The test has been developed by collaborative efforts of Accurate Diagnostic Labs and RUCDR Infinite Biologics at Rutgers University
The joint venture between Accurate Diagnostic Labs and RUCDR, utilizing the Spectrum Solutions’ DNA 1000 Saliva Collection Kit, is the first Emergency Use Authorization (EUA) clearance from the FDA to allow for saliva testing. This is a new development that, when administered under the supervision of a trained health professional, will allow for self-administered sample collection by individuals who may be in quarantine or self-isolation or for those showing no outward signs of illness, while reducing exposure to healthcare professionals and patients.
The search for SARS-CoV-2 RNA in 60 saliva samples yielded the same results as conventional nasal swab tests taken from the same patients.
Here is the FDA authorisation report:
“Working with Accurate Diagnostic Labs healthcare providers, we ran a study side-by-side, taking swabs — either nasal swabs or throat swabs — and we looked at those versus looking at saliva. We found 100% concordance in detecting a patient that had the virus,” said Dr. Andrew Brooks chief operating officer of RUCDR Infinite Biologics and professor of Genetics at Rutgers University.
“This is a significant improvement in a couple of ways. Obviously, putting a very long swab in your nose is not easy, and it’s rather painful, so with saliva, there’s less pain,” Dr. Brooks explained. Additionally, “to do the swab method, you need to have a professional person stand in close proximity to the patient, exposing them to respiratory droplets to insert the swab into the nasal cavity. Obviously, that potentially puts the professional and patient at risk of getting exposed to the virus,” said Dr. Shaila Nayak, Medical Director of Accurate Diagnostic Labs. The new method, which involves a proprietary preservative solution, eliminates the risk to those handling the samples, including our front-line laboratory professionals handling these specimens each day, Dr. Nayak said.
According to Stephen Fanning, CEO of Spectrum Solutions, the company that is responsible for manufacturing the collection device, “You remove the device from the package and spit into it. You remove the funnel, place the cap on the tube and turn it, which releases the preservation agent into the tube. Our proprietary preservative basically does a couple things. First and foremost, it preserves the [ribonucleic acid, or RNA] markers, and we are confident it inactivates the coronavirus, making the sample safer to work with in the laboratory.”
The new validation of the saliva testing method came after researchers at Accurate Diagnostic Labs and RUCDR, both headquartered in New Jersey, were able to confirm the reliability of the results during a comprehensive trial. “We did a clinical study to determine whether or not saliva could be used in place of nasal pharyngeal or oral pharyngeal swabs for detecting COVID-19 in both symptomatic and asymptomatic patients,” said Dr. Brooks. “With this data and the EUA clearance, testing can be immediately available for expanded collection on a global scale.”
“Now imagine – you pull up, you roll down your window, they give you the collection device, it takes seconds to spit into it. You put the cap on, which releases the preservation solution into the vial,” said Rupen Patel, CEO of Accurate Diagnostic Labs. “You wipe it with a disposable alcohol pad, and you hand it back to the person at the window and you go off on your way. Twenty-four to 48 hours later, you get your test results. All this can happen while mitigating exposure and using best efforts to reduce the use of valuable PPE (Personal Protective Equipment).”
“Since February, we have been fighting global supply shortages of PPE, swabs, and extraction kits. Our collaboration with Dr. Brooks’ lab, which is just down the road from us, allowed our two labs to quickly scale a high-throughput option, allowing us to be one the largest COVID-19 testing options available. By partnering with Spectrum Solutions, a company based in Utah, we can continue to scale saliva collection device solutions made here in the United States,” continued Mr. Patel.
“For the past month, we have focused on providing solutions to health systems, first responders, and essential employees,” said Mr. Patel. “Completing these studies and receiving this approval will allow us to continue that mission while expanding our capabilities to begin to test more people that may be spreading the virus without knowing it. As a minority small business owner, I understand we need to do everything we can to get back to work while first and foremost ensuring we can keep our communities safe.”