FDA Warns About Danger for False Negatives From Healing COVID Take a look at

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The US Meals and Drug Administration (FDA) has issued a security communication concerning the potential for false outcomes from a fast COVID-19 take a look at from Healing Inc, which is being utilized in Los Angeles and different giant metropolitan areas in the USA.

The true-time reverse transcription polymerase chain response (PCR) take a look at was developed by Menlo Park, California–primarily based healthcare start-up Healing Inc. Outcomes are analyzed by the corporate’s scientific lab, KorvaLabs Inc. The take a look at, which is allowed for prescription use solely, acquired emergency use authorization from the FDA on April 16, 2020. By November 9, the corporate had processed 6 million take a look at outcomes, according to the company.

The FDA alert cautions that false destructive outcomes from any COVID-19 take a look at can result in delays in or the dearth of supportive remedy and improve the danger for viral unfold.

To mitigate the danger for false negatives, the company advises clinicians to carry out the Healing take a look at as described within the product’s Reality Sheet for Healthcare Suppliers. This consists of limiting its use to individuals who have had COVID-19 signs for 14 days or much less. “Contemplate retesting your sufferers utilizing a unique take a look at if you happen to suspect an inaccurate end result was given lately by the Healing SARS-Cov-2 take a look at,” the FDA alert states. “If testing was carried out greater than two weeks in the past, and there’s no purpose to suspect present SARS-CoV-2 an infection, it isn’t essential to retest.”

The alert additionally notes {that a} destructive end result from the Healing PCR take a look at “doesn’t rule out COVID-19 and shouldn’t be used as the only real foundation for remedy or affected person administration choices. A destructive end result doesn’t exclude the opportunity of COVID-19.”

In accordance with a press launch issued by Healing on October 7, its PCR take a look at is being utilized by the Division of Protection, in addition to the states of Alaska, California, Colorado, Delaware, Florida, Georgia (Atlanta and Savannah), Illinois (Chicago), Louisiana, Texas, and Wyoming. The corporate additionally operates CLIA-certified laboratories in San Dimas, California, Washington, DC, and Pflugerville, Texas.

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