The Meals and Drug Administration on Monday issued an alert to sufferers and healthcare suppliers warning them of a threat of false unfavorable outcomes with a SARS-CoV-2 laboratory-based check from San Dimas, California-based Healing.
The company asserted that the check, to which it granted Emergency Use Authorization in April, should be carried out in accordance with its labeling to make sure right outcomes.
“When the check will not be carried out in accordance with its authorization or as described within the approved labeling, there’s a higher threat that the outcomes of the check is probably not correct,” the FDA wrote in a security communication.
The PCR-based check is allowed to be used on throat swab, nasopharyngeal swab, nasal swab, or oral fluid specimens for the detection of nucleic acid from SARS-CoV-2. The FDA assertion highlighted that use of nasal swabs and oral fluid specimens is proscribed to symptomatic people inside 14 days of COVID-19 symptom onset, and specimen assortment should be immediately noticed and directed throughout the pattern assortment course of by a skilled healthcare employee on the specimen assortment website.
“A unfavorable outcome doesn’t rule out COVID-19 and shouldn’t be used as the only foundation for remedy or affected person administration choices,” the company mentioned. “A unfavorable outcome doesn’t exclude the potential of COVID-19.”
The company additional emphasised that the implications of a false unfavorable outcome embody delayed remedy or lack of supportive remedy, and lack of monitoring of contaminated people and their shut contacts for signs that may end up in elevated threat of unfold of COVID-19 inside the neighborhood.
Healing acquired Korvalabs in Could and transformed its sports activities doping check facility for COVID-19 testing. The agency has been performing testing for the Los Angeles County Hearth Division and Sheriff’s Division, town of Lengthy Seaside, the states of Alaska and Florida, and the U.S. Air Power, in addition to on samples collected at drive-through testing websites in California and Delaware.
In an e-mail, Healing CEO Fred Turner mentioned that the agency “disagrees with the evaluation” made by FDA that the check has efficiency points. The agency intends to publish the outcomes of a giant scientific trial quickly, he mentioned.
This story first appeared in our sister publication, Genomeweb.