOWN
Centro Studi Internazionali, Italy
NETWORK
Responsible Party
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Principal Investigators
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Maurizio Cipolla, MD
Role: STUDY_DIRECTOR
Medical director of UCCP CATANZARO, Italy
Locations
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Unità' Complesse di cure primarie (UCCP), ASP Catanzaro
Catanzaro, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Phan LT, Nguyen TV, Luong QC, Nguyen TV, Nguyen HT, Le HQ, Nguyen TT, Cao TM, Pham QD. Importation and Human-to-Human Transmission of a Novel Coronavirus in Vietnam. N Engl J Med. 2020 Feb 27;382(9):872-874. doi: 10.1056/NEJMc2001272. Epub 2020 Jan 28. No abstract available.
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Other Identifiers
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VivaDiag-2020
Identifier Type: -
Identifier Source: org_study_id
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