SOUTH PLAINFIELD –South Plainfield-based laboratory, Accurate Diagnostic Labs, partnered with Rutgers University Cell & DNA Repository (RUCDR) Infinite Biologics and Robert Wood Johnson (RWJ) Barnabas Health, to design, deploy and analyze the new COVID-19 saliva test, the first of its kind in the country. The team will be working with the White House COVID-19 task force and several research facilities throughout the world to help stop the crisis. The FDA approved the saliva test after Accurate Diagnostic Labs helped fast-track the validation and verification of the saliva testing methodology by conducting a series of clinical trials. The saliva test was put into effect at the Kilmer Vehicle Inspection/Driving Testing Center testing site in Edison on April 15 for Middlesex County residents by appointment only. By week’s end, Robert Wood Johnson Hospital and University Hospital in Newark will also be implementing the saliva tests as well as several other locations over the upcoming weeks. Soon, thousands of samples a day will be sent to be analyzed at Accurate Diagnostic Labs, located at 3000 Hadley Road in South Plainfield.
“This is a breakthrough,” said Rupen Patel, CEO Accurate Diagnostic Labs. “The saliva test will allow for pain-free testing that is quick and much easier. Results of the test are available in 24-48 hours, which is faster than waiting three days for the traditional nasal swab test. There is also very little exposure for healthcare professionals.”
“It’s truly incredible to know that a laboratory in South Plainfield is having such a phenomenal impact on COVID-19 testing,” said Councilman Derryck White, Chair of the South Plainfield Economic Development Committee, serving on the Public Safety Committee as well as Administration and Finance Committee. “ADL has partnered with such prestigious institutions as Rutgers' RUCDR Infinite Biologics and RWJ Barnabas Health to create a test that has the potential to save lives.”
Patel says there has never actually been a shortage of testing kits. The problem has been that there is a shortage of swabs.
“The largest manufacturer of the Universal Transport Medium (UTM) swab was in Milan, Italy and when they were locked down, they were not able to supply to the world with the swabs,” Patel said. “And that's why we had the shortage, so somebody had to come up with a different medium to do the testing. That was one of the reasons that the government was trying to figure out if there were other ways to do the tests. I don’t think anyone thought saliva could work until there was enough research and development.”
Accurate Diagnostic Labs and Rutgers University Infinite Biological Lab have had a long-standing relationship as ADL performs diagnostic testing for RUCDR clinical trials.
“When this whole outbreak came up, we wondered how we could do something different,” Patel said. “Dr. Brooks is the brain behind this whole thing. Working with the different manufacturers and providers, he created this test. We were joint partners from the beginning to develop this test.”
Dr. Andrew Brooks is the COO and Director of Technology Development at RUCDR Infinite Biologics. After the test was created, it had to be put quickly into clinical trials so the FDA could approve it. At the end of February and beginning of March, ADL reached out to healthcare providers they had relationships with to ask for any swabs they were not using so a clinical trial could be conducted at Rutgers to do the initial testing and compare the effectiveness of the oral saliva kit versus the nasal swab kit.
“The oral saliva kit is a spectrum solution that actually takes RNA (ribonucleic acid, or genetic material) from the saliva and then it just preserves it there so it doesn't destroy that RNA by the time it gets back to the lab,” Patel said. “The main concept was to preserve RNA. So this entire methodology is based on the RNA, not the DNA.”
The challenge of the clinical trial was to find enough patients who had symptoms of COVID-19.
“In February and early March, cases of COVID-19 around this area were very minimal,” Patel said. “You literally couldn't find positive patients at that time, but we had relationships with providers in the area that actually had a lot of patients with clinical symptoms presenting in their offices. They identified those patients who could be positive, and we were able to conduct the clinical trial.”
Patel says the saliva test studies resulted in 100% accuracy in comparison to other testing methods during clinical trials. He addes that there are many advantages of the saliva tests. Throat swabs require the healthcare provider to swab the patient's throat as far back as the tonsils. This causes gagging, which is uncomfortable for the patient and may expose the healthcare worker to the virus. Nasal swab testing is very painful as the swab has to be inserted deep into the nasal canal in back of the nose, and also exposes the healthcare provider to germs.
“Several aspects work much better using the saliva test,” Patel said. “We want to protect front end healthcare providers and prevent them from being exposed to a patient who might be a positive. With the saliva test, the healthcare provider doesn't have to be right in front of the person. They can just hand over the kit to them and observe them from six feet away."
For the saliva test, the patient just spits into a tube with a wide mouth holder and seals it. Then it is given to the healthcare provider.
"The saliva test is a simple method of testing versus having somebody very close to the patient while the provider either goes into their nose with a swab or into the back of throat making the person gag," Patel said. "Fear of exposure is what everybody has, so actually saliva works much better in that respect.”
Accurate Diagnostic Labs was founded by Patel over 20 years ago and has since grown into one of the largest privately held clinical laboratories in the country. With 400 employees, ADL is a full-service core laboratory and works with various entities in laboratory testing for clinical trial drug development and data repository.
The laboratory has a team of medical experts that provide consultation services to physicians to determine the most effective testing methods, offering support for healthcare providers in the diagnosis and management of acute and chronic disease.
“Everyone at Accurate Diagnostic Labs takes pride in what we do, and the team is incredible,” said Patel. “We call ourselves an Accurate family, so we treat everyone as a family. I think everyone has stepped up and done a phenomenal job. I feel fortunate to have such a great team here.”
The saliva test to detect COVID-19 that ADL helped create is groundbreaking. Bookes says that extracting the virus ribonucleic acid (RNA) from saliva is equivalent, or may be even more sensitive than taking it from a swab sample, while greatly reducing the risk for possible contamination and infection for healthcare workers.
“We’ve heard so many experts say that more testing with quicker results will ensure quicker self-quarantine and treatment,” White said. “The type of innovative testing that the Rutgers, RWJ and Accurate Diagnostic Labs has developed will ensure a more rapid result and will potentially minimize the spread of COVID-19.”
Middlesex County is the first county in New Jersey to implement the saliva test. April 15 was the first day the COVID-19 saliva test was put into effect. It is only available by appointment at the drive-thru facility at Kilmer Vehicle Inspection/Driving Testing Center for Middlesex County residents. Other testing centers throughout the state will be offering the saliva test as well. The testing center is open on Mondays, Wednesdays and Fridays. Online appointments must be made one day prior starting at 10a.m.
Residents must have a valid prescription from a doctor or be exhibiting symptoms of fever of 100.4 or higher for adults of children or a fever of 99.6 in adults 65 years of age of older as well as respiratory symptoms and/or shortness of breath. Printout confirmation for proof of residency in the form of a valid driver's license, state-issued identification or two pieces of mail, such as a bank statement or utility bill, must be presented upon arrival at the testing site.
Implementing a saliva collection method allows for far broader screening than what is now possible, but in order to procure the best sample of saliva, the person to be tested should not eat, drink, smoke or chew gum 30 minutes before the test is administered.
White says that if residents continue to follow the suggested guidelines of social distancing, hand washing and being careful not to touch the face, we can continue to flatten the curve.
“We are so blessed and privileged to be a part of a community with facilities like Accurate Diagnostic Labs and others coming together to step up with innovative ways to combat the virus,” White said. “Our community is resilient, and I am confident we will come through this stronger than ever.”
“I’m very proud of everyone here at Accurate Diagnostic Labs and how we are able to help the local community and beyond,” Patel said. “The employees at ADL are not afraid to go out front and do their jobs because they understand that they are part of the healthcare team. Even though they're not healthcare professionals, they have taken an oath to work specifically on this pandemic healthcare situation. They take the pride in doing what they do and want to help solve this global phenomenon.”
Appointments can be made online for both Middlesex County testing sites. The Kilmer testing site is located at 33 Kilmer Road in Edison. Middlesex County is operating an additional testing site in South Brunswick at the Motor Vehicle Inspection Station in Dayton, however, they are administering nasal swab testing. Plans are in the works to possibly offer the saliva swab at the South Brunswick location soon as well. Residents interested in making an appointment for Friday, April 17 can begin doing so at 10 a.m. today.