Quidel Corp, San Diego, has received FDA premarket notification (510(k)) clearance for its Solana C. difficile assay for the direct, qualitative detection of Clostridium difficile DNA in the unformed stool specimens of patients suspected of having C. difficile infection.
C. difficile is the most frequently identified enteric pathogen in patients with antibiotic-associated diarrhea and colitis. According to the US Centers for Disease Control and Prevention, C. difficile was responsible for approximately half a million infections in the United States in 2011, with 29,000 patient deaths occurring shortly after the initial diagnosis.1 C. difficile bacterial infections are life threatening, especially for the elderly, for the immunocompromised, and for patients on a prolonged antibiotic regimen.
Traditional methods for diagnosing C. difficile infection, such as glutamate dehydrogenase or toxin antigen tests, can lack sensitivity and increase lab costs due the need for additional confirmatory testing. In addition to requiring significant technical expertise, cytotoxicity assays and toxigenic culture tests require 24 to 48 hours and 3 to 5 days, respectively, before reliable results can be obtained.
Quidel’s molecular assay generates a result in about 35 minutes, without an upfront nucleic acid extraction step. The Solana instrument can process up to 12 different assays or patient samples in each batched run, and may provide workflow advantages to healthcare professionals in laboratories certified to perform moderate complexity tests.
“We are excited to introduce a Solana assay that can make a profound difference in the lives of people that are affected by C. difficile infection through a quick and accurate diagnosis,” says Douglas Bryant, president and CEO of Quidel. “The laboratorian will benefit from the Solana platform’s ability to address the particular workflow needs of the moderately complex laboratory setting in a cost-effective manner by neatly balancing higher volume sample testing at scale with customizable, on-demand assay processing.”
For more information, visit Quidel.