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BACTEC™ Pyrazinamide (PZA) Drug Kit is for pyrazinamide susceptibility testing. Principal use is with BACTEC PZA Test Medium in conjunction with the BACTEC 460TB instrument.

Pyrazinamide is provided in lyophilized form along with a special Reconstituting Fluid (RF) for use with BACTEC PZA Test Medium for susceptibility testing of Mycobacterium tuberculosis.

For conventional PZA drug susceptibility testing of M. tuberculosis a special medium with a pH of 5.5 is required.¹ For the BACTEC PZA susceptibility test, BACTEC PZA Test Medium with a pH of 6.0 should be used.² Lyophilized PZA along with a Reconstituting Fluid is provided to make the BACTEC procedure more convenient. The drug should be rehydrated with Reconstituting Fluid provided with the kit. RF contains a growth promotion substance, polyoxyethylene stearate (POES). When the reconstituted PZA is added to the medium, POES is also introduced into the medium. RF should also be added to BACTEC 12B Medium used to establish the culture prior to testing. RF is also added to the PZA Test Medium control vial.

Refer to the PZA Test Medium package insert (PP-071JAA).

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"^6-9 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids. Contaminated material should be sterilized by autoclaving before discarding. Reconstitute the drug vial only with Reconstituting Fluid (refer to the BACTEC PZA Test Medium package insert, PP-071JAA).