NEW YORK (Reuters Health) – The Prove-it sepsis assay (Mobidiag, Helsinki, Finland) is highly sensitive and specific in identifying bacterial species in blood samples and provides much faster results than conventional culture, the current gold standard, new research shows.

Prove-it is a PCR and microarray test that can identify more than 50 common sepsis pathogens by measuring the expression of gyrB, parE, and mecA genes of these species, according to the report in the December 10th online issue of The Lancet.

“This assay could enable fast and earlier evidence-based management for clinical sepsis,” according to lead author Dr. Paivi Tissari, from Helsinki University Hospital Laboratory and co-researchers.

In the study, 2107 blood samples that were positive by culture were then evaluated for bacterial species by Prove-it.

Eighty-six percent of the samples included a pathogen covered by Prove-it, the report indicates. Overall, the test was 94.7% sensitive and 98.8% specific in identifying bacterial species. In identifying methicillin-resistant Staphylococcus aureus, the test was 100% on both measures.

On average, Prove-it provided results 18 hours faster than did conventional culture. Practically speaking, Prove-it results were usually available the same working day, whereas culture results took an additional 1 to 2 days.

In a related editorial, Dr. Shin Lin, from Stanford University, California, and Dr. Samuel Yang, from Johns Hopkins School of Medicine, Baltimore, comment that “although further study is needed before widespread application, the work by Tissari and co-workers is a major advance.”

“By combining elements of nucleic-acid and standard culture-based methods, the Prove-it sepsis assay represents an approach that encompasses the best of both worlds, bringing molecular methods to the threshold of broad pathogen detection.”

Six of the 14 authors of this report are employed by Mobidiag.

Lancet 2009.