According to a May 14 article from FierceBiotech, a new study at NYU Langone Health shows substantial problems with Abbott’s ID NOW technology for COVID-19 testing. The study found that depending upon sample handling, ID NOW can miss “nearly half of positive cases.” The study has been pre-published on preprint server bioRxiv, and it has not been peer-reviewed yet. According to Abbott’s website, ID NOW for COVID-19 amplifies the viral RNA to make it detectible. On the other hand, Abbott-sponsored testing has found higher accuracy, as noted below.
Despite False Negatives, Production Ramped Up for Abbott’s ID NOW
At NYU, each subject had samples collected twice, once with a dry nasal swab and once with a longer swab—the samples were tested using both ID NOW and Cepheid’s Xpert Xpress test. Both are small devices that provide quick results. Among the dry nasal swab samples that returned a positive result with Cepheid’s test, about 48% falsely read as negative when running through Abbott’s ID NOW.
Across both the dry and submerged sample collection and transport methods, the ID NOW tests missed one-third of the samples detected positive by Xpert Xpress, according to the NYU researchers. Abbott has shipped about 1.7 million ID NOW tests nationwide, “with the majority focused on COVID-19 outbreak hot spots and priorities given to healthcare workers and first responders. Abbott said it is currently manufacturing 50,000 tests per day, with plans to increase capacity up to 2 million tests per month by the end of June.” The FDA indicates that it is “evaluating reports of inaccurate results and that it is in direct communication with Abbott….”
Cleveland Clinic Finds 14.8% False Negatives with ID NOW Testing; Rollout in May and June.
An earlier April 23 piece from MedTech Dive also focuses on the ID NOW product. They note that Cepheid beat Abbott to the punch in being the first to get “emergency use authorization for a point-of-care coronavirus test.” Abbott’s test has the potential to detect positive cases in five minutes and negative results in 13 minutes. Poised as a possible platform for the “U.S. coronavirus testing infrastructure,” concerns exist in that at, “the time of the EUA, Abbott did not share data on the accuracy of the test. A spokesperson said ‘performance was established by testing a limited number of contrived samples,’ and performance characteristics would continue to be collected in the field.”
A recent Cleveland Clinic assessment looked at over 200 specimens and evaluated five testing platforms. Abbott’s ID NOW and DiaSorin’s Simplexa had higher false negatives than counterparts. The Cleveland Clinic looked at many “traditional and rapid testing platforms,” to review the performance of tests now in use and those being considered for use in the clinical setting. Updating directions to avoid diluting samples is important, and overall, the Clinic found about 14.8% false negatives.
The initial priority with ID NOW was to test front line healthcare workers, “and as we start to ramp up manufacturing for ID NOW as we’ll start to implement those actions in the month of May into June, we’ll start to roll this out into a second phase where we’ll start to be able to test more of the general population,” Abbott CEO Robert Ford said. CVS and Walgreens expanded their drive-thru testing services this month using the test. Ford indicates that the tests are sold for the same price as other testing (e.g., strep and flu) using the ID NOW platform.
Abbott’s most recent Covid-19 focus is detecting antibodies (as opposed to the actual virus), specifically “IgG,” a protein produced late in an infection. Also, Abbott is currently at work on a test for “IgM,” a protein that can show more recent exposure.
Abbott Touts Positive Research on ID NOW in May 21 Press Release
Finally, in a May 21 press release, Abbott outlines recent studies showing better performance than other sources have reported. They note that an interim analysis on ID NOW COVID-19 rapid testing shows over about a 95% “positive agreement” (test sensitivity) and over 98% “negative agreement” (test specificity) as compared to lab-based PCR methods. The interim analysis related to “ongoing multi-site clinical study in urgent care clinics.” Two other Abbott-sponsored studies also support the validity of this testing: one at the Everett Clinic in Washington and an additional “ongoing study of hospitalized and nursing home patients.” The studies find that the tests work best in “earlier post symptom onset,” when the viral load is most detectible.
“We’re pleased that ID NOW is delivering on what it was designed to do—quickly detect the virus in people who need to know now if they’re infected,” said Philip Ginsburg, M.D., senior medical director, infectious disease, Rapid Diagnostics, Abbott. “This is great news for people who are experiencing symptoms and want to take action before they infect others, reducing the spread of infection in society.” The press release focuses on three ongoing studies: An Urgent Care Clinic study, the Everett study, and the study of hospitalized and nursing home patients.
In the first study, 256 subjects are enrolled so far. The ID NOW identified 29 of 29 positive samples and 226 of 227 negative samples. The Everett study involved 955 subjects and found 91.3% positive agreement and 100% negative agreement when “compared to lab-based PCR assays.” In the hospitalized and nursing home study so far, Abbott has shown an 85.7% positive agreement and 97.6% negative agreement compared to the CDC assay.
Call to Action: With so many different data points from seemingly credible sources, who to believe? TrialSite News will be closely following developments in both virus and antibody testing as the science develops.Source: