Molecular Detection of Mycobacterium tuberculosis in Donor Tissue
Test Code
VBMTB
Description
In very rare instances, donor derived tissue may contain M. tuberculosis complex (MTBC) that can cause infection in transplant recipients. This molecular test may be used to qualitatively identify the presence of MTBC in donor tissue.
Current US guidelines do not require testing for MTBC on donor tissue. This assay is performed on a research use only (RUO) basis, and has been validated as a lab-developed test (LDT) for certain sources using clinical diagnostic testing criteria (CAP/CLIA).
Data from our laboratory suggests that the limit of detection is dependent on the submitter's sample preparation. Therefore, a validation for each submitter's sample type is required.
Collect
Processed donor samples
Unacceptable Conditions
- Specimens not frozen at -70oC or below
- Missing shipment manifest/requisition with specimens or incomplete specimen labeling and documentation
- Inappropriate specimen type
Storage Transport Temp
Specimens should be kept at -70 oC or below, and shipping much be overnight on dry ice.
Specimens must be packaged, shipped, and transported according to the current edition of the Internaltional Air Transport Association (IATA) Dangerous Goods Regulation. Follow shipping regulations for UN 3373 Biological substance, Category B when sending potential MTBC specimens.
Stability
Submit samples refrigeratedPerformed
Sundays, twice per month
Methodology
Real-time PCR for MTBC
Turnaround Time
Approximate turnaround time is 2-14 days.
Department
Infectious Disease Laboratory, Mycobacteriology
Synonyms
MTBC PCR, donor testing
Study Offerings
RUO
CAP/CLIA
Interpretation
Results are Mycobacterium tuberculosis complex Detected or Not Detected.
This test is performed as research use only for donor bone tissue.
CPT Code
N/A - not a clinical test
Billing Codes
VBMTBNew York Approved
Other
New York Approval Comments
This test is not intended for diagnostic testing.FDA
LDT
Other