PNEUMOCYSTIS DNA PCR TEST

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87798 x1

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. This real-time PCR assay provides 96.7% sensitivity and 100% specificity, with a limit of detection of 4.6 copies/µL for detection of Pneumocystis from bronchoalveolar lavage (BAL) fluid.

Qualitative Real-Time PCR (Polymerase Chain Reaction) on the Roche Lightcycler® 480 II

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

BAL, sputum, tracheal aspirate*, or bronchial wash* in a sterile leak-proof container.

* Reported with a rare specimen comment applied.

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

• CSF and all other non-respiratory samples.
• 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.

• Refrigerated with ice packs
• Frozen

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

A Detected (positive) result indicates presence of Pneumocystis jirovecii DNA. It does not rule out the presence of or co-infection with other organisms, and Pneumocystis jirovecii may not be the causative agent of the clinical symptoms.

A Not Detected (negative) result indicates that Pneumocystis jirovecii DNA was not present at a level above the limit of detection. It does not exclude the presence of Pneumocystis jirovecii.

Results should be correlated with clinical presentation and history.

This test was developed, and its analytical performance characteristics 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.