COVID-19

Testing Solutions

The Cellex qSARS-CoV-2 Antigen Rapid Test is currently not available for diagnostic, screening or other regulatory use in the U.S. 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 screening or surveillance of SARS-CoV-2 infections.

• SARS-CoV-2 Viral Antigen Rapid Test.
• Reliable & Accurate.*
  • 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.

Helpful Resources:

Interim Guidance for Rapid Antigen Testing for SARS-CoV-2 – CDC

CLIA POC AG Test Enforcement Discretion

AMA CPT Assistant – COVID-19 October 2020

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.

Helpful Resources:

FDA EUA Letter

Instructions for Use

Provider Fact Sheet

Patient Fact Sheet

GeneFinder™ Video

Nasopharyngeal Swab Technique

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 allows test to be administered in any location. Note: Tests can only be sold to CLIA authorized laboratories or facilities with CLIA oversight
• 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.

Helpful Resources:

FDA EUA Letter

Instructions for Use

Provider Fact Sheet

Patient Fact Sheet

Media coverage using Cellex™

CDC COVID-19 Serology Surveillance Strategy