Fungiplex® Pneumocystis IVD PCR

PCP is an opportunistic infection, occurring more commonly in people with a weakened immune system, and is now more prevalent in the HIV-negative at-risk population, where the patient population for pneumocystosis is similar to those at risk of other fungal diseases (aspergillosis and candidiasis).
Low sensitivity of microscopy techniques leads to poor clinical outcomes in patients with haematological malignancies due to the disease being associated with much lower fungal loads than in the HIV patient cohort.
Rapid, reliable diagnostics support physicians in the timely treatment of patients with appropriate drug therapy for improved patient outcomes.
PCR is now recommended for the routine diagnosis of PCP,¹ and can help to understand the differences in fungal load across the many patient risk groups.

¹ A. Alanio et al J Antimicrob Chemother (2016) 71: 2386–2396 DOI: https://doi.org/10.1093/jac/dkw156

The Fungiplex^® Pneumocystis IVD PCR Kit is a real-time PCR designed to detect Pneumocystis jirovecii as well as a beta-actin gene endogenous control. The beta-actin gene is included to provide information on the quality of the sampling and ensure that sufficient viable material is present to identify Pneumocystis infection.
The Fungiplex^® Pneumocystis PCR is quantitative and 5 DNA standards are provided at appropriate concentrations to generate a standard curve enabling sample quantification. Quantification is important for patients at risk of PCP and can determine the difference between infection and colonisation with this ubiquitous fungus.
Detection of P. jirovecii DNA by quantitative real-time PCR from respiratory tract specimens is included as mycological evidence for ‘Probable’ invasive pneumocystosis, according to the EORTC/MSGERC definitions.<sup>2

2</sup>  J. P. Donnelly et al Clin Infect Disease (2019) DOI: https://doi.org/10.1093/cid/ciz1008
 

The Fungiplex^® Pneumocystis IVD PCR Kit provides results in just over 1 hour from extracted DNA, helping the laboratory support clinical decision-making when time matters. 

The Fungiplex^® Pneumocystis IVD PCR Kit is suitable for the routine testing of patients at risk of PCP, and is compatible with samples taken for other biomarker tests:

• Validated on DNA extracted from bronchial lavage samples, both bronchoalveolar lavage (BAL) and non-directed bronchial lavage (NBL)
• Validated on DNA extracted from throat swabs.
  
  

The Fungiplex^® Pneumocystis IVD PCR Kit is provided in an easy to use master mix format and is designed to run on the following existing laboratory equipment:

• ABI 7500
• ABI QuantStudio 5
• Bio-Rad CFX
• Hain FluoroCycler® XT
• Roche Lightcycler 480 II
• Qiagen RotorGene.

The thermal cycling conditions are consistent with all other PCRs in the Fungiplex^® range and therefore can be combined with multiple diagnostic tests in the same analysis.