The new five-minute test being used to diagnose people with the novel coronavirus, and touted by President Donald Trump, is producing false negatives, a new study claims.
Researchers from the Cleveland Clinic tested 239 specimens of the virus among five of the most commonly used test including Abbott Laboratories’ ID NOW test.
The test was hailed for being able to detect a positive result in just five minutes and a negative result in 13 minuets.
However, the ID NOW positively confirmed the virus in just 85 percent of samples meaning it produced false negatives 15 percent of the time, reported NPR.
Cleveland Clinic tested nearly 300 samples known to contain coronavirus in five of the most commonly used test, including Abbott Laboratories’ test (pictured)
The test was hailed, including by President Donald Trump, for being able to deliver a positive result in just five minutes and a negative result in 13 minutes. Pictured: Trump holds a new COVID-19 test kit developed by Abbot in the Rose Garden of the White House, March 30
In the study, Abbott’s test positively confirmed 85 percent of samples, meaning it produced false negatives 15 percent of the time. Pictured: A healthcare worker offers a Coronavirus test kit to a driver at the appointment-only San Gabriel Valley Airport testing site in El Monte, California on April 17, 2020.
Dr Gary Procop, of Cleveland Clinic’s department of laboratory medicine and the study’s lead author, told NPR tests should be accurate at least 95 percent of the time.
‘So that means if you had 100 patients that were positive, 15 percent of those patients would be falsely called negative,’ Procop said.
‘They’d be told that they’re negative for COVID when they’re really positive. That’s not too good.’
However, in a statement to DailyMail.com, the Illinois-based company assured that its test is reliable and accurate.
Abbott said that problems with the test’s accuracy in the study could be that virus samples were stored in a solution known as viral transport media before they were tested – something it communicated with customers last week.
‘Last week when we identified that viral transport media could be diluting samples, we immediately communicated with our customers that they should use the direct swab method,’ the statement read.
‘When the direct swab method is used, the test is performing as expected and we are confident in its performance.’
Cleveland Clinic say it will not be using Abbott’s test or another test anymore because it was less than 95% accurate. Pictured: Dr Gary Procop, the study’s lead author
Procop said the samples were stored in viral transport media but said there is no evidence that this affected the test’s accuracy.
‘They need to prove to us that they can actually deliver a sensitivity greater than 95 percent [if samples are placed directly in the machine], or else we’ll be putting citizens at risk,’ he told NPR.
Procop said Cleveland Clinic has stopped using Abbott’s test because of the study results and another test, the DiaSorin Simplex, which only identified 89.3 percent of infections.
Instead, the hospital will be relying on the three other tests that performed better in the study.
This includes the Center for Disease Control and Prevention’s test, the test made by Cepheid, a molecular diagnostics company, and the test made by pharmaceutical company Roche.
Those tests accurately identified positive samples 100 percent, 98.2 percent and 96.5 percent, respectively.
‘If you have patients coming into hospital and you’re going to put them into what has been determined to be a COVID-free ward, you have to have the most sensitive test available,’ Procop told NPR.
‘Because once you put somebody with COVID into a COVID-free ward, it’s no longer a COVID-free any more. It’s your new COVID ward.’
Abbott is currently shipped 50,000 tests every day and hopes to produce two million tests every month by June.
Procop believes Abbott’s test are still useful as long as patients are warned about false negatives and are advised to maintain social distancing measures.
‘It is a risk that if you tell somebody they’re negative and they’re truly positive that they will relax social distancing, not wear a face mask etc. and could transmit the disease,’ he said.
‘If you get back a negative test and think: “I don’t have it and I can go to a mixer.” And now everybody at the mixer has now been exposed to you.’