CE marking
Conformité Européenne: subject to one or more European product safety Directives. It indicates a product’s compliance with the applicable European Union regulations and enables the commercialisation of a product in 32 European countries.
Compulsory testing
Where a person has no choice in being tested, e.g. as directed under a Public Health Order.
Exposure-Prone Procedure
Defined by TGA in the dictionary of Regulations as: for an in-vitro diagnostic medical device, means testing performed outside the laboratory environment, near to or at the side of the patient, that is not done under the supervision of a trained laboratory professional.
Defined by NPAAC as: pathology testing performed in close proximity to a patient by a healthcare worker, usually outside the precincts of a traditional laboratory. Testing is undertaken at the time of, and for use during, a consultation or episode of care.
HCV antibody
Antibody to hepatitis C virus, which can be detected in the blood usually within 2 or 3 months of hepatitis C infection or exposure. The terms HCV antibody and anti-HCV antibody are equivalent, but in these guidelines, HCV antibody is used throughout.
Mandatory testing
Refers to situations where people may neither participate in certain activities nor access certain services unless they agree to be tested. Examples include testing before blood, tissue and organ donation, and for immigration purposes.
Occupational exposure
An exposure that may place an employee at risk of HIV or hepatitis C virus infection through percutaneous injury (e.g. a needlestick or cut with a sharp object), contact of mucous membranes, or contact of skin with blood, tissues or other potentially infectious body fluids to which Universal Precautions apply.
Point-of-care testing
Defined by TGA in the dictionary of Regulations as: for an in-vitro diagnostic medical device, means testing performed outside the laboratory environment, near to or at the side of the patient, that is not done under the supervision of a trained laboratory professional.
Defined by NPAAC as: pathology testing performed in close proximity to a patient by a healthcare worker, usually outside the precincts of a traditional laboratory. Testing is undertaken at the time of, and for use during, a consultation or episode of care. 36
Serology
Testing for the presence, evidence of, or quantity of antibodies specific for infectious or other agents, biochemistry, or substances in blood (serum, plasma or whole blood).
Specificity
The probability that a person without the disease will have a negative test result.
Sustained virological response (SVR12)
Undetectable viral load 12 weeks after completion of antiviral therapy for hepatitis C.
