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. New Orders Ship 4/10/2020.
Pinnacle BioLabs informed the FDA of intent to file Emergency Use Authorization and has began shipping kits to end users. For the most up-to-date information regarding emergency use authorization to fight COVID-19 visit the FDA's guidance page here: https://www.fda.gov/media/135659/download.
The Pinnacle BioLabs Package Insert is available here:
The Quick Guide for collecting your specimen and interpreting your results is available here.
Download the clinical trial from Sun Yat-Sen Univeristy.
Order by phone by dialing 1-800-687-9707