COVID-19
Testing Solutions
Viral & Antibody Tests
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 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.
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.