Bruker has introduced the new, CE-IVD marked Fungiplex Candida fast diagnostic assay, a multiplex real-time PCR test for the rapid identification of the most common pathogens associated with invasive candidiasis (IC). The new Fungiplex Candida assay does not require any culture steps, and typically gives results in just 2–3 hours directly from patient blood, plasma, or serum samples.
The company has also introduced the CE-IVD marked Micronaut-AM (antimycotics) test plate for the automated or manual antifungal susceptibility testing (AFST) of yeasts from cultures. Micronaut-AM is from the product range of recently acquired Merlin Diagnostika GmbH, a leader in specialty susceptibility testing products across a range of human and veterinary application areas.
The new Fungiplex Candida assay is a multiplex real-time PCR test for the most common pathogens associated with IC, a major cause of morbidity and mortality in health care environments. The sensitivity of blood culture for diagnosing IC is low, typically reported at 50 percent, and is coupled with slow turnaround times of 2–3 days. Delayed diagnosis and delays to the initiation of appropriate treatment are associated with high mortality and extended hospital stays. The assay enables the early identification of Candida infection without the need for blood culture and is validated against DNA extracted from whole blood, serum, and plasma. Fungiplex Candida detects the main causative pathogens of IC: C. albicans, C. parapsilosis, C. tropicalis, C. dubliniensis, and differentiates C. krusei and C. glabrata.
The assay reports the identification results in less than 2 hours from DNA extraction and displays excellent clinical performance, in a user friendly format compatible with existing laboratory equipment. This assay delivers the potential to aid earlier diagnosis, reduce hospital spend, and improve patient outcomes.