PNEUMOCYSTIS DNA PCR TEST

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87798

Pneumocystis jirovecii (formerly known as Pneumocystis carinii) is an opportunistic fungal pathogen that causes life-threatening Pneumocystis pneumonia (PCP) in immunocompromised patients, including those with HIV. Patients may present with non-specific symptoms such as fever, cough, shortness of breath, and fatigue. Pneumocystis cannot be cultured in vitro and has classically been diagnosed based upon clinical symptoms and radiographic findings with confirmation via microscopic visualization of stained organisms which has lower sensitivity that is reliant upon reader expertise.

Qualitative Real-Time PCR (Polymerase Chain Reaction)

No cross-reacting organisms or interfering substances were identified during validation.

Transfer 0.5 mL of bronchoalveolar lavage (BAL) fluid or sputum to a sterile, leakproof container. Tracheal aspirate and bronchial wash will be reported with a rare specimen comment.

BAL, sputum, tracheal aspirate*, or bronchial wash* = 0.5 mL

* Reported with a rare specimen comment applied.

BAL

• Room Temperature/Ambient: 30 days
• Refrigerated: 30 days
• Frozen: 30 days

Sputum

• Refrigerated: 14 days
• Frozen: 14 days

• Two unique patient identifiers are required on the specimen container.
• Specimens with particulate matter or viscosity that would not allow the specimen to be pipetted will be rejected.

Samples may be shipped on dry ice or frozen ice packs.

Ship on dry ice to arrive Monday-Friday using a next day delivery service. Frozen ice packs may be substituted if sample is shipped the day of collection.

24-48 hours, Monday through Friday

Not detected

PCR testing should be done in conjunction with other clinical diagnostics. A positive PCR result indicates the DNA was detected in the sample and that organism could be the cause of disease. Some organisms (molds and yeasts) can be commensals (or colonizers) and found in non-sterile locations such as the respiratory, GI, and urinary systems – without causing disease. A negative result indicates DNA was not detected in the sample but does not rule-out that organism as the cause of disease. All results should be interpreted considering the full clinical picture.

This test was developed, and its analytical performance characteristics were determined by MiraVista Diagnostics. It has not been cleared or approved by the FDA; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.