Mycobacteria Testing Systems

Transcription

1 Mycobacteria Testing Systems Mycobacteria Specimen Collection, Processing and Staining 10-2 Manual Mycobacteria Testing 10-5 Automated Mycobacteria Testing BD Diagnostics Diagnostic Systems Catalog 2005/

2 Mycobacteria Specimen Collection, Processing and Staining Mycobacteria Specimen Collection FALCON Sputum Collection Kit For the safe collection, transport and handling of sputum, particularly in cases of known or suspected mycobacterial infection. Kit contains 72 collection systems, including 50 ml conical Falcon Tubes. Mycobacteria Specimen Digestion and Decontamination x 75 ml x 150 ml MycoPrep Specimen Digestion/Decontamination Kit This kit contains reagents necessary for the preparation of respiratory and non-respiratory (blood excluded) specimens for identification of mycobacteria. The kit includes bottles of NaOH-citrate solution (containing a plastic ampule with NALC) and powdered phosphate buffer. After activation of the NALC ampule, the NALC-NaOH mixture is stable for 24 hours. This kit should be stored at room temperature contains 10 bottles (75 ml) of NALC-NaOH solution and 5 packages of powdered phosphate buffer (ph 6.8) contains 10 bottles (150 ml) of NALC-NaOH solution and 10 packages of powdered phosphate buffer (ph 6.8). Rapid and Cold Acid-Fast Procedure (TB Quick Stain) TB Quick Stain Kit The BBL TB Quick Stain Kit is used for the staining of mycobacteria and features a simplified two-step variation of the classic Ziehl-Neelsen stain that eliminates the need to heat the slide. This kit is recommended for the staining of specimens from liquid culture and contains one bottle (250 ml) of Carbolfuchsin and one of Methylene Blue. TB Quick Stain Carbolfuchsin Individual component of the TB Quick Stain Kit, contains 3 bottles (250 ml each). TB Quick Stain Methylene Blue Individual component of the TB Quick Stain Kit, contains 3 bottles (250 ml each) BD Diagnostics Diagnostic Systems Catalog 2005/2006

3 Mycobacteria Specimen Collection, Processing and Staining Ziehl-Neelsen (hot) Acid-Fast Procedure BBL TB Ziehl-Neelsen Stain Kit The BBL TB Ziehl-Neelsen Stain Kit employs the classical Ziehl-Neelsen technique with a heating step in the procedure. Enhances the detection of acid-fast microorganisms without the use of a fluorescent microscope. Contains one bottle (250 ml) each of Carbol Fuchsin ZN, Decolorizer, and Methylene Blue Carbolfuchsin ZN Individual component of the BBL TB Ziehl-Neelsen Stain Kit, contains 4 bottles (250 ml each). Methylene Blue Individual component of the BBL TB Ziehl-Neelsen Stain Kit, contains 4 bottles (250 ml each). Decolorizer Individual component of the BBL TB Ziehl-Neelsen Stain Kit, contains 4 bottles (250 ml each). Kinyoun (cold) Acid-Fast Procedure BBL TB Kinyoun Stain Kit The BBL TB Kinyoun Stain Kit facilitates staining using the Kinyoun stain technique, enabling detection of acid-fast microorganisms without the use of a fluorescent microscope. Each kit contains 1 bottle (250 ml) each of Carbolfuchsin KF, Decolorizer, and Brilliant Green K. Brilliant Green Individual component of the BBL TB Kinyoun Stain Kit, contains 4 bottles (250 ml each). Carbol Fuchsin Individual component of the BBL TB Kinyoun Stain Kit, contains 4 bottles (250 ml each). BD Diagnostics Diagnostic Systems Catalog 2005/

4 Mycobacteria Specimen Collection, Processing and Staining TB Fluorescent Stain Kits TB Fluorescent Stain Kit M (Morse, Blair, Weiser and Sproat) The BBL TB Fluorescent Stain Kit M is a fluorescent stain kit for mycobacteria that is contains auramine and is especially suitable as an overlay stain. Contains one bottle (250 ml) each of Auramine M, Decolorizer, and Potassium Permanganate TB Fluorescent Stain Kit T (Truant, Brett and Thomas) The BBL TB Fluorescent Stain Kit M is a fluorescent stain kit for mycobacteria that contains auramine-rhodamine. Rhodamine reduces non-specific background fluorescence that may be present in either culture or clinical specimens. Contains one bottle (250 ml) each of Auramine- Rhodamine T, Decolorizer, Potassium Permanganate Auramine M Individual component of the TB Fluorescent Stain Kit M, contains 4 bottles (250 ml each). Auramine-Rhodamine T Individual component of the TB Fluorescent Stain Kit T, contains 4 bottles (250 ml each). Decolorizer Individual component of the TB Fluorescent Stain Kit M and the TB Fluorescent Stain Kit T, contains 4 bottles (250 ml each). TB Potassium Permanganate Individual component of the TB Fluorescent Stain Kit M and TB Fluorescent Stain Kit T, contains 4 bottles (250 ml each). Accessories and Supplies for Acid-Fast Procedures ml x 250 ml BBL Acid Fast Bacilli QC Slide Acid fast Bacilli (AFB) QC Slides are conventional 1 x 3 microscope slides imprinted with two circles. One circle is an acid-fast positive control with Staphylococcus aureus and Bacillus subtilis plus inactivated Mycobacterium tuberculosis H37Ra. The other circle is a negative control with an unstained mixture of non-acid-fast cocci (Staphylococcus aureus) and bacilli (Bacillus subtilis). Sufficient for 50 tests. Acridine Orange Stain Acridine Orange Stain is used for the detection of microorganisms in direct smears by fluorescence and is especially useful where the number of microorganisms is extremely low. As an added convenience, a Gram stain can be performed directly over the Acridine Orange stain. BD Difco 10-4 BD Diagnostics Diagnostic Systems Catalog 2005/2006

5 Manual Mycobacteria Testing Manual growth & detection, identification and antimicrobial susceptibility testing of mycobacteria MGIT (Mycobacteria Growth Indicator Tube) Growth & Detection BBL MGIT Tubes (4 ml) The BBL MGIT Tubes contain 4 ml of Middlebrook 7H9 Broth base with a fluorescent indicator and is intended for the manual detection and recovery of mycobacteria. The broth is contained in a plastic tube with screw-top cap and supplemented with BBL MGIT OADC enrichment ( ) and BBL MGIT PANTA antibiotic mixture ( ). Acceptable specimen types are digested and decontaminated clinical specimens (except urine) and sterile body fluids (except blood). A culture-positive sample is identified by the observation of non-homogenous turbidity or fluorescence, the latter of which is observed using a 365 mm UV transilluminator, a longwave UV light (Wood s lamp) or the BBL MicroMGIT Reader. BBL MGIT OADC Enrichment The OADC enrichment provides substances essential for the rapid growth of mycobacteria in BBL MGIT 4 ml Tubes. OADC stands for oleic acid, albumin, dextrose and catalase. Sufficient for ca. 150 tests (6 ready to use vials containing 15 ml each). BBL MGIT PANTA Antibiotic Mixture The PANTA Antibiotic Mixture suppresses growth of contaminating or normal flora, enhancing growth and detection of mycobacteria in MGIT Tubes. Each vial contains a lyophilized antibiotic mixture of polymyxin B, amphotericin B, nalidixic acid, trimethoprim and azlocillin. Sufficient for ca. 150 MGIT tubes (6 vials). MGIT Antimicrobial Susceptibility Testing BBL MGIT AST SIRE Testing Kit The BBL MGIT AST SIRE Testing Kit is used for susceptibility testing of Mycobacterium tuberculosis in culture to streptomycin, isoniazid, rifampin and ethambutol (SIRE) in a qualitative test lasting 4-13 days. The kit contains 2 vials of each lyophilized antimicrobic (S, I, R, and E) and must be reconstituted with 4 ml of sterile/deionized water. Sufficient for 80 tests. MGIT System Accessories and Supplies BACTEC MicroMGIT Fluorescence Reader The BACTEC MicroMGIT Fluorescence Reader is used for the qualitative reading of fluorescence in BBL MGIT Tubes (4 ml). The Reader has a standard 9 volt battery, has a low voltage indicator, and has dimensions of 9.2 cm x 14.5 cm x 12.0 cm. (WxDxH). A calibration tube is included. BD Diagnostics Diagnostic Systems Catalog 2005/

6 Manual Mycobacteria Testing Manual growth & detection, identification and antimicrobial susceptibility testing of mycobacteria Dehydrated Culture Media and Enrichments for Mycobacteria Testing g g g g x 20 ml x 100 ml Lowenstein Medium Base Media for the growth and recovery of Mycobacteria. Can be used with glycerol to prepare a variety of coagulated egg media. Middlebrook 7H9 Broth Middlebrook 7H9 Broth is used for the isolation, cultivation and antimicrobial susceptibility testing of mycobacteria. Middlebrook ADC Enrichment ( ) and Glycerol or Tween 80 must be added. Middlebrook 7H10 Agar Middlebrook 7H10 Agar is used for the isolation, cultivation and susceptibility testing of mycobacteria. Middlebrook OADC Enrichment ( ) and Glycerol must be added; the complete medium (with OADC) is available under Middlebrook 7H11 Agar Base Middlebrook 7H11 Agar Base is used in qualitative procedures (e.g. E-Test) for the isolation, cultivation and susceptibility testing of fastidious strains of mycobacteria. Middlebrook OADC Enrichment ( ) and Glycerol must be added to the Agar Base before use. Middlebrook ADC Enrichment Used to supplement culture media for the cultivation of Mycobacteria. BD Difco BD Difco BD Difco x 20 ml ml x 100 ml Middlebrook OADC Enrichment Used to supplement culture media for the isolation and cultivation of Mycobacteria BD Diagnostics Diagnostic Systems Catalog 2005/2006

7 Manual Mycobacteria Testing Manual growth & detection, identification and antimicrobial susceptibility testing of mycobacteria Prepared Media for Mycbacteria Testing (BD Stacker and Tubed, A = 20 mm x 148 mm, C = 20 x 112 mm, K = 16.5 mm x 102 mm) Herrold's Egg Yolk Agar with ANV & Mycobactin J Herrolds Egg Yolk Agar with ANV and Mycobactin J is used for the selective isolation and differentiation of Mycobacterium paratuberculosis. ANV (amphotericin, nalidixic acid and vancomycin) inhibits contamination and Mycobactin J is a growth factor for M. paratuberculosis. Tube size C. Herrolds Yolk Agar with ANV and without Mycobactin J Herrolds Yolk Agar with ANV and without Mycobactin J is used for the selective isolation and differentiation of mycobacteria other than Mycobacterium paratuberculosis. ANV (amphotericin, nalidixic acid and vancomycin) inhibits contamination. M. paratuberculosis is unable to grow on media lacking Mycobactin J. Tube size C. Lowenstein-Jensen Medium Mycoflask Lowenstein-Jensen Medium is an enriched egg-based medium used for the cultivation of Mycobacterium tuberculosis (causative agent of tuberculosis) and other mycobacterial species. The long shelf life of this product is ideal for laboratories that process only a few specimens. Lowenstein-Jensen Medium Slants Lowenstein-Jensen Medium is an enriched egg-based medium used for the cultivation of mycobacteria, including Mycobacterium tuberculosis. It is non-selective and should be used in parallel with the selective version of the medium (e.g. Mycobactosel L-J Medium) is used. Tube size A. Lowenstein-Jensen Medium Slants Lowenstein-Jensen Medium is an enriched egg-based medium used for the cultivation of mycobacteria, including Mycobacterium tuberculosis. Tube size C. Lowenstein-Jensen Medium Slants with 5% NaCl L-J Medium Slants with 5% NaCl are intended for the isolation and cultivation of mycobacteria that can tolerate 5 % Sodium chloride (e.g. M. fortuitum and M. chelonae subsp. absessus). Tube size C Lowenstein-Jensen Medium Slants with Glycerol and PACT Lowenstein-Jensen Medium Slants with Glycerol and PACT are used for the cultivation of mycobacteria, especially M. tuberculosis. It is a selective medium containing polymyxin, amphotericin, carbenicillin, and trimethoprim (PACT). 5 ml. Tube size A. Lowenstein-Jensen Medium Deeps Lowenstein-Jensen Medium Deeps contain an enriched egg-based medium and are used for the cultivation of mycobacteria, including Mycobacterium tuberculosis. Deeps are tubes of hardened agar medium which are inoculated by "stabbing" the inoculum into the agar. Used for catalase test. Tube size A. Middlebrook 7H9 Broth with Glycerol Middlebrook 7H9 Broth with Glycerol is a nonselective liquid culture medium for the cultivation of mycobacteria, including M. tuberculosis. It is used primarily for growth of pure cultures of mycobacteria for use in laboratory studies. 5 ml. Tube size K. BD Diagnostics Diagnostic Systems Catalog 2005/

8 Manual Mycobacteria Testing Manual growth & detection, identification and antimicrobial susceptibility testing of mycobacteria Middlebrook and Cohn 7H10 Agar Slants Middlebrook and Cohn 7H10 Agar is a culture medium for the cultivation of mycobacteria., especially mycobacteria other than tuberculosis (MOTT). Tube size A. Middlebrook and Cohn 7H10 Agar Slants Middlebrook and Cohn 7H10 Agar is a culture medium for the cultivation of mycobacteria. Tube size C. Middlebrook 7H10 Agar with OADC Middlebrook 7H10 Agar contains a variety of inorganic salts which provide substances essential for the growth of mycobacteria. The sodium citrate, when converted to citric acid, holds certain inorganic cations in solution. Glycerol is an abundant source of carbon and energy. Oleic acid, as well as other long chain fatty acids, can be utilized by tubercle bacilli and plays an important role in the metabolism of mycobacteria. Catalase destroys toxic peroxides that may be present in the medium. The primary effect of albumin is that of protection of the tubercle bacilli against toxic agents, therefore enhancing their recovery by primary isolation. Partial inhibition of bacteria is achieved by the presence of the malachite green dye. Middlebrook and Cohn 7H11 Agar Slants Middlebrook and Cohn 7H11 Agar Slants are used for the isolation and cultivation of mycobacteria and contain a modified version of Middlebrook and Cohn 7H10 media. Middlebrook and Cohn 7H11 Agar Slants with Aspartic Acid and Sodium Pyruvate Middlebrook and Cohn 7H11 Agar Slants with Aspartic Acid and Sodium Pyruvate is used for isolation and identification of nonchromogenic mycobacteria, especially M. tuberculosis. The aspartic acid is included to increase the rate of niacin production. Stonebrink TB Medium Slants with PACT Selective Medium Stonebrink TB Medium with PACT is intended for the isolation of mycobacteria, especially Mycobacterium tuberculosis. It is a selective medium containing Polymyxin, Amphotericin, Carbenicillin, and Trimethoprim (PACT). 5 ml. Tube size A BD Diagnostics Diagnostic Systems Catalog 2005/2006

9 Manual Mycobacteria Testing Manual growth & detection, identification and antimicrobial susceptibility testing of mycobacteria BD Sensi-Disc Susceptibility Test Discs for Mycobacteria Susceptibility Testing, Blister Pack per cartridge, 50 discs each Ethambutol (Myambutol ) EM Ethambutol (Myambutol ) EM Ethionamide (Trecator ) EA Isoniazid (Isonicotinyl Hydrazine) INH Isoniazid (Isonicotinyl Hydrazine) INH Rifampin RA Rifampin RA Streptomycin S Streptomycin S-50 BD Diagnostics Diagnostic Systems Catalog 2005/

10 Manual Mycobacteria Testing Manual growth & detection, identification and antimicrobial susceptibility testing of mycobacteria Tests for the Differentiation of Mycobacteria Taxo INH Test Strips Taxo INH Test Strips are used for the detection of izoniazid (INH) and its metabolites in urine. When INH or its metabolites are present in a urine sample, contact with the Taxo INH strip will change the strip color to green, blue or purple. This strip is a modification of Kilburn and Kubica s procedure for detecting niacin produced by M. tuberculosis. Sufficient for 25 tests; storage should be at 2-8 C Taxo INH Test Control The Taxo INH Test Control is an impregnated disc that will yield a positive result in the test procedure. Sufficient for 50 tests Taxo TB Niacin Test Strips Taxo TB Niacin Test Strips assist in the detection of mycobacteria by detecting niacin in culture medium. All mycobacteria produce nicotinic acid, or niacin, which accumulates in culture medium and can be detected using these strips. When Taxo TB Niacin Test Strips turn yellow, the culture is mycobacteria positive and when no color appears, the culture is negative. Sufficient for 25 tests Taxo TB Niacin Test Control Taxo TB Niacin Test Controls are impregnated with nicotinamide and give a positive reaction when tested with a TB Niacin Test Strip. Sufficient for 50 tests Taxo Nitrite Test Strips Taxo Nitrite Test Strips are used for differentiation of microorganisms (particularly mycobacteria) based on the reduction of nitrates to nitrites. The nitrate reduction test separates slow growing mycobacteria that are nitrate-positive (e.g., M. tuberculosis, M. kansasii and M. fortuitum) from rapid growers that are negative or only weakly positive (e.g., M. bovis, M. avium complex and M. intracellulare). The presence of the enzyme nitrate reductase is detected by appearance of a blue-colored end product on the strip, indicating a positive reaction. Sufficient for 25 tests BD Diagnostics Diagnostic Systems Catalog 2005/2006

11 Automated Mycobacteria Testing BD BACTEC MGIT 960 System BD BACTEC MGIT 960 Instrument and Accessories BACTEC MGIT 960 Instrument The BACTEC MGIT 960 Instrument is a nonradiometric and fully automated system for the rapid detection of mycobacteria in clinical specimens other than blood. The BACTEC MGIT 960 is also used for the antimicrobial susceptibility testing of mycobacteria, including SIRE and PZA susceptibility testing. The BACTEC MGIT 960 instrument has a maximum capacity of 960 BBL MGIT tubes (7 ml), or with a 42-day detection protocol, approximately 8000 specimens per year. The BACTEC MGIT 960 System, in conjunction with the BD EpiCenter Data Management System, allows for long-term data storage and historical trending as well as a bi-directional interface with a LIS. This enables long-term tracking of individual TB patients, infection control and epidemiology analysis BACTEC MGIT 960 Starter Group Includes: User's Manual, Quick Reference Guide, Spare Barcode Label for BBL MGIT 960 Tubes, Plugs for Bad Stations, Temperature QC Device, Calibration Kit, Cord Set, Air Filters and Software for BACTEC MGIT Quick Reference Guide User's Manual Temperature Control Tube 3 tubes are needed in each instrument. BD BACTEC MGIT 960 Growth & Detection Bactec MGIT Barcoded Tube (7 ml) The MGIT Tube is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 system. Each plastic tube has a screw-top cap and contains 7 ml of modified Middlebrook 7H9 Broth base, which is supplemented with BACTEC MGIT Growth Supplement ( ) and BBL MGIT PANTA antibiotic mixture ( ). Acceptable specimen types are digested and decontaminated clinical specimens (except urine) and sterile body fluids (except blood). Additionally, these tubes can also be used for antimicrobial susceptibility testing of mycobacteria, including SIRE and PZA testing. MGIT tubes should be stored between 2-25 C. BACTEC MGIT 960 Supplement Kit The kit includes 6 vials of lyophilized BBL MGIT PANTA Antibiotic Mixture and 6 vials of 15 ml BACTEC MGIT 960 Growth Supplement. The BACTEC MGIT Growth Supplement contains Middlebrook OADC enrichment (Oleic acid, Bovine albumin, Dextrose, Catalase and Polyoxyethylene stearate [POES]). The MGIT PANTA Antibiotic Mixture contains Polymyxin B, Amphotericin B, Nalidixic acid, Trimethoprim and Azlocillin. The Supplement Kit should be stored between 2-25 C and is sufficient for approximately 100 tests. BD Diagnostics Diagnostic Systems Catalog 2005/

12 Automated Mycobacteria Testing BD BACTEC MGIT 960 System BD BACTEC MGIT 960 Antimicrobial Susceptibility Testing BACTEC MGIT 960 SIRE Kit The BACTEC MGIT 960 SIRE Kit is used for susceptibility testing of Mycobacterium tuberculosis in culture to the critical concentrations of streptomycin, isoniazid, rifampin and ethambutol (SIRE) in a qualitative test lasting 4-13 days. The SIRE Kit contains 1 vial of each lyophilized antimicrobic (S, I, R, and E) and 6 vials of SIRE Supplement. The antimicrobics must be reconstituted with 4 ml of sterile/deionized water before addition to MGIT tubes. The kit must be stored at 2-8 C and is sufficient for 40 tests BACTEC MGIT 960 PZA Kit The BACTEC MGIT 960 PZA Kit is used for susceptibility testing of Mycobacterium tuberculosis in culture to pyrazinamide (PZA) in a qualitative test lasting 4-17 days. The PZA Kit contains 2 vials of lyophilized antimicrobic and 6 vials of SIRE Supplement.. PZA must be reconstituted with 2.5 ml of sterile/deionized water before addition to MGIT tubes. The BACTEC MGIT 960 PZA Kit includes 2 lyophilized drug vials and 6 PZA Supplements. The kit must be stored at 2-8 C and is sufficient for 50 tests kit BACTEC MGIT 960 PZA Tubes The BACTEC MGIT 960 PZA Medium is a tube containing modified Middlebrook 7H9 Broth with a reduced ph of 5.9 and is to be used for susceptibility testing of Mycobacteria tuberculosis. EMB (Ethambutol) 7.5 kit The EMB 7.5 Kit is intended for the susceptibility testing of M. tuberculosis to MOP (Method of Proportion) high concentration of ethambutol (7.5 µg/ml). Contains 1 vial of lyophilized antimicrobic and 2 vials of SIRE Supplements and is sufficient for 20 tests. INH (Isoniazid) 0.4 kit The INH 0.4 Kit is intended for the susceptibility testing of M. tuberculosis to MOP (Method of Proportion) high concentration of isoniazid (0.4 µg/ml). Contains 1 vial of lyophilized antimicrobic and 2 vials of SIRE Supplements and is sufficient for 20 tests. STR (Streptomycin) 4.0 kit The STR 4.0 Kit is intended for the susceptibility testing of M. tuberculosis to MOP (Method of Proportion) high concentration of streptomycin (4.0 µg/ml). Contains 1 vial of lyophilized antimicrobic and 2 vials of SIRE Supplements and is sufficient for 20 tests. BACTEC MGIT 960 AST Starter Kit Includes: User Manual, Quick reference guide, 2 x Transport rack, 16 x 5-tube AST Set carrier, 16 x 2-tube AST Set carrier, 3 x 3-tube AST Set carrier, 3 x 4-tube AST Set carrier and 3 x 8-tube AST Set carrier. AST Transport Rack AST Quick Reference Guide tube AST Set carrier One set includes 3 carriers BD Diagnostics Diagnostic Systems Catalog 2005/2006

13 Automated Mycobacteria Testing BD BACTEC MGIT 960 System tube AST Set carrier One set includes 3 carriers tube AST Set carrier One set includes 3 carriers tube AST Set carrier One set includes 3 carriers tube AST Set carrier One set includes 3 carriers BD BACTEC 9000 MB Media MYCO/F-Sputa Medium MYCO/F-Sputa Medium is modified Middlebrook 7H9 broth with CO2 that supports the growth and detection of mycobacteria after Supplement/F or BACTEC PANTA/F Solution has been added. Used in the BACTEC 9000MB fluorescent series instrument for the in vitro culture and recovery of mycobacteria. Acceptable specimens for this media are digested, decontaminated clinical specimens and sterile body fluids other than blood. Supplement/F Supplement/F is a required supplement for MYCO/F-Sputa Medium in the recovery of mycobacteria. It is also used to reconstitute BACTEC PANTA /F Antibiotic Supplement, which is then added to MYCO/F-Sputa bottles prior to specimen inoculation. Supplement/F contains polyoxyethylene stearate (POES), bovine serum albumin and other nutrients that enhance the growth of mycobacteria. Sufficient for ca. 50 tests. BACTEC PANTA /F Antibiotic Supplement BACTEC PANTA/F Antibiotic Supplement contains antimicrobial agents used to suppress the growth of contaminating or normal flora that have survived the specimen decontamination process. PANTA/F is reconstituted with Supplement/F and recommended as an addition to BACTEC MYCO/F-Sputa Medium for the primary isolation of mycobacteria from clinical specimens. PANTA/F Supplement contains polymyxin B, amphotericin B, nalidixic acid, trimethoprim and azlocillin. Contains supplement for ca. 50 tests. BD Diagnostics Diagnostic Systems Catalog 2005/