Abbott’s 5-minute coronavirus test yields false negative results 15% of the time, research shows


The new five-minute test used to diagnose people with the new coronavirus, and touted by President Donald Trump, produces false negatives, a new study claims.

Researchers at the Cleveland Clinic tested 239 copies of the virus as one of the five most commonly used tests, including the Abb NOW Laboratories’ ID NOW test.

The test was praised for detecting a positive result in just five minutes and a negative result in 13 minuets.

However, the ID NOW positively confirmed the virus in only 85 percent of the 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 tests, including the Abbott Laboratories test (shown)

Cleveland Clinic tested nearly 300 samples known to contain coronavirus in five of the most commonly used tests, including the Abbott Laboratories test (shown)

The test was praised, including by President Donald Trump, for being able to yield a positive result in just five minutes and a negative result in 13 minutes. Pictured: Trump has a new COVID-19 test kit developed by Abbot in the White House rose garden, March 30

The test was praised, including by President Donald Trump, for being able to yield a positive result in just five minutes and a negative result in 13 minutes. Pictured: Trump has a new COVID-19 test kit developed by Abbot in the White House rose garden, March 30

The test was praised, including by President Donald Trump, for being able to yield a positive result in just five minutes and a negative result in 13 minutes. Pictured: Trump has a new COVID-19 test kit developed by Abbot in the White House rose garden, March 30

In the study, Abbott's test confirmed 85 percent of the samples positive, meaning it produced false negatives 15 percent of the time. Pictured: A health worker offers a driver a Coronavirus test kit at the test site at San Gabriel Valley Airport in El Monte, California on April 17, 2020.

In the study, Abbott's test confirmed 85 percent of the samples positive, meaning it produced false negatives 15 percent of the time. Pictured: A health worker offers a driver a Coronavirus test kit at the test site at San Gabriel Valley Airport in El Monte, California on April 17, 2020.

In the study, Abbott’s test confirmed 85 percent of the samples positive, meaning it produced false negatives 15 percent of the time. Pictured: A health worker offers a driver a Coronavirus test kit at the test site at San Gabriel Valley Airport in El Monte, California on April 17, 2020.

Dr Gary Procop, of the Cleveland Clinic’s laboratory medicine department and the study’s lead author, said that NPR tests should be accurate at least 95 percent of the time.

“So that means if you had 100 patients who were positive, 15 percent of those patients would be mistakenly called negative,” Procop said.

“They would be told they are negative for COVID if they are really positive. Thats not so good. ‘

However, in a statement to DailyMail.com, the Illinois-based company assured that the test was reliable and accurate.

Abbott said problems with the accuracy of the test in the study could be virus samples stored in a solution known as viral transport media before they were tested – something that was communicated to customers last week.

“When we discovered last week that viral transport media could thin samples, we immediately communicated to our customers that they should use the direct swab method,” the statement said.

“If the direct swab method is used, the test will perform as expected and we are confident in performance.”

Cleveland Clinic says it will no longer use the Abbott test or any other test because it was less than 95% accurate. Pictured: Dr. Gary Procop, lead author of the study

Cleveland Clinic says it will no longer use the Abbott test or any other test because it was less than 95% accurate. Pictured: Dr. Gary Procop, lead author of the study

Cleveland Clinic says it will no longer use the Abbott test or any other test because it was less than 95% accurate. Pictured: Dr. Gary Procop, lead author of the study

Procop said the samples were stored in viral transport media, but there was no evidence that this affected the accuracy of the test.

“They have to prove to us that they can actually deliver a sensitivity of over 95 percent [if samples are placed directly in the machine]or else we endanger civilians, “he told NPR.

Procop said that Cleveland Clinic no longer uses Abbott’s test because of the study results and another test, the DiaSorin Simplex, which identified only 89.3 percent of infections.

Instead, the hospital relied on the three other tests that did better in the study.

This includes the Center for Disease Control and Prevention test, the test made by Cepheid, a molecular diagnostics company, and the test made by pharmaceutical company Roche.

Those tests accurately identified positive samples of 100 percent, 98.2 percent and 96.5 percent, respectively.

“If any patients come into the hospital and you are going to take them to a department that has been found COVID-free, you must have the most sensitive test,” Procop told NPR.

‘Because once you put someone with COVID in a COVID-free department, it is no longer COVID-free. It is your new COVID department. ‘

Abbott currently ships 50,000 tests daily and hopes to produce two million tests by June.

Procop believes that Abbott’s test is still helpful as long as patients are warned about false negatives and advised to take social distance measures.

“There is a risk that if you tell someone they are negative and they are really sure that they are social distance, not wearing a face mask, etc. And can transmit the disease,” he said.

“If you get a negative test and think,” I don’t have it and I can go to a mixer. “And now everyone at the mixer is now exposed to you. ‘

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