the period in which an individual becomes HIV-infected and before HIV antibodies can be detected by a serological assay.

a complete procedure for detecting the presence or concentration of an analyte, including all the components of a test kit used to identify HIV p24 antigen or HIV-1/2 antibodies, in the case of HIV.

refer to when consenting HIV-positive clients are assisted by a trained provider to disclose their status or to anonymously notify their sexual and/or drug injecting partner(s) of their potential exposure to HIV infection. The provider then offers HIV testing to these partner(s). Assisted partner notification is done using contract referral, provider referral or dual referral approaches.

refers to when HIV has spread rapidly in a defined subpopulation (such as men who have sex with men, sex workers, transgender people, people who use drugs, or people in prison or other closed settings) but is not well established in the general population. This type of epidemic suggests that there are active networks of people with high risk behaviours within the subpopulation. The future course of the epidemic is determined by the nature of the links between subpopulations with a high HIV prevalence and the general population. Numerical proxy: HIV prevalence is consistently over 5% in at least one defined subpopulation but is below 1% in pregnant women attending antenatal clinics.

to issue a report on HIV status. Initially reactive test results, including reactive self-test results, need to be confirmed according to the national validated testing algorithm.

an assisted partner notification service approach in which HIV-positive clients enter into a contract with a trained provider and agree to disclose their status and the potential HIV exposure to their partners by themselves, and refer their partners to HIV testing services (HTS) within a specific time period. If the partner(s) of the HIV-positive individual does not access HTS, or contact the health provider, within that period, then the provider will contact the partner(s) directly and offer voluntary HTS.

an assisted partner notification service approach in which a trained provider accompanies and provides support to HIV-positive clients when they disclose their status and the potential exposure to HIV infection to their partners. The provider also offers voluntary HTS to the partner(s).

refers to when individuals who are self-testing for HIV receive an in-person demonstration from a trained provider or peer before or during HIVST, with instructions on how to perform a self-test and how to interpret the self-test result. This assistance is provided in addition to the manufacturer-supplied instructions for use and other materials found inside HIVST kits.

refers to when HIV is firmly established in the general population. Although subpopulations at high risk may contribute disproportionately to the spread of HIV, sexual networking in the general population is sufficient to sustain the epidemic. Numerical proxy: HIV prevalence is consistently over 1% in pregnant women attending antenatal clinics.

any intended or unintended cause of physical, economic, emotional or psychosocial injury or hurt from one person to another, a person to themselves, or an institution to a person, occurring before, during or after testing for HIV.

a process in which a person collects his or her own specimen (oral fluid or blood) and then performs a test and interprets the result, often in a private setting, either alone or with someone he or she trusts.

is the final report that is given to the patient; it is the final interpretation of the patient disease state and is based on a collection of testing results generated from one or more assays. HIV status may be reported as HIV-positive, HIV-negative or HIV-inconclusive.

the result from a single test on a given assay.

often referred to as index case, index patient or index partner HIV testing. This is a focused HTS approach in which the household, family members (including children) and partners of people diagnosed with HIV are offered HTS. For additional details on index partner testing, see definitions on assisted partner notification, contract referral, dual referral, partner notification services, passive referral and provider referral.

a medical device, used alone or in combination, intended by the manufacturer for the examination of specimens derived from the human body solely, or principally, to provide information for diagnosis, monitoring or determining compatibility. For example, an in vitro diagnostic medical device can be used for: diagnosis, as an aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction and determination of physiological status.

behaviour within an intimate relationship that causes physical, psychological or sexual harm to those in the relationship, including acts of physical violence, sexual violence, emotional or psychological abuse and controlling behaviours.

defined groups who, due to specific higher-risk behaviours, are at increased risk of HIV irrespective of the epidemic type or local context. These guidelines refer to the following groups as key populations: men who have sex with men, people who inject drugs, people in prisons and other closed settings, sex workers and transgender people.

any person who performs functions related to health-care delivery and has been trained to deliver these services but has no formal professional or para-professional certification, nor a tertiary education degree.

the probability that a person with a negative test result is not infected with HIV, that is, that he or she is truly negative.

a test result that does not show a reaction indicating the presence of analyte, which in the context of HIV refers to HIV-1 p24 antigen or HIV-1/2 antibodies.

also known as disclosure or contact tracing; is defined as a voluntary process whereby a trained provider asks people diagnosed with HIV about their sexual partners and/or drug injecting partners, and then, if the HIV-positive client agrees, offers these partner(s) HTS. Partner notification is provided using passive or assisted approaches.

is a partner notification service in which HIV-positive clients are encouraged by a trained provider to disclose their status to their sexual and/or drug injecting partners by themselves, and to also suggest HTS to the partner(s) given their potential exposure to HIV infection.

refers to when individuals use an HIV rapid diagnostic test for self-testing to screen potential sex partners and determine his or her own HIV status and their partner(s)' HIV status.

the probability that a person with a positive test result is infected with HIV, that is, that he or she is truly positive.

a dialogue and the provision of accurate information to a client by a lay provider or a health worker before an HIV test is performed.

an assisted partner notification service approach in which, with the consent of the HIV-positive client, a trained provider confidentially contacts the person's partner(s) directly and offers the partner(s) voluntary HTS.

part of quality management focused on providing confidence amongst stakeholders that quality requirements will be fulfilled.

is the set of procedures designed to monitor the test method and results to ensure appropriate test system performance. It includes testing control materials, charting the results and analysing them to identify source of error, and evaluating and documenting any remedial action taken as a result of this analysis.

an element of quality management focused on increasing the ability to fulfil quality requirements.

a system to direct and control an organization with regard to quality. Systematic and process-oriented efforts are essential to meet quality objectives. Principles of quality management include categories such as documents and records, organization, personnel, equipment, purchasing and inventory, process control, information management, occurrence management, assessments – external and internal, process improvement, customer services and facilities and safety.

in vitro diagnostic medical device of immunochromatographic or immunofiltration format for the detection of HIV-1/2 antibodies and/or HIV p24-1 antigen in the context of HIV.

a test result that shows a reaction indicating the presence of analyte, which in the context of HIV includes HIV-1 p24 antigen or HIV-1/2 antibodies.

a situation in which additional testing is performed for an individual immediately following a first test, during the same testing visit, due to HIV-inconclusive status or discordant test results. The same assay(s) is used and, where possible, the same specimen.

refers to certain situations in which individuals should be retested after a defined period of time: (1) HIV-negative people with recent or ongoing risk of exposure; (2) people with an HIV-inconclusive status; and (3) HIV-positive people before they enrol in care or initiate treatment. Reasons for retesting before initiation of care or treatment include ruling out laboratory or transcription errors and ruling in or ruling out seroconversion.

denotes the probability that an HIV assay/algorithm will correctly identify all specimens that contain HIV-1/2 antibodies and/or HIV-1 p24 antigen.

is when an individual's immune system produces a quantity of HIV-1/2 antibodies sufficient to be detectable on a given HIV serology assay.

a couple in which one partner is HIV-positive and one partner is HIV-negative.

refers to an assay that detects the presence of antibodies in human specimens. Such assays typically use serum or plasma, but also capillary/venous whole blood and oral fluid. For example, rapid diagnostic tests, immunoassays and certain supplemental HIV assays are serology assays.

denotes the probability that the assay/algorithm will correctly identify specimens that do not contain HIV-1/2 antibodies and/or HIV-1 p24 antigen.

the rational redistribution of tasks and the increased scope of work among different cadres of health-care providers, including trained lay providers.

an HIV testing approach whereby a trained provider or self-tester performs a single HIV rapid diagnostic test. Individuals with a reactive test result are encouraged by a trained provider, or by written or pictorial information, to link to a facility for further HIV testing to confirm their status, and if confirmed HIV-positive, to prevention, treatment, care and other support. Individuals with a non-reactive test result are advised to link to appropriate HIV prevention services and retest if they tested within six weeks of possible HIV exposure or are at ongoing HIV risk.

the combination and sequence of specific assays used within HIV testing strategies.

describes a testing sequence to attain a specific objective. In the context of HIV, a testing strategy takes into consideration the presumed HIV prevalence in the population being tested, either high HIV prevalence (5% and above) or low HIV prevalence (below 5%).

refers to when individuals self-test for HIV using only a self-test kit that includes manufacturer-provided instructions for use. As with all self-testing, users may be provided with links or contact details to access additional support, such as telephone hotlines or instructional videos.

the period between HIV infection and the detection of HIV-1/2 antibodies using serology assays, which marks the end of the diagnostic window period and the end of seroconversion.