SARS-CoV-2 RT-PCR Go-Vial® Test

Biomeme’s SARS-CoV-2 RT-PCR Go-Vial® Test detects the RNA of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19). This test detects two different SARS-CoV-2 genes and is conveniently multiplexed together with our RNA Process Control (RPC) for RNA extraction and RT-PCR.

Biomeme Go-Vials™ already contain lyophilized master mix, enzymes, and multiplexed primers/probes for the following triplex reaction:

Go-Vials™ are are not pre-aliquoted enabling the use of pipetting robots (or multichannel pipettes) to set up reactions using plastics that are compatible with your specific PCR machine; a single vial contains enough assay for 65x 20µL or 130x 10µL reactions.

Each order includes the following:

Note: SARS-CoV-2 Go-Vials® are approved for IVD in Canada only.

If you are looking for lower throughput solutions, take a look at Biomeme's SARS-CoV-2 RT-PCR Go-Strips® and/or Go-Plates®. These kits are used with Biomeme's ultra-portable Franklin® Thermocyclers and 96-well Thermocyclers.

This test is intended for the qualitative detection of RNA from SARS-COV-2 in nasopharyngeal, nasal, and oropharyngeal swab specimens and nasopharyngeal wash/aspirate or nasal aspirate specimens.

Highlights

• Best-in-class molecular in-vitro diagnostic test

• Detects all COVID-19 variants of concern

• A multiplexed reaction means that all 3 targets are in a single reaction. So, a single reaction equates to a single sample.

• Includes a quantified exogenous positive control for RNA extraction and RT-PCR. It is a shelf-stable, lyophilized pellet of MS2 bacteriophage that you can expect to be detected at the same Cq every time.

• Because each test is lyophilized, you are able to add more sample (“template”) to the test (20 µL) which will directly increase sensitivity without throwing off your reagent concentrations.

• Most other assays require shipment on dry ice and storage in a -80°C freezer which can increase the risk of components going bad due to freeze and thaw cycles. With our test, there is no need for refrigeration, lab equipment, or mixing of wet reagents.

• Most assays come in multiple components or in bulk and need to be mixed and aliquoted by an experienced molecular biologist, further increasing the risk of contamination. There is no mixing or aliquoting of components required with our test. It’s already taken care of.

Resources

• Biomeme SARS-CoV-2 Video Showcase (How To Product Demo Videos)

• Biomeme SARS-CoV-2 Instructions For Use

• Biomeme SARS-CoV-2 Instructions for Use - Health Canada

• Biomeme SARS-CoV-2 Real-Time RT-PCR Test - Letter of Authorization from FDA

• Patient Fact Sheet

• Healthcare Provider Fact Sheet

If you have any other questions, check out help.biomeme.com to learn more.

IVD (EUA) Regulatory Statement

For Use Under an Emergency Use Authorization (EUA) Only. Rx Only | For In-Vitro Diagnostic Use.

This IVD test kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a that meet requirements to perform high complexity tests.

DISCLAIMERS:

• 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.

RUO Regulatory Statement

For Research Use Only (RUO). Not for use in human or veterinary diagnostics.