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The article by Nolte et al. (3) implied that Pasco MIC panels are not reliable in the detection of resistant strains of Streptococcus pneumoniae. These findings are contrary to data from a recent study (5) which was submitted as part of a Food and Drug Administration (FDA) 510(k) application that was approved on January 17, 1995. Therefore, it is important to understand the variations in the experimental design of these two studies that led to such different findings. The article by Nolte et al. outlines test methods which deviate from those described in the Pasco package insert (4). These deviations are as follows. (i) The organism inoculum was prepared incorrectly in diluent (water) with Tween rather than the MIC blood supplement. The Pasco package insert indicated that one should prepare the inoculum of fastidious, slowly growing organisms by the turbidity method and then should ‘‘prepare the subsequent dilution of the organism suspension in 12.5 ml of an appropriate supplemental diluent.’’ National Committee for Clinical Laboratory Standards (NCCLS) document M7-A3, referenced in the package insert (1), described appropriate supplements to be used for specific fastidious or slowly growing organisms. (ii) The Pasco package insert described a one-step inoculation procedure which simultaneously provided for inoculation of the test organism and supplementation of the panel. Instead, 100 ml of the MIC blood supplement was added to each of the wells of the panel, effectively diluting by 50% the Mueller-Hinton broth. The resulting nutritionally deficient medium likely accounted for those pneumococcal strains which ‘‘failed to grow sufficiently for MIC determination.’’ It is our belief that these changes in methodology have led to misleading conclusions regarding the ability of the Pasco panels to detect pneumococcal resistance. The Pasco panels have undergone some minor modifications to better comply with the latest NCCLS recommendations (2). However, these modifications would not account for the difference in the data obtained in the Nolte et al. study and that obtained in the independent laboratory study. Deviation from the methodologies described in package inserts for commercial products may critically impact carefully formulated test systems. Acceptance of the FDA 510(k) substantiates that the Pasco system is a reliable system for use in the detection of resistant strains of S. pneumoniae.

Reliability of pasco MIC system for use in detection of resistant Streptococcus pneumoniae