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33471/33524 - Cryptococcus qPCR (Lower respiratory) & Cryptococcus qPCR (CSF)

Test Code: 33471/33524

Cryptococcus

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Clinical and Procedure
Clinical Utility

Cryptococcal infections are caused by inhalation of spores of the fungi Cryptococcus neoformans or Cryptococcus gattii. This infection primarily affects the lungs but can spread to other organs, most notably the central nervous system (meningitis). Can range from mild to life-threatening, particularly in immunocompromised individuals (e.g., people with HIV/AIDS). Early initiation of antifungal therapy is crucial for optimal outcomes. However, Cryptococcal infections are now detected across the United States and this is suspected due to climate change and the travel habits of people. The utility of PCR (using a BAL, sputum or CSF specimen) has brought on advances in the detection and therapeutic monitoring, leading to increased survival rates and increased quality of care.

Procedure

Extraction of fungal DNA from BAL, CSF, or sputum specimens followed by PCR amplification of 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

All specimens were positive for UIC, with CT values ≤35.
No signal was detected in the following off-target fungal, bacterial, and viral pathogens:

Aspergillus fumigatus Escherichia coli 11775 Parainfluenza 4B VR-1377
Adenovirus strain 24 Enterococcus faecalis ATCC 35550 Rhinovirus VR-1645
Burkholderia cepacia 13945 Haemophilus influenzae 8142 RSV A VR-26
Blastomyces parvus ATCC 10785 Human Coronavirus ATCC 25238 RSV B VR-1794
Candida albicans ATCC 18804 Influenza A H1N1 A/New Jersey/8/76 Staphylococcus aureus 12600
Candida auris MYA-5002 Influenza B VR-295 Staphylococcus epidermidis 35547
Candida glabrata ATCC 66032 Klebsiella pneumoniae 35555 Serratia marcescens 264
Candida krusei ATCC 6258 Mycobacteroides abscessus Streptococcus pneumoniae Z 022
Candida parapsilosis ATCC 22019 Moraxella catarrhalis ATCC 25238 Streptococcus pyogenes ATCC BAA-947
Candida tropicalis ATCC 750 Mucor racemosus ATCC 42647 SARS CoV-2
Coxsackievirus B4 0810075CF Pseudomonas aeruginosa 35422 Swine Flu VR-1737
Enterobacter cloacae ATCC 35549 Paracoccidioides brasiliensis ATCC 10237  
Turnaround Time

Same day (< 24 hours from receipt of specimen), Monday through Saturday.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
Lower respiratory 33471 87798 No

5 mL (min. 0.5 mL)*

Assay Range for C. neoformans is 250 copies/mL to 1.25E+09 copies/mL 

Assay Range for C. gattii is 400 copies/mL to 1.25E+09 copies/mL

• If reflex NGS testing is being considered please submit at least 5 mL of BAL.*
• Collect in a sterile, screw top tube.
• Store frozen and ship on dry ice for overnight delivery.

CSF 33524 87798 No

2 mL (min. 0.5 mL)

Assay Range for C. neoformans is 276 copies/mL to 1.25E+09 copies/mL 

Assay Range for C. gattii is 250 copies/mL to 1.25E+09 copies/mL

• Collect in a sterile, screw top tube.
• Store frozen and ship on dry ice for overnight delivery.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Eurofins Viracor test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 18000 W 99th St. Ste, #10, Lenexa, KS 66219.

Causes for Rejection

Respiratory sample received in trap, specimen received outside stability, insufficient specimen volume 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. https://www.cdc.gov/cryptococcosis/index.html
2. https://www.cdc.gov/cryptococcosis/testing/index.html
3. Cryptococcal Disease in Diverse Hosts. David B. Meya, M.B., Ch.B., Ph.D., and Peter R. Williamson, M.D., Ph.D. N Engl J Med 2024;390:1597-610. DOI: 10.1056/NEJMra2311057
4. Pyrgos V, Seitz AE, Steiner CA, Prevots DR, Williamson PR. Epidemiology of cryptococcal meningitis in the US: 1997–2009. PLoS One 2013; 8(2): e56269.
5. Castelblanco RL, Lee M, Hasbun R. Epidemiology of bacterial meningitis in the USA from 1997 to 2010: a population based observational study. Lancet Infect Dis 2014; 14: 813-9.
6. Brizendine KD, Baddley JW, Pappas PG. Predictors of mortality and differences in clinical features among patients with cryptococcosis according to immune status. PLoS One 2013; 8(3): e60431.
7. World Health Organization. WHO fungal priority pathogens list to guide research, development and public health action. October 25, 2022 (https://www.who.int/publications/Cryptococcus gattii Species Complex as an opportunistic pathogen: underlying medical conditions associated with the infection. mBio 2021; 12(5): e0270821.

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