ORLANDO, FL — April 2, 2020 — MicroGenDX Laboratories, the world leader in providing PCR and next generation DNA sequencing in microbial identification, has validated a real-time reverse transcriptase PCR (rRT-PCR) assay for the specific detection of the SARS- CoV-2 virus. MicroGenDX laboratory is the first national laboratory to offer validated COVID-19 testing using saliva and sputum samples. Read the validation summary that exceeds the requirements of the FDA Emergency Use Authorization. Additionally, the test has been validated for both nasopharyngeal (nasal) and oropharyngeal (oral) swabs.
“We looked at the data regarding viral detection rates with various sample types,” explains MicroGenDX CEO, Rick Martin. “A saliva or sputum sample has a higher detection rate than nasal swabs, and we are confident our test is sensitive enough to detect COV19 in sputum, even if the patient does not have a productive cough.”
As indicated in a 2020 JAMA Study of Clinical Sputum Specimens for COVID, patients may have higher viral shedding patterns at different collection sites, with sputum collection being the most consistent sample method after bronchoalveolar lavage. While other laboratories and tests rely on nasal and throat swabs, MicroGenDX designed their COVID-19 collection method around sputum to more accurately identify the SARS- CoV-2 virus.
MicroGenDX planned the collection technique around saliva and sputum to prevent reliance on supply materials currently in shortage such as swabs and Viral Transport Media. The laboratory's solution to the latter was to validate sterile saline as a viable transport media for testing.
“Our goal is to remove as many hurdles from people getting answers about COVID- 19,” continues Martin. “Given the challenges the healthcare system is having with procuring both swabs and transport media, we wanted to have another option for the health care provider to test patients.”
MicroGenDX runs its COVID-19 Rapid PCR Test at its diagnostic laboratory in Lubbock Texas with a 24-hour turnaround from time of sample receipt. The laboratory has begun running tests at a capacity of 5,000 COVID-19 samples a day and plans to increase that number to 10,000 per day in the near future.
MicroGenDX accepts samples from every state, joining the national response to COVID-19 at a time when hospital systems and drive-up testing facilities are hitting capacity and struggling to keep up with ever-increasing demand. The laboratory is currently bolstering its existing diagnostic teams to scale testing in accordance with the growing public need.
MicroGenDX is listed on the FDA website as a resource laboratory for COVID-19 Testing as “Southwest Regional PCR dba MicroGenDX Laboratory.”
For more information on how to receive MicroGenDX testing kits as either a patient or provider, please visit https://microgendx.com/covid19/.
MicroGenDX is the global leader in molecular testing services through PCR and Next Generation DNA Sequencing to identify microbes in human samples having run more than 400,000 DNA tests over the last 12 years. We are a state-of-the-art, CAP- accredited, CLIA-licensed Molecular Diagnostic facility backed by a team of molecular biologists, biochemists, bioinformaticians, computer scientists, and physicians. Our advanced instrumentation provides the industry’s most informative microbial diagnostic tests for ENT, orthopedic, urology, wound care, OB/GYN and other areas of medicine.