Calm before spring storm? Compass on COVID

Do you think this could be a looming problem?
Dr. Carroll (MUSC): It’s something we’re worried about and that’s why we’re taking a closer look at those individuals. The Johnson & Johnson vaccine has a lesser effectiveness than the other vaccines, so it is something we’re going to pay attention to. We don’t have solid data to say that’s the case yet, but we have those cases collected and are starting to take a look. There could be other explanations.

Mike Black, what’s your experience?
Mike Black, MBA, MT(ASCP), DLM, assistant VP, laboratory services, and laboratory service line administrator, Avera Health, Sioux Falls, SD: We have seen decreases in percent positivity and test ordering, which has increased our testing abilities by PCR. We are monitoring the variants and continue to send random positives to the South Dakota health lab for confirmatory variant testing.

Our vaccination statistics are good, and the turnout for vaccinations in South Dakota has been good, too. Is that what you’re seeing, Dan?

Dan Ingemansen (Sanford): Yes. Our mutual state of South Dakota is predominantly served by two health systems, and we have connections to all of the rural communities and a responsibility to provide those vaccinations. Having two large health systems that are rural explains why we are where we are with vaccinations.Would you agree, Mike?

Mike Black (Avera): Absolutely. Our health systems work closely and that has been part of the success as we’ve moved forward in South Dakota. It’s a good relationship.

Lauren Anthony, what can you tell us?
Lauren Anthony, MD, system laboratory medical director, Allina Health, Minneapolis: The incidence in our asymptomatic population is below one percent, and even in our symptomatic population it’s low. On average everything is below five percent. There have been infections post-vaccine.

We have had queries about variants. The ICU physicians were seeing a spike in mortality and were concerned if they were dealing with a variant. The state worked with them. The state is sequencing about 10 percent of positives.

Diana Kremitske, Geisinger is a huge system. Is the COVID news there good news?
Diana Kremitske, MS, MHA, MT(ASCP), VP, Diagnostic Medicine Institute, Geisinger, Danville, Pa.: Our story is similar to everybody else’s story. In addition, we’re not doing any sequencing for variant testing but we have been asked what’s causing individuals to become sick post-vaccine. Our microbiologist experts are going to be discussing with our infectious disease experts what the game plan is in those circumstances.

I’d like to turn the conversation a bit to, what’s the next chapter to support our communities? College and university athletic teams in our surrounding areas are requesting help with their surveillance testing. We are exploring how to provide not only the on-site immediate testing for officials who show up for games but also for the sports team. We’re having conversations about how to help a minor league team in the area with testing, though nothing is settled yet. We’re fortunate because our organization has the medical contract with some of these organizations.

We’ve also been asked to provide CLIA directorship for one of their student health centers that is providing COVID testing. This is for a small, local private community college, just to get our toes in the water to see how it goes. We’re early on in that process and I’d be more than happy to report back.

Labs are looking at a new line of business as schools and leagues reopen. It sounds like an important opportunity to serve your communities. Is anyone else getting involved with the local sports scene regarding the need for testing?
Dan Ingemansen (Sanford): We were contacted early and we developed mobile laboratory trucks and have three different units that have been following the PGA Tour, the Korn Ferry Tour, which is developmental, and the PGA Tour Champions. This weekend we’ll be in Atlanta testing for the NBA All-Star Game.

It’s been interesting, but it’s like having a whole other service line. It takes another mindset and skill set. And it takes one dedicated person just to work through all the regulatory hurdles because we’re testing in different states with different regulations. We’ve had to have on-site inspections before we could start testing.

Tony Bull (AdventHealth): We did PCR testing at the Daytona Speedway Rolex 24 race. It was difficult because all the drivers were from other countries so there was a language barrier. To fly into Amsterdam, they also had to have an antigen test that had to be done no more than four hours before their flight departed. We had tested them at the Speedway and then we have a storefront testing site at the Orlando airport. Those same patients showed up a day or two later to be tested again in order to get on their flight. That was an eye-opener.

Would anyone like to comment on how antigen testing is being used or will be used?
Diana Kremitske (Geisinger): We are going to institute antigen testing for travel purposes and make this service accessible to the community. We’re going to pilot test it in a couple of easily accessible outpatient phlebotomy sites. So these will be mid-turbinate swab, self-collected. It’s not going to be a point-of-care test; those specimens will come to the laboratory for testing.

Dr. Crawford (Northwell): The Department of HHS has put out an RFI for expanding the national testing capacity to 25 million per month for the purposes of opening up K–8 schools. And they’re being agnostic in their messaging so far about whether it’s PCR or antigen based. That’s a story worth paying attention to. HHS is asking for four regional coordinating hubs that will work with up to 40 regional laboratories, including university laboratories. I think the expectation is that it will be the big box labs that do something. But the question is, who’s going to be coordinator and devote their life to K–8, which is not something that is in our current job descriptions, and then who is going to provide the actual testing? HHS is saying: Use the existing unleveraged capacity, with the expectation that it’s not going to hurt the supply chain, which is an interesting way of thinking about it. This federal discussion is something we should keep our eye on, including the fact that the February 17 HHS press release said this $650 million program for K–8 school testing is just a down payment on further COVID testing funding.

With regard to travel, my understanding now is you need to have a PCR test result before you step into the airplane gate. Maybe not, but I do wonder if antigen testing is going to pass muster for air travel.

It reminds me of what we talked about in prior calls: Why is there no pathologist on these important national committees and panels that are determining such things?
Dr. Crawford (Northwell): An answer I’ve gotten is that these committees are civic servants only, not public/private. The private is only advisory.

Any additional comments on antigen testing?
Janet Durham, MD, medical director, Wisconsin operations, ACL Laboratories, and president, Great Lakes Pathologists, West Allis, Wis.: We have been using the antigen testing at our urgent care centers because of the EUA for the patients having to be symptomatic; that’s the location where we’ve had success with those.

Interestingly, this past week we had an increase in testing the first time since January 3; it went up 5.8 percent. But the volume of positives is going down.

The struggle now for us is in pre-procedure testing: The gastroenterologists would like to have that PCR testing rapidly, instead of in the 24- to 72-hour window prior to the procedure. It’s because patients don’t want to take time off from work. The scheduling for those procedures is heavy on Mondays, with some on Tuesdays, and then it plummets until the end of the week because people don’t want to take those extra days off. But we don’t have enough reagent to be able to do all of that rapid. We have that capacity for PCR but not rapid. So that’s a new struggle in trying to figure out how we can keep everybody happy.

There has been discussion about variant testing, but our understanding is that it’s not our role to do the sequencing. It’s done by the state. Everyone is happy with that for now.

Where are we standing with antibody testing? It’s been waiting in the wings patiently and for a long time, but is it now getting a certain updrift in your system?
Dr. Durham (ACL): We wanted to make sure when the vaccines rolled out that clinicians and everyone else understood the difference in antibody testing—that the antibody test we had available was for the nucleocapsid, not the spike, protein, so don’t do that test if you’re looking for vaccine purposes if the patient has antibodies. Our first line of business was to make sure everyone was aware of that. The scientists were not suggesting a check on vaccine status. But people are eager to learn that, and that is likely where we’re headed. Maybe that’s going to be what airlines, for example, are going to be using to check if a person is immune. We are getting ready for that so we’ll be able to offer both types of testing. We are waiting for some of the vendors to get their formal approval, but we’re doing validation now to be prepared.

Diana Kremitske, are you at Geisinger also preparing for an onslaught of serology testing?
Diana Kremitske (Geisinger): We are not. The serology testing has been incredibly low volume. It did not take off. Clinically we don’t know what to do with that information.

Does anyone else have an opinion on or a recent experience with serology testing?
Dr. Crawford (Northwell): For the purposes of the health worker survey last spring, we stood up a capacity of 10,000 tests per day, which we consumed over a period of weeks, to go through about 50,000 Northwell health care workers. And our volume has stayed in about the 2,500 to 3,000 per day range ever since. That’s a lot of testing. Our seropositivity rates, which were over the summer consistently in the 17 to 18 percent range, are now comfortably in the 31 to 33 percent range. It’s a nonrandom sample because it’s provider ordered. But I’ve asked our ambulatory leadership, what are you doing with all these tests? The answer: for patients who are more complicated. It might be those who are immunosuppressed or have cancer or autoimmune diseases, trying to get a sense of where their antibody levels might be before and after vaccination.

There’s a sense that from a medical standpoint, and this is without an evidence base, at least here in our New York region, that serological data may help inform the discussion about whether a patient may be susceptible to further infection by COVID-19. Noting who becomes PCR positive 14 or more days after a vaccine in these immunocompromised patients is of high interest now. It’s also a starting point for discussions about getting PCR Ct values for these complicated patients.

So the discussions are evolving without a clear evidence base to guide them, but the drumbeat of serologic test orders remains. To me, the saving grace is that from a strategic standpoint, the NCI stood up a national consortium to explore the seroscience of COVID, and Northwell is one of the member institutions. I’m hoping over the course of the next year or three we will build the evidence base for what serologic testing means in the vaccination age.

Stan Schofield, let’s hear from you about antibody or other testing at NorDx.
Stan Schofield, president, NorDx, and senior VP, MaineHealth: There’s been little interest or uptake. We’ve offered it since June 1 and we’ve had about 600 test results. We’re looking into the quantification assay from Roche to see if it’s going to be of value either for travel or vaccination validations. That’s all that’s happening at the moment.

As far as sequencing goes, the state is doing it. We’re sending 100 positive random samples for the state’s sequencing program, as well as post-vaccine 14-day cases. We’re doing nothing other than what everyone else has reported.

Maine has a lot of summer camps, and we’re contracting with them for their summer testing this year.