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Originally published January, 1998

IVD Technology News

Laboratorians issue blood-substitute wish list for manufacturers

Making instruments work invisibly with blood substitutes should be a primary goal for manufacturers of blood substitutes and related instrumentation, according to a panel of laboratorians.

"The goal should be to have instrumentation that can provide reliable results without interferences caused by the use of blood substitutes," said Melvin Glick, PhD, director of the toxicology section at Wishland Memorial Hospital and of the toxicology section and clinical chemistry laboratory at the Veterans Administration Hospital, Indianapolis.

Glick's comments were made last November at a Chicago-area conference on the impact of blood substitutes on clinical laboratory systems sponsored by the American Association for Clinical Chemistry (AACC).

"In order to interpret the results of current lab tests, laboratorians need to know what blood substitutes patients have received and in what concentrations," said Demetra Callas, PhD, a postdoctoral fellow at Loyola University (Chicago). "But what we're looking for is instrumentation that is not subject to interferences, or a reagent that will clear blood substitutes from patient samples so that it's not necessary to identify those samples as containing blood substitutes."

Referring to the problems caused when blood substitutes by different manufacturers are combined, Glick suggested that each manufacturer engineer its product to include a unique molecular handle. "That would enable it to be pulled out and distinguished from others." He also recommended that instrument manufacturers provide a list of tests that should not be performed in the presence of blood substitutes. "When manufacturers launch new products, they should provide the claims and specifications of their instruments for all analytes as part of their premarket submissions to FDA," Glick said.

"For every instrument, diagnostic manufacturers should provide standard interference protocols and profiles, interference correction ranges, and instructions on how to set up experiments," said John Chapman, DrPH, professor of pathology and laboratory medicine at the University of North Carolina School of Medicine and executive director of the core and clinical chemistry laboratories for the University of North Carolina Hospitals. "It's essential that manufacturers educate their laboratory customers about any problems using blood substitutes on their instruments."

"Blood substitute manufacturers also have to provide more information," said Chapman. "Labs need to have an up-front label or other mechanism for determining what kind of substitute has been used in a sample. They also need to know what the in vivo clearance rate is for every blood substitute, and how to clear such products from patient samples."—Steve Halasey