Mesa Biotech Inc, San Diego, recently announced that is has obtained the CE mark for its Accula RSV test, a molecular diagnostic intended to detect respiratory syncytial virus (RSV) at the point of care.

Mesa Biotech is a privately held molecular diagnostics company that has developed an affordable and easy-to-operate polymerase chain reaction (PCR) testing platform designed specifically for point-of-care applications. The company’s RSV test will be marketed by select distributors in the European Union. FDA clearance of the test for marketing in the United States is pending.

“We are excited to introduce the second test in our PCR-based infectious disease diagnostic portfolio in the EU,” says Hong Cai, cofounder and chief executive officer of Mesa Biotech. “The Accula RSV brings reference laboratory performance to the point of care, enabling clinicians to quickly and accurately diagnose and treat their patients.”

RSV is an RNA virus attributable to outbreaks of respiratory tract infections. RSV infections can occur throughout the year, but typically peak during the winter months. Studies indicate that nearly 100% of children will suffer from an RSV infection by age 2.

RSV causes upper respiratory tract infections as well as bronchiolitis of the lower respiratory tract, which often becomes severe in infants and toddlers with underlying diseases. Diagnosis of RSV is difficult because the initial symptoms can be similar to those caused by other infectious agents. Considering that RSV is highly contagious, accurate diagnosis and prompt treatment of patients can have a positive effect on public health.

According to the World Health Organization, the global burden of RSV-associated acute lower respiratory infection is estimated at 33 million annually, resulting in more than 3 million hospitalizations and almost 60,000 in-hospital deaths among children under 5 years of age.

The Accula system, a palm-sized, reusable dock with disposable test cassettes, offers the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays used at the point of care, while providing the superior sensitivity, specificity, and information content of laboratory-based PCR testing.

The Accula RSV test is indicated for use with nasal swab collection, which is less invasive than nasopharyngeal swabs and provides a more comfortable specimen collection experience for patients, and especially for children.

For further information, visit Mesa Biotech.

Featured image: Using indirect immunofluorescence microscopy, this photomicrograph revealed the presence of the respiratory syncytial virus (RSV) in an unidentified tissue sample. RSV is the most common cause of bronchiolitis and pneumonia among infants and children under 1 year of age. Photo by Dr. Craig Lyerla courtesy Centers for Disease Control and Prevention.