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A total of 952 consecutive vaginal swabs were obtained from patients who attended obstetric or gynecologic clinics affiliated with the Children's Hospital of Buffalo, New York. Swabs were cultured comparatively on 5% sheep blood agar (BA), selective sheep blood agar containing 1.25 micrograms/ml trimethoprim-23.75 micrograms/ml sulfamethoxazole (SXT), and(More)
This document provides guidance for establishing shelf-life and in-use stability claims for in vitro diagnostic reagents such as reagent kits, calibrators, and control products. Setting the standard for quality in clinical laboratory testing around the world. The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization(More)
Clostridium difficile is the cause of most cases of pseudomembranous colitis, the most severe form of antibiotic-associated diarrhea. Rapid diagnosis guides both the treatment and the control of nosocomial spread of infection. Two enzyme immunoassay (EIA) kits developed for the rapid detection of C. difficile toxin A in fecal specimens, Premier (Meridian(More)
Two enzyme immunoassays (EIAs) detecting Chlamydia trachomatis from endocervical swabs, Syva MicroTrak (MT) and Abbott Chlamydiazyme (CZ), were compared with a tissue culture (TC) standard. Initially, 8% (100 of 1250) of specimens were TC positive, yielding sensitivities of 94% (94 of 100) for MT and 79% (79 of 100) for CZ with identical 98% specificities(More)
Total Product Life Cycle (TPLC) is a conceptual framework for assessing any product or service (medical or otherwise). This article will address how the Center for Devices and Radiological Health of the U.S. Food and Drug Administration utilizes TPLC in a regulatory paradigm. TPLC will help guide the regulation of market-driven evolution of medical devices(More)
OBJECTIVE The purpose of this study was to determine whether an enrichment method would improve the performance of an enzyme imunoassay test, the ICON Strep B, for detection of group B streptococci (GBS) in vaginoperineal swabs. METHODS The study was done in 3 phases. First, in 250 maternity patients, 2 swabs per patient were tested simultaneously by an(More)
Using strains of Neisseria gonorrhoeae from Western New York, the National Committee for Clinical Laboratory Standards' (NCCLS) interpretive criteria for disk diffusion susceptibility testing was evaluated on chocolate-Mueller-Hinton agar (CMH) and GC agar. The reference method for comparison was the NCCLS agar dilution minimum inhibitory concentration(More)
Protein profiles of in vivo propagated and in vitro cultivated Treponema pallidum subsp. pallidum (Nichols strain) were analyzed using two-dimensional gel electrophoresis (2D-PAGE). A comparative study between the two protein profiles (as detected by silver stain, Western blotting, and autoradiography) demonstrated two in vitro synthesized polypeptides with(More)
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