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Testing Donor Tissue for M. Tuberculosis Complex

Donor tissue may have a detectable presence of Mycobacterium Tuberculosis complex (MTBC) or nontuberculous mycobacterium (NTM), which may be transmitted to patients. The FDA has recently issued new guidance recommending the screening of donor tissue for Mtb infection or contamination before use to reduce the risk of transmission.

National Jewish Health Advanced Diagnostic Laboratories offers customized extraction and detection testing for donor tissue samples to help determine sample safety.

About Donor Tissue Sample Testing

Advanced Diagnostic Laboratories has developed a unique semi-automated, rapid turnaround PCR assay for MTBC detection from viable bone matrix. In addition, we can design custom detection protocols, supported by culture, for two-stage verification of potential organisms in donor tissue that will help you accurately pre-screen donor tissue samples.

PCR and Cell Culture Methods for Donor Tissue Screening

  • All potential MTBC samples must be handled in a BSL3 laboratory.
  • FDA guidelines recommend screening donor tissue before use. National Jewish Health recommends dual-method testing to ensure the highest accuracy for detection of potential MTBC.
  • Evaluation for suitability to detect inhibition recommended.
  • Test is performed as Research Use Only (RUO) for donor tissue pre-screening.



View FDA Guidance - Jan 2025


Our Expertise

National Jewish Health Advanced Diagnostic Laboratories has extensive experience diagnosing tuberculosis (TB) and mycobacterial diseases, dating back to 1899. Our Mycobacteriology Laboratory is recognized worldwide as a leading diagnostic laboratory for MTBC and NTM.



How to Order

Call 303.398.1669 or email ADxSales@njhealth.org to speak with our business development team about how we can partner to meet your tissue testing needs.