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. 1978 Mar;7(3):255-60.
doi: 10.1128/jcm.7.3.255-260.1978.

Premarket evaluation of commercial toxoplasmosis indirect fluorescent-antibody reagents

T M Durham, H M Colvin

Premarket evaluation of commercial toxoplasmosis indirect fluorescent-antibody reagents

T M Durham et al. J Clin Microbiol. 1978 Mar.

Abstract

The quality of commercial toxoplasmosis indirect fluorescent-antibody reagents was evaluated over a 6-year period. Seven manufacturers 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 of the products tested met the Center for Disease Control requirements. Performance criteria are outlined, and suggestions are offered to assist laboratorians in obtaining toxoplasmosis indirect fluorescent-antibody reagents of high quality.

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