System is designed for automated ABO/Rh testing and antibody screening at transfusion services, donor centres and reference laboratories performing blood group serology testing
Olympus America, a provider of high-throughput automated blood bank instruments to the North American donor market since the 1980s, reports that the US Food and Drug Administration (FDA) has cleared the Tango automated blood bank system for use in the United States.
The FDA has also licenced blood grouping and anti-human globulin reagents specifically formulated and manufactured exclusively for use on the Tango instrument.
The Tango system is designed for transfusion services, donor centres and reference laboratories performing blood group serology testing.
It is capable of performing a host of functions including blood group determinations, antibody screening, and donor ABO/Rh confirmation testing.
It is already widely used in Europe.
The Tango system is manufactured by Biotest.
"This is an extraordinary development, not only for Olympus, but for the entire blood banking arena," said Stephen Wasserman, group vice president for the Olympus America diagnostic systems group.
"Tango offers outstanding flexibility, value, performance, accuracy and ease of use to transfusion services, with enhanced specificity and sensitivity.
"There is already substantial pent-up demand for the system".
With a throughput of approximately 190 wells per hour depending on the test configuration, Tango provides laboratorians a more efficient tool in areas where real estate is tight and functionality is key.
The benchtop analyser measures just 1.3x0.7x0.7m and weighs 130kg.
The Tango automates positive sample identification, recording of reagents (lot numbers, expiration dates), sample dilutions, reagent addition and mixing, incubation, washing, centrifugation, and result interpretation.
The system uses eight-well strips for both flexibility and value.
ABO/Rh testing is performed using strips containing dried antisera in the wells.
Antibody screening is performed using a new solid phase methodology that eliminates the need for indicator red cells, as found in other solid phase systems.
Multiple configurations are available for the antibody screen testing (pooled, two-cell and three-cell screens).
In field trials, this methodology showed superior or equivalent specificity and sensitivity when compared to all reference methods, says Olympus.
For greater flexibility, Tango also features batch and random access operating modes and Stat sample interrupt.
For easy use and maximum efficiency, it will use a Windows 2000 operating system, Pentium processor, touch screen interface and image analysis software.
Olympus will offer a variety of acquisition options including leases, cost per test programs and outright instrument purchase.Olympus Diagnostic Systems provides innovative solutions that meet the high productivity demands of hospitals, integrated healthcare delivery networks, reference labs, blood banks and pharmaceutical labs.
Olympus says it offers the broadest standardised line of random access chemistry-immuno analysers, along with lab automation systems, comprehensive patient safety systems, blood bank analysers and reagents.
Olympus solutions save laboratories time, enhance patient safety, maximise productivity, and deliver fast, reliable results, says the company.