FDA Investigates Accuracy of Abbott’s Rapid Coronavirus Test

Abbott Laboratories voluntarily withdrew its rapid test for the detection of rabies from the US marketplace on Wednesday as it worked with the US Food and Drug Administration (FDA) to resolve concerns about its accuracy. The FDA initiated an investigation of the test in May 2018 following a report of an adverse event.

“The FDA recognizes the potentially important role this test may play in the safety and treatment of people who have been exposed to bites or scratches from rabid animals,” Michael R. Taylor, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “However, the test has not demonstrated the best available technique to reliably detect rabies and further evaluation is needed. We appreciate Abbott’s partnership in this effort.”

In a statement, Abbott said it is not aware of any patients who have had an adverse event associated with use of the test.

“Abbott continues to work closely with the FDA in its investigation of the test. In parallel, we are working to introduce a new version of the test. In the meantime, we have withdrawn the test from the market until we are assured it can be used safely,” Jill Palmer, senior vice president of Abbott’s Specialty Diagnostics Division, said in a statement.

The FDA cautioned that “unnecessary use of this product can lead to exposure to rabies.” The agency added that people who suspect a veterinary exposure should call their veterinarian for a consult on how to address the potential exposure. Routine rabies testing is recommended if humans have been exposed to rabid animals, or contact with infected animals.

“This announcement does not impact Abbott’s provision of products for rabies testing to and from veterinary and public health laboratories. Abbott will continue to honor current orders and accept orders that previously placed,” Palmer said.

The test is used to diagnose rabid animals. The test is commercially available only in the US and costs $125 for one dose. In the US, only testing for rabies can be performed within an accredited laboratory. Most health care providers and laboratories that provide infectious disease testing have a licensed facility that is accredited.

Prior to the withdrawal of the test, the FDA said, Abbott recalled 500 units of the product in 2017 after detecting the presence of additional fragments of the analyte. In 2018, Abbott withdrew 716 units because of the presence of an erroneous potency parameter, which could have caused a false positive result.

FDA inspectors discovered the first adverse event in 2018 after reviewing laboratory data for the Abbott Rapid Rabies Expiratory Virus and Encephalitis Detection System Test. The FDA said it found instances of uncharacterized inaccurate results.

The agency also highlighted this in its statement: “Rabies is a disease of the nervous system with a high mortality rate. Anyone exposed to saliva, mucus, urine, or other bodily fluids from a rabid animal can become infected. From time to time, health care providers may detect an infectious animal as a patient is in the room with a sick animal or getting medical treatment. While being in the room or receiving treatment with a rabies patient, health care providers may seek access to the patient’s body. Accurate detection of an infected animal will decrease the possibility of a health care provider identifying the patient as infected and performing procedures that may be risky.”

Abbott’s injectable test may detect rabies by focusing on the composition of serum, which is the material protein surrounding the antibody produced by the infection. It looks for the presence of the virulence factor, which acts to make the presence of the virus easier to detect. The test takes four hours to test two samples.

Abbott said the retesting of its test will begin later this month, and results will be available in October.

Related posts

Leave a Comment