CLIA Waived FDA Approved COVID-19 Rapid Antibodies Tests

 

EUA CLIA 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  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.

Minimum order quantity is 1 box (60 tests) and all product sales are final and cannot be returned.

 

Product Information- EUA CLIA COVID-19 IgG and IgM Antibodies Rapid Test

 

Product Information - COVID-19 IgG & IgM Rapid Test
Product Information - COVID-19 IgG & IgM Rapid Test
COVID-19 Rapid Test From Premier Biotech[...]
Adobe Acrobat document [532.1 KB]

 

Fact Sheet- Recipiants - EUA CLIA COVID-19 IgG and IgM Antibodies Rapid Test

 

Product Information - COVID-19 IgG & IgM Rapid Test
Product Information - COVID-19 IgG & IgM Rapid Test
Fact-Sheet-Recipiants-EUA200485-S005-Pre[...]
Adobe Acrobat document [269.4 KB]

 

Fact Sheet- Provider - EUA CLIA COVID-19 IgG and IgM Antibodies Rapid Test

 

Product Information - COVID-19 IgG & IgM Rapid Test
Product Information - COVID-19 IgG & IgM Rapid Test
Fact-Sheet-HCP-EUA200485-S005-Premier-Bi[...]
Adobe Acrobat document [326.8 KB]

 

Package Insert - EUA CLIA COVID-19 IgG & IgM Rapid Antibodies Test

 

Package Insert - COVID-19 IgG & IgM Rapid Test
Package Insert - COVID-19 IgG & IgM Rapid Test
Attachment 1_06_clean version Proposed P[...]
Adobe Acrobat document [1.4 MB]

 

FDA EUA CLIA issued December 21, 2020

 

FDA EUA Letter 12.21.20.pdf
EUA200458-S005 Hangzhou Reissue LOA 12-2[...]
Adobe Acrobat document [275.1 KB]

 

COVID-19 Serology Procedure Video 

 

COVID-19 Serology Procedure Video
COVID-19 Rapid - Generic Procedure Video[...]
MP4 video/audio file [31.3 MB]
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