Existing problems in the testing for infectious diseases.

Abstract

Current methods for testing donated blood for presence of infectious viral agents in the USA differ from those used in other countries because of the USA Food and Drug Administration's (FDA) control which inhibits rapid introduction of testing methods or improvements. Delays in FDA approval may occur because of concerns about methodology or the state of knowledge about the disease it is intended to detect as well as due to variability between manufacturers. Despite strict FDA control, testing problems continue to occur in the USA. No approved method detects infectious agents during the "window period," and variations in detection, i.e., false positives and false negatives (even with confirmatory testing), continue to occur. The effect of physical and chemical changes (e.g., various anticoagulants) on samples has not been thoroughly evaluated. Test performance problems include lapses in sample identification, failure to use routine laboratory controls, improper calculation and reporting of results, improper acceptance of test runs and failure to properly detect and retest samples when carryover from very reactive samples occurs. For these reasons, transfusion-related disease transmission continues to occur. The current USA emphasis on good manufacturing practices should provide continuous improvements.