OraSure Technologies Inc. recently announced that the FDA has granted a CLIA waiver for its OraQuick HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens.

ADVANCE speaks with Stephen R. Lee, PhD, executive vice president and chief science officer, OraSure Technologies, about the product.

ADVANCE: Why was this product created?
Dr. Lee: There is a large need in the market for a rapid HCV test. According to the CDC, there are an estimated 4 million people in the U.S who are infected with Hepatitis C and more than 180 million worldwide. Despite the availability of laboratory testing for the past 20 years, the majority of these infected individuals remain undiagnosed. Availability of a highly accurate rapid, CLIA-waived test will expand testing opportunities in locations such as clinics, physician offices and community outreach centers; and will enable more individuals to be correctly diagnosed and gain the chance to receive medical treatment and prevent life-threatening liver disease.

New research has also supported the expansion of current HCV testing protocols in the U.S.; recommendations include birth cohort screening vs. the current strategy of screening based solely on established risk factors. For example, according to a new study published in the Annals of Internal Medicine, a broader and more proactive HCV screening strategy in the U.S. could identify more than 800,000 currently unidentified cases, and save many thousands of lives each year.

ADVANCE: How does it work?
Dr. Lee: OraQuick HCV is quick and easy to use, and works on the same platform as the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. The OraQuick HCV Antibody Test Kit consists of a single-use test device, and a single-use test developer solution. Additional items provided include a reusable test stand and disposable specimen collection loop.

A fingerstick or venous blood sample is collected with the Specimen Collection Loop and then mixed into a vial containing pre-measured developer solution. The collection device is inserted into the vial, and the result is visually readable in about 20 minutes.

ADVANCE: How does it improve upon already-available technology?
Dr. Lee: The OraQuick HCV Rapid Antibody Test is the first and only rapid Hepatitis C test to gain FDA approval. The OraQuick HCV test takes only 20 minutes to show a result, when current EIA tests take much longer and require complex instrumentation and a blood draw. The simplicity, portability and speed of the OraQuick HCV Rapid test enables expanded testing and increased diagnosis at a time when new therapies will encourage clinicians to identify and treat the disease.

In the clinical studies conducted by the company, which were the basis of the FDA approval, the accuracy of the HCV test (as measured by specificity and sensitivity) for detection of HCV antibodies was shown to be equivalent to results obtained from currently available, laboratory-based tests.

ADVANCE: What's unique about it?
Dr. Lee: OraQuick HCV is the first and only FDA-approved rapid HCV test, which provides results in 20 minutes. By receiving the CLIA waiver approval, the rapid HCV test can now be used by more than 180,000 sites in the U.S. to test people who are at risk for hepatitis C, such as outreach clinics, community-based organizations and physician offices. In addition to expanding testing, we expect this test to be a valuable public-health tool for expanding awareness of the HCV epidemic.

ADVANCE: How will it help patients?
Dr. Lee: According to the CDC, as many as 75 percent of people infected with HCV are still undiagnosed. Increased testing and diagnoses are critical to helping infected individuals receive life-saving medical treatment.

ADVANCE: How does it help lab professionals perform their jobs?
Dr. Lee: It is the first FDA approved rapid test for HCV and provides results faster than conventional laboratory testing.