NEW HAVEN — There were more questions this week on the accuracy of Abbott’s quick turnaround test for COVID-19, reinforcing the decision by major hospitals in the state to use other platforms to get results on whether patients have the respiratory disease.
New York University Langone’s Tisch Hospital found that the test missed almost half of the positive cases when it compared the Abbott ID NOW COVID-19 to Cepheid’s diagnostic test.
The hospital used “nasopharynegeal swabs transported in a viral transport medium as well as dry nasal swabs for the Abbott assay,” according to MassTech. Abbott earlier said its test should only use the dry swabs.
The hospital researchers reported that regardless of how the samples were collected, Abbot ID NOW COVID-19 failed to identify one-third of the tests using the viral transport medium and more than 48 percent using the dry swab recommended by Abbott.
An earlier test undertaken by the Cleveland Clinic, also found a high percentage of false negative results, although Cleveland was not using the dry swab.
A study by Loyola University Medical Center determined that the Abbott ID NOW test missed 25 percent of positive cases.
Dr. Scott Sussman, head of clinical redesign at Yale New Haven Hospital, issued a statement that an Abbott ID NOW COVID-19 test that clears a patient for the coronavirus should be followed up by a more sensitive test.
He clarified, in case there was any confusion, that the hospital has a testing site at 100 Sargent Drive, but it has no connection to the CVS Health facility at 60 Sargent Drive that uses Abbott ID NOW.
Sussman said this Abbott test is less sensitive than the tests used by the hospital and by Yale Medicine.
“The loss of sensitivity is based on the source of the sample (nasal vs nasopharynx) and the method of laboratory testing (two different nucleic acid amplification methods),” he wrote. “The reduced ability of ID NOW to detect the virus makes a false negative slightly more likely.”
Sussman said an Abbott ID NOW test that shows a patient positive for the virus, “can be helpful in patient counseling and management.”
If it comes back negative, Sussman said it should not be used as reassurance to send a patient back to work, clearance for medical or surgical procedures or letting a patient out of self-isolation.
“If there is a negative test and still symptoms, retesting using a more sensitive test methodology should be considered,” he wrote.
The appeal of the test is the quick turnaround to get results, which is 5 minutes for a positive result and negative results in 13 minutes.
Scott Stoffel, a spokesman for Abbott, criticized the NYU study, charging that “the results are not consistent with other studies.”
He pointed to a study in Washington state, where he said “out of approximately 1,000 subjects, there were 23 positive for COVID-19 on a lab test and ID NOW picked up 21, demonstrating 91 percent sensitivity and 100 percent specificity. We have many questions for the (NYU) study authors.”
“While no test is perfect, Abbott's ID NOW is delivering reliable results when and where they're needed most. The test is performing as expected by the more than 1,000+ sites using ID NOW for COVID-19,” Stoffel said.
“The world needs a variety of tests in labs and at point of care, and as many as possible, if we are to help reduce the risk people have every single day of contracting the virus. ID NOW is an important tool in that equation,” Stoffel said.
The Abbott ID NOW test is used at the White House, where two staffers have been diagnosed with COVID-19.
President Trump called the ID NOW test “a game-changer” when he introduced it in the Rose Garden.
Connecticut also has a contract with CVS Health, which uses Abbott ID NOW testing for the large drive-through site the company put up at 60 Sargent Drive in New Haven.
Tara Burke, spokesperson for CVS Health, said the company is happy with its partnership with Abbott Labs where it has collected more than 100,000 tests at five sites in the country.
“We are very pleased at how it has worked out for us,” Burke said.
There is no word yet on whether the contact for the Sargent Drive site will be extended beyond the end of the month.
Dr. Ajay Kumar, chief clinical officer at Hartford Healthcare, said they are not using ID NOW because of the high percentage of false negatives. The healthcare system uses Cepheid’s diagnostic test, Quest, Jackson Laboratories and Lab Corp, as well as another Abbott product that takes longer to show results.
Dr. Syed Hussain, the regional chief clinical officer for Trinity Health of New England, said they have unlimited capacity to test, which is the virtue of being able to consult on the best procedures across its network of hospitals. In Connecticut their hospitals include St. Mary’s in Waterbury and St. Fancis in Hartford. They do not use Abbott ID NOW.