News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Airlines Are Partnering with Health Companies and Clinical Laboratories to Implement At-Home COVID-19 Testing Prior to Flights

Because air travel volumes are low, experts believe it is timely to develop COVID-19 testing systems and gain insight on which protocols are most effective

As the COVID-19 pandemic surges on, several international airlines now require customers to complete at-home COVID-19 testing before they can travel. This is triggering unusual business practices. For example, one airline allows its passengers to use frequent flier miles to purchase mail-in COVID-19 test kits.

Frequent Flyer Miles for COVID-19 Testing

Across the United States, Hawaii has one of the lowest rates of infection, partly thanks to the state’s strict quarantine regulations. In a state, however, that depends on tourism for its economic health, the pandemic has caused serious financial difficulties. In an effort to prevent spread of the coronavirus while also encouraging tourism, Hawaiian Airlines now offers “Pre-travel COVID-19 Test Options” on its website.

To be allowed to skip the state’s mandatory 14-day self-quarantine before arriving on the islands, flyers can take a pre-travel coronavirus test with the following conditions:

  • The test must be from a state-approved testing provider.
  • The test must be administered no more than 72 hours prior to the scheduled departure time of the final leg to Hawaii.
  • For trans-pacific travel, test results must be received prior to flight departure.

Additionally, the airline accepts frequent flyer miles to pay for mail-in COVID-19 tests. In exchange for 14,000 HawaiianMiles, a passenger receives a test kit in the mail. The kit features a video call during which a healthcare professional guides the consumer on taking a saliva sample. The user then ships the sample to a qualified clinical laboratory. Results are returned electronically within 24 hours of the lab receiving the sample.

Hawaii’s COVID-19 portal states, “The state of Hawaii will ONLY accept Nucleic Acid Amplification Test (NAAT) from a certified Clinical Laboratory Improvement Amendment (CLIA) lab test results from Trusted Testing and Travel Partners” that are participating in the state’s pre-travel testing program. Honolulu and Maui are the only two arrival airports allowed. A negative result must have come from a test performed within 72 hours prior to the final leg of the passenger’s trip to Hawaii, according to the portal.

“A negative pre-travel test is an alternative to two weeks in self-isolation for arrivals to the archipelago,” the UK’s Independent reported.

JetBlue and Vault Health Partner to Offer COVID Testing to Airline Passengers

In another instance of an airline getting involved in at-home testing, JetBlue (NASDAQ:JBLU) is partnering with Vault Health to offer at-home testing. The process is similar to the Hawaiian Airlines program. However, rather than purchasing the test with frequent flyer miles, JetBlue offers polymerase chain reaction (PCR) tests at a discount.

Business Travel News reported that passengers must provide a confirmation code while ordering the $119 test from Vault Health’s webpage. “Vault provides a kit for an at-home saliva test, and users administrate it while on a video chat supervised by Vault to ensure the test is done properly. The user sends it overnight to a clinical laboratory and the results are provided within 72 hours,” Business Travel News stated.

Joanna Geraghty of JetBlue
“We continue to hear from health officials that [COVID-19] testing is incredibly important in the fight against the coronavirus, and we want to make sure our customers have options for testing, especially prior to travel,” said Joanna Geraghty, President and Chief Operating Officer, JetBlue, in a press release. “As more and more regions reopen, many are requiring test results to enter. Now with easier testing options, those safety requirements may not be a deterrent for travel, but rather provide greater public health and peace of mind with little inconvenience.” (Photo copyright: Spectrum News NY1.)

In “Coronavirus Testing Before Flying Could Become the Norm as Airlines Try to Boost Confidence and Woo Travelers,” the Washington Post reported, “There is no common standard, so it has been left to airlines and airports to design their own SARS-CoV-2 testing programs and for travelers to sort out requirements for their particular destination.”

In addition to airlines such as Hawaii Airlines and JetBlue instituting programs for coronavirus testing, some airports are as well. Tampa International Airport, for example, test-piloted a voluntary testing program for all arriving and departing passengers from October 1st to October 31st. The airport partnered with BayCare, a 15-hospital Tampa area healthcare network, to provide both rapid antigen and PCR tests.

“Testing services will be offered on a walk-in basis … seven days a week from 8 a.m. until 2 p.m. The pilot will be open to all ticketed passengers who are flying or have flown within three days and can show proof of travel. The PCR COVID-19 test costs $125 and the antigen test costs $57,” a press release stated.

Tampa Airport CEO Joe Lopano told the Washington Post, “This could be—especially if adopted by other airports—another way to instill confidence.”

COVID-19 Testing by Retailers Expanding as Well

Travelers aren’t the only people who need testing. Some employers also are requiring negative tests before employees can return to work.

In “Costco Begins Selling an At-Home Self-Collection COVID-19 Test Kit; One of 12 Kits That Have Received FDA Emergency Use Authorization,” Dark Daily reported on retail giant Costco’s (NASDAQ:COST) response to increased demand for COVID-19 testing by offering direct-to-consumer, at-home test kits to its members. The kits sell at two price points: $129 for a “basic” kit, and $139 for a kit that includes “Video observation for travel.” The more expensive test is accepted by Hawaii for its Trusted Testing Partner Program.

As with all at-home kits, the consumer collects their own specimen and sends it off to a qualified clinical laboratory for processing. AZOVA, a telehealth company, supplies the kits to Costco for resale and provides a smartphone app where customers can check and display the test results.

P23 Labs’ TaqPath SARS-CoV-2 assay is the test being used, which, according to P23, “has a 98% sensitivity and 99% specificity,” Business Insider reported.

When COVID-19 Testing Fails

Of course, coronavirus testing isn’t 100% guaranteed. The Independent reported in November that a passenger on a Dubai to New Zealand flight who had tested negative prior to flying, was, in fact, positive for coronavirus and had infected seven other passengers during the flight. New Zealand’s Institute of Environmental Science and Research conducted and published a study following the incident, titled, “A Case Study of Extended In-Flight Transmission of SARS-Cov-2 En Route to Aotearoa New Zealand.”

The researchers found that “All seven SARS-CoV-2 genomes were genetically identical, with the exception of a single mutation in one case, and all genomes had five signature mutations seen in only six other genomes from the >155,000 genomes sequenced globally. Four of these six related genome sequences were from Switzerland, the country of origin of the suspected index case.”

They added, “By combining information on disease progression, travel dynamics, and genomic analysis, we conclude that at least four in-flight transmission events of SARS-CoV-2 likely took place.”

At-home test kits for COVID-19 are here to stay. That large businesses in multiple industries are now partnering with COVID-19 test developers and clinical laboratory companies to accomplish testing of customers and employees means independent labs that process coronavirus testing can look forward to increasing COVID-19 testing business.

“We need to be using the time now, when [travel] volumes are relatively low, to test the systems and gain insight on which protocols are most effective,” Mara Aspinall, biomedical diagnostics professor at Arizona State University, President and CEO of the Health Catalysts Group, an investment and advisory firm, and former President/CEO of Ventana Medical Systems (now Roche Tissue Diagnostics), a billion-dollar division of Swiss pharmaceutical and diagnostics manufacturer Roche, told the Washington Post.

—Dava Stewart

Related Information:

‘Swap Frequent-Flyer Miles for COVID Test’ Says Airline

Negative COVID-19 Test Result Required Prior to Departure to Avoid 14-Day Quarantine in Hawaii. Tests ONLY Accepted from TRUSTED TESTING AND TRAVEL PARTNERS

JetBlue to Give Passengers At-Home Covid-19 Testing Access

JetBlue to Offer At-Home Pre-Travel COVID-19 Tests

JetBlue and Vault Health Partner to Make At-Home COVID-19 Tests More Widely Available to Customers

Coronavirus Testing Before Flying Could Become the Norm as Airlines Try to Boost Confidence and Woo Travelers

TPA Launches First in the Nation COVID-19 Testing for All Departing and Arriving Passengers

Domestic U.S. Travel Advisories

American Airlines Expands At-Home Coronavirus Testing

COVID: Passenger Infected Four Others on Flight After Testing Negative, Report Says

A Case Study of Extended In-Flight Transmission of SARS-Cov-2 En Route to Aotearoa New Zealand

Costco Begins Selling an At-Home Self-Collection COVID-19 Test Kit; One of 12 Kits That Have Received FDA Emergency Use Authorization

Study of Cross-Contamination of Biopsy Specimens in 69 Anatomic Pathology Laboratories Raises Concerns about Test Quality and Patient Safety

Extraneous tissue cross-contamination found in all participating pathology laboratories Cross-tissue contamination, regardless of specimen volume or how frequently reagents were changed

Pathologists and histotechnologists have long known that traditional methods of processing tissue for diagnosis have the potential to cross-contaminate human biopsy specimens. This risk to patient safety and diagnostic accuracy was accepted over the decades because of the limitations of technology and inability to more precisely measure the performance of individual work processes in the histology laboratory.

In recent years, two things have begun to change this long-standing status quo in medical laboratories. These developments now make it possible to more accurately measure the performance of histology work processes. In turn, this allows an understanding of the true rate of errors that happen from the time a human biopsy specimen arrives in the anatomic pathology laboratory until the completed slides are ready to be diagnosed by a pathologist. (more…)

Financial Experts Predict Sales of Digital Pathology Systems Will Nearly Triple in the United States by 2019

Pathology groups and clinical laboratories gain the benefits of increased connectivity, greater productivity, and a tool to reduce costs

Acceptance of digital pathology systems is growing steadily in both North America and Europe. One sign of this acceptance is the rapid increase in the purchase of digital pathology systems by anatomic pathology laboratories in these regions.

In fact, one consulting company says that the digital pathology market is poised to explode over the next seven to eight years. This will happen as medical laboratories acquire and deploy digital pathology systems to improve their connectivity with other providers, to improve productivity of pathologists, and as a tool to reduce costs. (more…)

Agilent’s $2.2 Billion-Dollar Acquisition of Dako Likely to Shake Up the Anatomic Pathology and Histology Marketplace

Pathology laboratories that are customers of Dako should take notice of the coming change of ownership

Once again, a major player in histology and anatomic pathology tissue processing has been acquired. Yesterday it was announced that Agilent Technologies Inc. (NYSE: A), of Santa Clara, California, will pay $2.2 billion to acquire Dako, the cancer diagnostics company in Glostrup, Denmark. It is the largest acquisition in Agilent’s 13-year history.

The high price paid for Dako is just the latest confirmation that Wall Street investors consider molecular diagnostics and anatomic pathology to be a high-growth, profitable sector of laboratory medicine. With 2010 revenues of $340 million, Agilent will pay $2.2 billion, which is a 5.8 times multiple of Dako’s annual revenue.

Pathologists and clinical laboratory managers following the histopathology market will recall that Ventana Medical Systems, Inc., was acquired by Roche Holding AG (RHHBY) in February, 2008. The purchase price was approximately $3.4 billion, representing a multiple of 10.2 times Ventana’s 2007 revenue of about $290 million.
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Lean and New Diagnostic Technologies Fuel Innovations at the Pathology Department at University of Nebraska-Omaha

Dark Daily gets tour of clinical lab and anatomic pathology activities

DATELINE: Omaha, Nebraska—This city may be in America’s heartland and best-known for corn-fed beef and billionaire-investor Warren Buffet, but its premier academic center clinical pathology laboratory is breaking new ground in several important ways.

Last Thursday, your Dark Daily editor was hosted for a site visit by the Department of Pathology and Microbiology at the University of Nebraska-Omaha (UNO). From adoption of digital pathology solutions to assertive use of Lean and Six Sigma techniques across the span of clinical laboratory and histology laboratory operations, advanced use of latest-generation medical laboratory testing technology was on display.

Using Lean and Value Process Maps in the Clinical Laboratory

Across the United States, every academic center Department of Pathology has activities and goals which distinguish it in specific ways when compared to other pathology departments. During this site visit, Dark Daily recognized three distinct laboratory management activities taking place in the clinical pathology laboratory at the 525-bed University of Nebraska Medical Center laboratory.

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