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AFB Mycobacterium tuberculosis Amplified Direct Detection  

 
IMPORTANT! Pre-approval needed from state or local health department. Local or State Health Department. Send approval to NPHL@unmc.edu or call (402) 559-9444.

NPHL has moved to an electronic ordering system, NUlirt, and it is now the preferred method to order all tests. Once ordered, print a "batch list" (see NUlirt Guide).

Forms Required - Nulirt batch list or NPHL Test Request Form (completed in entirety) must accompany the specimen to include the following information: symptoms and date of onset, pregnancy status, travel and vaccine history. Testing will not be performed without all required information.

Please call NPHL Client Services at (402) 559-2440 or toll free at (800) 334-0459 for further clarification.

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Test: AFB Mycobacterium tuberculosis Amplified Direct Detection Supplemental Forms Required – Mycobacterium tuberculosis (MTB) Supplemental  
Synonym: TBAPR, TB PCR, Qualitative Real Time PCR, TB NAAT  
Method: Cepheid GeneXpert MTB Assay to detect Mycobacterium tuberculosis (MTB) complex directly from sputum  
Availability: Monday - Friday by 0800. STAT testing is not indicated and should not be performed. If for isolation release protocol, two sputum specimens may be tested per patient, but must be collected at least 8 hours apart.  
Specimen: Early morning Sputum (expectorated or induced). Source of specimen indicated on requisition is required. MTB testing must be accompanied by an Acid Fast Bacilli Culture order (AFBCU). Routinely, only one specimen per patient will be tested (If for isolation release protocol, 2 specimens may be tested, but must be at least 8 hours apart.) Positive AFB smears on first time AFB positive patients will be automatically reflexed for testing.
Please note on test request form if sputum from a Cystic Fibrosis patient  
Collection Device: Sputum in a sterile leak-proof container. Gastric aspirate, body fluid and tissue in a sterile leak-proof container. Store and transport refrigerated at 2-8°C.
Specimen Labeling: Test subject to CLIA regulations and required 2 patient identifiers on specimen container and requisition forms  
Volume: 5-20 ml sputum  
Storage/Transport:

Prior to and during shipment:  Refrigerated at 2-8 °C. Place each individual specimen in a sealed bag. Shipping instructions, including specimen-handling requirements during transport:
Package and ship as UN3373 Category B, Biological Substance. Place in biohazard bag with absorbent material. Refrigerated specimen should be shipped on cold packs. Transport by NPHL ground courier (NPHL brown shipper not required). If courier not available, contact Client Services (866) 290-1406 to arrange pickup.    
See instructions and shipping address: http://nphl.org/

 
Unacceptable: Bloody specimens, leaking containers, Non sputum specimen. Swabs.  Specimens with food or solid particles.  
Specimen Stability: Refrigerate 2-8°C up to 7 days  
Reference Interval: Negative
A negative result does not exclude M. tuberculosis complex infection.  
Reportable Disease: MTB complex will be reported immediately to local or state health department. Refer to Nebraska DHHS Title 173, Communicable Diseases  
Comments: This test utilizes quantitative real time PCR technology that can be used on either acid fast bacilli (AFB) smear positive specimens or AFB smear negative specimens. Based on CDC recommendations, the test is appropriate for patients showing symptoms of active pulmonary tuberculosis and for whom the test result would alter case management or TB control activities. A specimen with a first time AFB positive smear on a suspect tuberculosis patient will also be automatically reflexed for Mycobacterium TB Amplified Direct Testing. Only one specimen per patient will be tested. Order in NUlirt   
Revised: 9/2/2020 
If you have questions about proper specimen collection, please call NPHL Client Services at (402) 559-2440 or toll free at (800) 334-0459.

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