ACMD advice on Hepatitis C and Human Immunodeficiency Virus point of care tests

Advisory Committee on Medical Devices (ACMD), 15 March 2013 (Meeting 12)

The Therapeutic Goods Administration (TGA) asked the ACMD to consider acceptable levels of sensitivity and specificity for Hepatitis C (HCV) and Human Immunodeficiency Virus (HIV) PoCTs.

The ACMD provided the following advice:

1. In relation to point of care testing devices used in the diagnosis of HIV infection:

The ACMD recommends that, when compared to Western Blot testing of known HIV positive specimens (not including seroconversion specimens), the sensitivity of point of care testing devices should be 100% and the specificity at least 99%.

1. In relation to point of care testing devices used in the diagnosis of Hepatitis C infection:

The ACMD recommends that the sensitivity of point of care testing devices for the detection of HCV should be at least 99.5%, and the specificity at least 99%.