Immucor Inc, Norcross, Ga, has received FDA premarket notification (510(k)) clearance for the latest release of ImmuLink, a centralized data management system that supports greater testing efficiency and safety within transfusion medicine.
Version 1.7 includes a molecular module that helps users manage the workflow associated with running Immucor’s PreciseType human erythrocyte antigen (HEA) test, reducing manual data entry and significantly increasing the number of tests a lab may perform and report. Enhancements include an antigen transfer interface to eliminate manual entry of antigen results into a laboratory information system; barcode capability to assist with sample tracking during DNA extraction on the QiaCube from Qiagen, Hilden, Germany; and a molecular driver to help users set up PreciseType HEA.
Additionally, the software now aggregates all serology and molecular in vitro diagnostic test results from the company’s Echo, NEO, and PreciseType platforms. The software generates a single report with a complete donor or patient testing history.
“ImmuLink has always been a broad data management solution that manages serological test results, and now, with the release of ImmuLink v1.7, also manages results generated by our FDA-approved red cell genotyping assay, the PreciseType HEA test,” says Keith Chaitoff, chief marketing officer at Immucor. “With ImmuLink, customers save time, improve testing efficiency, and increase test result accessibility so that a patient may safely receive the best matched donor blood.”
The PreciseType HEA test is eligible for reimbursement across the United States.
For more information, visit Immucor.