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FDA Clears the Olympus Treponemal Pallidum Assay For Use With EDTA Samples Five Days Post-Collection


Syphilis Screening System Designed For Use On PK7200 Automated Microplate System

Melville, N.Y. (March 17, 2003) - Olympus Diagnostic Systems Group today announced an enhancement to the PK™ TP System, an in-vitro diagnostic microhemagglutination test to be used in qualitative screening for detection of Treponema Pallidum (TP) antibodies in human serum or EDTA plasma.

On Feb. 21, 2003, the Food and Drug Administration cleared a modification to the PK TP System that will allow blood donor centers to perform syphilis screening on EDTA donor samples up to five days after collection. Previously samples had to be tested within two days. The two-day limitation creates problems over weekends and holidays when blood may not be tested within two days of collection. It was also a limiting factor after the September 11 tragedy when the volume of donations precluded completion of all testing with two days of collection. By expanding the allowable sample age to five days post-collection, these problems are completely eliminated and will be important in the future during periods of high volume blood donations.

Approximately 89% of the North American blood supply is screened for syphilis using the PK TP System. The Olympus PK TP System is used on the PK7200 automated microplate system and has allowed blood donor centers to completely automate the syphilis screening process for blood donors. This includes simultaneous testing of ABO/Rh, syphilis, cytomegalovirus; objective, accurate result interpretation; full automation from sample handling to data transmission including positive sample ID; and a throughput of 240 samples per hour. The PK TP assay kit provides benefits that save time, trim costs and raise productivity in blood banks.

For additional information, please contact Candace Williams, Director/Immunohematology Systems, Olympus Diagnostic Systems Group, at (800) 628-7152, ext. 2681. Fax: (972) 432-9532. Email: Candace.Williams@olympus.com

About Olympus Diagnostic Systems Group
Since 1981, Olympus Diagnostic Systems Group has provided innovative solutions that meet the high productivity demands of hospitals, integrated healthcare delivery networks, reference labs, blood banks and pharmaceutical labs. Offering the broadest standardized line of random access, chemistry-immuno analyzers and lab automation systems, Olympus' solutions save laboratories time, maximize productivity and deliver fast, reliable results.

Olympus Diagnostic Systems Group also offers rapid response technical support nationwide through Olympus Technical Services. Service and support are available to customers seven days a week, 24 hours a day, by calling 1-800-223-0130. From telephone troubleshooting and remote modem diagnostics…on-site customer training and service for hardware, software, application support…as well as training and field support at Olympus' Irving, Texas facility…Olympus Diagnostic Systems Group provides comprehensive customer-tailored solutions to ensure maximum system uptime with reliable results.

For additional information about the Olympus product line, and other services, please call the Olympus Diagnostic Systems Group at (800) 223-0125, or visit the Olympus web site at www.olympusamerica.com.

About Olympus
Olympus Optical Co., Ltd., with its wholly owned subsidiaries, is a global leader in designing, manufacturing and marketing optical-digital product solutions for health care and consumer segments. The company leverages R&D investment in technology and manufacturing processes across diverse business lines that include:

  • minimally invasive diagnostic and surgical endoscopes;
  • advanced clinical and research microscopes;
  • chemistry-immuno analyzers and lab automation systems; and
  • digital and film cameras, and digital voice recorders.
  • In the U. S. and Canada, Olympus America Inc. serves health care, scientific and commercial laboratory markets with integrated product solutions and financial and other service offerings and is the leading brand in gastrointestinal endoscopy and clinical and educational microscopes. The company's market-leading consumer camera products and services business spans North and South America. Olympus America Inc. works collaboratively with its customers and parent company to develop state-of-the-art products and services that are innovative, intelligent, and easy to use. For more information, visit www.olympusamerica.com.