“From sample collection through testing, we are working to help in the fight against COVID-19.” – Scott Rabuka, Senior Director of Molecular Products at DNA GenotekTM.
On June 18th, DNA Genotek hosted a webinar with Nature titled “Overcoming the challenges of sample collection in the time of COVID-19”. Scott Rabuka, Senior Director of Molecular Products, and Dr. Rafal Iwasiow, VP of Innovation and Technology, highlighted how safe, at-home sample collection is aiding the work against SARS-CoV-2. The webinar also featured P23 Labs’ Chief Medical Officer (CMO) Dr. Bernedette Mandes Wildemore, who showcased P23 Labs’ validation data which received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
The important highlights from the webinar will be/are covered in this blog. In case you missed it, you can view the full webinar in the video link below.
Sample collection for COVID-19 testing
Scott Rabuka began the webinar by providing an overview of the products that DNA Genotek offers for sample collections that can be used for downstream molecular testing of the COVID-19 virus. We currently have 2 products that we recommend for sample collection for COVID-19.
These products enable non-invasive at-home self-collection of oral samples, reducing exposure risk for patients and healthcare workers, while also reducing the burden on the healthcare system overall.
prepIT⋅Q2A – An alternate workflow for viral RNA preparation
Scott Rabuka then spoke about DNA Genotek’s prepIT⋅Q2A sample preparation reagent and the market need it addresses with 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 and ORAcollect⋅RNA. 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.
R&D efforts to support COVID-19
Dr. Rafal Iwasiow explained how our R&D team at DNA Genotek has been focusing on the technical performance of our portfolio of products. There are four areas in which DNA Genotek is supporting the current COVID pandemic and how our customers are using our products to enable testing for SARS-CoV-2:
- Inactivation of SARS-CoV-2 using consumer safe stabilization chemistries in OMNIgene®⋅ORAL and ORAcollect⋅RNA;
- Compatibility of DNA Genotek collection kit chemistries with 3rd party RNA extraction kits;
- Alternate workflows using prepIT⋅Q2A (Quick to Assay) reagent;
- Leveraging DNA Genotek’s 510(k) clearances to support at-home self-collection
(To learn more about these four areas and our R&D efforts for COVID-19, you can watch the whole webinar video here).
P23 Labs EUA and the OMNIgene®·ORAL – A case study
P23 Labs, LLC is a laboratory located in Arkansas focused on molecular genetic testing.
“Regardless of the source, any testing samples for COVID-19 need to be collected from the patient at the right time and from an appropriate location. The detection of this [pandemic] virus has been approved for nasopharyngeal (NP) swabs as well as oropharyngeal (OP) swabs, to a less reliable degree. Unfortunately, collection from either of these methods is not only invasive but also relatively uncomfortable for the affected patient. Furthermore, repeated collection may be necessary for appropriate detection.” – Dr. Bernedette Mandes Wildemore, CMO of P23 Labs, LLC.
To address the unpleasant collection method of nasopharyngeal (nasal) and oropharyngeal (throat) swabs, P23 sought to secure FDA Emergency Use Authorization for a collection method that was not only sensitive but safe, accurate and reproducible.
Intended use of P23 Labs’ SARS-CoV-2 assay
P23 Labs’ TaqPath SARS-CoV-2 Assay is a real-time reverse transcription-polymerase chain reaction (rRT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 found in throat swabs, nasopharyngeal swabs, as well as additional sample types. This test is also authorized for use with saliva samples that are either self-collected at home or in a health care setting under the supervision of a healthcare provider using the OMNIgene®•ORAL(OME-505) device.
As part of their EUA submission to the FDA, P23 Labs demonstrated that OMNIgene⋅ORAL saliva samples performed as well as nasopharyngeal samples and that they demonstrated sample stability across various shipping and storage conditions without loss of detection or recovery. Across all positive and negative COVID-19 patient samples, they demonstrated a 100% concordance with OM-505. P23 Labs concluded that OMNIgene®⋅ORAL collected saliva samples are suitable for self-collection and ambient temperature transport to the laboratory for testing.
“Leveraging our many years of experience in the collection and stabilization of both human and microbiome nucleic acids, both DNA and RNA, we have been supporting customers interested in pursuing testing for SARS-CoV-2.” – Dr. Rafal Iwasiow, VP of Innovation and technology at DNA Genotek.
The COVID-19 pandemic has forced the world to come together to solve a global crisis. DNA Genotek is doing our part by helping to overcome sample collection challenges, adding to the list of viral RNA extraction methods available to our labs, and working with our customers and Regulatory bodies to increase access to testing across the globe.
Contact us to discuss how DNA Genotek can assist with your sample collection requirements at email@example.com
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