COVID-19 Rapid Tests

 

COVID-19 IgG and IGM Rapid Test in 10 Minutes

 

 

A Serology Based Test for the Detection of COVID-19

The COVID-19 IgG and IgM Rapid Test provided by Premier Biotech is used for the qualitative detection of SARS-CoV-2 antibodies in whole blood, serum, or plasma.  The procedure is easy to administer and offers reliable results at 10 minutes that remain valid for 20 minutes.

 

Why Serology Testing for COVID-19?

Serology testing will allow us to develop a better understanding of how the virus spreads and the true denominator to determine statistics like fatality rates. Serology tests use a patients blood, serum, or plasma to identify the presence of IgM and IgG antibodies. Serology testing allows determination of active infection and whether someone has built up an immunity to the virus based on past exposure. Unlike PCR based testing, Serology testing provides rapid results in 10 minutes.

 

  • Typically, IgM peaks at day 5.
  • IgG peaks at 14-21 days.
  • IgM appears first and then slowly drops off. As IgM diappears and IgG picks up, this indicates the patient is likely entering recovery and at some point no longer contagious.
  • IgM and IgG are helpful bio-markers to make the determination of patients immune status, whether or not they are contagious, recovering, etc.

Quick Reference Guide - COVID-19 Rapid Test

 

COVID-19 Quick Reference Guide
COVID-19 Quick Reference Guide-Non-Brand[...]
Adobe Acrobat document [486.9 KB]

 

Package Insert - COVID-19 Rapid Test

 

Package Insert - COVID19-PB-001-V1 Rapid Test Cassette Generic EN PI-Lancet
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma) Package Insert
COVID-19 Quick Reference Guide-Non-Brand[...]
Adobe Acrobat document [486.9 KB]

 

FDA EUA issued June 4, 2020

 

Premier Biotech FDA EUA Letter 6.4.20pdf
EUA-Hangzhou-Rsign-letter_6.4.20_Premier[...]
Adobe Acrobat document [336.4 KB]

 

PCR and Serology Testing Explained 

 

PCR And Serology Based Testing Explained.pdf
PCR And Serology Based Testing Explained[...]
Adobe Acrobat document [395.9 KB]
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