Premarket evaluation of commercial toxoplasmosis indirect fluorescent-antibody reagents

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Abstract
The quality of commercial toxoplasmosis indirect fluorescent-antibody reagents was evaluated over a 6 yr period. Manufacturers (7) voluntarily submitted their products for evaluation in the Center for Disease Control Premarket Evaluation Program. Each product was tested in accordance with the Center for Disease Control performance and labeling specifications and evaluation methods. Only 49% of all the products tested met the Center for Disease Control requirements. Performance criteria are outlined and suggestions offered to assist laboratorians in obtaining toxoplasmosis indirect fluorescent-antibody reagents of high quality.