FDA Approves First Saliva-Based Coronavirus Test
Using its emergency-use authorization powers, the Food and Drug Administration (FDA) has approved the first saliva-based coronavirus test. The test is from Rutgers University's RUCDR Infinite Biologics lab and developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs. Andrew Brooks, chief operating officer and director of technology development at the Rutgers lab, explained that patients will spit into a tube several times and then give it to a health care professional for testing. "Saliva testing will help with the global shortage of swabs for sampling and increase testing of patients, and it will not require health care professionals to be put at risk to collect samples," Brooks said. "Saliva testing will also be important for people who are in quarantine because they don't know how long it will be until they are no longer infectious." According to one report, the Rutgers lab can process 10,000 patient samples a day. The test must be conducted only "in a health care setting under the supervision of a trained health care provider," and any patients who receive negative results from the saliva test must use a second testing method to confirm the findings.
College of American Pathologists Launches Quality Control Program for COVID-19
College of American Pathologists
In response to the COVID-19 pandemic, the College of American Pathologists (CAP) released a new proficiency testing (PT) program for the detection of the SARS-CoV-2 coronavirus. PT is used to evaluate the performance of individual laboratories for specific tests, and also tracks continuing performance and compares performance with other laboratories. Raouf Nakhleh, chair of the CAP's Council on Scientific Affairs, said: "In the midst of the enormous pressure laboratories are facing, along with everyone working in health care during the COVID-19 crisis, laboratories are seeking to measure their performance when testing for the disease." CAP's Microbiology Committee members piloted the new program with a set of laboratories before making it available, which enabled them to assess specimen performance across multiple methods and testing platforms. Specifically, the program is for the detection of SARS-CoV-2 by nucleic acid amplification testing. It provides samples that are non-infectious and target consensus gene regions N, E, RdRp, S, and ORF1a. In addition, the program allows laboratories to assess their entire workflow from nucleic acid extraction through detection.
Lab Test Volumes Plummet as Patients Put Off Care Due to COVID-19
Clinical labs and diagnostic firms are ramping up the production of SARS-CoV-2 tests, but the volume for non-COVID-19 testing is declining as patients postpone elective procedures and regular doctor's visits. The National Independent Laboratory Association (NILA) says the decline in test volumes "is forcing many regional [and] community laboratories to reduce their workforce." NILA Administrator Mark Birenbaum say his group has received reports from member labs of drops in testing volume ranging from 40 percent to 90 percent. In vitro fertilization labs and other specialty sites have completely shut down, he says. Birenbaum adds that some NILA member labs are saying, "if you factor in all the capital investment and everything, the [Medicare rates] don't cover their costs." Kyle Fetter, executive vice president and general manager at a cycle management and lab informatics firm, says toxicology and pain medication testing volumes have dropped more than 50 percent. He observes, "Patients are still on these [pain] medications, so it is probably not a great thing that they are not monitoring it as much through pain and toxicology testing. But it's a very clear trend that that testing is way down." One area that has seen less of a drop-off is non-invasive prenatal testing, Fetter says. However, he points out that those volumes are still down about 20 percent. Fetter forecasts, "At the price [the Centers for Medicare & Medicaid Services] is going to pay for COVID-19 testing, if a lab is super efficient, they will potentially break even."