Premarket evaluation of commercial toxoplasmosis indirect fluorescent-antibody reagents.
AUTOR(ES)
Durham, T M
RESUMO
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.
ACESSO AO ARTIGO
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=274910Documentos Relacionados
- Optimal fluorescein-to-protein ratios of bacterial direct fluorescent-antibody reagents.
- Automation of the Indirect Fluorescent-Antibody Test for Toxoplasmosis
- Modified indirect fluorescent-antibody test for aspergillosis.
- Fluorescent-antibody reagents for the identification of Clostridium botulinum.
- Evaluation of the Indirect Fluorescent-Antibody Technique for Identification of Naegleria Species
