A wait-and-watch season of respiratory viruses

The self-check option benefits telehealth patients, he says, who can receive a prescription to pick up a collection kit from their local Cleveland Clinic pharmacy during a remote visit rather than have to schedule an in-person clinic visit. And with the self-collected specimen the health care system requires less “swabbing capacity,” he says. “Instead of having a swabbing tent or a drive-through collection, we use the self-check process,” averting what can become a specimen collection “pinch point.” Though the SelfCheck test for SARS-CoV-2 was offered last year, this is the first year the multiplex version will be offered. “We plan to use those workstreams this winter to give everybody another set of options.”

The laboratory received an EUA for its lab-developed SARS-CoV-2 test early in the pandemic. “We first got an EUA just so we could do testing,” Dr. Rhoads says, “and then it grew iteratively” to include the self-check process. “We all recognized the challenge with specimen collection and recognized there was an opportunity for unsupervised self-collected specimens that could help with workflow.” They’ve built on the same test since then, he says, with the latest addition the inclusion of influenza A and B.

Cleveland Clinic’s testing workflow is at this point well established, Dr. Rhoads says. And though the lab doesn’t have explicit contingency plans for a sudden supply chain failure, “We’re testing samples on each of three different platforms,” he says. “So we have a balance between redundancy and operational efficiency. We have multiple workflow streams in operation, and we can flex back and forth to different platforms as needed.”

After a year with few supply chain problems, Dr. Rhoads is more confident that manufacturers can maintain adequate supplies for the laboratories they serve. “At the same time I know it always works until it doesn’t, until it’s broken.” And occasional challenges still arise, he says. “I think the analogy with the grocery store is a good one. You never know which part of the shelf is going to be bare this week, where the supply chain challenge is going to come from. There are still supply chain challenges in general, but it feels, at least on the consumer end, more sporadic than systemic.”

Diagnostic companies are confident too. “A lot of the manufacturers of these tests have invested in manufacturing infrastructure, and Cepheid is certainly among them, so we do expect to keep up with demand this year. Even higher than expected demand,” Dr. Persing tells CAP TODAY.

DiaSorin Molecular has proved itself from a procurement perspective, Dr. Tabb says. “At least having the raw materials ready so that we can turn on a dime and increase our production if necessary. And in the meantime,” she says, “we have stock and inventory ready for people to validate going into this season.”

At Roche Diagnostics, supply readiness comes from its manufacturing expansion and strong internal modeling, “to help predict what we think flu will look like, which allows us to then manufacture appropriately,” says Allison McMullen, PhD, D(ABMM), medical and scientific affairs manager for molecular diagnostics. And this year’s prediction, says Jamie Phillips Deeter, MS, PhD, Roche senior scientific partner: “A high-burden and an elongated flu season.”

For respiratory virus testing, Roche is always looking at what comes next, Dr. McMullen says. “We’re always keeping our eye on the needs and how to do it best, and right now we have a comprehensive portfolio for flu that can reach patients wherever they are.” This includes, she notes, the GenMark system for syndromic testing.

Equal access to testing is a focus at Roche, Dr. Phillips Deeter says. “There’s not necessarily equal access to tests, and so we’re passionate about making sure that those who need it, no matter where they’re located, no matter if it’s population-specific, are able to get the test they need.”

New this year for Cepheid is the addition of a third independent SARS-CoV-2 target to its Xpert Xpress CoV-2/Flu/RSV Plus assay. And this year Cepheid received clearance for its eNat transport medium, in addition to viral transport media.

DiaSorin last year acquired Luminex and with it the Aries system. The company is close to submitting to the FDA a SARS-CoV-2, flu A/B, and RSV test on the Aries, Dr. Tabb says. DiaSorin Molecular also is awaiting clearance for its Simplexa COVID-19 & Flu A/B Direct test, submitted this past March to the FDA for 510(k) clearance. And the company is developing a new system for rapid molecular point-of-care testing, called the Liaison Nes. “The first product on the Liaison Nes will be a combo test for SARS-CoV-2, flu A, and flu B, but it’s not for this season,” Dr. Tabb says, noting that the product will be undergoing clinical studies in the coming months. “So it’s coming soon to a lab near you. Hopefully next year.”

DiaSorin Molecular is “constantly monitoring the databases and making sure that our primers and probes detect the strains that are circulating,” Dr. Tabb says. She cites as an example the H5N1 strain of influenza, detected in the U.S. this spring. When the sequence for a new strain such as H5N1 becomes available, “we have an active bioinformatics team that takes those and compares our primers and probes across all our respiratory product lines at DiaSorin Molecular and Luminex to make sure we’re still able to detect those strains.”

Dr. Tabb says that laboratories are taking a watch-and-wait approach to testing. “They might start by offering a multiplex test that has flu A, B, and SARS-CoV-2, but at a certain point if there is no flu A or B, they might transition back to a SARS-CoV-2 standalone and only do flu testing on request. It depends on the customer, the patient cohorts they are testing, and what their clinical staff is asking for.”

Charna Albert is CAP TODAY associate contributing editor.