It has been over a year since sample collection for COVID-19 diagnostic testing began. Over the past year researchers, diagnostics labs, test kit providers, and clinical test manufacturers have been working endlessly to find scalable solutions to identify and sequence the SARS-CoV-2 virus that can offer efficiency, reliability and scalability, thus relieving some of the burden currently resting on healthcare workers, infrastructure, and donors. Initially, sample collection efforts for COVID-19 focused mainly on the use of nasopharyngeal swabs, requiring trained personnel and an invasive sample collection procedure. In 2020, as sample collection expanded to include self-collected saliva, the US Food and Drug Administration (“FDA”) authorized the use of OMNIgene·ORAL as part of a COVID-19 Test Kit. [1],[2]
Since then, diagnostic companies and laboratories have added OMNIgene•ORAL to their diagnostic workflow and Emergency Use Authorizations (“EUAs”) for COVID-19 testing. These include:
And that is not all. With the increasing number of EUAs from the FDA and adoption of OMNIgene⋅ORAL from different federal government health agencies and labs around the world, saliva is evolving to become a scalable and practical collection method for COVID-19 diagnostic testing and research. And here is why...
“[OMNIgene•ORAL]‘s intuitive ease-of-use facilitates minimally supervised or in most cases complete self-collection and is a tremendous advance to current COVID-19 sample collection methods.” - Eddie McIntyre, Executive Vice President of P23 Labs. [1]
The chemistry, sealed behind a plastic film within the cap of the OMNIgene•ORAL (OME-505) device, immediately stabilizes the SARS-CoV-2 RNA molecules within the donor’s saliva at room temperature, once the cap has been closed.[10] The collection process is simply ‘spit and cap’ – followed by capping the sample, and inverting the tube to ensure sample mixture. This patented design enables fast, easy collection, prevents donor interaction with the stabilization chemistry, and greatly reduces human error – allowing the collection process to occur anywhere at any time and by anyone who can independently spit, without the administration or even supervision by healthcare personnel.
In comparison, when collecting COVID-19 samples using nasopharyngeal swabs, a healthcare professional must administer the test for the donor; therefore, bringing them into close contact with each donor they test, increasing the risk of spread. Many laboratories and companies, including DNA Genotek and P23 Labs, recognized this clinical process and increased transmission risk as a major speedbump for COVID-19 diagnostic testing and sought out a solution to improve the current COVID-19 sample collection method and process.
“P23 is focused on providing testing options to populations that are currently underserved by the testing options available today. This EUA with DNA Genotek’s collection device will enable testing for people that do not have the ability to get to a collection center or are at home because they are sick, quarantined at increased risk for infection or simply concerned about exposing themselves by traveling to a collection site.” - Eddie McIntyre, Executive Vice President of P23 Labs.[1]
The ability to collect saliva samples for COVID-19 anywhere without healthcare supervision opens doors to testing programs that can help drive our fight to reducing infections and tracing the eradication of the disease.
For example, Ambry Genetics received an EUA from the FDA to utilize OMNIgene•ORAL to provide COVID-19 viral infection testing for population screening and back to work programs.
Ambry Genetics developed the CARE Program™ (Comprehensive, Assessment, Risk & Education), which is a back-to work program that offers employers a precision medicine approach to help address critical challenges surrounding COVID-19 testing and employee management.[11]Their CARE Platform helps employers address critical challenges surrounding COVID-19 testing, specifically:
In another example, the UK government has adopted OMNIgene•ORAL (validated by Chronomics) for their program, Test to Release for International Travel, which permits UK travelers the option to purchase a COVID-19 test privately from testing companies, including Chronomics. Donors who receive a negative test result can reduce their self-isolation period.[8]
“Our COVID-19 PCR laboratory test, using DNA Genotek’s OMNIgene®•ORAL as the saliva collection device, is non-invasive, easy to self-administer and the gold standard in COVID-19 tests. We all have a responsibility to minimize the spread of Covid-19 and our saliva test makes it far simpler to provide customers with an easy and accurate way to test for the virus,” said Dr. Tom Stubbs, CEO of Chronomics.[8]
It is programs like these that will help communities around the world reduce the spread of COVID-19 and allow us to return to our daily lives sooner.
The OMNIgene•ORAL saliva device can be used from anyone, anywhere... The stabilization chemistry within the OMNIgene•ORAL (OME-505) device is the key to quality of sample, stabilization for accurate testing and the inactivation of the virus to prevent spread during sample handling.
OMNIgene•ORAL stabilizes RNA for target viral detection within the saliva sample at room temperature for up to 21 days and maintains sample integrity throughout temperature fluctuations encountered during sample transport and handling conditions.[12]
“A saliva-based collection method for COVID-19 laboratory tests is a valuable addition to our testing portfolio for helping diagnose SARS-CoV-2 infection. Now, Genophyll Enterprises has access to a robust and safe biomaterial collection approach for the detection of COVID infections. This expansion of testing methods is critical to informing patient management decisions and containing the spread of COVID-19.” - Aditi Luthra, CEO, Genophyll Enterprises. [13]
As Aditi Luthra mentioned in the quote above, OMNIgene•ORAL is a robust and safe biomaterial collection approach for COVID-19 detection. Not only because of its easy, self-collection and stabilization at room temperature, but the chemistry’s ability to inactivate the virus reduces the risk of spread to those handling the samples during sample transport and upon laboratory receipt and processing. [14]
The high quality of viral nucleic acids within saliva collected with OMNIgene•ORAL produces accurate and reliable results for COVID-19 diagnostic tests.
“The DNA Genotek OMNIgene•ORAL device was the ideal choice for our CRL Rapid Response test as our studies demonstrated it to be more sensitive and accurate than the standard COVID-19 anterior nasal swab test.” - Robert Thompson, CEO of Clinical Reference Laboratory. [15]
The saliva collection device (OME-505) is also compatible with qPCR and RT-qPCR assays and most third-party extraction kits and assays. Below are some examples of validated processing and analysis techniques granted EUAs with OMNIgene•ORAL saliva collection kits.
|
FDA EUA Lab |
RNA extraction |
Molecular testing platform |
|
P23 Labs |
MagMAX Viral/Pathogen Isolation kit |
TaqPath 1 atep Multiplex Master Mix (with TaqPath COVID-19 Combo kit) |
|
Clinical Reference Laboratories (CRL) |
Zymo Quick RNA/DNA Viral MagBead Kit |
BioRad CFX 96 TOUCH Thermal Cycler (with Co Diagnostics Logix Smart test) |
|
Ambry Genetics Laboratory |
MagMAX Viral/Pathogen Isolation kit
|
TaqPath 1 atep Multiplex Master Mix (with TaqPath COVID-19 Combo kit) |
In addition to OMNIgene•ORAL, DNA Genotek also introduced their prepIT•Q2A sample preparation reagent to address supply challenges and shortages of viral RNA extraction kits in the age of the COVID-19 pandemic. prepIT•Q2A enables rapid, liquid-based removal of inhibitors found in saliva samples collected with OMNIgene•ORAL. It is a 30-minute start to finish process with 5 minutes of hands-on time, allowing you to go quickly from sample directly to the downstream assay. prepIT•Q2A has been validated for qRT-PCR applications.[16]
It is evident that high quality, stabilized nucleic acids from saliva samples collected with OMNIgene•ORAL, with easy self-collection from anyone, anywhere is enabling faster, broader, and scalable community detection programs, and can contribute to reducing the spread of SARS-CoV-2. Reliability and accuracy downstream, coupled with compatibility with most sample processing and analysis techniques, places OMNIgene•ORAL at the forefront, as a scalable and robust collection method for COVID-19 diagnostic testing.
If you are interested in learning more about DNA Genotek’s OMNIgene•ORAL saliva collection kits, please contact us by e-mail at info@dnagenotek.com. You can also click the picture below to request a free trial of OMNIgene•ORAL for your lab.
[1] https://www.dnagenotek.com/ROW/pdf/press-releases/OMNIgene-ORAL-EUA-with-P23.pdf
[2] P23 Labs’ FDA Letter: https://www.fda.gov/media/138295/download
[3] https://www.dnagenotek.com/ROW/pdf/press-releases/DNAG-Ambry-EUA.pdf
[4] Ambry Genetics EUA Letter: https://www.fda.gov/media/145406/download
[5] Clinical Reference Laboratory's EUA: https://www.fda.gov/media/140664/download
[6] https://www.dnagenotek.com/ROW/pdf/press-releases/Health-Canada-OMNIgene-ORAL.pdf
[8] https://www.dnagenotek.com/ROW/pdf/press-releases/DNAG-Chronomics.pdf
[9] https://www.costco.com/covid-19-saliva-pcr-test-kit%2c-redeemed-by-azova.product.100706742.html
[10] OMNIgene®•ORAL (OME-505) collection instructions: https://www.dnagenotek.com/ROW/support/collection-instructions/omnigene-oral/OME-505.html
[11] Ambry’s CARE Program: https://www.ambrygen.com/covid
[12] OMNIgene•ORAL (OME-505) data sheet: https://www.dnagenotek.com/ROW/pdf/PD-BR-00372.pdf
[13] https://www.dnagenotek.com/ROW/pdf/press-releases/DNAG_3B-Blackbio-Biotech.pdf
[14] Inactivation of SARS-CoV-2: https://www.dnagenotek.com/ROW/pdf/MK-01430.pdf
[15] OraSure’s OMNIgene®·ORAL Device Included in EUA Granted to Clinical Reference Laboratory for Self-Collected SARS-CoV-2 Saliva Test PRESS RELEASE: https://www.dnagenotek.com/ROW/pdf/press-releases/Clinical-Reference-Laboratory-EUA-Release-7.31.20.pdf
[16] https://www.dnagenotek.com/ROW/pdf/MK-AN-00039.pdf