Candida albicans Real-time PCR Kit, IVD

NZYtech’s Candida albicans Real-time PCR Kit, IVD, provides the set of reagents, enzymes, and oligonucleotides (primers and probes) for the qualitative detection of the C. albicans genome, using the real-time PCR technique. The kit detects the RPR1 gene which was previously identified as a good genetic marker for C. albicans. NZYtech’s Candida albicans Real-time PCR Kit, IVD, was designed to have a broad detection profile, while remaining specific to the C. albicans genome. The kit’s primers and probes have 100% homology to 100% of the C. albicans sequences available in the GenBank database (November, 2022). In addition, the set of oligonucleotides was specifically designed for the detection of this organism and do not show significant homology with other genomes, which reflects the high specificity and detection sensitivity of the test. As such, the kit was designed to be specific to C. albicans genome and to avoid detection of other organisms causing vaginal infections. The internal control, included in kit, validates the efficacy of the extraction process as well as the absence of PCR inhibitors potentially present in the human biological samples. Periodically, NZYtech revisits C. albicans target gene sequence and, if necessary, will release a new version of this kit. Additionally, the kit includes two external controls (a positive control and a negative control) as described below. The positive control consists of nucleic acid fragments that contains the two target sequences detected by the kit (RPR1 gene and human β-actin gene).

In this kit, the qualitative detection of DNA is based on the real-time PCR technology, which is a reference methodology in laboratory diagnosis. It is a methodology of high sensitivity ans specificity to accurately detect the presence of this organism. NZYtech Candida albicans Real-time PCR Kit, IVD, is based on the principle of researching the presence of Candida fungus DNA, isolated and purified with a extraction system. The extracted DNA is subjected to a PCR amplification, in a single reaction, using two highly specific primer/probe sets exploiting the TaqMan® principle. In the presence of C. albicans DNA, from infected patients, the TaqMan® probe specifically binds to conserved regions of the RPR1 gene which are flanked by two specific primers pairs. A second primers/probe set acts as an internal control, detecting a sequence of nucleic acids of human β-actin gene (ACTB), which thus allows confirming the efficiency of the process of capturing the biological material collected from the patient. In addition, this internal control demonstrates that no reaction inhibition has occurred by PCR inhibitors potentially present in the clinical/environmental samples. To allow identification of the amplification of the two specific targets in a single reaction, probes specific for C. albicans and for human β-actin are labelled with FAM™ and HEX™ reporter dyes, respectively. Thus, this kit consists of a duplex assay which the target referring to C. albicans is detected in the optical FAM optical channel and the human target gene is detected in the HEX optical channel. These oligonucleotide/probe sets are provided in optimized concentrations to ensure amplification of human DNA, even when present at extremely high concentrations, does not limit the efficiency of the C. albicans primers/probe sets.

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