Photo courtesy of
Ortho Clinical Diagnostics
The US Food and Drug Administration (FDA) has granted 510(k) clearance to the ORTHO VISIONTM Analyzer, a system that automates in vitro testing of human blood.
The system is now commercially available in the US and Puerto Rico.
The ORTHO VISION Analyzer automates test processing functions, including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading, and interpretation and data management requirements using ID-MTS Gel Cards and digital image processing.
Tests that can be performed with the system include:
- ABO/Rh/grouping
- ABO/Rh confirmation
- Antibody screen
- Antibody identification
- Selected cell panel
- Rh phenotype (C,c,E,e)
- Donor confirmation
- Crossmatch (AHG)
- Antigen typing
- Serial dilutions for titration studies
- DAT (polyspecific)
- DAT (IGG)
- Cord blood testing
The system can be used as a standalone instrument or interfaced to a laboratory information system.
The ORTHO VISION Analyzer was designed with secure monitoring technologies for safety checks and balances, and it allows transfusion medicine professionals to track steps in the immunohematology testing process.
Through Ortho Clinical Diagnostics’ proprietary Intellicheck Technology, the ORTHO VISION Analyzer verifies and documents diagnostic checks throughout the testing process, while e-Connectivity Technology provides 24/7 remote data tracking that monitors instrument performance while maximizing uptime. Laboratory personnel can log on anytime, anywhere to collaborate on interpreting results in real time.
“With the launch of the ORTHO VISION Analyzer, our goal is to help improve the safety of blood transfusions by reducing the lab’s reliance on manual methods,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics, the company developing the ORTHO VISION Analyzer.
A version of the ORTHO VISION Analyzer is already commercially available in Europe, Japan, Latin America, Canada, and Australia.
For more information on the system, visit the Ortho Clinical Diagnostics website.
