CATIE News

8 February 2017 

New point of care hepatitis C antibody test approved in Canada

On January 17, 2017, Health Canada approved the use and sale of a point-of-care antibody test for screening people for exposure to hepatitis C virus (HCV). The test is called the OraQuick HCV rapid antibody test and is manufactured by Orasure Technologies in Bethlehem, Pennsylvania. It will be distributed in Canada by KNS Canada.

About the test

The OraQuick test has been approved in other high-income countries. It works by checking a small drop of blood (taken from a finger prick) for antibodies to HCV. The test is more than 98% accurate at detecting those antibodies. It provides results in 20 minutes.

A positive test indicates that a person has been exposed to HCV at some point in the past. However, the test does not reveal if the person is currently infected. In cases of a positive result, healthcare providers and clinics can refer their patients to a local laboratory that will take a sample of their blood and have it checked for HCV’s genetic material. The presence of HCV’s genetic material indicates that HCV is being produced in the liver, and a discussion about treatment options should follow.

Access

Test kits should be ready for sale by late February or early March. Healthcare professionals and clinics can contact KNS Canada to place orders.

The cost per test is $29.95. It comes in boxes of 25 kits per box, and the cost per box is $748.75. Clinics can negotiate discounts for bulk orders.

Uses

The OraQuick test is meant to be administered by a healthcare professional and is not for home use. In general, point-of-care tests are used in clinics, hospitals, mobile testing units and other locations and in situations where a rapid result is needed.

In Canada, researchers estimate that 44% of people who are infected with HCV are unaware of their infection status.

About HCV

HCV infects the liver and slowly degrades this organ. As HCV-associated liver injury accumulates, the liver becomes dysfunctional and internal bleeding, infections and other serious complications occur. If left untreated, the liver eventually stops working and death can ensue. HCV infection also increases the risk for liver cancer.

Several treatment options are available for HCV infection; access to them may vary from one province to another and by the degree of liver injury.

CATIE resources

Hepatitis C point of care testing: What is its impact on testing and linkage to care?Prevention in Focus

High acceptance for rapid hepatitis C testingCATIE News

CATIE’s hepatitis C information

Other resources

OraQuick HCV antibody test –KNS Canada Inc.

—Sean R. Hosein

REFERENCE:

Health Canada. Oraquick rapid HCV antibody test. Medical device license. 17 January 2017.