How are we doing in meeting the challenge?
We’re now almost five months in since the notorious SARS-CoV-2 first reared its ugly head in December in Wuhan, with the first diagnosed case in the US following soon after in January. In the US, the pandemic caught laboratories seriously unprepared to meet the demands for testing, despite having a few months to watch its spread elsewhere before numbers became pressing here. As late as March although the president assured the country that anyone could get tested who wanted to, the reality was that we were still very much behind the burgeoning demand.
So how are we doing now?
On April 1, I published a piece that outlined the state of affairs then (COVID-19 Testing for the Physician Office Laboratory). At that point it was pretty much just public health labs and Quest and LabCorps who had COVID-19 testing capabilities. But TAT (Turnaround Time) was too slow (about a week)to be as effective as was needed, with many cases only being confirmed after the virus had progressed to critical stage. The main reason was that testing was qPCR and ICP based RNA amplification, which requires special equipment, takes time and only a relatively small number of labs have that capability. For the most part this was until recent weeks still the case, although things are changing rapidly.
According to Monday’s presidential press briefing this week, we’re now looking at 9 million point-of-care (POC) tests deployed within the next few weeks, totaling over 12 million in all throughout the United States, as we begin to turn our attention to detecting antibodies for treatments and/or vaccines. This is a huge step forward particularly in the availability of POC tests, which was essentially nil at the outset. The primary factor in such a rapid ramp up is generally seen to be the FDA’s fast-path provisional approval for new tests and devices. However, reports are starting to emerge of false results and thus the unreliability of some POC assays. This was always anticipated, but the general view was that sacrificing some accuracy for wide availability and fast results was an acceptable trade-off. But we’re apparently seeing up to nearly 15% false negatives in some cases, according to one study — which may be an unacceptable degree of risk.
An additional $9 billion in federal funds is earmarked to states for testing. The funds come with specific allocation directions, including testing for nursing homes, the disabled, prisons and the Office of Minority Health and Health Equity (OMHHE) — areas that have been identified as higher risk.
So how are we doing? Overall much better than we were initially. But like most things, the answer is: pretty good in some ways, but still not good enough in others.