Mycobacterium tuberculosis complex Rapid Molecular Detection/Identification (PCR)

Test Order Name - Identification of Mycobacterium tuberculosis Complex by Real-Time PCR

Synonym(s) - Mycobacterium tuberculosis complex Detection and Rifampin Resistance Detection by PCR

Methodology - Real-time PCR (Cepheid GeneXpert)

Acceptable Specimen Type(s) for Testing - Sputum (expectorated or induced) sediment

Transport / Collection Medium - Sterile collection vial

Storage and Preservation of Specimen - Keep sediments refrigerated 2 to 8°C for a maximum of 10 days. Storage beyond 10 days must be at -35°C or below.

Minimum Volume Required - 0.5 milliliters sputum sediment

Additional Collection Instructions - Only concentrated sputum sediments accepted

Additional Required Information - Collection date required

Send Out? - No

Turnaround Time - 24 hours

Testing Restrictions - None

Limitations / Notes / Disclaimers - Detection of Mycobacterium tuberculosis complex (M.tb. complex) by this assay is dependent upon the number of organisms present in the sample. Hence, reliable results require proper specimen collection, handling, and storage. Careful compliance to this protocol is essential for avoiding erroneous results. A positive test result does not necessarily denote the presence of viable organisms but is presumptive for the presence of M.tb. complex. Mutations or polymorphisms in either the primer or probe binding sites of the target organisms may negatively affect the detection of novel or unknown strains of M.tb. complex. Moreover, some specimens with very few viable organisms will be negative by this assay but may be positive by culture.