Mycobacterium tuberculosis Complex Speciation, Real-Time

 Laboratory Fee Schedule

Procedure Number: N/A

CPT: N/A

Synonym(s): MTB Cx, Tuberculosis, TB, M. bovis, BCG, bacillus Calmette-Guérin, PCR, AMCC, AMRC
Requisition Form G-MYCO
Test Description Differentiation of M. bovis and M. bovis BCG from the rest of the M. tuberculosis complex by real-time PCR.
Pre-Approval Needed No
Supplemental Information Required N/A
Supplemental Form(s) N/A
Performed on Specimens from (sources) Human
Sample/Specimen Type for Testing •    Clinical specimens (all types)
•    Referred isolates (all types)
Minimum Volume/Size Required •    Clinical specimen: 3 mL to 15 mL
•    Pure isolate liquid culture: 2.0 mL 
•    Solid culture: At least one, viable pure isolate   
Storage/PreservatioTransport Mediumn Prior to Shipping •    Store refrigerated at 2–8°C (clinical specimens) or at ambient temperature (isolates) until shipment.   
Transport Medium •    N/A for clinical specimens.
•    Maintain isolates on any agar or transport medium that supports the growth of Mycobacteria spp.
Specimen Labeling •    At least two patient identifiers required on specimen (e.g., patient full name, date of birth, medical record number). 
•    Three patient identifiers are preferred. 
•    Patient identifiers on specimen label must exactly match identifiers on submission form. (e.g., abbreviated name on label and full name on form is not acceptable.)
•    Additional DSHS Laboratory specimen labeling guidelines available online here
Shipping and Specimen Handling Requirements

•    Ship clinical specimens refrigerated at 2 – 8°C on cold packs for overnight delivery
•    Ship according to Dangerous Goods Regulations, IATA, and/or CFR 49.
•    Category B Biological Substance, UN3373 shipping requirements apply to clinical specimens.
•    Ship isolates at ambient temperature.
•    Category A Biological Substance, UN 2814 shipping requirements apply to isolates.
•    Handle as infectious agent using universal precautions. 
•    Triple-contain in accordance with federal shipping regulations. 
•    Submitters are responsible for packaging and shipping specimens according to regulatory requirements. 
•    Laboratory does not supply collection kits or shipping materials for isolates.

Method Real-time PCR 
Turn-around Time One week after MTB complex culture is suspected of M. bovis or M. bovis BCG. 
Interferences/Limitations •    Growth prohibitive. 
•    If culture growth is limited, testing will be repeated when adequate growth available. 
Common Causes for Rejection •    Missing identifiers on specimen or submission form
•    Mismatch between specimen and/or submission form identifiers
Additional Information N/A