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INTENDED USE: The BBLCRYSTAL™ Neisseria/Haemophilus (N/H) Identification (ID) System is a miniaturized identification method employing modified conventional, fluorogenic, and chromogenic substrates. It is intended for the identification of frequently isolated Nelsseria and Haemophilus as well as several other fastidious bacteria from clinical specimens. INDICATIONS FOR USE: Use of this product is indicated when Neisseria, Haemophilus and the other fastidious organisms described in Table B-1 have been isolated in pure culture from clinical specimens in a clinical laboratory, and identification of the microorganisms is desired.

The main component of the BBLCRYSTAL™ N/H ID System is the base/lid assembly, consisting of the CRYSTAL base and lid. The BBLCRYSTAL lid consists of 29 dehydrated biochemical/chromogenic/fluorogenic substrates and one fluorogenic negative control, on the ends of plastic prongs. The base consists of 30 matching wells; its design allows inoculation of all 30 wells in a single step by pouring the suspension into a target area and tilting the base. The test inoculum rehydrates the dried substrates and initiates test reactions. The pure culture suspension is prepared by picking several small colonies of the same morphology from non-selective media such as Chocolate Agar, Trypticase® Soy Agar with 5% Sheep Blood, and Columbia Agar with 5% Sheep Blood, and Agar With 5% Horse Blood. Alternatively, selective media such as Martin Lewis Agar, Thayer-Martin Modified Agar, New York City Medium Modified, V Agar, and GC Agar Base with 1% IsoVitaleX® Enrichment may be used. A suspension of this culture is prepared in the BBLCRYSTAL™ ANR, GP, RGP, N/H ID Inoculum Fluid provided. The suspension is added to the target area of the panel base, which the user then rocks back and forth to inoculate all the wells contained in the base. After the base/lid assembly has been incubated for 4 hours at 35-37°C, the panel is placed on the BBLCRYSTAL Panel Viewer and the color reactions are visually compared to the BBLCRYSTAL N/H Color Chart provided. Each reaction is scored as a positive (+) or negative (-) and recorded on the BBLCRYSTAL N/H Report Form. After all results are read, a 10-digit numerical profile is calculated by assigning a value of 4, 2, or 1 to each positive reaction. (Negative reactions are assigned a value of "0".) The values for each column are then added together to obtain the 10 digit Profile Number. The BBLCRYSTAL ID System Electronic Codebook is loaded into the user's PC and the appropriate database is selected. Then the Profile Number and results of any off-line tests are entered, and the Codebook gives one of the following three results: - a definitive ID; - a tie between two or more species; or - no ID possible with data submitted. In the case of a definitive ID or a tie between two or more potential ID's, the user can access the statistics for that ID as well as background information for the species identified. In the case where no ID is possible, the Codebook suggests that the user perform a purity check of the test isolate. If culture purity has been established, the Codebook indicates that (i) the test isolate is producing atypical BBLCRYSTAL reactions (which may also be caused by procedural errors), (ii) the test species is not part of the intended taxa, or (iii) the system is unable to identify the test isolate with the required level of confidence. Once again, the Codebook indicates that additional testing must be done to establish an identification.