Cepheid this week released Xpert Norovirus as a CE IVD marked product in Europe.
Xpert Norovirus is a qualitiative in vitro diagnostic test for rapid identification and differentiation of norovirus genogroups I and II that runs on the company's GeneXpert system.
Norovirus is a highly contagious virus and is the most common cause of viral gastroenteritis worldwide. Noroviruses can be transmitted from an infected person, contaminated food or water, or by touching contaminated surfaces. Nausea, vomiting, watery diarrhea, and abdominal pain characterize infection. Globally, the virus affects approximately 267 million people and causes more than 200,000 deaths each year.
Noroviruses are divided into five genogroups, GI to GV. Xpert Norovirus detects and differentiates the GI and GII genogroups, which account for the majority of human infections.
"In the hospital setting, patients admitted with severe norovirus infection can be a source of this infection to other patients," Kate Templeton, honorary senior lecturer in medical microbiology at the University of Edinburgh, said in a statement. "It is important that patients infected with norovirus are identified as early as possible. Rapid molecular testing, when combined with prompt infection control measures of infected patients, provides an important new weapon in our battle against healthcare-associated infections."
BD Diagnostics this week announced the CE marking and European launch of the BD MAX GC rt PCR assay, an in vitro diagnostic assay intended to test Neisseria gonorrhoeae-positive results from the BD ProbeTec GC Qx Amplified DNA assay performed on the BD Viper system.
The new assay, which runs on the company's BD MAX system, may be used to detect GC DNA in residual male or female urine specimens, or residual endocervical, vaginal, or male urethral swab specimens that have tested positive for GC using the BD ProbeTec GC Qx Amplified DNA assay.
Compared to culture, nucleic acid amplification tests are more sensitive, allow testing of a wide range of specimen types, and can support extended transportation and storage conditions. NAATs have exhibited high sensitivity in both symptomatic and asymptomatic patient populations and demonstrated equivalent sensitivity between male urine and urethral swab specimens, and between clinician-obtained and patient-collected vaginal swabs.