COVID-19

Testing Solutions

Viral & Antibody Tests

Supporting Product Literature:

CARESTART™ Self-Administered, Over The Counter (OTC) Antigen Rapid Test

This test is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. This test is authorized for non-prescription, home use with self-collected (unobserved) direct anterior nasal swab specimens from individuals aged 14 years or older, or with adult collected anterior nasal swab specimens from individuals aged 2 years or older.

This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA.  This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, this product 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

NOTE: mutated Omicron Variant should not affect performance since test detects the nucleocapsid protein antigen (“N-Protein”) of the virus.*

    • CareStart™ OTC available in individually packaged kits (2 tests per box)
    • FDA has provided Emergency Use Authorization
    • High sensitivity and specificity
    • Self-administration using anterior nasal swab collection (short swab)
    • Self-contained, lateral-flow cassette; this test is interpreted by a compatible smartphone
    • Does not require CLIA certificate of waiver when self-administered for home use
    • Results in 10 minutes
    • 2 tests per box – Minimum order required (20 kits).

*Data on file with manufacturer; please contact Spartan Medical to request information.

Helpful Resources:

FDA EUA Letter

Instructions for Use

Instructions for Use (Home Use)

Provider Fact Sheet

Link to FDA Website

 

Spartan Medical Inc. is an authorized reseller and contracted to distribute this product. 

Supporting Product Literature:

The GeneFinder™ COVID-19 Plus RealAmp Kit (Viral Test)

GeneFinder™ COVID-19 Plus RealAmp Kit is a One-Step Reverse Transcription Real-Time PCR Kit designed to detect novel coronavirus (COVID-19) qualitatively through Reverse Transcription reaction and Real-Time Polymerase Chain Reaction. GeneFinder™ is a one-step, high-performance, three-gene system targeting N gene, E gene and RdRp gene for high sensitivity and reproducibility. Three-gene systems provide much greater resistance and adaptability over one or two gene systems in the likely event the Coronavirus mutates.

This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA.  This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, this product 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

 

  • FDA has provided Emergency Use Authorization (EUA).
  • True positive test results; 100% quantitative gene-based test.
  • GeneFinder™ is a one-step, three-gene system, providing a critical advantage over the one or two gene systems in the likely event the virus mutates.
  • 100 tests per kit; high through-put in 2 hours on inexpensive real-time PCR equipment.
  • Test Kits are “open platform,” meaning that they can be tested using most open platform lab analyzer on the market.

Helpful Resources:

FDA EUA Letter

Instructions for Use

Provider Fact Sheet

Patient Fact Sheet

GeneFinder™ Video

Nasopharyngeal Swab Technique

 

 

Spartan Medical Inc. is an authorized reseller and contracted to distribute this product.

 

All necessary regulatory documentation, instructions for use, published studies, patient education tools, etc. (as applicable) can be provided upon request by contacting cs@spartanmedical.com or (888) 240-8091. We are available at any time to meet with Providers and Staff to answer any questions about Spartan Medical’s entire portfolio of advanced medical solutions.