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The BBL™ MycoPrep™ Specimen Digestion/Decontamination Kits are used for the digestion and decontamination of clinical specimens suspected to contain mycobacteria, especially Mycobacterium tuberculosis.

The majority of clinical specimens sent to the mycobacteriology laboratory for cultural confirmation of suspected mycobacterial infection (e.g., sputum, bronchial or tracheal lavage) are contaminated by rapidly growing normal flora. To maximize the mycobacterial yield, contaminated specimens require treatment with a digestion and decontamination procedure. N-acetyl-L-cysteine-sodium hydroxide (NALC-NaOH) solution is recommended as a gentle but effective digesting and decontaminating agent.¹

For each lot or shipment, examine kit components as described under "Product Deterioration." Process a culture containing acid-fast organisms as per established laboratory quality control procedures for mycobacterial specimens.

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.

Each sealed glass ampule within the bottle contains a minimum of 0.370 g NALC (C₅H₉NO₃S).

*Adjusted and/or supplemented as required to meet performance criteria.

*Adjusted and/or supplemented as required to meet performance criteria.

For in vitro Diagnostic Use.

The NALC-NaOH reagent contains strong alkali and causes severe burns. Take off all contaminated clothing immediately. Gloves and eye/face protection must be worn. NaOH is irritating to the eyes and skin. In the event of eye or skin contact, rinse immediately with an eye wash system or tap water for at least 15 min and seek medical advice. If ingested, give milk, egg white or large amounts of water and seek medical advice. Keep out of reach of children.