On August 11, 2020, Biomeme’s SARS-CoV-2 Real-Time RT-PCR Test was issued an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA). Emergency use of our test is limited to laboratories that meet requirements to perform high complexity tests.
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Table of Contents
SARS-CoV-2 Test Overview
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 our test already contains lyophilized master mix, enzymes, and multiplexed primer/probes for the following triplex reaction:
- Orf1ab - Open reading frame 1ab gene
- S - Spike gene
- RPC - RNA Process Control
What Makes Our Test Different
There are considerable advantages to using our test in comparison to other assays...
Variants of Concern, Interest, and Under Monitoring
|Variant||WHO Label||Biomeme Assay Detection|
|B.1.1.529, BA.1, BA.1.1, BA.2, BA.3, BA.4 and BA.5 lineages||Omicron*|
* = Includes all currently monitored descendent lineages of Omicron. The full list of Pango lineages can be found here.
A multiplexed reaction means that all targets are in a single reaction. So, a single reaction equates to a single sample.
RNA Process Control (RPC)
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 every time.
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.
Pre-Mixed & Pre-Aliquoted
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.
Pooled Sample Collection
Most assays are developed and authorized for use for individual sample collection. Biomeme’s test is approved for pooled sample collection, which multiplies the sample throughput for a given test by 10x without sacrificing sensitivity and accuracy of results.
Test Form Factors
3-Well Go-Strips (96 rxns)
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.
96-Well Go-Plates (96 rxns)
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 (up to 260 rxns per vial)
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.
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 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.
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 organizations that want to launch temporary test sites, please contact One Health Labs to get started.
Sample Collection Kits & Prep
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 using 3 sample collection methods:
- Individual Sample Collection
- 5X Wet Media Pooled Sample Collection
- 10X Dry Swab Pooled Sample Collection
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.
Third Party Validation
Northwell Health is New York State’s largest healthcare employer, with more than 68,000 employees and home to 23 hospitals and more than 700 outpatient facilities, as well as urgent care centers, kidney dialysis centers, acute inpatient rehabilitation, sub-acute rehabilitation and skilled-nursing facilities, a home care network, a hospice network, and other services.
Northwell completed a clinical evaluation of the Biomeme SARS-CoV-2 Real-Time RT-PCR Test with clinical nasopharyngeal and oropharyngeal samples with a range of Ct values. This evaluation utilized 65 samples tested with 4 comparator platforms: GenMark ePlex, Hologic Panther Fusion, Wadsworth/CDC, and Roche Cobas 8800.
It found a 98% correlation (64/65).
Sunnybrook Health Sciences Centre (SHSC), commonly known as Sunnybrook Hospital or Sunnybrook is an academic health science center located in Toronto, Ontario, Canada. It is the largest trauma center in Canada and home to Canada’s largest veterans center.
Sunnybrook reported on the results of a clinical and specificity evaluation which included clinicalsamples positive for SARS-CoV-2 as well samples positive for Adenovirus, Human bocavirus, H1N1, H3N2, various HCoV strains, hMPV, Parainfluenza virus, Human metapneumovirus (HMPV), and Respiratory syncytial virus (RSV).
Our test correctly called all of the samples (100% Sensitivity / 100% Specificity).
One Health Labs is our CLIA certified lab (Certification No. 39D2172055) specializing in high complexity diagnostic testing in and out of the lab. Back on May 13, 2020, they received Emergency Use Authorization (EUA) from the FDA for their SARS-CoV-2 Test which utilizes the Biomeme Platform.
Organizations seeking temporary test sites can contract with One Health Labs to offer physician ordering, sample collection, and COVID-19 testing. Please email email@example.com to see if your organization qualifies or visit onehealthlabs.com to learn more.
Biomeme can now domestically manufacture in excess of 1M SARS-CoV-2 assays per month to support the needs of the global healthcare community
- SARS-CoV-2 Video Showcase (Vimeo)
- FDA Letter of Authorization
- FDA Instructions For Use
- Health Canada Instructions for Use
- Patient Fact Sheet
- Healthcare Provider Fact Sheet
- Biomeme Help Desk
- Biomeme Shop
• 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.