On Sunday, the Department of Health and Human Services confirmed that they’re investigating how improperly manufactured COVID-19 test kits were sent out to medical professionals in the first batch. The FDA is also looking into it. Meanwhile, to expedite the ability to detect the virus, they granted the state of New York permission to use their own tests.
Health officials investigating useless test kits
In the face of what could turn out to be a massive outbreak of the COVID-19 respiratory disease, health officials scrambled to get test kits made up and shipped out to State Health departments. When they finally arrived, the first batch of tests didn’t work. There were two types of kits initially sent out, when the first version wouldn’t produce consistent results on known samples, they tried the second test. Those didn’t work either. Now officials are investigating why. New York had some tests on hand that did work, so they got special permission to use them. The biggest problem is People with the virus that test negative. That led to a contagious patient in Texas being allowed to walk around loose in the community spreading the virus invisibly for days.
New York knew by Friday that the kits were totally useless so they put in a call to the Food and Drug Administration. They heard back on Saturday with the go ahead. On Sunday, they announced their first confirmed case. a 39-year-old Manhattan woman was infected “while traveling in Iran.” She’s currently “isolated in her home with ‘respiratory symptoms’ but is not in serious condition,” Governor Andrew Cuomo announced.
Working kits are on the way
Alex Azar, the Secretary for the Department of Health and Human Services told reporters, that we have 75,000 test kits currently on hand and “over the next week that will expand radically.” He promises that they will work. They “launched an investigation and is assembling a team of non-CDC scientists to better understand the nature and source of the manufacturing defect in the first batch of COVID-19 test kits that were distributed to state health departments and others.” The FDA is on the case too. Commissioner Stephen Hahn released a statement saying, after hearing complaints from the Centers for Disease Control and Prevention, the “FDA worked with CDC to determine that problems with certain test components were due to a manufacturing issue. We worked hand in hand with CDC to resolve the issues with manufacturing.”
They took a look at the way the kits were being made and from what they can tell from their investigation so far, is that they should work as long as they are made properly. The “FDA has confidence in the design and current manufacturing of the test that already have and are continuing to be distributed. These tests have passed extensive quality control procedures.”
JUST IN: New York Gov. Andrew Cuomo announced Sunday night that the state has its first coronavirus patient. https://t.co/FqrxJG7xvQ
— ABC News (@ABC) March 2, 2020
Public at risk in Texas
We want to avoid a repeat of what happened in San Antonio, Texas. A CDC press release announces “an individual who was previously released Saturday after showing negative test results, is being reevaluated after a later test came up showing positive results.” A malfunctioning test put the public at risk for days. “The patient was treated at a local hospital for several weeks after they returned from Wuhan, China,” the press release states, “but did not show any symptoms and two consecutive tests collected in the span of more than 24 hours resulted in negative tests. However, after the patient was released, a later sample showed a weak but positive result, so out of caution, they are bringing the individual back into isolation.”
Basic incompetence is going to end up destroying us all. One would think that the companies involved in manufacturing the test kits to detect infection from the new 2019-nCoV virus bioweapon would make certain that they worked before they shipped them out the door but they didn’t.
dan