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:
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%.
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%.
