Test Directory

Used for rapid detection of M. tuberculosis, when used in conjunction with mycobacterial culture. This test does not provide rifampin resistance information and is most useful for non-sputum specimens. This test should not be used to determine bacteriologic cure or to monitor response to therapy. This test is not intended for the detection of latent tuberculosis and must not be used as a substitute for tests intended for detection of latent tuberculosis such as the tuberculin skin test or an interferon gamma release assay.

1. Collect one of the acceptable sample types.
2. Fresh, undigested specimens are preferred.

1. Transport specimen in the original collection container.
2. This test must always be performed in conjunction with mycobacterial culture.
3. Specimen source is required.

Transport to the laboratory refrigerated. 

• Specimen must arrive within 7 days of collection; if greater than 7 days of collection, the specimen will be rejected.
• Blood
• Specimen in anaerobe vial or viral transport medium (including but not limited to M4, M5, BD viral transport media, thioglycolate broth)
• Swabs
• Tissues in formalin fluid

 See patient report.

Specimen volumes less than indicated may decrease sensitivity of testing.

This rapid PCR assay detects Mycobacterium tuberculosis complex nucleic acid and, therefore, does not distinguish between viable, disease-related organisms and nucleic acid persisting from prior infection. Test results should be correlated with patient symptoms and clinical presentation before a definitive diagnosis is made.

A negative result does not rule out the presence of M tuberculosis complex or active disease because the organism may be present at levels below the limit of detection for this assay.

The sensitivity of this test with stool specimens is 80% and testing of additional stool specimens should be considered if the result from the first specimen is negative.