About a week ago, I opined what I would do if I were President. How I’d order mass testing via any means possible for the folks across this great land. Because unless and until we know who is infected, all we can do (which is exactly what a good portion of us are doing) is to quarantine everyone.

And, you’ve seen how great that idea is. Wholesale unemployment. Restaurants disappear forever. The economy in a tailspin.

Yes, we need to test everyone- and then quarantine those that are infective. Those that aren’t could be released into the wild after about a week of testing.   (The wait is related to the fact that many of the tests taken do not provide instantaneous results.)  And, maybe we’ll have to adopt the process than many of the nascent nations use for voting- an index finger mark for those who are free of the disease, one that lasts about a week.

Will there be failures? Unfortunately yes- since we can bet that folks who haven’t been tested will wander about- not knowing (or not caring) that they are putting everyone else at risk.

But, this process is clearly going to be expensive. We are either going to have to scrub down every building that we allow folks to enter or otherwise disinfect the exposed surfaces to ensure we don’t create another new wave.  (That’s still cheaper in the long run than shutting down national economies wholesale.)

All this was pretty much science fiction, since we didn’t have a reasonably priced, quick, and simple test.

But, leave it to small business.  There’s small company from Waltham (MA) that started up a generation ago (1991), which developed a small, portable, point of care analyzer. It’s capable of presenting on-screen results, devoid of interpretation or subjectivity concerts. (The firm even introduced color-coded test consumables to make sure the user effects the proper test- and does so correctly.)

Among the unique aspects of this device is that it runs isothermally, so there is no heating or cooling period that makes tests run longer. Some of its results are ready in 2 minutes (with 6 minutes to confirm negative results) to  up to 13 minutes. All in all, pretty darned fast.

This device, called ID Now, been used to check for flu (Influenza A and B), Strep (Streptococcus A), and RSV (respiratory sincytial virus, an infant’s disease) since 2014. Moreover, it sports the largest installed base of point-of-care detection units. It helps that it is about the size of a toaster and weighs about 6.5 pounds.

And, then, Alere was subsumed by Abbott Laboratories back in 2017.  (This- acquisition by a larger firm-  is another situation that obtains for those highly successful, formerly small medical innovators.)

So, why a I discussing it now?

Because this device is now capable of detecting the key nucleic acid (RNA) in the SARS-CoV-2 virus. Positive results will manifest in 5 minutes or more, with full negative confirmation after about 13 minutes. And, it’s been authorized by the FDA to start doing so- NOW.

The process is very simple. A sample swab from the patient’s nose or throat is mixed into a chemical solution. This action forces the virus to explode, releasing its genetic material into the solution. Once placed in the device, the RNA is replicated and amplified, which means results can be obtained quickly and accurately. In so doing, clinicians can make real time, educated decisions about that patient’s care.

(Want a more detailed process description? The swab is placed in a sample receiver which is filled with elution/lysis buffer; there’s a transfer cartridge to transfer the eluted sample to the Test Base. The Test Base contains everything needed to amplify the SARS-CoV-2 virus, plus an internal control. The results- seeking out the unique portion of the target pathogen’s RNA- manifest via fluorescently labeled molecular beacons.)

We still will need to use other devices to reach everyone, since this (now) Abbott unit will only be producing 5 million test kits each month. (50,000 new test kits each day.) But, that’s way more than our other choices.

Moreover, the ID Now device can be deployed in urgent care clinics, hospital emergency rooms, or a physician’s offices. Note that Abbott plans to work with the government to deploy the tests where they are most needed (for now). (Please note how politics will be played with this device two paragraphs below.) At the very least, this should flatten the curve in those regions, since we will know who has the virus and who doesn’t.

What also makes this test different is that it need not occur in a clinical laboratory setting- so there is no long distance shipping to a test center, which adds to the delay in obtaining results.  (Consider that more than 85000 folk have been tested in California, but we only know the results for a little more than 28000 of them!)  You do realize that if we test 1 million people a day, that means 6 months to test us all.  By then, those who didn’t have the virus could have been infected in the interim.  We need to test MILLIONS a day!

But, where to deploy the devices is yet another problem?  Not to mention that the units run around $ 15K apiece. Do we ship them to places where there are few cases of Covid-19, so we can easily isolate those infected.  Or, places like Manhattan or Miami that are overrun with infected folks- which means we’ll know what they have, but can’t really use the results to minimize the next wave of sufferers.

(There’s more hope for the situation.  Another company just got emergency approval from the FDA for its coronavirus test. Mesa Biotech Inc’s point of care device (Acula) needs about 30 minutes to obtain results. And, Henry Schein will be offering a blood test to discern SARS-CoV-2 antibodies- delineating a past or current infection in the subject; their test is complete in about 15 minutes. They promised to have several hundred thousand test kits available by March 30th- with even more being shipped this month [April].)

Abbott, itself,  also has a much larger analysis system- the m2000 Real Time system.  This unit has had FDA approval to effect high volume, high throughput analysis for Covid-19. The results are based upon PCR (polymerase chain reaction) (see that second diagram above), which means the results won’t be available stat- but after a few hours. But, it can process some 470 tests each day (ideal for hospital use).

Let’s get tested!