COVID-19 Rapid Test Update


Pinnacle BioLabs COVID-19 Dual IgG/IgM Rapid Test

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.

Emergency Use Authorization

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:

  • 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

Package Insert

The Pinnacle BioLabs Package Insert is available here:

Quick Guide

The Quick Guide for collecting your specimen and interpreting your results is available here.

Clinical Trial

Download the clinical trial from Sun Yat-Sen Univeristy. 

Online Ordering

Order by phone by dialing 1-800-687-9707