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BACTEC™ Diluting Fluid is used in procedures where mycobacterial cultures are diluted for inoculation. Its main use is in the standard BACTEC drug susceptibility testing of M. tuberculosis.^1,3-7 In this procedure the inoculum is diluted 1:100 for the control vial. Diluting Fluid may also be used to dilute cultures in other procedures such as the NAP test or any other test where dilution of a test culture suspension is required.²

Use of Diluting Fluid is a part of the BACTEC drug susceptibility testing of M. tuberculosis. The Diluting Fluid contains a detergent, polysorbate 80 (Tween 80), and a fatty acid-free albumin. These substances help in the dispersal of mycobacteria in a suspension. The albumin is fatty-acid free so that it does not compete with ¹⁴C labelled fatty acid present in the medium. The concentration of polysorbate 80 is minimal so that it may not interfere in the drug susceptibility test but still helps in the dispersion of mycobacteria to give a uniform and homogenous suspension.

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.

The user should examine the Diluting Fluid vials for evidence of deterioration prior to use. For a quality control check of bacterial procedures, please refer to the S.I.R.E. Drug Kit package insert (PP-118JAA) or the BACTEC 460TB System Product and Procedure Manual (MA-0029).

Quality Control Certificates are provided with each Diluting Fluid Kit. Quality Control Certificates show test organisms utilized for this type of product.

As part of the daily maintenance schedule, Performance Test Vials (BACTEC Performance Test Kit) should be tested on the BACTEC 460TB System 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, PP-046JAA).

The BACTEC Diluting Fluid vials contain the following reactive ingredients prior to processing:

BACTEC Diluting Fluid is for in vitro Diagnostic Use.

This product contains dry natural rubber.

Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions"^8-11 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 such as cloudiness, bulging or depressed septum. DO NOT USE any vial showing evidence of contamination. A contaminated vial could contain positive pressure. Vial contamination may not be readily apparent. Vials displaying turbidity, contamination, or discoloration (darkening) should not be used. Vials that exhibit evidence of damage should be discarded prior to inoculation. On rare occasions, the glass bottle may be cracked and the neck may break during removal of the flip-off cap or in handling. Also on rare occasions a vial may not be sealed sufficiently. In both cases, the contents of the vials may leak or spill, especially if the vial is inverted. If the vial has been inoculated, treat the leak or spill with caution, as pathogenic organisms/agents may be present. Before discarding, sterilize all inoculated vials by autoclaving.

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.¹² Use a proper protective gown, mask, and gloves while handling specimens and cultures of potential pathogens. Follow the CDC and OSHA recommendations.¹²

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