Mobidiag’s new Prove-it™ Sepsis application for Fungi is a DNA-based rapid assay detecting fungi directly from positive blood culture, or pure culture specimen. The assay identifies 7 most relevant Candida species, and 6 targets more in the combined Pan-Yeast detection. The fungal application can be added on to the bacterial detection of the Prove-it™ Sepsis assay, covering altogether almost 80 sepsis-causing pathogens.

“Mobidiag’s product family is growing again due to the great flexibility of the Prove-it™ technology”, said Jaakko Pellosniemi, CEO of Mobidiag. “The Prove-it™ StripArray platform has large content capacity and therefore, new capture oligos detecting more targets can be added onto the same microchip and even whole new applications designed”, he continued. “The application for Fungi is already in use as a research-use-only product, and has been tested with hundreds of clinical samples. The data acquired thus far is excellent”, Pellosniemi concluded. Mobidiag is currently stating up evaluations to CE-IVD mark the application during the year 2010.

The Lancet published impressive results of Prove-it™ Sepsis study

Identification of sepsis-causing bacteria using a new microarray platform is highly accurate and delivers results an average of 18 hours faster than the conventional culture-based system. These are the conclusions of Prove-it™ Sepsis clinical evaluation published in The Lancet*, one of the world’s leading medical journals. Article e-prints are available at Mobidiag’s stand no. 379.

The study was carried out by collecting 3318 blood samples of which the positive blood-cultures (n=2107) were analyzed in parallel with conventional culture and the Prove-it™ Sepsis assay. The clinical sensitivity and specificity were 95 % and 99 %, and 100 % for both measures for MRSA. The assay coverage was 86 %. Measured in working days, the 18-hour time advantage means 1–2 days earlier results.

In The Lancet commentary, this work is considered a major advance in sepsis diagnostics. By combining elements of molecular biology and standard culture-based methods, Prove-it™ Sepsis brings together the best of both worlds. Although the assay brings additional costs in making the diagnosis, the early and accurate identification of pathogens is a crucial requisite for targeted antimicrobial treatment, might improve the patient outcome and save expensive hospital days. This challenge is the focus of the next study.

*Tissari P, Zumla A, Tarkka E, Mero S, Savolainen L, Vaara M, Aittakorpi A, Laakso S, Lindfors M, Piiparinen H, Mäki M, Carder C, Huggett J, Gant V; Accurate and rapid identification of bacterial species from positive blood cultures with a DNA-based microarray platform: an observational study; The Lancet 2010; 9719: vol 375.