Ann: CE-IVD received for COVID-19 test, page-69

A coronavirus test made by Abbott Laboratories and introduced with considerable fanfare by President Donald Trump in a Rose Garden news conference this week is giving state and local health officials very little added capacity to perform speedy tests needed to control the COVID-19 pandemic.

Millions of tests are urgently needed as the virus keeps communities across the country in lockdown and hospitals are overwhelmed with patients.

The document circulated among HHS and FEMA officials March 30 and obtained by Kaiser Health News said 5,500 cartridges―which translates to 5,500 tests—and 780 devices would be shipped to 55 state and local public health labs all over the U.S. An additional 1,200 tests would go to the Pacific territories. Smaller numbers would be sent to the CDC’s lab in Atlanta and the HHS’ Strategic National Stockpile.

Labs in all 50 states were set to receive roughly the same number of Abbott’s test cartridges and the devices on which they run―100 tests and 10 or 15 devices—the document shows, regardless of how many confirmed COVID-19 cases officials had reported in each state.

Accuracy has been a broad problem in the testing for the novel coronavirus. Abbott Labs declined to address specifics on the clinical accuracy of its tests, which was fast-tracked through the Food and Drug Administration’s review process, saying that accuracy data and other performance characteristics will continue to be collected in the field.

State officials are scrambling to obtain Abbott’s highly touted machines after it said they could detect the novel coronavirus in as little as five minutes, or give a negative test result in about 13 minutes. That compares with at least 45 minutes to several days to get results from most of the other types of COVID-19 tests being used.

https://www.fiercebiotech.com/medtech/trump-touted-abbott-s-quick-covid-19-test-hhs-document-shows-only-5-500-are-way-to-entire-u