By Nancy I. Maanao
(Tumon, Guam) A major study by a leading medical center says the machine Guam uses to test most Guamanians for Coronavirus is wrong nearly half the time it's used.
There's a reason hospitalized patients with COVID-19 are testing negative at the Guam Public Health Laboratory, then reclassified back to positive status at the hospital. It's the same reason public health officials have known about since April 16.
The manufacturer of the machines - Abbott Laboratories - used at the GPHL to test for Coronavirus told public health officials on that date that the way they've been using the machines is wrong. The machine is called the Abbott ID NOW. In mid-April, Abbott sent an urgent notice around the world that its machine would yield a high rate of false negatives if used incorrectly.
On April 23, Dr. Felix Cabrera with the governor's COVID-19 Physicians Advisory Group said the Abbott ID NOW machine's 14 percent false negative rate was not suitable for a clinical setting. And while the governor has said Dr. Cabrera is in charge of testing for GovGuam, those machines still are in use at both the GPHL and GMH (the designated COVID-19 hospital), and the method of testing has not been corrected.
The Department of Public Health and Social Services and the Physicians Advisory Group knew about the testing problems exactly one month ago.
Now, a study out of New York University says those same machines DPHSS is using miss 48 percent of positive Coronavirus cases.
“Overall, our study revealed low sensitivity with high false negative results by Abbott ID NOW platform irrespective of use of viral transport media, which raises concern regarding the performance of the assay and its suitability as a diagnostic tool for symptomatic patients. The resolution could be to reflex all negative results for confirmation by a method with higher sensitivity. However, such requirement would, except for positives, severely diminish the value of the rapid results of the assay.” - Performance of Abbott ID NOW rapid SARS-CoV-2 NAAT, New York University
The study, which has yet to receive peer review, has now been widely reported throughout the globe by Bloomberg, the New York Times, the Wall Street Journal, NPR, Reuters, the Washington Post, and more. The U.S. Food and Drug Administration also issued an alert on the machine, "in the spirit of transparency."
“Based on our findings we could argue that the Abbott ID NOW detects samples with high viral load or possibly viable virus that could be of importance for transmission. But, the fact that it misses positive samples on patients being admitted to the hospital with clinical picture of COVID- 19 makes this technology unacceptable in our clinical setting.” - Performance of Abbott ID NOW rapid SARS-CoV-2 NAAT, New York University
The study recommends that negative results from the machine should be confirmed by a more reliable machine. On Guam, however, positive results from more reliable machines are being retested using the Abbott ID NOW machines and then coming out negative. #assbackward
According to the Wall Street Journal, Abbott will be issuing a second change in instructions to the use of its machines.
“It is our responsibility to provide healthcare professionals and the public with accurate information, and that's why we're doing the following: "Further clarifying our product information to provide better guidance to healthcare providers that negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Negative results should be presumed negative, but if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular assay. We are also reinforcing proper sample collection and handling instructions. We are communicating this to our customers.” - Abbott Laboratories, May 14, 2020 statement
The government of Guam never even followed the first change in instructions. Will they follow the new method, and more importantly, does it matter? Even the U.S. Food and Drug Administration has sent out an alert about the machines.
If you show symptoms of COVID-19 and you test negative on the Abbott ID NOW machine, the FDA says to confirm the negative result with a more reliable test.
The bulk of Coronavirus tests have been run by the GPHL, which has been using the Abbott ID NOW machines for more than a month now. The infection curve that the governor and her Physicians Advisory Group have relied upon to make decisions is based largely on the test results run by GPHL. The people tested all presented with symptoms of COVID-19, some even tested positive for it on a different, more reliable machine. How flat is the infection curve? How many people falsely tested positive?
The week before Kandit raised this issue to GovGuam on April 22, COVID-19 state surgeon and Guam Regional Medical City CEO Dr. Michael Cruz said that using test kits not aligned with the Abbott machines was out of the question. At the time, several businessmen were trying to sell test kits and machines other than Abbott technologies to GovGuam, mostly from a South Korea brand that the U.S. Government had been purchasing.
Gov. Lou Leon Guerrero agreed with Dr. Cruz. On April 22 Kandit first asked about GovGuam's misuse of the Abbott ID NOW following the urgent notice Abbott sent on April 16. On April 23, the Joint Information Center responded stating in a release that Abbott approved its use of a dilution method on Guam, which clearly contradicted the April 16 instructions.
Later that day on April 23, Ms. Leon Guerrero herself said Guam's dilution method was consistent with the proper use of the machine.
On May 4, Abbott responded to an inquiry by Kandit News on the matter and reinforced its April 16 instructions: Guam's dilution method was wrong.
On May 6, the Joint Information Center buried a notice at the bottom of its daily infection count release admitting that its method of testing using the Abbott ID NOW machines was wrong, and stating that the machines would be moved from the GPHL to the Northern Public Health Center, where the test swabbing occurs.
On May 7, the administration stated it had not used the Abbott ID NOW machine since April 16, despite numerous statements to the contrary by Ms. Leon Guerrero, Dr. Cruz, Dr. Cabrera, public health director Linda DeNorcey, and the Joint Information Center.
On May 8, Dr. Manglona with the GPHL told senators in a virtual oversight hearing that public health still was using the machine, and still was diluting the test swabs against Abbott instructions.
Thousands of tests of symptomatic residents have been run on those machines by GPHL during this time period.
On a macro scale, might the government of Guam have inadvertently triggered the start of the herd immunity theory due to the stubbornness and pride of the governor and her team?
Only time will tell; but the GMH emergency room already is telling a story. It's busy again. God be with us.