It gets even more confidence inspiring, the brand new Abbott rapid testing machines being used by some hospitals are inaccurate as well. https://theworldlink.com/news/local...cle_362a5018-ac67-11ea-a7b1-e3c40dbd50fa.html Local false positive case highlights accuracy of rapid COVID-19 testing AMANDA LINARES The World Jun 13, 2020 COOS BAY — A patient at Bay Area Hospital, who had not been exposed to or had many symptoms related to COVID-19, surprised healthcare officials earlier this month when she unexpectedly tested positive for the new coronavirus. Taken aback by the result, healthcare providers at BAH ordered another test, which was evaluated using the hospital’s newly-acquired Abbott ID NOW testing machine, a rapid, molecular point-of-care test that detects COVID-19 in about 13 minutes or less. Doctors questioned the accuracy of the initial positive result, which was also evaluated on the rapid testing machine, as they reviewed the patient’s condition. She had not been exposed to any other known coronavirus cases and had only one symptom consistent with COVID-19, which was a fever. Kelli Dion, a public information officer at BAH, said the result for the second test, which was returned within about an hour of the first test, came back negative. In an effort to confirm the negative result, Dion said a third test was ordered and sent to the Oregon State Public Health Laboratory which has testing equipment with higher sensitivity rates to detect positive cases than the Abbott rapid testing machine. According to Dion, the timeframe for receiving results from the state lab is a bit longer as the facility is located outside of the county. Last Friday, BAH announced in press release that the patient was indeed negative for COVID-19 as confirmed by the state lab. The accuracy of tests are typically measured through its sensitivity and specificity rates as ways to identify whether a patient is positive or negative, said Dion. At BAH, the Abbott rapid testing machine has a sensitivity of about 60% to 70% depending on how the sample is gathered, said Dion. The specificity rate of the machine, which determines how accurate a test identifies negative cases, also impacted a patient’s results. Last month, a press release from the U.S. Food and Drug Administration warned the public that based on early data gathered from test results nationwide of facilities using the Abbott rapid testing machine that the machine can potentially produce inaccurate COVID-19 results. According to the press release, the test may specifically return false negative results. According to Dion, healthcare providers at BAH are aware of the rates associated with the rapid testing machine and will on a case-by-case scenario determine which patients, who meet the needs to receive a COVID-19 test, will have their tests evaluated by the rapid testing machine and/or the state lab. “It really just depends on what the patient’s needs are when they present as to whether we’re going to use the rapid test or a state test,” said Dion. “… The medical staff decides which one they’re going to use based on what the needs are at the time.” Patients who receive a COVID-19 test will be examined for other symptoms related to the coronavirus and screened to determine if they’ve been potentially exposed to someone with COVID-19. If they somehow test negative, but they present all the factors consistent with the new coronavirus, then an additional test will be ordered via the state lab and the patient will be treated as a potential positive case, Dion explained. More data is currently being collected on the accuracy of test results from rapid testing machines, according to the FDA’s press release. It also stated that no test is 100 % accurate due to performance characteristics, specimen handling or user error. At BAH, a nasopharyngeal swab procedure is used to collect specimen as Dion said it produces the most accurate results. The procedure includes a 6-inch thin, flexible swab which is used to collect nasopharyngeal specimen in the back of a patient’s nose for about 15 seconds. The patient who tested false positive received a nasopharyngeal swab, said Dion. “The Abbott ID (rapid testing machine) is a huge help to us in ruling out patients for COVID-19,” said Dion. “But just like any other lab test if it’s not consistent with the patient’s presentation the provider is going to treat the patient and not the lab test.” This may include ordering additional tests and/or confirming with the state’s lab. “Apart from the possibility of this false positive case the hospital has not had an inpatient test positive for COVID-19 despite robust testing for potential cases,” read a press release from Bay Area Hospital. “The hospital will remain vigilant despite the overall low prevalence of the disease in Coos County.” “In short, Bay Area Hospital continues to put patient and staff safety as a top concern and believes the facility is a safe environment for anyone needing to receive medical care.” According to Dion, all patients are being tested prior to any surgery as a way to clear them before they have a scheduled surgery. When possible, those tests are being done in advance and are being sent to the state lab. Officials at Bay Area Hospital in collaboration with Coos Health and Wellness have continued to treat its false positive case as if it were a positive case for COVID-19 out of an abundance of caution. According to a press release from the hospital, other causes for the patient’s fever, which launched the order of the COVID-19 test, were found and she is responding to the appropriate treatment for those causes.