Bio Testing Labs
Bio Testing Labs, the High Complexity CLIA Lab run by Bio Testing Supplies, is now offering an RT-PCR Saliva Test. This delivers a much needed, fast turnaround time and easy-to-collect PCR testing solution to the U.S.
Bio Testing Labs’ RT-PCR Saliva Test
As COVID-19 cases continue to rise globally, fast and accurate SARS-CoV-2 diagnostic testing is undoubtedly essential. While multiple forms of testing are available, clinics continue to rely on real-time RT-PCR nasopharyngeal swabs, despite their low sensitivity, risk to healthcare workers, and global shortages of swabs and PPE. Alternatively, the use of saliva as a diagnostic technique for SARS-CoV-2 is promising, as it requires minimally invasive collection, can be reliably self-administered, and provides comparable sensitivity to nasopharyngeal swabs.
Bio Testing Labs’ Saliva RT-PCR test is the next step towards accomplishing our vision of returning the world to a level of normalcy through properly utilized testing strategies. Our extraction-free protocol, paired with readily available reagents and collection devices, allows us to offer a quick turnaround time and easy-to-collect test that requires saliva only — no swab needed.
Bio Testing Labs’ benefits include:
No swab or special saliva collection device is required. We only require a sterile collection container.
By removing the extraction step from PCR, we are able to eliminate the bottleneck that delays results.
We make tracking patients samples easy, and automate the mandated governmental reporting requirements to make placing orders and tracking results easy.
We offer rapidly scalable testing solutions, poised to support your growth demands.
Fast, Accurate & Reliable Testing Solutions
Curious as to what makes our saliva test so much faster than other PCR tests, and how we are able to provide such a quick turnaround time? Watch this brief video.
Read Transcription »
Hi my name is Brandon Hensinger, president of Avrio Genetics and its pandemic division Bio Testing Supplies. We created Bio Testing Supplies in the beginning stages of the COVID-19 pandemic to provide testing solutions to the United States and abroad, and also to provide consultative and educational services to people throughout the world in order to help them not only have access to testing, but to help them understand how and when to use the tests that exist on the market.
One of the most common questions that we get when we go into the market and we talk about our Real Time PCR Saliva Tests is, “Why is your test so much faster? Why are you able to offer a faster turnaround time when so many other labs and so many other groups have a turnaround time, in some cases, of up to 7-10 days?”
I wanted to address that specific concern because it is actually related to our specific protocols that we are using here in the laboratory. Most PCR testing, or I should say all PCR testing, includes a step called “extraction”. In fact, there’s two different steps in PCR, there’s “extraction” where you are capturing the DNA, or the RNA, that is in the sample, and then there is “amplification” where you are actually amplifying that RNA and looking for whatever you are looking for in the sample, and in this case COVID, or SARS-CoV-2 RNA.
What we have done, is we have removed what causes a bottleneck, which is the extraction step. Studies have shown, and we have validated this to be true, that you are able to directly amplify the samples and directly test the saliva samples without doing DNA extraction. DNA extraction is actually what causes the majority of the bottlenecks in all of these COVID labs throughout the world. Because up to this point, all of these genetic laboratories who have been doing testing haven’t had an issue with extraction being a bottleneck because they haven’t had such a massive influx of testing.
Now all of a sudden during COVID, when so many labs tried to launch COVID PCR testing, they realized their extraction steps weren’t able to support the massive influx of samples, so it causes a bottleneck. By us offering an extraction-free protocol, we have removed that bottleneck and we are able to analyze those samples directly and look at the samples directly to see whether or not there is COVID RNA in those samples, and therefore that would mean that the patient has tested positive for COVID.
So removing that step allows us to deliver a very fast turnaround time, unlike any of the other labs that are out there. So, we believe that by providing a quick turnaround time, our saliva test, in addition to a rapid antibody test, will deliver the testing people need in order to get back to work, and to get back to normal life, and ultimately to determine if they have COVID or if they have been exposed to it.
Here at Bio Testing Supplies, our mission has been, and will always be, to provide superior testing solutions and educational solutions that will help people return back to normal life. And we believe that by launching this new PCR test here in our newly established Houston laboratory will help us to accomplish just that, and will help all of you have the testing that you need and get back to normal life.
This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by laboratories designated by the Yale School of Public Health, Department of Epidemiology of Microbial Diseases, that includes the Clinical Molecular Diagnostics Laboratory, Department of Pathology, Yale School of Medicine, located at 310 Cedar St., New Haven, CT 06510, that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a and meet the requirements to perform high complexity tests.
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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.