COVID-19

Testing Solutions

Viral & Antibody Tests

Supporting Product Literature:

CELLEX™ QSARS-COV-2 ANTIGEN RAPID TEST (VIRAL)

The Cellex™ qSARS-CoV-2 Antigen Rapid Test is an in vitro immunochromatographic assay for qualitative detection of nucleocapsid antigens of the SARS-CoV-2 virus in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider. This self-contained, point-of-care (POC) test provides reliable and accurate results in 15 minutes and was developed by Cellex™, a U.S. biotechnology company. The Cellex Antigen test has demonstrated high sensitivity and specificity. It is a portable, lateral-flow cassette (like a home pregnancy test), that can be used in any location and does not require a reader or lab equipment. It is intended to aid in the rapid diagnosis of SARSCoV-2 infections.

  • FDA EUA Submission #: EUA202955; Under Notification Path.
  • SARS-CoV-2 Viral Antigen Test.
  • Reliable & Accurate results for the diagnosis of SARS-CoV-2 infections.*
    • 94.6% Positive Percent Agreement (sensitivity).
    • 99.5% Negative Percent Agreement (specificity).
  • Rapid results in only 15 minutes.
  • Simple, mid-nasal swab or nasopharyngeal swab test.
  • Portable, lateral-flow cassette (like a home pregnancy test) for testing in any location.
  • Self-contained kit includes 25 test cassettes & swabs; no reader or lab equipment needed.
  • Internal control (C line) on lateral flow to determine validity of test.

* Nasopharyngeal specimen test performance date.

The below image is a graphical representation showing increasing viral load from time of infection to onset of symptoms, and indicating the time period where a moderate/high sensitivity Antigen test and very high sensitivity RT-PCR test may potentially capture a positive SARS-CoV-2.

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. The GeneFinder™ has received Emergency Use Authorization (EUA) from the FDA and is manufactured at an FDA registered facility. 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.

 

  • 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.

Supporting Product Literature:

Cellex™ qSARS-CoV-2 IgG/IgM Rapid Test (Antibody)

The Cellex™ qSARS-CoV-2 IgG/IgM Rapid Test is a serologic test that has received FDA Emergency Use Authorization (EUA) and was developed by Cellex™, a U.S. biotechnology company. The Cellex™ qSARS-CoV-2 IgG/IgM Rapid Test is a whole blood, lateral-flow antibody test that has demonstrated high sensitivity and specificity in detecting IgM & IgG antibodies. It is a portable cassette, does not require a swab with transport media or lab equipment, and only takes 15-20 minutes to determine results. Most importantly, the Cellex™ qSARS-CoV-2 IgG/IgM Rapid Test was more accurate at ruling out cases, showing a 99.7% negative predictive value at 5% prevalence.

 

  • FDA has provided Emergency Use Authorization (EUA).
  • Combined Serology Test for IgG and IgM Antibodies.
  • Sensitivity 93.8%
  • Specificity 96.0%
  • More accurate at ruling out cases, showing a 99.7% negative predictive value at 5% prevalence.
  • Rapid results in only 15-20 minutes.
  • 25 tests per kit; simple whole blood test without swabs, transport media or lab equipment.
  • Self-contained portable cassette can be administered in any location.
  • Built-in internal control (C line) on lateral flow to determine validity of test.
  • Additional Positive/Negative Control Set offered separately to ensure proper performance of assay.
All necessary regulatory documentation, instructions for use, published studies, patient education tools, etc. (as applicable) can be provided upon request by contacting cs@spartanmedspine.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.