OPERATIONAL STANDARDS FOR CASA INSTRUMENTS

Computer-aided sperm analysis (CASA) technology is 7 years old. Over 1 20 papers have been written that verify the technology or apply it in basic and clinical studies. Most of the technical problems with CASA, such as the dependence of velocity on video frame rate, inaccuracy of count and percent motility for low- and high-concentration specimens, parameter dependence on the number of frames analyzed, sensitivity of the subjective threshold setting, confusion over the presence of debri s, and different implementations of algorithms across instruments, sti ll persist. A critical review of the literature reveals that no standa rd practices are followed within or across instruments. Moreover, no s tandards have been embraced or recommended by professional societies. Despite its potential to provide objective measurements of specimen an d individual sperm parameters, and to automate the laboratory semen an alysis, the promise of CASA has not been fulfilled. Unless laboratory medicine defines instrument performance and laboratory standards and c ooperates with industry to achieve these goals, CASA technology may re main a research curiosity. This outcome is especially worrisome in the context of increasing requirements for laboratory accuracy, precision , standardization, and accreditation under the Clinical Laboratory Imp rovement Act of 1988.