Specimen:

Various Sample Types

Collection Medium:

Miscellaneous container; contact laboratory

Delivery Instructions:

Submit specimen to laboratory as soon as possible after collection.

Specimen
Instructions:

Submit only 1 of the following specimens, minimum amounts listed on 
each sample type:

Body Fluid
1 mL of body fluid. Send specimen refrigerated in a screw-capped, 
sterile container. Maintain sterility and forward promptly.
Note: 1. Specimen source is required on request form for processing.
      2. If ordering electronically, no form is required with the
         specimen.

Respiratory Specimens
3 mL from a respiratory specimen (e.g., bronchoalveolar lavage fluid, 
bronchial washings, sputum). Send specimen refrigerated in a 
screw-capped, sterile container. Maintain sterility and forward 
promptly.
Note: 1. Specimen source is required on request form for processing.
      2. If ordering electronically, no form is required with the
         specimen.

Stool
5 g to 10 g of stool. Send specimen refrigerated in a screw-capped, 
sterile container. Maintain sterility and forward promptly.
Note: 1. Specimen source is required on request form for processing.
      2. If ordering electronically, no form is required with the
         specimen.

Tissue
Send fresh tissue specimen (5 to 10 mm) in a screw-capped, sterile 
container refrigerated. Maintain sterility and forward promptly. The 
high sensitivity of amplification by PCR requires the specimen to be 
processed in an environment in which contamination of the specimen by 
Mycobacterium tuberculosis complex DNA is not likely.
Note: 1. A biopsy specimen of tissue fixed with formalin in a paraffin
         block is also acceptable.
      2. Specimen source is required on request form for processing.

Urine
2 mL from a random urine collection. Send specimen refrigerated in a 
screw-capped, sterile container. Maintain sterility and forward 
promptly.
Note: 1. Specimen source is required on request form for processing.
      2. If ordering electronically, no form is required with the
         specimen.

Analytic Time:

Upon report.

Reference Range:

Negative

Interpretive Data:

A positive result indicates the presence of Mycobacterium tuberculosis 
complex DNA. Members of the Mycobacterium tuberculosis complex detected 
by this assay include Mycobacterium tuberculosis, Mycobacterium bovis, 
Mycobacterium bovis BCG, Mycobacterium africanum, Mycobacterium 
canetti, and Mycobacterium microti. The other species within the 
Mycobacterium tuberculosis complex (Mycobacterium bovie subspecies 
caprae and Mycobacterium pinnepedi) should, in theory, be detected 
using the primer and probe sequences in this assay, but they have not 
been tested at this time. This assay method does not distinguish 
between the species of the Mycobacterium tuberculosis complex.

Methodology:

Polymerase Chain Reaction (PCR)

CPT Code:

87556