MycoReal® Kit Pneumocystis

Detection of the mt LSU gene of Pneumocystis jirovecii.

Background: Pneumocystis jirovecii (formerly Pneumocystis carinii) is a yeast-like fungus which can be found worldwide. Pneumocystis jirovecii is a distinct species that only infects humans, while the related species P. carinii can be found in rodents and other mammals. Airborne transmission of Pneumocystis from host to host has been demonstrated in rodent models and several observations suggest that interindividual transmission occurs in humans. Both healthy and immunocompromised people can be colonised with P. jirovecii. While it does not affect healthy people, P. jirovecii can cause an interstitial Pneumocystis-pneumonia (PCP) in HIV-patients, persons with primary immune deficiencies, including hypogammaglobulinemia and severe combined immunodeficiency (SCID), patients receiving long-term immunosuppressive regimens for connective-tissue disorders, vasculitides, or solid-organ transplantation, patients with hematologic and nonhematologic malignancies, including solid tumors and lymphomas, and persons with severe malnutrition. Currently the diagnosis of PCP relies on microscopic methods or PCR, as P. jirovecii cannot be cultured in routine microbiology laboratories. The detection of P. jirovecii in high-risk patients indicates a Pneumocystis-pneumonia.

Description: MycoReal® Kit Pneumocystis is a non-automated IVD test, based on real-time PCR, for the qualitative detection of DNA (mt LSU gene) of P. jirovecii. Proper specimens are DNA extracts of samples from the human respiratory tract (bronchoalveolar lavage, BAL). This test is suitable for patients of all ages with suspected infection with P. jirovecii and is intended as an aid in the diagnosis of infection with this pathogen in combination with patient history and additional clinical information. The test is for professional use only and the use is limited to qualified personnel instructed in real-time PCR and in vitro diagnostic procedures. A probe-specific amplification-curve in the FAM channel indicates the amplification of P. jirovecii specific DNA. An internal DNA positive control (DNA IPC) is detected in Cy5 channel and is used as DNA extraction as well as real-time PCR inhibition control. The target for the DNA IPC (artificial target DNA) is extracted with the sample.

Product Features:
- Amplification and detection: mt LSU of Pneumocystis jirovecii
- Real-time PCR with rapid hot-start Taq DNA polymerase
- ROX™ dye as passive reference
- Internal Positive Control System to exclude false-negative results
- Optimized to handle PCR inhibitors
- PCR- platforms: runs on all established standard real-time PCR- platforms
- Harmonized thermal profiles to run RNA and DNA samples simultaneously