National Hepatitis C Testing Policy May 2007


Page last updated: July 2007

Anonymous de-linked test: Testing of samples that have been irreversibly de-identified.

Compulsory testing: Testing when a person has no choice about being tested.

Confirmatory testing: Testing that leads to a diagnosis being confirmed. A confirmatory test is the test that gives the diagnosis.

Custodial settings: Includes the various settings in which adults and juveniles can be detained or imprisoned—prisons, juvenile justice centres, and remand and other detention centres.

Discriminatory NAT: Used in the ARCBS to discriminate activity which could be either HIV or HCV related.

Exposure prone procedure: Exposure prone procedures (EPPs) are a subset of invasive procedures characterised by the potential for contact between the skin (usually finger or thumb) of the health care worker (HCW) and sharp surgical instruments, needles or sharp tissues (spicules of bone or teeth) in body cavities or in poorly visualised or confined body sites (including the mouth). In the broader sense an EPP is considered to be any situation where there is a potentially high risk of transmission of bloodborne disease from HCW to patient during medical or dental procedures.

Gold-standard test: A test that unequivocally identifies the presence of an infection.

Heteroduplex mobility analysis: Method by which nucleic acid species of similar composition are separated in a gel on the basis of mass or charge, or both, to demonstrate differences in sequence or structure.

Home collection: Taking blood or another type of sample in a non–health care environment without the supervision of trained personnel and then forwarding the sample to a laboratory for analysis.

Home-based testing: Testing conducted in a non-laboratory or non–health care environment without the supervision of trained personnel.

Home-use IVD: Devices used for testing in the home, as distinct from point-of-care testing. Two common reasons for using home-use in-vitro diagnostic devices in Australia are for home collection, self-diagnosis and management and for home collection of a sample to be tested elsewhere and/or interpreted without the involvement of a health care practitioner.

Indeterminate test result: A result that is neither clearly negative nor clearly positive.

In-house tests: A test that is developed or modified from another source within the confines of a laboratory, validated for use within that laboratory only, and not supplied for use outside that laboratory. For the purposes of this document, 'laboratory' means an Approved Pathology Laboratory, as defined in section 23D of the Commonwealth's Health Insurance Act 1973; the term 'supplied' is used with reference to the definition of the term 'supply' in the Therapeutic Goods Act 1989—that is,
'supply' includes
(a) supply by way of sale, exchange, gift, lease, loan, hire or hire-purchase; and
(b) supply, whether free of charge of otherwise, by way of sample or advertisement; and
(c) supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in persons or animals; and
(d) supply, by way of administration to, or application in the treatment of, a person or animal.

IVD: Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination (with other diagnostic goods for in-vitro use), intended by the manufacturer to be used in-vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient or to monitor therapeutic measures.

Mandatory testing: Where testing is pre-condition of obtaining a service or benefit.

PCR testing: A technique whereby nucleic acid (cell genetic material) is amplified in order to detect the presence of particular and specific nucleic acid sequences.

Predictive values: Parameters that define the chance of a reactive test being truly positive (the positive predictive value) or a non-reactive test being truly negative (the negative predictive value) for the substance that a test is designed to detect.

Quality assurance: The methods by which the integrity of tests and testing is assured.

Qualitative test: A test that detects the presence or absence of an agent or substance without measuring the level or quantity of that agent or substance.

Quantitative test: A test that not only detects the presence of an agent or substance but also gives the level or amount of the agent or substance.

Reference testing: Testing conducted to clarify the nature of samples' reactivity or status following initial tests conducted with standard tests in the same or another laboratory.

Sensitivity: The proportion of reactive results found by a given test in a known positive population. Indicates the potential false negative rate of a test.

Serology: Scientific testing to determine the presence, evidence or quantity of antibodies specific for infectious or other agents, chemicals or substances in blood.

Specificity: The proportion of non-reactive results found by a given test in a known population of negative samples. Indicates the potential false positive rate for a test.

Supplemental test: A test performed after initial, standard or screening testing, usually to clarify the sero-status of a reactive sample.

Test Kit: An IVD assay, where an assay is an analysis done in-vitro to determine the presence of a substance and the amount of that substance in a specimen taken from the human body.

Window period: The time between when a person has been exposed to hepatitis C and the time that detectable level of hepatitis C antibodies are present in the blood