December 19, 2011 — A new rapid test for diagnosing influenza types A and B — the first to offer a digital readout of results — has been granted a Clinical Laboratory Improvement Amendments (CLIA) waiver from the US Food and Drug Administration.
The Veritor System (BD Diagnostics) eliminates the need for clinicians to subjectively interpret test results, according to a press release and information on the company's Web site.
The company reports that the test "delivers very good analytical sensitivity and specificity," offering a combination of speed, accuracy, and convenience.
In response to a request from Medscape Medical News, Andrew Pavia, MD, FAAP, FIDSA, chief of the division of pediatric infectious diseases at the University of Utah in Salt Lake City, reviewed the press release describing the device and the information on the company's Web site.
He said that he was unable to find published performance data on the test, but stressed that with currently available tests often falling short in terms of their sensitivity, there is plenty of room for improvement. "We very much need more accurate tests for influenza that can be used in doctor's offices," he said.
The BD Diagnostics Web site says the test helps cut down on false-positive results "by examining the sample and compensating for many of the effects of nonspecific binding" to help deliver more accurate results.
The Veritor System consists of a palm-sized reading device and a rigid, flat, finger-sized device with a reservoir into which patients' samples, along with a process reagent, are added. A unitized tube containing the correct volume of process reagent is included with the device, which helps speed workflow, according to the company.
Company data suggest that the test requires minimal hands-on time. The test device is ready to insert into the reader 10 minutes after the sample from the patient is added. Ten seconds after the test device is inserted into the reader, an objective digital test result is displayed.
BD Diagnostics says the compact digital Veritor System has been designed to read and interpret results of new assays as they become available.
Dr. Pavia has disclosed no relevant financial relationships.
Medscape Medical News © 2011 WebMD, LLC
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Cite this: New Rapid Flu Test Features Digital Readout - Medscape - Dec 18, 2011.