Federal officials send nursing homes antigen tests, but accuracy questioned after Gov. DeWine false positive

Federal officials send nursing homes antigen tests, but accuracy questioned after Gov. DeWine false

CLEVELAND, Ohio (WOIO) - There are new questions about Covid-19 tests being sent to nursing homes by the federal government.

Officials announced last month they’re sending tests to every nursing home in the country.

Now advocates have questions about their accuracy and how quickly nursing homes are getting them.

It’s been four weeks since the U.S. Department of Health and Human Services announced it is sending several hundred Covid-19 tests to every nursing home nationwide, with rapid results that could come back as fast as 15 minutes.

The number of tests each nursing home will receive depends on its size.

Their first priority is coronavirus hotspots.

So how many tests have been sent to Ohio so far?

19 Investigates found 50 nursing homes, including 11 in northeast Ohio have received or will be receiving these tests in the next few weeks, according to data from HHS.

There are 960 nursing homes in Ohio.

Paula Mueller is the founder of a watchdog group called Elderly Advocates.

She's hearing rapid tests aren't ready to go yet in most Ohio nursing homes.

“They have the physical test thing, they have the equipment. But they don’t have, like if you’re diabetic you have a testing machine, you need the strips you need the needles. They don’t have the pieces to go with the tests,” Mueller said.

Mueller and many others question how much they can rely on these tests in the first place.

They're antigen tests, the same type Governor Mike DeWine took before he intended to meet President Trump last week.

That test gave him a false positive result.

False positives are rare.

But Harvard Medical School reported antigen tests can have false negative results as high as 50 percent.

Dr. Amy Edwards, an infectious disease expert with University Hospitals, says antigen tests look for little 'bits' of the virus.

“They are notoriously plagued with problems with accuracy,” she said.

Tests sent nationwide

Antigen tests will be sent to more than 15,000 nursing homes nationwide.

The FDA gave them emergency approval to get them out quickly.

HHS officials have previously said the antigen tests are being used for surveillance and monitoring, since many of the same people are being tested often, like staff members.

Mueller said she will believe the tests are ready to go when she sees it.

“We’re going to keep watching. Because so far, we’re hearing why they won’t get it,” Mueller said.

2,429 Ohio nursing home residents have died from Covid-19, according to the latest data from the Ohio Department of Health.

HHS test information

UPDATE: 19 Investigates received a statement from an HHS spokesperson Wednesday:

No one is advocating for anyone to use tests with 50 percent accuracy. The FDA standard is over 80 percent accuracy.

BD and Quidel are so far the only two diagnostics companies to receive COVID-19 emergency use authorizations from FDA for antigen tests. As a result, their tests should demonstrate a minimum sensitivity of ≥ 80% for all sample types submitted. It is mentioned in the  Antigen Template for Manufacturers (May 11, 2020). Nursing homes are receiving antigen tests from these two companies.

On Tuesday, HHS sent us more information on the tests being sent to nursing homes.

HHS stated fighting this pandemic requires using different technologies, including antigen tests.

According to their Frequently Asked Questions, negative antigen test results do not rule out Covid-19 and should not be used as the sole basis for treatment.

“Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19,” HHS states.

But they also said positive results are confirmed “in areas of high prevalence or for patients with known risk factors.”

HHS said instruments and tests started shipping July 20 and will continue to ship to nursing homes over 14 weeks.

3,900 nursing homes received priority shipping, based on CDC hotspot data and other considerations.

Here is the number of tests nursing homes can expect to receive, based on their size:

-Small facilities –150 tests, 1 instrument;

-Small-medium facilities –240-250 tests,*1 instrument;

-Medium facilities –325-330 tests,*1 instrument;

-Large facilities – 600tests, 1 instrument;

-Major outlier facilities – 900+ tests, 2 instruments

(*Note from HHS: The range accounts for variations in kit size between BD and Quidel. Tests for the BD Veritor™ Pluscome in kits of 30 andthosefor the Quidel Sofia 2 in kits of 25.)

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