Assuntos
Aprovação de Drogas , Genômica , Notificação de Abuso , Projetos de Pesquisa/legislação & jurisprudência , United States Food and Drug Administration , Volição , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/métodos , Indústria Farmacêutica/legislação & jurisprudência , Indústria Farmacêutica/métodos , Guias como Assunto , Humanos , Farmacogenética/legislação & jurisprudência , Formulação de Políticas , Estados UnidosAssuntos
Química Clínica/instrumentação , United States Food and Drug Administration/organização & administração , Segurança de Equipamentos , Reações Falso-Negativas , Marketing de Serviços de Saúde , Kit de Reagentes para Diagnóstico , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudênciaRESUMO
The consequences of omitting cultures in dipstick-negative urines submitted to the authors' microbiology laboratory were evaluated retrospectively in 1,079 clean-catch midstream samples. Using positive dipstick readings for leukocyte esterase, nitrite, and/or protein as evidence of a positive screen, the sensitivity, specificity, positive predictive value, and negative predictive value for specimens containing more than or 10(3) CFUs/mL (10(6)/L) were 80%, 71%, 48%, and 91%, respectively. Clinical data were reviewed in 38 patients with one or more dipstick-negative, culture-positive urines. Most of these patients lacked clinical or other laboratory evidence suggesting urinary tract infection. Problems with specimen collection were suspected in 19 neurologically compromised patients. Only two patients with dipstick-negative urines received treatment based on the culture reports. Symptoms persisted in both. The authors conclude that in their predominantly male veteran population, clinically significant bacteriuria is an unlikely finding in a dipstick-negative urine.