Newly cleared viral diagnostic tested at Beaumont

1/2/2008

A new test, the first molecular diagnostic panel to simultaneously detect the most prevalent respiratory viruses, including flu and the common cold, has potential in combating "superbugs."

The test, referred to as the xTAGTM Respiratory Virus Panel, or RVP, was just cleared by the Food and Drug Administration. Beaumont Hospital, Royal Oak was one of four hospitals in North America involved in testing the RVP. The speed and reliability of the new test will help prevent the inappropriate treatment of viruses with antibiotics. The overuse of antibiotics contributes to the creation of antibiotic-resistant bacteria or "superbugs."

"The new test will benefit both physicians and patients," says Mark Kolins, M.D., chief of Clinical Pathology, Beaumont, Royal Oak and medical director of the Reference Laboratory. "Symptoms of respiratory disease overlap, making it very difficult to determine if the illness is caused by a virus or bacteria. The RVP will assist in diagnosing respiratory infections quickly and helping doctors recommend appropriate treatments. The test will also identify what types of viruses are circulating in the community. This can assist public health officials in preventing outbreaks."

FDA cleared test kits will be provided for Beaumont's use in about one month.

With a painless, noninvasive throat swab, the test can assess the presence or absence of 12 viruses and viral subtypes and provide results in a matter of hours. Traditional testing requires multiple individual diagnostic tests and can take several days to provide a diagnosis. RVP tests for:

  • Influenza A, influenza A-H1, influenza A-H3 and influenza B, which cause the majority of flu cases in the U.S.;
  • Adenovirus, a virus that the Centers for Disease Control have recently identified as causing multiple deaths;
  • Respiratory syncytial virus, or RSV A and B, the most common cause of bronchiolitis and pneumonia among infants and children;
  • Metapneumovirus, a recently discovered virus that causes flu-like symptoms;
  • Parainfluenza 1, 2, and 3, which can cause upper or lower respiratory infections in adults and children and are thought to be responsible for about half of croup cases and 10-15 percent of bronchiolitis and bronchitis cases; and
  • Rhinovirus, which causes the common cold.

Respiratory viruses are a major cause of lost time from work and school, resulting in significant financial and social losses. Annual direct and indirect costs of these viruses in the United States are estimated at more than $10 billion.

Respiratory viruses are the cause of significant morbidity and mortality in the United States each year:

  • Respiratory viral infections are the seventh leading cause of death in the United States, claiming the lives of more than 60,000 annually.
  • Respiratory viruses are responsible for 75-80 percent of all doctor visits.
  • Each year, up to 20 percent of U.S. residents get the flu. More than 200,000 people are hospitalized in the United States because of influenza and 36,000 die.
  • There are 66 million colds in the United States every year.
  • 11 million adults and 5.3 million children (2.8 million under the age of 5) are diagnosed with lower respiratory viral infections annually. These viruses lead to the hospitalization of 208,000 adults and 430,000 children.

The Luminex Corporation, headquartered in Austin, Texas, developed the new diagnostic test. The xTAGTM RVP is manufactured by Toronto-based Luminex Molecular Diagnostics.