FDA EUA APPROVED
TRULY EXTRACTION-FREE. SIMPLE, YET SUPERIOR.
FDA EUA APPROVED
Xfree™ COVID-19 Direct RT-PCR
Truly Extraction-free. Simple, Yet Superior.
Learn how Xfree™ can save money while increasing your lab capacity and report results faster.
The Xfree™ COVID-19 Direct RT-PCR test is offered lyophilized in a single vial, in the trusted BioGX Sample-Ready™ “Just Add Water” format where no other reagent is required. The test is available for the most ubiquitous real-time PCR platforms already available in thousands of laboratories. The fast and simple workflow is designed to help laboratories to increase their testing capacity without adding expert molecular staff or new automation.
This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of 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.
Rehydrate Xfree™ master mix with 400ul of molecular grade water
Dispense 15ul into 96 or 384 well plate and add 5ul of direct patient sample
Seal plate and run direct sample protocol on a PCR platform of choice
The staff at GENETWORx have been very pleased with the performance of the BioGX Xfree COVID-19 test. In our studies, the test performed superior to other SARS-CoV-2 tests we evaluated in head-to-head comparisons. BioGX test is very simple to use while providing increased quality assurance of well-by-well monitoring of the PCR reaction. The product also offers the consistency and platform flexibility to rapidly increase throughput without needing to invest in additional resources and new systems.