GS™ COVID-19 Real-Time PCR Kit

Quick and Reliable Solutions for 2019 Coronavirus Disease(COVID-19) and SARS-CoV-2

For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic use

GS™ COVID-19 Real-Time PCR Kit

A novel coronavirus disease (COVID) outbreak was first reported to the World Health Organization (WHO) in December 2019. The SARS-COV-2 virus has spread rapidly throughout the world and the WHO raised the alert identifying COVID-19 as a pandemic on March 11, 2020.

The GS™ COVID-19 RT-PCR KIT provides accurate, reproducible, high-quality results for clinical decision-making for patients with suspected COVID-19 (coronavirus) infection. The GS™ COVID-19 RT-PCR KIT performs a qualitative molecular assay that allows the detection of SARS-COV-2 nucleic acids in samples from patients who meet COVID-19 clinical and/or epidemiological criteria.

The GS™ COVID-19 RT-PCR KIT is a real-time reverse transcription polymerase chain reaction (RT-PCR) test which detects three genes from the SARS-CoV-2 virus from clinical nasopharyngeal swab specimens. In addition, the GS™ COVID-19 RT-PCR KIT also includes an internal positive control gene (GUSB) that serves as an extraction, reverse transcription, and PCR amplification control for each sample to minimize false negative results.

Features of the newly developed diagnostic kit:

Accuracy: Assay 3 target genes unique to SARS-CoV-2 having higher specificity and exhibiting lower risk for mutation

Specificity: Targeted specificity to 100% of currently available complete genomes for SARS-CoV-2.

Simplicity: Ready to use all-in-one master mix reagents and controls minimize variability

Throughput: Two kit package options of viral detection for up to 94 specimens

High quality, high performance and reliability

The GS™ COVID-19 RT-PCR KIT runs on the Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument. Kits are available for the 96 well plate (22 clinical samples) and 384 well plate (94 clinical samples) and provides test results in less than 90 minutes.

Resources:

IFU
Letter of Authorization
Fact Sheet provider
Fact Sheet patient

For more up-to-date information on the current coronavirus outbreak, visit the WHO or CDC websites.

• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and,
• This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Contact us if you want to order or call 1-480-598-5378 for more questions. Please allow up to 48 hours for a response to your quote request.