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33350 - NTM Nontuberculous Mycobacteria RT PCR Panel

Test Code: 33350

33350 - Nontuberculous Mycobacteria RT qPCR Panel

Nontuberculous Mycobacteria (NTM) are environmental organisms that can be found in soil, dust, and water including natural water sources (such as lakes, rivers, and streams) and municipal water sources (such as water that people drink or shower in). NTM can form difficult-to-eliminate biofilms, which are collections of microorganisms that stick to each other, and adhere to surfaces in moist environments, such as the insides of plumbing in buildings. Although anyone can get an NTM infection, NTM are opportunistic pathogens placing some groups at increased risk, including those with underlying lung disease or depressed immune systems. These pathogens are typically not transmitted person-to-person. However, person-to-person transmission of M. abscessus has been reported in patients with cystic fibrosis. Nontuberculous mycobacteria (NTM) are mycobacteria other than M. tuberculosis (the cause of tuberculosis) and M. leprae (the cause of leprosy). NTM are also referred to as atypical mycobacteria, mycobacteria other than tuberculosis (MOTT), or environmental mycobacteria. Nontuberculous mycobacteria pulmonary disease (NTM-PD) is often overlooked as awareness of the disease has previously been low. Testing rates are often variable and the overlap in symptoms of NTM-PD and co-existing lung disease means that it is likely to be significantly underdiagnosed.

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Clinical and Procedure
Clinical Utility

Mycobacterium avium complex, also referred to as MAC, consists of multiple species of mycobacteria. They include Mycobacterium avium and Mycobacterium intracellulare. These species, which can be difficult to differentiate, can cause disease and are found in various environmental settings across the globe. Several different syndromes are caused by Mycobacterium avium complex. For those who are immuno-compromised, it can often take the form of a pulmonary pathogen. Disseminated infections are usually associated with HIV infection. In HIV infected persons, manifestations may include night sweats, weight loss, abdominal pain, fatigue, diarrhea and anemia. Less commonly, pulmonary disease in non immunocompromised persons is a result of infection with MAC.

Mycobacterium abscessus complex (MAbC) is one of the most clinically relevant species among nontuberculous mycobacteria. MAbC’s prevalence has increased over the last two decades. These increases can be explained by high rates of antimicrobial resistance seen in MAbC.

About the Test

If not diagnosed early enough and left unchecked, NTM chronic lung disease can lead to a decline in lung function, worsening symptoms, and a decrease in the overall quality of life for patients. Early diagnosis is critical for the appropriate management of nontuberculous mycobacterial (NTM) lung disease. NTM lung disease can often be missed due to its nonspecific or overlapping symptomatology in patients with underlying structural lung disease, resulting in NTM being undiagnosed or misdiagnosed. Despite it's increasing prevalence, the index of suspicion for NTM lung disease remains low, making early diagnosis an ongoing challenge. Molecular diagnostics (PCR) allow for a sensitive and specific means of detecting these pathogens in samples without the extended turn-around times associated with culture.

Procedure

Extraction of genomic DNA from lower respiratory specimens is followed by the amplification of specific DNA targets using real-time PCR methods. An internal control is added to ensure that extraction was performed correctly and that the PCR reaction was not inhibited.

Specificity

MAbC: Mycobacterium abscessus, subsp. abscessus, subsp. bolletii, subsp. massiliense.
No cross reactivity:  Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Neisseria meningitidis, Staphylococcus aureus, Pseudomonas aeruginosa, Streptococcus pneumoniae, Burkholderia cepacian, Serratia marcescens, Cryptococcus neoformans, Candida auris, Candida albicans, human coronavirus 229E, human adenovirus 24, coxsackievirus B5, influenza A 2009 H1N1, human metapneumovirus, influenza A H3N2, influenza B, parainfluenza virus 2, human rhinovirus, RSV A, RSV B, SARS-CoV2

MAC: Mycobacterium avium, subsp. avium, subsp. paratuberculosis, subsp. hominissuis, subsp. sylvaticum, Mycobacterium intracellulare, Mycobacterium intracellulare, subsp. chimaera, Mycobacterium colombiense.
No cross reactivity: Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Neisseria meningitidis, Staphylococcus aureus, Pseudomonas aeruginosa, Streptococcus pneumoniae, Burkholderia cepacian, Serratia marcescens, Cryptococcus neoformans, Candida auris, Candida albicans, human coronavirus 229E, human adenovirus 24, coxsackievirus B5, influenza A 2009 H1N1, human metapneumovirus, influenza A H3N2, influenza B, parainfluenza virus 2, human rhinovirus, RSV A, RSV B, SARS-CoV2

Mycobacterium spp.: Inclusivity established with: Mycobacterium abscessus, subsp. abscessus, subsp. bolletii, subsp. massiliense, Mycobacterium avium, subsp. avium, subsp. paratuberculosis, subsp. hominissuis, subsp. sylvaticum, Mycobacterium intracellulare, subsp. chimaera, Mycobacterium colombiense, Mycobacterium fortuitum, Mycobacterium kansasii, Mycobacterium simiae, Mycobacterium terrae, Mycobacterium xenopi, Mycobacterium scrofulaceum, Mycobacterium malmoense, and Mycobacterium gordonae.

The Mycobacterium spp. assay will detect M. tuberculosis; however, it does not differentiate species. If M. tuberculosis is suspected and a Detected result is returned, the sample should be re-tested for M. tuberculosis using an independent method.

Turnaround Time

24-48 hours after receipt of specimen.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
Lower respiratory 33350 87551, 87552 and 87561 No

2 mL (min. 0.5 mL)

MAbC only: subsp. abscessus
LLoQ = 1000 copies/mL

subsp. bolletii
LLoQ = 1,000 copies/mL

subsp. massiliense
LLoQ = 1,000 copies/mL

BAL, Bronch/Trach Wash, Sputum

  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 4 days of collection.
Shipping

Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 4 days of collection.

Causes for Rejection

Specimens received in trap containers, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Eurofins Viracor’s interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

1. A rare case of Nocardia and non-tubercular mycobacteria coinfection of lung, bone and joints in a young female Dipankar Pal*, Arindam Naskar, Soumyadip Chatterji, Manab Kumar Ghosh, Shekhar Pal, Dushyant Lahre and Amartya Kumar Misra
2. Pulmonary nocardiosis caused by Nocardia cyriacigeorgica in patients with Mycobacterium avium complex lung disease: two case reports Kazuma Yagi1 , Makoto Ishii1*, Ho Namkoong1 , Takahiro Asami1 , Hiroshi Fujiwara2 , Tomoyasu Nishimura3 , Fumitake Saito1 , Yoshifumi Kimizuka1 , Takanori Asakura1 , Shoji Suzuki1 , Tetsuro Kamo1 , Sadatomo Tasaka1 , Tohru Gonoi4 , Katsuhiko Kamei4,5, Tomoko Betsuyaku1 and Naoki Hasegawa
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850244/#:~:text=Hence%2C%20the%20incidence%20can%20only,19]%2C%20[20].
4. Non-tuberculous mycobacterial infections in solid organ transplant recipients: An update Cybele L. Abad* and Raymund R. Razonable
5. Prevalence of Nontuberculous Mycobacteria in Cystic Fibrosis Clinics, United Kingdom, 2009 - Volume 19, Number 7—July 2013 - Emerging Infectious Diseases journal - CDC
6. Mycobacterium Avium Intracellulare - StatPearls - NCBI Bookshelf (nih.gov)
7. Nontuberculous Mycobacteria (NTM) Infections | HAI | CDC
8. Mycobacterium avium complex-associated cholecystitis in AIDS patient: a case description and review of literature - PubMed (nih.gov) Firas El Chaer 1, Nadine Harris 1, Hana El Sahly 1 2, Vagish Hemmige 1, Elvia Martinez Blanco 3, Laila Woc-Colburn 4
10. Mycobacterium abscessus complex: A Review of Recent Developments in an Emerging Pathogen - PMC (nih.gov) Laura Victoria, 1 , 2 , * Amolika Gupta, 3 Jose Luis Gómez, 3 and Jaime Robledo 1 , 2
11. Failure to Recognize Nontuberculous Mycobacteria Leads to Misdiagnosis of Chronic Pulmonary Tuberculosis (plos.org) Mamoudou Maiga
12. Diagnosis and Treatment of Nontuberculous Mycobacterial Lung Disease: Clinicians' Perspectives – PMC (nih.gov) Yon Ju Ryu, M.D.,1,* Won-Jung Koh, M.D.,2,* and Charles L. Daley, M.D

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