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 SEPTI-CHEK™ AFB Culture Bottle |
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| Cat. # | Desc. | Qty. | Unit |
| 243558 | SEPTI-CHEK™ AFB Culture Bottle | 10 | SP |
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The BBL™ SEPTI-CHEK™ AFB Culture Bottle, BBL™ SEPTI-CHEK™ AFB Supplement and BBL™ SEPTI-CHEK™ AFB Slide are intended for use as an integrated, contained, in vitro diagnostic system for the detection and isolation of mycobacteria from sputum, bronchial washings or aspirate, body fluids (pleural, CSF, ascites, synovial), urine, stool, biopsy tissues or wounds and skin when mycobacteriosis is suspected.
| Catalog # | Description | Quantity | Unit |
| 243558 | SEPTI-CHEK™ AFB Culture Bottle | 10 | SP |
The BBL™ SEPTI-CHEK™ AFB Culture Bottle, BBL™ SEPTI-CHEK™ AFB Supplement and BBL™ SEPTI-CHEK™ AFB Slide are intended for use as an integrated, contained, in vitro diagnostic system for the detection and isolation of mycobacteria from sputum, bronchial washings or aspirate, body fluids (pleural, CSF, ascites, synovial), urine, stool, biopsy tissues or wounds and skin when mycobacteriosis is suspected. The BBL™ SEPTI-CHEK™ AFB Culture Bottle, BBL™ SEPTI-CHEK™ AFB Supplement and BBL™ SEPTI-CHEK™ AFB Slide are intended for use as an integrated, contained, in vitro diagnostic system for the detection and isolation of mycobacteria from sputum, bronchial washings or aspirate, body fluids (pleural, CSF, ascites, synovial), urine, stool, biopsy tissues or wounds and skin when mycobacteriosis is suspected. Mycobacteria are infectious agents responsible for persistent and chronic clinical conditions most commonly of a respiratory nature, and some are spread by coughing and expectoration.1,2 As a group, these organisms are capable of infecting nearly every organ of the body. This has become increasingly evident and frequent in cases of underlying immune dysfunction associated with conditions such as HIV infection and drug abuse.3,4 Historically, the most frequently encountered human pathogenic Mycobacterium is M. tuberculosis.1,2 In some populations, this has been exceeded by the Mycobacterium avium complex.3,4 The mycobacteria have several characteristics which distinguish them from other bacteria. The most notable of these are resistance to decolorization after staining, relatively slow growth, and resistance to digesting agents.5 Conventional culture media used for mycobacteria isolation are most often Lowenstein-Jensen (LJ), or Middlebrook 7H9, 7H10 or 7H11.6 Growth in these media is observed in a range of 3 – 56 days, depending on the species isolated and concentration of viable bacteria. The SEPTI-CHEK AFB system is designed to promote rapid growth in a broth medium, while providing simultaneous subculture on three different media, a presumptive identification, and the ability to perform identification and susceptibility testing. Mycobacteria are infectious agents responsible for persistent and chronic clinical conditions most commonly of a respiratory nature, and some are spread by coughing and expectoration.1,2 As a group, these organisms are capable of infecting nearly every organ of the body. This has become increasingly evident and frequent in cases of underlying immune dysfunction associated with conditions such as HIV infection and drug abuse.3,4 Historically, the most frequently encountered human pathogenic Mycobacterium is M. tuberculosis.1,2 In some populations, this has been exceeded by the Mycobacterium avium complex.3,4 The mycobacteria have several characteristics which distinguish them from other bacteria. The most notable of these are resistance to decolorization after staining, relatively slow growth, and resistance to digesting agents.5 Conventional culture media used for mycobacteria isolation are most often Lowenstein-Jensen (LJ), or Middlebrook 7H9, 7H10 or 7H11.6 Growth in these media is observed in a range of 3 – 56 days, depending on the species isolated and concentration of viable bacteria. The SEPTI-CHEK AFB system is designed to promote rapid growth in a broth medium, while providing simultaneous subculture on three different media, a presumptive identification, and the ability to perform identification and susceptibility testing. Test procedures for the SEPTI-CHEK AFB Mycobacteria Culture Bottle with supplement added, and the SEPTI-CHEK AFB Slide have been prepared in compliance with National Committee for Clinical Laboratory Standards (NCCLS) Vol. 5, No. 20, Quality Assurance for Commercially Prepared Microbiological Culture Media. Upon receipt of a new shipment or lot number, one of the following organisms is recommended for inoculation of SEPTI-CHEK AFB Mycobacteria Culture Bottle or SEPTI-CHEK AFB Slide at 104 CFU/bottle: a)
and one of the following organisms is recommended for inoculation at 105 CFU/bottle: b)
The growth in the bottle of the (a) group is checked after 21 and 28 days at 37°C with the following anticipated results:
Growth of the (a) group on slides should be observed after 21 days with the following expected results:
The (b) group should show no or weak growth in the bottle after 7 days at 37°C. If the SEPTI-CHEK AFB Mycobacteria Culture Bottle with supplement added or the SEPTI-CHEK AFB Slide do not give the expected results, do not use the media until Technical Services (U.S.A.) has been contacted, 1-800-638-8663.
SEPTI-CHEK AFB Slide: A slide with three numbered sides containing media — Side 1 — Non-selective Middlebrook 7H11 Agar, modified, suitable for growth of most mycobacteria. Side 2 — Egg based medium, suitable for growth of most mycobacteria. Side 3 — Chocolate Agar for initial isolation of bacteria other than mycobacteria, which will grow on this agar only after extended incubation. BBL™ SEPTI-CHEK™ AFB Slide: Approximate Formula* Per L of Processed Water
in vitro Diagnostic As with any diagnostic procedure, clinical considerations and professional judgement should be used in interpreting any test result, particularly a single test result. The SEPTI-CHEK AFB System is intended for use in laboratories experienced in handling mycobacteria or mycobacteria-containing specimens.7 Since M. tuberculosis is highly infectious, specimens and SEPTI-CHEK AFB components should be handled by qualified personnel in compliance with "Universal Precautions"8 and institutional guidelines. Bottles and slides should be autoclaved prior to being discarded. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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.
