Preliminary evaluation of an experimental clinical chemistry analyzer developed for space medicine.

An experimental clinical chemistry analyzer system was designed and built to demonstrate the feasibility of clinical chemistry as part of a medical-care system at NASA's planned space station Freedom. We report the performance of the experimental analyzer, called a medical development unit (MDU), for selected analytes in a laboratory setting in preparation for a preliminary clinical trial at patients' bedsides in an intensive-care unit. Within-run CVs ranged from 0.7% for sodium to 7.1% for phosphorus; day-to-day CVs ranged from 1.0% for chloride to 23.4% for calcium. Correlation of patients' blood sample analyses compared well with those by Ektachem E700 and other high-volume central laboratory analyzers (r ranged from 0.933 for creatine kinase MB isoenzyme to 0.997 for potassium), except for hemoglobin (r = 0.901) and calcium (r = 0.823). Although several CVs obtained in this study exceeded theoretical desired precision limits based on biological variations, performance was adequate for clinical laboratory diagnosis. We examined the effect of potentially interfering concentrations of hemoglobin, bilirubin, and lipids: the only effect was negative interference with calcium analyses by high concentrations of bilirubin. We also examined the effects of preanalytical variables and the performance of experimental sample-transfer cups designed to retain sample and reference liquid in microgravity. Continued development of the MDU system is recommended, especially automation of sample processing.