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BACTEC™ PANTA™ PLUS is an antimicrobial supplement composed of BACTEC PANTA Supplement and BACTEC Reconstituting Fluid. Principal use is with the BACTEC 460TB System instrument.

BACTEC PANTA Supplement is recommended as an addition to BACTEC 12B Medium during the primary isolation of mycobacteria and direct drug susceptibility testing from clinical specimens.^1,2 PANTA Supplement suppresses the normal flora associated with the digested and decontaminated clinical specimens.

Since the BACTEC system utilizes a liquid medium, it is important to add an antimicrobial supplement to suppress growth of contaminating microorganisms which may survive the decontamination process of specimens. Contamination may be reduced by supplementing the medium with a mixture of antimicrobials prior to inoculation. PANTA Supplement which contains polymyxin B, amphotericin B, nalidixic acid, trimethoprim and azlocillin is available in a lyophilized form. The concentrations of antimicrobials have been selected after a careful evaluation of their effect on the growth of mycobacteria and their ability to reduce non-mycobacterial contamination.^1,3 Reconstituted PANTA is added into 12B vials prior to inoculation of the specimen (inoculation of the specimen must be performed within 2 h of the addition of PANTA to the 12B vial). The leftover PANTA should be frozen at -20°C or colder for up to 6 months.

The addition of PANTA should enhance primary isolation of mycobacteria from clinical specimens. Reconstituting Fluid (RF) contains a growth promoting substance POES (polyoxyethylene stearate).⁴ Thus, it is recommended that when PANTA is not used, in the case of an aseptically collected specimen, 0.1 mL of RF alone be added to 12B Medium prior to inoculation of the specimen.

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 PANTA PLUS Kit. Quality Control Certificates show test organisms utilized for this type of product.

BACTEC PANTA Supplement vials displaying deterioration or moisture and BACTEC Reconstituting Fluid vials displaying turbidity, contamination, or discoloration (darkening) should not be used.

Follow the procedures described in the BACTEC 12B Mycobacteria Medium package insert (PP-116JAA) and in the BACTEC 460TB System Product and Procedure Manual (MA-0029).

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 BACTEC PTK package insert PP-046JAA).

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

The BACTEC PANTA PLUS Kit vials contain the following active ingredients prior to processing:

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"^5-8 and institutional guidelines should be followed in handling all items contaminated with blood or other body fluids.

DO NOT USE if lyophilized product shows evidence of moisture.

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.

Positive 12B Mycobacteria Medium culture vials for subculturing or staining, etc.: Before sampling 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.⁹ Use a proper protective gown, mask and gloves while handling specimens and cultures of potential pathogens. Follow the CDC and OSHA recommendations.⁹

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