COVID-19
Testing Solutions
Viral & Antibody Tests
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:
Instructions for Use (Home Use)
Spartan Medical Inc. is an authorized reseller and contracted to distribute this product.
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:
Spartan Medical Inc. is an authorized reseller and contracted to distribute this product.