by James C. Sherlock
I provide this update to bring our readers up to speed on the always complex and sometimes confusing subject of COVID-19 testing.
High and medium throughput laboratory testing
There are multiple laboratory platforms widely distributed for which FDA-authorized COVID-19 tests are available[1]. Among these are:
- the Roche 8800 high-throughput machine. It can run up to 1,056 tests[2] in an eight-hour shift and up to 4 hours of walk-away time while the samples are running
- the Roche 6800 medium-throughput machine. This one can run up to 384 tests[3] in an eight-hour shift and up to eight hours of walk-away time while the samples are running
- the Becton-Dickenson BD Viper. This low-throughput system found in hundreds of U.S. labs delivers up to 24 results every three hours.
- the Abbott M-2000 Realtime System. A medium-throughput machine, this device can run tests for 470 patients in 24 hours. One hundred and seventy-five are in labs across the country, and they should have been capable of running about a million COVID-19 tests in the last three weeks according to Dr. Deborah Birks at a briefing in Washington April 9. But they have run less than 10% of that amount. “We have a million tests out there,” Birx said. “They’re not running. We’ve only run 88,000 tests in three weeks off of those machines, with a million test kits.”
“The Abbott Company worked really hard three weeks ago in getting a million tests out there to be utilized, said Deborah Birx, the Trump administration’s global response coordinator yesterday. “They can make a million tests a week for all of our laboratories that have these platforms. So far to date, somewhere around 250,000 tests have been utilized in three weeks. That’s why we have really been appealing to the lab directors to bring all of these machines on.”[4]
On Saturday April 11, a test developed by Accurate Diagnostic Laboratories and RUCDR Infinite Biologics at Rutgers University that uses saliva rather than nose swabs was given an Emergency Use Authorization (EUA) by the FDA. It has the dual advantage that samples can be collected without exposing clinicians to transmission of the virus (saves personal protective equipment as well) and of containing a preservative that renders coronavirus in the sample inactive. They have developed a high-throughput version for batch analysis in their labs. Results are available in 24 to 48 hours. This system is operational today in New Jersey.
The largest of America’s commercial labs, LabCorp and Quest Diagnostics, each have authorized tests.
Vice President Mike Pence also addressed lab testing yesterday:
We estimate that although we’re doing over 110,000 tests a day in the United States, that if our Governors and state labs would simply activate the machines that are already there, we could double the amount of testing in the United States literally overnight. …We have a team that now is reaching out to labs to see if can activate all of those machines.”[5]
Point-of-care testing
As of April 10, the FDA had granted Emergency Use Authorization (EUA) had been granted by the FDA for COVID-19 to 34 test kit manufacturers and commercial laboratories. Some are for research only, not for diagnostics.
Only three of the 34 are approved for use in patient-care settings: Abbott Diagnostics Scarborough, Inc. COVID-19 test for ID NOW. Mesa Biotech Accula SARS-Cov-2 Test for Accula Dock or Silaris Dock and Cepheid Xpert Xpress SARS-CoV-2 test for GeneXpert Xpress System. You will understand why all of the national attention is on the 15-minute test for ID NOW.
Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 is authorized for patient-care settings using the Abbott ID NOW platform: direct nasal swabs, 15-minute test, four per hour. ID NOW is by far the most widely used in the United States of the three test platforms listed here, with over 18,000 in operation. I checked with Abbott yesterday by phone. The company is selling the COVID-19 test modules for ID NOW platforms directly to those who order them. Abbott is currently not going through its distributors to sell the COVID 19 capsules, pending signing of distributor contracts for that product. Currently, when Abbbott takes the orders, it links the fulfillment information to its regional sales reps, who then contact the customer and expedite delivery.
Vice President Pence said yesterday that he and his team had spoken with Abbott Laboratories about how to significantly increase the number of cartridges for the 15-minute test.
“Remember, we’re not only scaling to rapid testing across the country today… We also want to work with Abbott Laboratories for the longer term… If the current trend lines hold … we will soon find ourselves on the downslope of the Coronavirus in this country. This epidemic in its current form will come to an end, but as we make decisions in the days ahead to reopen America, what President Trump also wants to do is have a policy in place to stay open and have the kind of surveillance testing available around the country so that the CDC can do the immediate contact tracing when you have a positive test, so that we can deploy resources like the 15-minute test specifically to nursing homes… Being able to increase the manufacture of those devices so that they can be deployed in the months ahead is also a focal point of our efforts… We are working closely with Abbott Laboratories to rapidly increase the availability of cartridges. Abbott is producing roughly 50,000 cartridges a day. FEMA acquired an initial supply and distributed those to the states. We are working with the states to not only distribute what is being made but also work with other suppliers to create additional cartridges” [6]
The other two point-of-care systems with EUA’s from the FDA are:
- the Mesa Biotech Accula SARS-Cov-2 Test. Approved for use in patient care settings using the Accula Dock or Silaris Dock (Bench or hand held), this device provides results in 30 minutes, two tests per hour.
- the Cepheid Xpert Xpress SARS-CoV-2 test. Cartridge technology. 45 minute test results on up to 4 tests at one time. Testing of nasopharyngeal swab specimens run on the point of care GeneXpert Xpress System.
That brings you relatively up to date on testing.
The Northam Administration
I have been critical of the Northam administration’s clear lack of focus on this issue across the spectrum of the tests available. Virginia is 12th in population and 21st in numbers of tests conducted among the states as of yesterday, putting the Commonwealth near the bottom in tests per 100,000 population.
The President’s task force is trying to get all 50 governors to focus on testing, and in particular make sure labs in their states are working at maximum capacity. I hope Governor Northam will do it.
I am particularly frustrated at the Northam administration’s refusal to address point-of care testing. After writing multiple columns in this space on testing to no apparent effect, I called the state Emergency Operations Center this weekend, told them about the ID NOW COVID-19 tests and gave them the direct line phone number to Abbott Diagnostics Scarborough. I suggested someone call to get information on the location of the ID NOW platforms in Virginia and the current distribution channel for capsules in this state. The Governor’s Monday press conference made no mention of the subject.
The only time I have heard point-of-care testing mentioned in one of the Governor’s press conferences was last week when Dr. Carey, the Secretary of Health and Human Resources, expressed surprise and confusion at the arrival of some of the ID NOW machines and test capsules from FEMA.
I honestly don’t know what it will take to get the Governor’s team in the game.
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
[2] https://diagnostics.roche.com/us/en/products/params/cobas-sars-cov-2-test.html.
[3] ibid.
[4] Presidential Press Conference April 13
[5]ibid.
[6] ibid.
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