Pneumocystis jirovecii DNA, Qualitative Real-Time PCR

Test Code

18835

Alias/See Also

LAB1936

Preferred Specimen

1 mL bronchoalveolar lavage, bronchial wash or sputum or
3 mm3 of tissue in a sterile leak-proof container

Minimum Volume

0.5 mL • 3 mm3

Transport Container

Plastic sterile leak-proof container

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: 24 hours
Refrigerated: 7 days
Frozen: 30 days

Methodology
Real-Time Polymerase Chain Reaction (PCR)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Mon-Sat; Report available: 2-3 days

Clinical Significance

This test is intended for HIV-positive and immunocompromised individuals with clinical presentation and/or radiographic findings consistent with P. jirovecii infection. This assay can be used to aid in the diagnosis of P. jirovecii pneumonia (PCP), enabling the initiation of specific therapy. The PCR test has higher sensitivity and specificity when compared to alternative diagnostic methods such as staining (GMS, Calcofluor white, DFA), (1,3) β-D-glucan test or imaging studies. Due to the analytical sensitivity of this assay, the test can be positive in colonized individuals without clinical evidence of PCP. The results of this test should be interpreted in the context of pertinent clinical findings and history.

Reference
1. Bateman M, et al. Medical Mycology. 2020;58 :1015-1028.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.