Our COVID-19 Antibody IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test device is a diagnostic test that utilizes lateral flow technology for the qualitative and differential detection for the presence of IgM and IgG antibodies against SARS-CoV-2 (COVID-19) using while blood, serum or plasma, delivering reliable test results in 10 – 15 minutes.
Our Covid-19 Antibody IgG/IgM Rapid test can be run remotely, without the use of laboratory equipment. Test results are easy to read and differentiates between the presence of IgG or IgM.
In general, the IgM antibodies can be detected as early as 8 days following point of infection with IgM detection about 8-10 days thereafter. Sensitivity for IgM is 100% and delivers 100% specificity. IgG detection confirming the IgG antibody presence has a sensitivity of 96.7% and with specificity of 100%.
Our COVID-19 IgG/IgM test is intended to screen patients for COVID-19 antibodies and a positive test can detect a current or previous infection.
Our Healgen brand has received the U.S. Food and Drug Administration Emergency Use Authorization (EUA), with high sensitivity and specificity confirmed by the U.S. National Institutes of Health. It also carries the European Union CE mark and is available for shipment throughout the United States as well as internationally. In the United States under the current EUA, the Healgen IgG/IgM Rapid Antibody Test can only be sold to High Complexity, CLIA approved labs.
Our Orient Gene brand offers the same high degree of sensitivity and specificity and also carries the European Union CE mark.
More information on the use of point of care testing in relation to Covid-19 can be found here.
This product is intended for professional use and not for home use.