Candida Real-time PCR Panel

Candida Real-time PCR panel for the rapid identification/detection of Candida albicans, C. glabrata, C. tropicalis, C. krusei, C. parapsilosis & C. auris. Allowing for appropriate anti-fungal therapy or modification of therapy with patients afflicted with one of the targeted organisms - many which have known drug resistance.

About Candida:

The incidence of candidemia has been rising worldwide over the last decades, amounting to be the fourth highest bloodstream infection in hospitalized patients.  This is believed to be due to the increase in predisposing factors, such as immunosuppression, critical illness, advanced age, the use of broad-spectrum antibiotics, as well as indwelling venous catheters¹.  Currently, clinicians utilize culture methods to ID Candida species, resulting in long turnaround times and sometimes misdiagnosis.  This Candida real-time PCR panel is a diagnostic qPCR assay detecting six clinically relevant Candida species to allow clinicians to rapidly treat patients identified with one or more of the six drug resistant Candida species in one sample type.

Candidiasis is a multifaceted disease caused by the yeast Candida.  Candida is a normal colonizer of the human body, living in places such as the mouth, throat, intestinal tract, and vulva-vaginal area.  When Candidiasis becomes invasive it is a serious infection, infecting the blood stream or internal organs.  Often times people who develop Candidiasis have underlying medical conditions which makes it difficult for clinicians to diagnose without supplementary testing. 

As an entity, candidemia is one of the most common healthcare-associated bloodstream infections in US hospitals, typically ranking as the third or fourth most common cause of healthcare–associated bloodstream infection.  The continued reliance on blood cultures, which are notoriously insensitive as markers of disease, remains a significant obstacle to early intervention for this condition. The development of reliable nonculture assays is critical to providing the opportunity for earlier intervention and more targeted antifungal therapy among large numbers of patients in whom traditional blood cultures are insensitive or provide untimely results.  Each Candida species presents its own unique characteristics with respect to tissue tropism, propensity to cause invasive disease, virulence, and antifungal susceptibility. Mucosal Candida infections—especially those involving the oropharynx, esophagus, and vagina—are not considered to be classically invasive disease.

Candidemia is one of the most common bloodstream infections in the U.S., with an incidence rate of approximately 9 per 100,000 people or roughly 25,000 each year.  Due to the symptomology similarities to bacterial or viral infections clinicians will either obtain a blood sample or a sample from a suspected infection site for specialized laboratory testing (serological or culturing).  The Candida yeast generally grows easily on standard culture media, but it can still take several days for proper identification to the species level.  The CDC has reported that several “automated” identification systems for yeast misidentify C. auris.  Polymerase Chain Reaction technology does not have this limitation.

Extraction of genomic acid from whole blood specimen followed by PCR amplification of targets using real-time PCR methods. An internal control is added to ensure that extraction was performed correctly, and that the PCR reaction was not inhibited.

No cross reactivity was observed with off target bacterial and fungal blood borne pathogens.