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Fast and highly sensitive mobile detection of SARS-CoV-2 using shelf-stable, pre-mixed and pre-aliquoted COVID-19 tests CE approved.
Our test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. It 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.
The test detects two different SARS-CoV-2 genes and it is conveniently multiplexed together with our RNA Process Control (RPC) for RNA extraction and RT-PCR. Each reaction well of test already contains lyophilised master mix, enzymes and multiplexed primer/probes for the following triplex reaction:
Clinical performance based on clinical studies: Biiomeme, Northwell Health and Sunnybrook Health.
Analytical Sensitivity (Limit of Detection): 1.8 genome equivalent per uL
There are considerable advantages to using our test in comparison to other assays.......
New Variants are developing all the time.
Our systems currently detect all know variants.
A multiplexed reaction means that all targets are in a single reaction. So, a single reaction equates to a single sample.
Our test kits include 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 everytime.
Because our test is lyophilized, you are able to add more sample (“template”) to the test (20µL) which will directly increase sensitivity without throwing off your reagent concentrations.
Most 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. Just add your purified RNA and get testing.
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.
Whether using Biomeme’s portable Franklin™ Real-Time qPCR Thermocycler to run up to 9 samples simultaneously or an approved lab-bound thermocycler such as the Bio-Rad CFX96 or ABI QuantStudio 5 to run up to 96 samples, you can expect results in about 1 hour using our SARS-CoV-2 test protocol.
Note: This does not account for time to complete sample prep which is variable depending on the number of samples being tested at a given time.
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test has been validated for use with the BD Universal Viral Collection Kit and our very own DNA/RNA Preservation Buffer. Samples collected in the BD Universal Viral Collection Kit should be handled and stored according to the manufacturer’s instructions. Samples collected in our DNA/RNA Preservation Buffer can be stored at room temperature (15–30 °C) for up to 14 days until sample extraction is performed using our M1 Sample Prep Cartridges.
Whether using Biomeme’s portable Franklin™ Real-Time qPCR Thermocycler to run up to 9 samples simultaneously or an approved lab-bound thermocycler such as the Bio-Rad CFX96 or ABI QuantStudio 5 to run up to 96 samples, you can expect results in about 1 hour using our SARS-CoV-2 test protocol.
Note: This does not account for time to complete sample prep which is variable depending on the number of samples being tested at a given time.
Testing, in the UK, is currently limited to laboratories certified under UKAS and conforming to ISO 15189 or ISO/IEC 17025 that meet requirements to perform high complexity tests.
In the United States, Biomeme is primarily working with CLIA high complexity labs that are in need of a medium throughput alternative for overflow testing in their high throughput labs or adding mobile testing capabilities to their satellite labs.
For organisations that want to work with us and/or launch temporary test sites, please contact us to get started.
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test has been validated for use with the BD Universal Viral Collection Kit and our very own DNA/RNA Preservation Buffer.
Samples collected in the BD Universal Viral Collection Kit should be handled and stored according to the manufacturer’s instructions. Samples collected in our DNA/RNA Preservation Buffer can be stored at room temperature (15–30 °C) for up to 14 days until sample extraction is performed using our M1 Sample Prep Cartridges.
Out test is designed to work with our portable Franklin™ thermocycler to deliver gold standard performance. Each order consists of a single pouch containing a pre-cut and pre-aliquoted tray of (32) 3-well Go-Strips with void filling caps. Each well contains a 20µL lyophilized triplex reaction with master mix, primers and probes.
Our test is also designed to work with certain lab thermocyclers including the Bio-Rad CFX96 and ABI QS5 w/ fast block. Each order consists of a single pouch containing a 96-well Go-Plate. Each well also contains a 20 µL lyophilized triplex reaction with master mix, primers and probes.
Bulk vials are also available but for Research Use Only (RUO). Bulk Vials are not pre-aliquoted enabling you to use a pipetting robot (or a multi-channel pipette) to set up your reactions using plastics that are compatible with your specific PCR machine. Each order consists of a single vial containing enough assay for 65 20uL, 130 10uL, or 260 5uL reactions. Re-suspend as many shelf-stable vials as needed for your PCR run and freeze the rest for later. Each reaction contains a your master mix, enzymes, primers and probes.