January 08, 2019 by Anne Paxton for CAP Today

Rapid PCR rules as labs ready flu arsenal

December 2018—With the memory of the 2017–2018 “high-severity” influenza season fresh in mind—49 million cases, 960,000 hospitalizations, a marginally effective vaccine, 79,000 deaths—clinical laboratories have been bracing for the customary annual surge in emergency room, outpatient clinic, and physician office influenza test orders. Although flu admissions have been rising somewhat, it is too soon to know how the season will play out, but laboratories are hoping for a season closer to average.

Avoiding a repeat of last year’s travails—lengthy turnaround times, supply shortages, and the need to triage patients for testing—is a must, many laboratory directors say. “We had difficulty keeping up with last year’s demand. It was extremely time-consuming,” says Mary Kay O’Connor, national laboratory director at Summit Health Management, the management arm of the Summit Medical Group, an 800-provider practice on the East Coast.

It was SMG’s core laboratory that performed the group’s influenza testing last season: about 285 tests a day during the height of the season. “At that time we did not utilize point of care because we did not believe the antigen tests were accurate enough,” O’Connor explains.

In midseason, O’Connor and colleagues realized that SMG would need to switch instruments due to high volume. “We had already been evaluating the Roche Diagnostics Cobas Liat and we could get reagents from Roche, so we switched to the Liat. But even with 10 analyzers running 16 to 18 hours a day straight, we still had difficulty keeping up with an efficient turnaround time.”

Now, SMG is poised for a more sweeping change. “We are putting Roche Diagnostics rapid PCR Liats in all of the testing locations that do strep and influenza testing, so they will do the molecular test on site.”

SMG is just one of the large physician groups that have made significant new instrument purchases, particularly for CLIA-waived rapid PCR tests, and have no plans to return to rapid antigen testing.

Training at SMG’s pediatric offices, which are slated to get eight Liats each, and urgent care centers started Dec. 4. “Once we have rolled out those sites, we will go out into the other offices. We’ll be installing about 100 Liats in multiple locations for internal medicine, family medicine, and several other service areas,” O’Connor says.

One problem she expects to avoid with the Liats is running out of reagents. “We have sequestered all of our reagents with our supplier for the entire year, and we have one lot number. Last year, we ran 15,243 flu tests, so we’ve sequestered about 16,000 tests for the coming year.”

The turnaround time of rapid PCR is a major selling point. “Obviously we were doing it in the core lab in less than a day, but it’s better if it’s done at point of care because the doctor can give a prescription or not give a prescription.”

As SMG integrates new physician groups that perform in-office antigen testing, they will be set up with Liats for immediate results. “This will be particularly helpful for pediatric practices, where they have a high volume of patients with upper respiratory and pharyngitis symptoms,” O’Connor says. Since the Liat testing has been linked to the laboratory information system and electronic health record via Roche’s IT 1000, the Liats will ease a lot of the offices’ paperwork burden, she adds.

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