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BACTEC™ S.I.R.E. Drug Kit contains antimicrobials for use with BACTEC 12B Medium in the testing of Mycobacterium tuberculosis. Principal use is with the BACTEC 460TB instrument.

BACTEC S.I.R.E. Drugs (Streptomycin, Isoniazid, Rifampin and Ethambutol) are recommended as additives to BACTEC 12B Culture Medium for the qualitative susceptibility testing of M. tuberculosis from culture.

The BACTEC procedure for drug susceptibility testing of mycobacteria is based on the same basic principle employed in the conventional method except that a liquid medium is used and instead of counting colonies after about 3 weeks, the growth is monitored radiometrically and the results are reportable within 4 to 12 days. BACTEC drug susceptibility is determined by following a modified version of the conventional proportion method.¹ The critical proportion for resistance is taken as 1% for all antituberculosis drugs. This means that if 1% or more of the test mycobacterial population is resistant, the culture is considered resistant for laboratory reporting purposes. Resistance is determined by comparing the rate of growth in the control vial and the 12B Medium vials containing the test drug.

DO NOT USE vials past their expiration date.

DO NOT USE vials that exhibit any cracks or defects; discard the vial in an appropriate manner.

Quality Control Certificates are provided with each S.I.R.E. Drug Kit. Quality Control Certificates show test organisms utilized for this type of product.

The user should examine all vials for evidence of deterioration prior to use. Vials displaying turbidity, contamination, or discoloration (darkening) should not be used. S.I.R.E. Drug vials displaying moisture (absence of fluffy appearance) should not be used. The performance of the drugs may be checked by susceptibility testing one or more quality control organisms with each susceptibility test set up.

ATCC 27294 H37Rv should always be included and should always be susceptible. If this culture shows resistance to any drug or if the control of the susceptibility test of any culture fails to grow (within 12 days) do not report the results. Repeat the test.

As part of the daily maintenance schedule, Performance Test Vials (BACTEC Performance Test Kit) should be tested on the BACTEC instrument. If low readings are obtained, yet Performance Test Vials were tested properly, possible instrument problems may be indicated (see the BACTEC PTK package insert, PP046JAA).

Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI (formerly NCCLS) guidance and CLIA regulations for appropriate Quality Control practices.

For in vitro Diagnostic Use.

This product contains dry natural rubber.

Pathogenic microorganisms, including hepatitis virus and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions"^2-5 and institutional guidelines should be followed in handling all items contaminated with blood or other body fluids.

Prior to use, each vial should be examined for evidence of damage, deterioration or contamination. DO NOT USE any vial showing evidence of contamination. Vials that exhibit evidence of damage should be discarded. On rare occasions, the glass bottle may be cracked and the neck may break during removal of the flip-off cap or in handling.

Before sampling positive 12B Medium culture vials for subculturing or staining, etc., it is necessary to release gas which may build up due to microbial metabolism. Aseptic techniques and established precautions against microbial hazards should be used at all times. Procedures should be performed in a suitable biological safety cabinet in a room with an appropriate ventilation system as recommended by the CDC.⁶ Use a proper protective gown, mask, and gloves while handling specimens and cultures of potential pathogens. Follow the CDC and OSHA recommendations.

To minimize the potential of leakage during inoculation, use syringes with permanently attached needles or securely fastened Luer-Lok™ brand tips.

Drug concentrations used in the conventional susceptibility testing may vary from laboratory to laboratory. It is very important to select an equivalent concentration of a test drug for the BACTEC susceptibility testing if the results obtained by the two methods are to be compared.

Addition of the accurate amount of a test drug into the culture medium is a critical step in the susceptibility testing.