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DIRECT DETECTION FOR NUCLEIC ACID OF M. TUBERCULOSIS COMPLEX – BD MAX MDR-TB ASSAY

Synonym(s):

​TB PCR, BD MAX MDR-TB Assay

Lab Section Category

Description

Indications

Specimen Required

As for Mycobacterial Culture, except that blood and bone marrow specimens should be collected in sterile screw-capped containers or plain Vacutainer tubes (NOT in Myco-F-Lytic vials) and delivered to the lab immediately. If delay is unavoidable, collect in EDTA or citrated tubes, though amplification results may be less consistent.  

Samples should be collected in sterile screw-capped containers and delivered to the lab immediately.

Storage and Transport

Collect in a dedicated container. Do not order non-CTBL tests using the same request form and on the same specimen. Specimens should reach CTBL within 24 hours of collection. If transport delay is unavoidable, store at 40C.

Method

​BD Max MDR-TB Assay using Real-time Polymerase Chain Reaction

Test Results

M. tuberculosis complex DNA Detected / Not detected / Indeterminate

Mutation in rpoB gene leading to Rifampicin resistance  Detected / Not detected / Indeterminate

 

Mutation in katG and inhA genes leading to Isoniazid resistance Detected / Not detected / Indeterminate

Reference Interval / Value

Turnaround Time

1-2 working days

Day(s) Test Set up

Monday - Friday

Remarks

Reflex Testing: These tests only provide preliminary information for empirical TB management. A reflex AFB culture, including an AFB smear for respiratory samples if the volume is adequate, is also set up for each specimen. These additional tests are chargeable. Written instruction from the doctor is necessary if these are not to be performed.

Change History Notes

Others

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