Physicians across the US are outraged that the FDA has banned the two top rapid flu tests at the peak of this deadly season leaving them ‘begging’ distributors for supplies.
The largest medical suppliers in the US are completely out of the rapid flu test kits that detect the virus within 10 minutes after the FDA took the top brands off the market on January 12 due to false positives.
Speaking to Daily Mail Online, President of Dealmed-Park Surgical, the largest medical supply distributor in New York, New Jersey, Connecticut and Pennsylvania, called the situation a ‘crisis’ and ‘can confirm that we have totally exhausted our stock and have physicians begging for product on the phones and need to turn them away.’
While new, more accurate tests are on the market, they are not being produced fast enough to keep up with the high demand this flu season, forcing doctors to resort to three-day blood tests to determine if someone is sick with the flu.
The ban came in the midst of a flu-season that is on track to becoming one of the worst in history and has already killed more than 37 children with hospitalizations climbing each day.
The FDA banned two top rapid flu test brands on January 12, 2018 – in the middle of one of the worst-flu seasons in recent history leaving physicians begging distributors for supplies
Michael Einhorn, President of DealMed-Park Surgical, serves 4,000 physicians offices and urgent care facilities in New York, New Jersey, Connecticut and Pennsylvania.
He told Daily Mail Online: ‘This is something that’s been going on for the last three weeks. There’s minimal talk about it and it’s just a crisis.’
His company shipped out 20,000 to 30,000 rapid flu tests this week alone and has and has another 20,000 tests on back order that he cannot fill.
‘The alternative rapid tests weren’t able to ramp up production in time,’ Einhorn said.
Fortune-500 distributors Henry Shein and McKesson have been out of flu tests for two weeks and Einhorn said they have reached out to his company to lend product.
Last January the FDA downgraded the two rapid flu tests Osom and QuickVue that detected the flu within 10 minutes through a nasal swab.
Some tests had produced false negatives and the FDA said they were ‘performing poorly, resulting in many misdiagnosed cases.’
The CDC notes that rapid influenza testing has a sensitivity ranging from 50 percent to 70 percent, meaning that half of flu cases could come up negative.
On January 12, 2017 the FDA sent out a notice giving manufactures one year to develop new rapid flu tests because by January 12, 2018 the Osom and QuickVue tests would no longer be available.
Einhorn said some physicians and urgent care facilities stocked up on the product before they went off the market and can use the tests until they expire.
But the slow production of the new tests have left doctors offices calling and emailing Einhorn nonstop in desperate need of rapid tests.
Stats released today show the rate of hospitalizations is soaring, not dipping, as the CDC had hoped
Physicians are finding alternatives to test for the flu, including taking blood samples from patients which take about three days for results.
In some cases, three days of untreated flu-symptoms can be long enough for deadly complications including pneumonia and sepsis to set in.
Einhorn added that the demand for rapid flu tests this year is ‘substantially higher’ and that doctors are ‘burning through them’.
‘For a typical flu season we maybe have half of those orders. This season we’re doubling our volume with less available product,’ he said.
‘It’s not as easy to buy something else,’ Einhorn added. ‘The FDA gave them a year but you don’t stop [distributing] flu tests in the middle of flu season.’
According to the CDC, at least 37 children have died and hospitalizations have climbed to 41.9 per 100,000 this week.
This year’s outbreak is on track to becoming one of the worst flu seasons in recent history due to a deadly strain that has become widespread in 49 states, excluding Hawaii.
The flu is especially dangerous because while most people suffering from the virus experience fever, chills, muscle aches, cough, congestion, runny nose, headaches and fatigue, not all those infected show symptoms.
With three months of flu season left, the CDC is urging everyone to get the flu shot and they say it is not too late to protect yourself from the H1N1 and B viruses that are beginning to emerge.