Pinnacle BioLabs COVID-19 Novel Coronavirus Dual IgG/IgM Rapid Test Clinical Pack

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Call 1-800-609-6419 For Ordering Information.  

At a glance:  The Pinnacle BioLabs COVID-19 Novel Coronavirus Dual IgG/IgM Rapid Test® Clinical Pack contains 25 test cassettes, buffer solution, package insert and Quick Reference Guide for sample collection and results interpretation.  The test may be performed using whole blood, serum or plasma and results are available in 15 minutes.  This test is for professional use only.  Call 1-800-609-6419 for order routing.  

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The Pinnacle BioLabs COVID-19 Novel Coronavirus Dual IgG/IgM Rapid Test® aids in the detection of Coronavirus with one drop of blood (10 µl) in 15 minutes, and can be performed, resulted and interpreted at the point-of-care.  The test is a colloid-gold immunoassay, the same test principle Pinnacle BioLabs has used in its Second Generation FIT® Colon Cancer Detection Test for nine years. In addition to being easily deployed to the world's largest cities or it's farthest corners, it's also clinically validated.  

The intelligent design features both IgG antigens to aid in the  detection of persons with Coronavirus for longer periods of time, as well as IgM antigens to aid in the detection of newly infected persons.  A recent study by the State of Delaware  shows specificity of ~99.5%, with no cross-reactivity with ANA or RSV.   The image below show results interpretation at the 15 minute mark.  A single line at the "C" region indicates a negative result, and should only be read at the 15 minute mark.  A line visible at the IgM line indicates possible  early infection.  The "triple bar"  positive indicates possible infection consistent with patients who have carried the virus for a longer period of time. 

Cross Reactivity / Analytical Specificity


Pandemics require widely deployable tests that are both easy to perform and easy to interpret. The Pinnacle BioLabs COVID-19 Novel Coronavirus Dual IgG/IgM Rapid Test is both.

Antigens for Early COVID-19 Detection

For professional use only. This test has not been reviewed by the FDA. Negative results do not rule out SARS- CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. Not for the screening of donated blood.