COVID-19 Rapid Test Serology Kit

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Prod SKU: AI-RTS TK 1xxx
Description

COVID-19 Rapid Test Serology Kit SKU AI-RTS TK 1xxx

Product Features:

 

• First CLIA-Waived test with an EUA
• 10-Minute dual antibody test utilizing whole blood,
serum or plasma
• Room temperature storage or refrigerated
(2-30˚C / 36-86˚F)
• Results compared to PCR:
• Sensitivity: IgG 98.8%; IgM 93.7%
• Specificity: IgG 98.7%; IgM 99.1%
• Procedural internal control included
• Complete kit buffer & Lancet included
• Detection of IgM antibodies indicates recent
infection and infectious stage.
• IgG antibodies gradually appear and increase
in the late stage of infection

 

As a single source diagnostics provider of FDA and EUA
approved tests to the healthcare marketplace with:
• A Policy that we will ALWAYS match or beat pricing in the ever-changing marketplace
• Unmatched supply of millions of FDA Emergency Use Authorized (EUA) COVID-19
Rapid Response test kits monthly
• FDA approved tests for infectious diseases, drug screening, health & wellness
• Ability to supply millions of tests per month on U.S. soil consistently
• Global logistics & fulfillment with immediate turnaround for domestic orders
• FDA medical quality system, temperature-controlled storage, QA/QC,
document controls, lot tracking, recall management,
date & expiration management

 

 

 

Disclaimers:
• This test has been authorized by FDA under an EUA for use by authorized laboratories.
• This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2,
not for any other viruses or pathogens.
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization
of emergency use of in vitro diagnostics for detection and/ or diagnosis of COVID-19 under Section 564(b)(1) of the
ACT, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• 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.
• This product is intended for professional use and not for home use.
• Not for the screening of donated blood.