Nebraska lab – In May 9-10, scientists at the Nebraska Public Health Laboratory developed and validated a PCR test for Andes hantavirus after U.S. responders lacked a way to quickly check asymptomatic people. The test supports a National Quarantine Unit in Omaha, where at le
On an outbreak’s timeline where days can feel like a lifetime. the Nebraska Public Health Laboratory kept working through May 9 and May 10 to build a polymerase chain reaction (PCR) test for Andes hantavirus—an effort driven by the gap between what’s needed to detect infection and what currently exists to detect it fast.
The stakes are tied to the MV Hondius. where at least 10 people have been sickened and three have died after sailing on board the ship with Andes hantavirus.. With more infections still possible, U.S.. officials have been watching at least 41 people for signs of the virus.. Symptoms can take up to 42 days to show. and at least 18 of those people are staying at the National Quarantine Unit in Omaha. Nebraska.. None of these people have tested positive for the virus since their arrival.
Part of what made the weekend rush necessary is that the United States did not have a PCR test for hantavirus. even though some other countries do.. The Centers for Disease Control and Prevention is developing one. but in the meantime the agency has used a blood test that can detect antibodies in infected people who are symptomatic—without being able to detect low levels of the virus in asymptomatic people.. The Nebraska lab. which supports the National Quarantine Unit. moved to bridge that gap with a PCR approach designed to pick up viral RNA even before symptoms appear.
“Our first indication is to say, ‘What can we do to do laboratory support for that unit?’” said Peter Iwen, director of the Nebraska Public Health Lab, explaining that the lab is part of the Laboratory Response Network and is tasked with rapid detection and rapid response to biothreat agents.
In Omaha. the lab is positioned near both the National Quarantine Unit and the Region VII Special Pathogen Treatment Center. a biocontainment unit that can treat patients with highly hazardous infectious diseases.. When the CDC was contacted. Iwen said the agency’s capability included serology testing for symptomatic people. but it “did not have an assay. such as a PCR assay. to be able to test asymptomatic people.” That limitation “got our ball rolling.”
The core distinction is straightforward: serology looks for the response to infection—antibodies—while PCR looks for the virus itself.. Iwen said that serology. such as the CDC’s approach. works on symptomatic blood samples a few days after symptoms appear.. PCR. he said. is designed to detect low levels of virus prior to symptoms. pointing to experience with a related hantavirus called Sin Nombre virus. where “prior to developing symptoms. people actually have a little bit of virus in their blood.”
In this case, the Nebraska PCR test relies on blood rather than a nasal swab.. Emily McCutchen. deputy director of the lab. said the process involves extracting viral RNA from a blood sample and then running a polymerase chain reaction to amplify genetic material so it can be detected.. “So it’s the same idea as with COVID. just the source is different because it’s a different type of virus. ” she said.
Developing a validated assay in time required more than technical know-how.. Iwen said that reagents and protocols were not immediately available. with the lab lacking what it needed to begin validation until Saturday morning [May 9].. He said they still needed RNA from the Andes hantavirus. extraction kits. and other PCR reagents before they could develop and validate the assay.. By Saturday afternoon, the lab began following a defined process for the test.
McCutchen said she worked late into Sunday night.. As the CLIA (Clinical Laboratory Improvement Amendments) director for the public health lab. she described herself as the person required to sign off that the validation met federal requirements.. She said she “actually didn’t sign off until about nine-o’-clock Sunday night. ” and that the travelers arrived at the unit at 2:30 am on Monday morning.
CLIA itself is central to understanding why the timeline mattered.. McCutchen said CLIA was established by the Clinical Laboratory Improvement Amendments of 1988 and is a code of federal regulations intended to ensure testing quality and results in Nebraska are comparable to tests performed anywhere else in the nation.. She said CLIA rules require certain measures for an assay, including accuracy, sensitivity, and precision, along with robust testing.
The weekend effort also intersected with uncertainty about earlier testing.. McCutchen said one U.S.. passenger initially told by the CDC that they had tested “mildly positive” for the virus—meaning results were inconclusive—has subsequently tested negative.. She added that the initial testing had been performed in the Netherlands before the passengers came to Nebraska. and that the lab tried to obtain information from testing sources that had not yet been successful.
[Editor’s Note: No people connected with the cruise ship outbreak in the U.S. have tested positive as of Monday, May 18.]
Even now, the lab’s role depends on consent and on how specimens arrive.. When asked whether all quarantined people at the Nebraska unit and elsewhere are being tested. Iwen said he was not sure everyone had been tested.. He said people “have to give consent to have their blood drawn. ” and that the lab runs tests when specimens are in hand.. He also said testing has been offered not only for the quarantine unit in Omaha. but for other areas in the United States where people with possible exposure are quarantining.
There is also an operational question that comes with any new test: can it grow quickly if more cases appear?. McCutchen said the team hoped it would not be necessary to scale up. but that during validation it took special consideration in selecting instruments to support the ability to scale if required.
Communication with federal partners has been another moving piece.. Iwen said. “everything has been going okay. ” while acknowledging “a lot of difficulties occurring at CDC.” He said the lab is connected. in contact. and trying to help each other.. He was asked as well about the World Health Organization; McCutchen said she personally does not communicate with WHO. while Iwen said the University of Nebraska Medical Center was designated as a WHO collaborating center several days ago.. “This is an international event,” he said, adding that having WHO involved in discussion “seems very, very important.”
The pattern across the timeline is consistent: the CDC’s ability covered serology for symptomatic people but not PCR for asymptomatic people. the Nebraska team started validation only once it had key reagents. and the testing plan then had to fit CLIA sign-off timing around travelers’ arrival. with the same consent-based. specimen-driven approach shaping who gets tested.
For now, the quarantine numbers provide a clear snapshot of the uncertainty responders are trying to manage.. Officials are monitoring at least 41 people in the U.S.. and at least 18 are in Omaha. with no positive tests reported since their arrival.. The Nebraska PCR test—built in a weekend and validated under CLIA—has been designed to give clinicians and public health teams a faster way to detect Andes hantavirus where antibodies tests fall short. even as symptom windows stretch out toward the 42-day mark.
Andes hantavirus PCR test Nebraska Public Health Laboratory National Quarantine Unit CLIA Laboratory Response Network MV Hondius CDC serology asymptomatic detection