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BBL™ Crystal™ Neisseria/Haemophilus ID Kit

Cat. #	Description	Qty.	Unit
245130	BBL™ Crystal™ Neisseria/Haemophilus ID Kit Identifies clinically significant Neisseria, Haemophilus and other fastidious organisms in 4 hours. The kit identifies 35 organisms from multiple media	20	SP

Intended Use:

The BBL Crystal™ 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 Neisseria and Haemophilus as well as several other fastidious bacteria.^1,2,6,15,18

Catalog #	Description	Quantity	Unit
245130	BBL™ Crystal™ Neisseria/Haemophilus ID Kit Identifies clinically significant Neisseria, Haemophilus and other fastidious organisms in 4 hours. The kit identifies 35 organisms from multiple media	20	SP

BBL Crystal™ Identification Systems
Neisseria / Haemophilus ID Kit
Revision: 2010/07 Revision Date: 07/01/2010

Intended Use:

Product Summary:

Micromethods for the biochemical identification of microorganisms were reported as early as 1918.³ Several publications reported on the use of the reagent-impregnated paper discs and micro-tube methods for differentiating enteric bacteria.^3,4,8,19,21 The interest in miniaturized identification systems led to the introduction of several commercial systems in the late 1960s, and they provided advantages in requiring little storage space, extended shelf life, standardized quality control and ease of use.

In general, many of the tests used in the BBL Crystal ID Systems are modifications of classical methods. These include tests for fermentation, oxidation, degradation and hydrolysis of various substrates. In addition, there are chromogen and fluorogen linked substrates, as in the BBL Crystal N/H ID panel, to detect enzymes that microbes use to metabolize various substrates.^{5,6,8-10,13-17}

The BBL Crystal N/H ID kit is comprised of (i) BBL Crystal N/H ID panel lids, (ii) BBL Crystal bases and (iii) BBL Crystal ANR, GP, RGP, N/H ID Inoculum Fluid (IF) tubes. The lid contains 29 dehydrated substrates and a fluorescence control on tips of plastic prongs. The base has 30 reaction wells. Test inoculum is prepared with the inoculum fluid and is used to fill all 30 wells in the base. When the lid is aligned with the base and snapped in place, the test inoculum rehydrates the dried substrates and initiates test reactions.

Following an incubation period, the wells are examined for color changes or presence of fluorescence that result from metabolic activities of the microorganisms. The resulting pattern of the 29 reactions is converted into a ten-digit profile number that is used as the basis for identification.²⁰ Biochemical and enzymatic reaction patterns for the 29 BBL Crystal N/H ID substrates for a wide variety of microorganisms are stored in the BBL Crystal N/H ID data base. Identification is derived from a comparative analysis of the reaction pattern of the test isolate to those held in the database. A complete list of taxa that comprises the current database is provided in Table 1.

User Quality Control:

Quality control testing is recommended for each lot of panels as follows –

1. Inoculate a panel with Moraxella (Branhamella) catarrhalis ATCC™ 25240 per recommended procedure (refer to "Test Procedure").

2. Prior to incubation, let panel remain at room temperature for 1 min (not more than 2 min).

3. Read and record reactions with the aid of the panel viewer and color reaction chart.

4. If any of the wells (except 1J) are positive per color reaction chart (after 1 – 2 min), DO NOT USE PANELS from this lot. Contact BD Technical Services.

5. If all wells are negative, then incubate panel for 4 h at 35 – 37°C.

6. Read panel with the panel viewer and color reaction chart; record reactions using the report pad.

7. Compare recorded reactions with those listed in Table 4. If discrepant results are obtained, confirm purity of quality control strain before contacting BD Technical Services.

8. The incubator door should not be opened repeatedly during the incubation period (preferably less than 3 times).

Expected test results for additional quality control test strains are listed in Table 5.

Reagents:

The BBLCrystal N/H ID panel contains 29 enzymatic and biochemical substrates. Refer to Table 3 for a list of active ingredients.

Table 3

Reagents used in the BBL Crystal N/H ID System


Panel Location	Substrate	Code	Pos.	Neg.	Active Ingredients	Approx. Amt. (g/L)

4A	Fluorescent negative control	FCT	n/a	n/a	Fluorescent coumarin derivative	≤1

2A	4MU-phosphate	FHO	blue fluorescence >FCT well	blue fluorescence ≤FCT well	4MU-phosphate	≤1

1A	L-proline-AMC	FPR	blue fluorescence >FCT well	blue fluorescence ≤FCT well	L-proline-AMC	≤1

4B	L-serine-AMC	FSE	blue fluorescence >FCT well	blue fluorescence ≤FCT well	L-serine-AMC	≤1

2B	LYS-ALA-AMC	FLA	blue fluorescence >FCT well	blue fluorescence ≤FCT well	LYS-ALA-AMC	≤1

1B	L-tryptophan-AMC	FTR	blue fluorescence >FCT well	blue fluorescence ≤FCT well	L-tryptophan-AMC	≤1

4C	L-phenylalanine-AMC	FPH	blue fluorescence >FCT well	blue fluorescence ≤FCT well	L-phenylalanine-AMC	≤1

2C	N-succinyl-ALA-PRO-ALA-AMC	FNS	blue fluorescence >FCT well	blue fluorescence ≤FCT well	N-succinyl-ALA-PRO-ALA-AMC	≤1

1C	ALA-ALA-PHE-AMC	FAA	blue fluorescence >FCT well	blue fluorescence ≤FCT well	ALA-ALA-PHE-AMC	≤1

4D	L-glutamic acid-AMC	FTA	blue fluorescence >FCT well	blue fluorescence ≤FCT well	L-glutamic acid-AMC	≤1

2D	L-arginine-AMC	FAR	blue fluorescence >FCT well	blue fluorescence ≤FCT well	L-arginine-AMC	≤1

1D	Ornithine-AMC	FOR	blue fluorescence >FCT well	blue fluorescence ≤FCT well	Ornithine-AMC	≤1

4E	Glycine-AMC	FGL	blue fluorescence >FCT well	blue fluorescence ≤FCT well	Glycine-AMC	≤1

2E	GLY-PRO-AMC	FGP	blue fluorescence >FCT well	blue fluorescence ≤FCT well	GLY-PRO-AMC	≤1

1E	4MU-β-D-galactoside	FBG	blue fluorescence >FCT well	blue fluorescence ≤FCT well	4MU-β-D-galactoside	≤1

4F	Saccharose	SAC	Gold/Yellow	Orange/Red	Saccharose	≤300

2F	Maltotriose	MTT	Gold/Yellow	Orange/Red	Maltotriose	≤300

1F	Carubinose	CAR	Gold/Yellow	Orange/Red	Carubinose	≤300

4G	Pyranose	PYO	Gold/Yellow	Orange/Red	Pyranose	≤300

2G	Maltobiose	MTB	Gold/Yellow	Orange/Red	Maltobiose	≤300

1G	Disaccharide	DIS	Gold/Yellow	Orange/Red	Disaccharide	≤300

4H	Riberol	RBL	Gold/Yellow	Orange/Red	Riberol	≤300

2H	Levulose	LEV	Gold/Yellow	Orange/Red	Levulose	≤300

1H	p-n-p-phosphorylcholine	PHC	Yellow	Colorless	p-n-p-phosphorylcholine	≤10

4I	γ-L-glutamyl-p-nitroanilide	GGL	Yellow	Colorless	γ-L-glutamyl-p-nitroanilide	≤10

2I	p-n-p-phosphate	PHO	Yellow	Colorless	p-n-p-phosphate	≤10

1I	ONPG	OPG	Yellow	Colorless	ONPG	≤10

4J	Urea	URE	Aqua/Blue	Yellow/Green	Urea	≤50

2J	Resazurin	REZ	Pink	Blue/Purple	Resazurin	≤1

1J	Ornithine	ORN	Purple	Yellow/Gray	Ornithine	≤200

Warnings and Precautions:

Precautions: in vitro Diagnostic

After review by the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) under CLIA '88, this product has been identified as high complexity. The CDC Analyte Identifier Code is 0412; the CDC Test System Identifier Code is 07807.

After use, all infectious materials including plates, cotton swabs, inoculum fluid tubes, and panels must be autoclaved prior to disposal or incineration.

Information shown on this page is a short summary extracted from the Package Insert, available as a PDF under the Related Documents section of this page.

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