ExiMed Ltd Services and Products
Corona virus
express testing
SARS-CoV-2 IgM/lgG Rapid Test
(COVID-19 IgM/lgG Rapid Test)
is in Vitro diagnostic test for the qualitative
determination of SARS-CoV-2 IgM and IgG antibodies
in human whole blood (fingertip/venous), serum or plasma.
For professional use only
Express tesing
Each test contains
VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test (COVID-19 IgM/IgG Rapid Test)
- - Test devices (40T or 25T)
- Buffer
- Pipettes (optional)
- Safety lancets (optional)
- Alcohol prep pads (optional)
- Package insert
Steps for a single test
Interpretation of Results
Specification
Not Available for Sales in the US
Product Name VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test (COVID-19 IgM/IgG Rapid Test) Test Principle Colloidal gold Sample Type Whole blood (fingertip/venous ), serum or plasma Sample Volume 10 μL Test Time 15 min Operation Temperature 15-30℃ Storage Temperature 2-30℃ Shelf Life (Unopened) 24 months
Independent Evaluation by Authorities and Third Parties
- COVID-19 Testing Project, USA
A total of 10 commercially available serological tests are evaluated by a group of researchers and physicians at UCSF, UC Berkeley, Chan Zuckerberg Biohub and Innovative Genomics Institute. - University Hospitals Leuven, Leadlife B.V., KU Leuven, Belgium
Diagnostic Performance of 7 Rapid IgG/IgM antibody tests and the Euroimmun IgA/IgG ELISA in COVID-19 patients. - Health Science Agency, Singapore Government
- Therapeutic Goods Administration (TGA), Department of Health, Australian Government
- Foundation for Innovative New Diagnostics (FIND)
**Warning**
NOT FOR AT-HOME TESTING.
The VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test (COVID-19 IgM/IgG Rapid Test) has ONLY been designed to act as a supplementary test for suspected cases of negative coronavirus nucleic acid detection or in conjunction with nucleic acid detection in the diagnosis of suspected cases. Results from IgM/IgG antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.
VivaDiag™ SARS-CoV-2 IgM/IgG Rapid Test (COVID-19 IgM/IgG Rapid Test) IS INTENDED FOR USE BY HEALTHCARE PROFESSIONALS AND CLINICAL LABS ONLY. DO NOT SEPARATE TEST COMPONENTS. IMPROPER USE MAY PRODUCE INVALID AND/OR UNRELIABLE TEST RESULTS.
DO NOT USE IF PACKAGE SEAL HAS BEEN REMOVED OR BROKEN.
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