Mycobacterium avium complex (MAC) PCR
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| WSLH Department: | CDD - Communicable Disease Division |
| WSLH Test Code: | MM00260 |
| Day(s) Performed: | Monday - Friday |
| Turn-around Time: | 1-3 days |
| Recommended Uses: | CDC recommends that TB NAAT be performed on at least one respiratory specimen from each patient with signs and symptoms of pulmonary TB for whom diagnosis of TB is being considered but has not yet been established, and for whom the test would alter case management or TB control activities, such as contact investigations (MMWR. 2009; 58: 7-10). M. avium complex PCR can be used to release a patient from respiratory isolation in the case of a smear positive, TB PCR negative result. |
| Pre-approval: | N |
| Contraindications: | Specimens from patients who have been undergoing antimicrobial therapy for MAC for more than 7 days (in the past 12 months) are not appropriate for this assay. Testing is not recommended for patients for whom suspicion of TB or M. avium complex infection is low. |
| Additional Tests Performed: |
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| Preparation for Collection: | Collect specimens prior to anti-mycobacterial drug treatment or within 7 days of start of therapy. Sterile preparation of site if applicable. |
| Specimen Requirements: | ** Submit 3-10 mL of a primary respiratory specimen (sputum, tracheal aspirate, bronchial washings, BAL). For primary, non-respiratory specimens (body fluids, CSF, stool, urine, lung and other tissues), please use the "Mycobacteriology Culture and Smear" section of the WSLH Reference Manual for recommended specimen volumes. Specimens with visible blood will be accepted. If AFB smear has not been performed, WSLH will perform AFB smear and culture testing and the submitter will be billed. ** Submit 0.5mL of decontaminated and/or concentrated sediment. ** All specimens should be submitted in sterile, leak-proof containers. ** If a specimen from a non-sterile site has not been decontaminated, WSLH will perform decontamination and the submitter will be billed. ** MAC PCR must be performed within 7 days of specimen collection. |
| Collection Instructions: | See Mycobacteria (AFB) Smear and Culture (MM00250) for detailed specimen requirements, patient preparation and collection instructions. |
| Collection Kit/Container: |
Mycobacteria (AFB,TB) Gastric Specimens
TB Sputum/Legionella |
| Requisition Form: |
CDD Requisition Form A
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| Required Information: | Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. |
| Rejection Criteria: | Specimens from patients who have received anti-mycobacterial drug treatment for more than 7 days in the past 12 months should not be submitted for this assay. Smear-negative specimens are not acceptable. |
| Specimen Handling: | Store specimens at 2-8 degrees Celsius. Ship with cool pack. Use pressure-resistant bags as inner packaging. |
| Packaging Requirements: | |
| Courier Information: | |
| Specimen Receiving Hours: | Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM |
| Results Include: | |
| Limitations: | **This real-time PCR assay detects the presence of M. avium complex DNA in clinical specimens. It detects a target in the 16S-23S internal transcribed spacer, which is specific for members of M. avium complex (M. avium, M. avium subsp. avium, M. avium subsp. paratuberculosis, M. intracellulare, M. chimaera, M. arosiense, M. colombiense, M. marseillense, M. bouchedurhonense, and M. timonense). This assay was developed and its performance characteristics determined by the Wisconsin State Laboratory of Hygiene. It has not been approved by the U.S. Food and Drug Administration. **MAC PCR is only performed on smear positive specimens due to limitations in sensitivity of the test. A negative result does not rule out infection with M. avium complex. **MAC PCR must always be performed in conjunction with mycobacterial culture and smear. |
| Additional Tests Recommended: | **For smear-positive, MAC PCR-negative results, consider testing a second smear-positive specimen to confirm the PCR result. No more than two specimens should be tested. **M. avium complex susceptibility if clinically warranted. |
| Additional Comments: | We recommend contacting the laboratory before submitting specimen to arrange for testing and transport: 800-862-1013. |
| Methodology: | This real-time PCR assay detects the presence of M. avium complex DNA in clinical specimens. It detects a target in the 16S-23S internal transcribed spacer, which is specific for members of M. avium complex (M. avium, M. avium subsp. avium, M. avium subsp. paratuberculosis, M. intracellulare, M. chimaera, M. arosiense, M. colombiense, M. marseillense, M. bouchedurhonense, and M. timonense). |
| Includes: | Nucleic acid amplification test (NAAT) for direct detection of M. avium complex DNA in human respiratory and non-respiratory specimens |
| Regulatory Compliance: |
| CPT Code: | 87561x1 |
| Price: | $175.00 Price Effective 1/1/25 |
| Fee Exempt Eligible: | N |
| Billing and Revenue Office: | 1-800-862-1065 arbill@slh.wisc.edu |