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