Remel Xpect Flu A&B Test Kit Detects Avian Flu

Lenexa, KS - Remel Inc., a unit of Fisher Biosciences and a global provider of high-quality microbiology products, confirmed that the Xpect Flu A&B test kit will successfully detect Avian Flu strains H5N1 and H9N2. Recent analytical-study results were submitted to the FDA (Food and Drug Administration) and cleared for incorporation into the Analytical Sensitivity section of the Xpect Flu A&B package insert. Testing was performed in China and concluded in August.

According to the Centers for Disease Control and Prevention (CDC), more than 200,000 people are hospitalized each year due to complications from the flu virus, and approximately 36,000 people die each year in the United States. There are many different strains of influenza that circulate globally, but most illness in humans is attributed to three different strains of influenza A (H1N1, H1N2, and H3N2) and influenza B. However, another strain of influenza A, H5N1, also known as "Avian Flu" or "Bird Flu," has received significant media attention since it was first reported in humans in Hong Kong in 1997.

The mortality rate of Avian Flu in humans is startling, and concern over the potential health threat is growing. Avian Flu virus H5N1 occurs mainly in birds and poultry, but as of Nov. 1, 2005, according to the World Health Organization (WHO), there have been 122 laboratory-confirmed cases and 62 deaths as a result of human infection. The CDC currently states, "To date, human infections with avian influenza A viruses detected since 1997 have not resulted in sustained human-to-human transmission. However, because influenza A viruses have the potential to change and gain the ability to spread easily between people, monitoring for human infection and person-to-person transmission is important." If the H5N1 virus mutates and becomes transmissible from human to human, it could easily spread among the human population and potentially cause an influenza pandemic, or a worldwide outbreak of the disease.

"The risk of such an outbreak makes early, rapid detection extremely critical," says Rodney Smith, president of Remel. "The spread of the Avian Flu virus among humans could be devastating. Rapid testing is essential, which is why we validated that the Xpect Flu A&B test could detect the Avian Flu strain the same way it detects other human strains of influenza virus."

At a speech earlier this month at the National Institutes of Health in Bethesda, Md., President Bush announced that he would ask Congress for $7.1 billion to prepare the U.S. for a possible flu pandemic by providing funds for early detection, containment and treatment.

The Xpect Flu A&B test from Remel is a simple, walk-away procedure with less than one minute hands-on time, and it provides accurate results for influenza A and B within 15 minutes.

"Many scientists and industry experts predict that sooner or later there will be a larger outbreak of Avian Flu in the human population," says Smith. "A rapid and reliable test like ours allows the physician to quickly identify patients who will benefit from antiviral treatment and establish the proper treatment regimen, which is essential in effectively controlling and preventing influenza."

The Xpect Flu A&B test kit is the only rapid test available with 100 percent specificity for both influenza A and influenza B. It also has the highest sensitivity for influenza B at 97.8 percent and excellent sensitivity for influenza A at 92.2 percent. As reported in a study published in the Journal of Clinical Microbiology in August 2004, the test showed excellent overall performance. According to the study, "Both influenza A and B type viruses were reliably detected, with no significant difference in performance statistics."

SOURCE: Fisher Biosciences