Pulmonary Fungal Pathogen Multiplex PCR Panel

1000

87801 x1

Multiplex PCR allows for the simultaneous detection of multiple fungal pathogens from a single sample. This is especially valuable in patients presenting with non-specific respiratory symptoms or community-acquired pneumonia, where fungal infections may mimic bacterial or viral causes. These fungi (Histoplasma, Blastomyces, Coccidiodes, and Pneumocystis) are common causes of opportunistic infections, particularly in HIV-positive or immunocompromised individuals. Early and accurate identification can significantly improve patient outcomes, and in addition, patients may have co-infections with more than one fungal pathogen and multiplex PCR can identify these cases, allowing for more comprehensive treatment planning.

Qualitative Real-Time PCR (Polymerase Chain Reaction)

403 MVista® Histoplasma DNA, PCR: When tested in cultures of 10 8 – 10 9 organisms/mL, cross-reactions occurred with Paracoccidioides brasiliensis, Aspergillus flavus, Aspergillus nidulans, and Aspergillus niger.

404 MVista® Blastomyces DNA, PCR: When tested in cultures of 10 8 – 10 9 organisms/mL, cross-reactions occurred with Cryptococcus neoformans.

405 MVista® Coccidioides DNA, PCR: No cross-reactions or interfering substances were identified during validation.

402 MVista® Pneumocystis DNA, PCR: No cross-reactions or interfering substances were identified during validation.

Bronchoalveolar lavage (BAL) fluid to a sterile, leakproof container. Tracheal aspirate and bronchial wash will be reported with a rare specimen comment.

BAL/Trachial Aspirate*/Bronchial Wash*: 0.5 mL

* Reported with rare specimen comment applied.

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

• CSF, sputum, 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.

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

BAL/Trachial Aspirate/Bronchial Wash: Same Day

Not detected

PCR testing should be done in conjunction with appropriate antigen or antibody testing. 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.

• 402 MVista® Pneumocystis DNA, PCR
• 403 MVista® Histoplasma DNA, PCR
• 404 MVista® Blastomyces DNA, PCR
• 405 MVista® Coccidioides DNA, PCR