Quidel (San Diego), a provider of rapid point-of-care (POC) diagnostic tests, reported that it has obtained FDA clearance for it what it called "new and improved" claims for the QuickVue Influenza A+B test.
The company's QuickVue Influenza test is a 10-minute diagnostic test for influenza that, among its new claims, has added to the package insert that the test is 94% sensitivity for detecting Influenza A when using nasal swab specimens.
The package insert for the test is being updated to include clinical study results for nasal swab, nasopharyngeal swab and nasal wash in addition to analytical study results for the detection of cultured avian influenza viruses.
"The QuickVue Influenza A+B test has been shown to detect cultured avian influenza viruses, including avian Influenza A subtype H5N1 virus," the company said. "However, as with other rapid tests for influenza, the ability of the QuickVue Influenza A+B test to detect influenza A in patients infected with H5N1 has not been established."
A clinical study to validate the performance of the QuickVue Influenza A+B test was completed in Australia during that continent's flu season from July through September.
The data from the Australian study reinforced the analytical study findings from the University of Rochester Medical Center (Rochester, New York), reported in May. The Rochester study demonstrated that the Quidel test had the highest sensitivity 95% of the time, was the easiest to use and provided the most rapid time to result compared with competing rapid tests, according to the company.
The company said its web site, www.quidel.com, and its influenza website, www.flutest.com, are being updated to include the new package insert, ease of use, speed to result and comparative claims data.
The "flutest" web site also includes flu prevalence data from the Centers for Disease Control and Prevention (CDC; Atlanta), which is updated weekly. The site allows users to enter their zip code to determine the prevalence of influenza in their specific location, as well.
Currently, the CDC is reporting that influenza activity in the U.S. is increasing, with visits to the sentinel providers (reporting physicians) above the national baseline.
The site also allows users to find a doctor in their area who is able to administer the QuickVue Influenza test.
Caren Mason, president and CEO of Quidel, also commented on the company's performance in a statement, saying that 2005 "has been a strong, foundational year for Quidel. We have seen market share gains over prior year in key product segments, strong demand for seasonal and non-seasonal tests throughout the year, a number of new products in preparation for market launch, and a strong projected finish in revenue and earnings."
Mason said that Quidel "is executing on all cylinders by achieving its strategic imperatives and operational commitments. The financial picture for Quidel is one of ever increasing strength and profitability."
In July 2004, Quidel reported an earnings slump for the second quarter and suspended future financial guidance at that time.
Other companies also are working on developing tests for influenza, including test possibilities for the avian flu, also known as HN51.
In late November, Response Biomedical (Vancouver, British Columbia) reported that it had achieved analytical sensitivity targets for its Flu A Test. Response said that by using a variety of Flu A strains, the performance results indicated that the RAMP Flu A Test produces results that are in excess of 100 times more sensitive than commercially available rapid influenza A tests, the company said.
Response also reported that it had initiated development of a separate RAMP test to specifically identify only the H5N1 strain.
Earlier in November Qiagen (Venlo, the Netherlands) reported the global launch of two test kits for the detection of the much-feared virus. And Tm Bioscience (Toronto) reported that it had developed an upper respiratory viral panel that it said detects all of the major human respiratory viruses, including H5N1 and SARS Corona, or severe acute respiratory syndrome. Additionally, Quest Diagnostics (Lyndhurst, New Jersey) said it has developed a test to detect the avian flu virus.