April 22, 2020 / By Curt Devine and Drew Griffin, CNN
(CNN) – The maker of a rapid coronavirus test widely used across the United States and distributed by the federal government has warned that its device can produce false negatives if a special solution is used to move or store patients’ samples.
Abbott Laboratories instructed health care providers last week not to use solutions known as “viral transport media” for samples tested on its ID NOW device, which runs one test at a time and can detect positive coronavirus cases in as little as five minutes and spit out negative results in 13 minutes.
The company says customers should instead only place swabs with patient samples directly in the device. When that method is used, the test performs as “expected,” an Abbott spokesperson said, adding that when the company learned about the issue it immediately notified its customers and the US Food and Drug Administration.
Abbott has promoted the ID NOW test as a “point-of-care” test, meaning doctor’s offices or clinics can collect samples from patients using swabs and quickly test the samples without having to transport them to specialized labs.