The Food and Drug Administration is cautioning in regards to the reliability of a broadly used speed test for the covid-19. The test, from Abbott Laboratories, has been linked with inaccurate results which may falsely reassure patients that they aren’t contaminated with the coronavirus.
Trump Administration has promoted the test as a key factor in controlling the epidemic within the U.S.A and is used for the day by day testing at the White House.
As first reported, as many as 15 to 20 out of each 100 tests could produce falsely negative results. A subsequent research launched this week indicated that the test could possibly be lacking as many as 48% of infections.
The FDA issued the alert on the Abbott test « in the spirit of transparency, » and mentioned in a press declaration, it is investigating whether or not the false-negative results could possibly be related to the kind of swab used during the speedy test, or the material the samples are being stored in when they’re transported.
It additionally cautions that « any unfavourable test outcomes that aren’t consistent with a affected person’s medical indicators and signs or necessary for affected person management needs to be confirmed with one other test. »
« We’re nonetheless evaluating the details about inaccurate outcomes and are in direct communications with Abbott about this important issue, » stated Tim Stenzel, chief of the FDA’s Office of In Vitro Diagnostics and Radiological Health. « We are going to proceed to check the data out there and are working with the Abbott company to create further mechanisms for studying the test. »
The Abbott speed test can nonetheless be used to determine positive coronavirus cases, in keeping with Stenzel, although unfavourable results could must go through a secondary process to be confirmed.
The FDA has received 15 « adverse event reports » in regards to the test indicating sufferers are receiving inaccurate results.
The FDA will proceed to observe data on the test and work with Abbott, which has agreed to conduct post-market research on their speed test. The studies will embrace at minimal 150 individuals who has been tested positive for coronavirus, and take place in clinical settings.
Abbot’s share dropped greater than 3% throughout after-hours trading on Thursday.
The corporate advised in late April that any issues with the test may stem from samples being stored in a special solution often known as viral transport media earlier than being tested, instead of being inserted straight into the testing machine. As a result, the corporate just lately instructed his users to keep away from utilizing it and to solely test samples put straight into the machine.
As well as, Abbott has continued to defend the accuracy of thier test, and pointed to different studies which have discovered it’s as correct as every other tests being used.
Exact, timely testing has been a serious problem within the covid-19 pandemic. Past issues with accuracy of speedy tests, there have additionally been issues certifying antibody exams – those could detect if somebody has been contaminated with coronavirus earlyer.
