Newsbytes

The goal of studying these samples is to identify a threshold representing the minimum amount of neutralizing antibody present in people who have never been vaccinated for COVID-19 nor infected with the SARS-CoV-2 virus, Dr. Laposata says. Levels of the antibody will be higher in those who are immune than in those who have never been vaccinated nor infected and are not immune. Once the level associated with immunity is determined, UTMB will be able to inform patients, when they receive test results, whether their neutralizing antibody levels are similar to those of people who have strong immunity to the virus, he adds.

Dr. Laposata expects to identify an immunity threshold in the near future, allowing UTMB to offer the test broadly this summer. Once the assay is widely available, physicians or health care facilities will be able to send the UTMB laboratory a serum sample or blood sample (for which the lab can separate serum from blood) to receive a result. Dr. Laposata estimates the test will cost between $100 and $200.

The medical center eventually plans to offer a T-cell immunity test as a companion to the neutralizing antibody test. T-cell immunity lasts longer than neutralizing antibody immunity, and having results from both types of tests would provide a more complete picture of patient immunity, Dr. Laposata says. The T-cell test, which is in a much earlier stage of development, will also be an automated, high-volume test, but it does not require live virus. Therefore, he adds, it would not need to be operated in as secure of an environment as the automated neutralizing antibody assay.

UTMB intends to use the automated neutralizing antibody testing system indefinitely, Dr. Laposata says. “We are looking at the world as having viral infections of one kind or another for the long term. The reason we have invested so much in this is that if the virus that comes next is another that produces disease, we should be able to measure immunity to it.”

—Renee Caruthers

Indica Labs and Xyall announce collaboration

Indica Labs and Netherlands-based Xyall have entered into a global strategic partnership that unites Indica’s artificial intelligence-powered, diagnostic digital pathology platform with Xyall’s automated tissue-dissection solutions.

“The collaboration will enable molecular laboratories to benefit from a fully digital and automated workflow for tissue macro dissection for molecular diagnostic testing,” according to a joint press statement from Xyall and Albuquerque, NM-based Indica.

The partnership brings together Indica’s flagship Halo AP anatomic pathology image-management and workflow software and Xyall’s Tissector HT high-throughput system for high-volume molecular labs and compact Tissector TT tabletop solution for low- to mid-volume molecular labs. Under the arrangement, slide annotations from Halo AP are automatically transferred to either of Xyall’s Tissector systems for use in tumor dissection.

“Our combined solution allows users to document and track each step of the dissection process,” Eric Runde, chief operating officer for Indica Labs, said in a press statement.

Halo AP is CE-IVD marked for use in primary diagnosis in the European Economic Area, Switzerland, and the United Kingdom. It is available for research use only in the United States.

Indica Labs, 505-492-0979

HL7 announces release of latest FHIR standard

The standards organization Health Level Seven International has published Fast Healthcare Interoperability Resources release five, which is intended to improve interoperability and data exchange.

FHIR R5, as it’s known, has been released as “a ‘trial use’ standard that retains prior mature, normative content while incorporating enhancements that are ready for implementation and feedback,” according to an HL7 press release.

This latest offering is designed to improve various aspects of patient data management, thereby minimizing interoperability-related errors, including duplicate lab tests and medication mistakes. It provides thousands of incremental updates, corrections, and other enhancements, HL7 reported.

FHIR R5 includes changes to the specification’s infrastructure that strengthen the management of coded terminologies and enhancements that allow extensions to be managed more effectively alongside the core specification. The new release also has topic-based subscription capabilities integrated into the core specification to support proactive event notifications in response to data changes in the source system, as well as new operations for managing large resources, such as groups and lists.

FHIR R5 was built, in part, using feedback gleaned from the global health care community’s experience with FHIR R4, published in 2018. HL7 plans to publish the next milestone release as a normative standard that is based on users’ feedback about FHIR R5.

Dr. Aller practices clinical informatics in Southern California. He can be reached at raller@usc.edu. Dennis Winsten is founder of Dennis Winsten & Associates, Healthcare Systems Consultants. He can be reached at dwinsten.az@gmail.com.