European guideline on HIV testing

(DRAFT November 2007)

Mario Poljak, Erasmus Smit

Institute of Microbiology and Immunology, Ljubljana, Slovenia

HPA Birmingham, Heartlands Hospital, Birmingham, UK

mario.poljak@mf.uni-lj.si
erasmus.smit@heartofengland.nhs.uk

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INTRODUCTION

Testing for human immunodeficiency virus (HIV) is a procedure of diagnosis or exclusion of

an HIV infection based on testing for the presence of anti-HIV specific antibodies and/or
specific viral proteins and/or viral RNA/DNA in an individual, preferably in blood sample. HIV
testing can be initiated by a health care provider or by individuals actively seeking HIV testing
and counselling. HIV testing is one of the most important single measures that society can
offer in its efforts to combat HIV infection, on both an individual and a society level
(Thorvaldsen, 2001).

HIV/AIDS in Europe
As of the end of December 2004, there have been 294,571 reported AIDS diagnoses in
Europe. Of these patients, at least 163,831 have died. European countries that have national
reporting systems for HIV infection had cumulatively reported 646,142 diagnoses of HIV
infection by the end of June 2005 (UNAIDS, 2006a).
Estimated HIV prevalence (the proportion of adults living with HIV) in Europe varies from
below 0.1% in parts of Central Europe to above 1% in parts of the former Soviet Union
(UNAIDS, 2006b). According to UNAIDS estimates, around 2.4 million people were living
with HIV in Europe and Central Asia at the end of 2006 (UNAIDS, 2006a), of whom at least
40% remain undiagnosed.

European guideline on HIV testing

The last European guideline of testing for HIV infection approved by the European Branch of
International Union against Sexually Transmitted Infections (IUSTI) and European office of
the World Health Organisation (WHO) had been published in 2001 (Thorvaldsen, 2001). The
present guideline represents an updated version of 2001 guideline in which several new
achievements in the field are incorporated.

Scope and purpose of present guideline

The main scope and purpose of guideline is to reduce the number of undiagnosed HIV
infections in individuals who seek evaluation and treatment in sexually transmitted infection
(STI) services or genitourinary medicine (GUM) clinics across Europe. It is aimed primarily at
adults and adolescents i.e. 16 years and older. Although the recommendations in this
guideline should prove useful across similar clinical settings, including general practice and
general medicine, they may not be appropriate for use in all clinical situations. Decisions to

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follow these recommendations must be based on the professional judgement of the clinician,
consideration of individual patient circumstances and available resources.

Evidence sources and review strategy

Evidence for this guideline was mainly provided by review of the Medline/Pubmed, Cochrane
Library, Embase, conference proceedings and other relevant guidelines up to September
2007. The main sources for this guideline were 2006 UK national guidelines on HIV testing
(Rogstad, 2006), 2006 UK National Screening and Testing Guideline on Sexually
Transmitted Infections (Smit, 2006) and recent HIV testing guidelines produced by the US
Centers for Disease Control (CDC) (CDC, 2006a; CDC, 2006b) and WHO/UNAIDS (WHO,
2007; UNAIDS, 2007). Similarly to other HIV guidelines, much of the advice presented in this
guideline is based on expert opinion and practice because of a lack of other evidence. The
system used to grade the evidence and guidance recommendations is that published by the
US Department of Health and Human Services Agency for Healthcare Policy and Research
(AHPCR). These are indicated in bold type throughout the text e.g. (Ia).

WHEN TO CONSIDER HIV TESTING

Recommendations:
 The recommended way of HIV testing in STI/GUM settings is provider-initiated HIV testing
using opt-out approach. Thus, any individual presenting to a STI/GUM facility should be
offered an HIV test regardless of signs or symptoms of disease or risk factors for infection.
(IIb, B)
 Pre-test and post-test discussions are necessary and the informed consent, counselling and
confidentiality must be clearly observed during HIV testing in STI/GUM settings. (IV, C)
 In the case of inability to comply with the recommendation to test all individuals presenting
to a STI/GUM facility, after clinical examination and pre-test discussion priority should be
given to groups with higher possibility of HIV-infection. (IV, C)
 The HIV testing should not be restricted to newly presented patients only, but all re-
presenting previously HIV negative patients should be offered and encouraged to have HIV
testing following possible re-exposure. (IV, C)

Benefits from knowing the diagnosis of HIV infection early

They are several benefits from early self-knowledge of HIV infection on both individual and
public health level. Knowing the diagnosis of HIV infection early, and thus being able to act
on this e.g. starting highly active anti-retroviral treatment (HAART) early, has been shown to

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dramatically improve the life expectancy of the individual (Gazzard, 2006; Soria, 2007) (IIa).
HAART is an important contributor in reducing transmission due to the reduction in HIV
burden and therefore infectivity in those individuals who are diagnosed early and treated
(Quinn, 2000) (IIa); there is also consensus that it is the best to start HAART before the
onset of severe immunosuppression (Gazzard, 2006) (IIb). Regardless of how
recommendations to initiate antiretroviral therapy might change in the future, early diagnosis
of HIV infection will remain preferable to late diagnosis (Thorvaldsen, 2001). Although meta-
analysis of 27 reports published from 1985-1997 suggested no significant impact of HIV
testing and counselling on sexual risk behaviour (Weinhardt, 1999), recent studies clearly
showed that once diagnosed with HIV infection, sexual and needle sharing risk behaviours of
infected people decrease substantially, while those who are unaware of their HIV status, do
not change their high risk behaviours (Fox, 1987; van Griensven, 1989; Doll, 1990; Clearly,
1991; Dawson, 1991; Desenclos, 1993; Wenger, 1994; Gibson, 1999; Marks, 2005; Marks,
2006) (Ia). Rates of unprotected sex, HIV transmission and acquisition of other sexually
transmitted diseases among HIV-positive individuals are significantly reduced after diagnosis
of HIV infection (Kamb, 1998; Allen, 2003; Crepas, 2006; Marks, 2006) (Ia).

Client-initiated vs. provider-initiated HIV testing

HIV testing and counselling can be initiated by individuals actively seeking such services
(client-initiated HIV testing) or by a health care provider (provider-initiated HIV testing). Both
types of HIV testing are applicable in STI/GUM settings.
Client-initiated HIV testing and counselling (also called voluntary testing), involves individuals
actively seeking HIV testing and counselling at a facility that offers these services including
health care facilities (WHO, 2007).
Provider-initiated HIV testing and counselling refers to procedure which is recommended by
health care providers to persons attending health care facilities as a standard component of
medical care. In the case of persons presenting with symptoms or signs of illness that could
be attributable to HIV, it is a basic responsibility of every heath care provider to recommend
HIV testing and counselling as part of the patient’s routine clinical management (WHO,
2007). In addition, in order to identify unrecognized or unsuspected HIV infection, health care
providers may recommend HIV testing and counselling also to patients in some settings even
if they do not have obvious HIV-related symptoms or signs. In this case HIV testing and
counselling is recommended as part of a package of services provided to all patients during
all clinical interactions in the particular health facility e.g. in STI/GUM settings.
Provider-initiated HIV testing and counselling can employ opt-in or opt-out approaches. With
opt-in approaches, patients must affirmatively agree to the test being performed after usually
extensive pre-test discussion. With opt-out approaches, after pre-test discussion individuals

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must specifically decline or defer the HIV test if they do not want the test to be performed
(WHO, 2007).

HIV testing in STI/GUM settings

Although HIV testing and counselling can be initiated by individuals actively seeking such
services (client-initiated HIV testing) the recommended way of HIV testing in STI/GUM
settings is provider-initiated HIV testing (CDC, 2006a; WHO, 2007) (IV, C). Thus, it is
recommended that all individuals who seek evaluation and treatment in STI/GUM facilities
should be offered an HIV test, as part of the initial screening for STI (III, B). The HIV testing
and counselling should not be restricted to newly presented patients only but all re-
presenting previously HIV negative patients should be offered and encouraged to have HIV
testing following possible re-exposure (Smit, 2006) (IV, C).
Provider-initiated HIV testing and counselling of all individuals who seek evaluation and
treatment in STI/GUM facilities should be voluntary and conducted only with the patient’s
knowledge and not mandatory nor compulsory. In STI/GUM settings the opt-out approach is
more appropriate than opt-in approach (IV, C). Thus all patients in STI/GUM facilities should
be informed orally or in writing that they will have HIV testing unless they decline or defer. A
patient who declines HIV test should have this documented in the medical record (IV, C).
Although in some parts of the world, opt-out approach put less emphasis on pre-test and
post-test discussions (CDC, 2006a), we believe that in European STI/GUM settings
extensive pre-test and post-test discussions are necessary and the informed consent,
counselling and confidentiality must be clearly observed during provider-initiated HIV testing
in STI/GUM settings (see details below).

HIV testing in STI/GUM settings with limited resources

Due to a restraint of resources, a particular European STI/GUM clinic may not be able to
comply with the recommendation to test all individuals who seek evaluation and treatment in
STI/GUM facilities. In these circumstances, after clinical examination and extensive pre-test
discussion priority should be given to the following groups (Thorvaldsen, 2001; Smit, 2006)
(IV, C):
 individuals who strongly believe that they might have been exposed to HIV;
 individuals whose symptoms are compatible with acute retroviral illness or
immunosuppression (comprehensive list of clinical features suggesting primary HIV
infection available in Rogstad, 2006);
 individuals who practice unsafe sex, e.g. unprotected anal/vaginal sex or sex with
multiple partners;

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  individuals who have past/current history of STI/STD particularly those associated
with an increased risk of HIV transmission;
 individuals who have been the victims of sexual assault;
 individuals who are known contacts of HIV infected patients;
 intravenous drug users (IVDU) with risk needle sharing behaviours;
 individuals who come or return from countries with a high HIV prevalence;
 individuals who travel outside Europe with exposure to high risk activity;
 individuals who have received blood transfusion or other blood products before
introduction of routine HIV screening (in most European countries before 1985);
 any pregnant woman regardless of risk factors.

HOW TO TEST FOR HIV

Recommendations:
 Venous blood is the preferred specimen for HIV testing. (IIa, B)
 HIV testing in samples other than venous blood should be avoided unless venepuncture is
difficult or not possible. (IV, C)
 In HIV testing use the most sensitive test as the first screening test and confirm reactive
results with more specific test which preferably test with a different method/antigens. (III,
B)
 All HIV testing procedures should be performed to the highest quality standard to ensure
consistency and reliability of results. (IV, C)
 Fourth generation screening assays which simultaneously test for anti-HIV-1 antibodies
and HIV-1 p24 antigen as well as anti-HIV-2 antibodies are recommended to be used as
HIV screening tests in European STI/GUM settings. (IV, C)
 Confirmation of reactive screening test results should be performed in a specialist
laboratory with experience in HIV confirmation. (IV, C)
 Line-Immuno Assay (LIA) or Western blot (WB) which distinguishes between the different
antibodies against the individual HIV-1 and HIV-2 antigenic components is the preferred
final confirmation assay. (IV, C)
 A subsequent second blood sample should be tested for confirmation of HIV infection to
exclude mislabelling, misidentification and clinic/laboratory mix-ups. (IV, C)
 The patient can be told after confirmation of the first blood that he/she is HIV infected but
final assurances can only be given after a second confirmatory blood. (IV, C)
 Health-care provider using rapid HIV tests should be aware that these do not test for p24

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 antigen and may be false-negative early on during primary HIV infection. (III, B)
 Sites using point of care tests should preferably be overseen by the local laboratory and
have a robust quality assurance programme. (IV, C)
 All laboratories should provide their latest external quality control scores to their users
upon request. (IV, C)
 There should be active encouragement to destigmatise HIV and there should be a system
in place to provide anonymous testing should a patient want it. (IV, C)

Diagnosis or exclusion of an HIV infection is based on testing for the presence of anti-HIV
specific antibodies and/or HIV-1 p24 antigen and/or viral RNA/DNA. HIV testing needs to
adhere to strict guiding principals in order to obtain near 100% sensitivity and positive
predictive value due to the seriousness of misdiagnosing a patient.

Recommended specimens for testing

Venous blood, with or without anticoagulant (plasma or serum), is the preferred specimen for
HIV testing because more than one test can be performed on the same blood specimen
should the test be inconclusive or if it needs confirmation (IIa, B). Venous blood samples
should be spun down using a clot separator and/or separated in carefully labelled tubes to
prevent the red blood cells haemolysing which may interfere and give low false positive
results in some tests (Novick, 1996). It is better practice to perform the HIV test from the
primary tube and not from split samples and it is recommended that the final confirmation
test is performed from the original tube (clot) to exclude the possibility of sample splitting
errors (IV, C).
Samples other than venous blood, such as finger prick blood, oral fluid or urine, can be also
used in HIV testing, but should the test be reactive or indeterminate then a blood sample
should be drawn for additional testing (III, B). Generally, HIV testing in samples other than
venous blood should be avoided unless venepuncture is difficult or not possible (Rogstad,
2006; Smit, 2006)(IV, C).

HIV testing algorithm

In HIV testing always use the most sensitive test as the first screening test and confirm
reactive results with more specific confirmatory test which preferably tests with different
method/antigens (III, B). The basic principal of a HIV testing algorithm rests on the fact that a
negative result of screening test excludes current HIV infection providing the patient is not in
the window period and an equivocal or reactive result of screening test is always followed up
by at least two further tests to confirm the initially reactive result (UNAIDS/WHO, 1997). All

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HIV testing procedures should be performed to the highest quality standard to ensure
consistency and reliability of results (IV, C).

HIV screening tests

The sensitivity of HIV screening tests have markedly improved over the years
(UNAIDS/WHO, 1999; Parry, 2003). Enzyme Immuno Assays (EIA), also known as Enzyme
Linked Immunosorbant Assays (ELISA), has so far been the vanguard of HIV testing (Parry,
2003). There are four generations of HIV screening EIAs. During the 1990s most
manufacturers converted from second generation EIAs that predominantly detected anti-HIV
of the IgG isotype to third generation assays capable of detecting anti-HIV of any isotype. As
a result of their added sensitivity for IgM anti-HIV, important at the early stages of
seroconversion, the third generation tests offer about a one-week advantage in early
detection compared to their second generation predecessors (Parry, 2003). Fourth
generation screening tests, which were introduced to the market a few years ago, enable
simultaneous screening for anti-HIV antibodies and HIV-1 p24 antigen in a single assay.
Fourth generation EIAs shorten the time post infection to a positive test i.e. the window
period to average of 5-7 days compared to third generation tests, and some of them can
detect antibodies against HIV-1 group O (Fiebig, 2003; Parry, 2003).
Even though HIV-2 has a low prevalence in Europe, it is recommended that HIV screening
tests which are used in STI/GUM settings simultaneously test for both HIV-1 and HIV-2.
Although HIV-1 and HIV-2 are different viruses, they usually have weak cross reactive
antibodies against each other’s antigens (Böttiger, 1990).
The recommended HIV screening test for use in European STI/GUM settings is the fourth
generation assays which simultaneously test for anti-HIV-1 antibodies and HIV-1 p24 antigen
as well as anti-HIV-2 antibodies. It would even be better to use fourth generation assays
which also detect infection with the outlier group of HIV-1 i.e. group O (IV, C).
Rapid HIV tests which use various other formats such as the lateral flow assay, are
becoming increasingly popular as screening tests and are usually used as point of care tests
(for details see below). Their performances are similar to EIAs, but are usually less sensitive
during seroconversion mainly because they do not simultaneously test for HIV-1 p24 antigen.
However, it should be stressed that sensitivity of screening test is usually an issue only
during primary HIV infection. Low or absent anti-HIV antibody levels have been described in
some individuals with full blown AIDS (Pedersen, 1987; Sullivan PS, 1999) as have cases of
assay failure when an extremely varied HIV strain, e.g. non-group M HIV-1, was present
(CDC, 1996). However, there have not been any such reports with third and fourth
generation screening tests recently. It is also important to note that anti-HIV antibody titres

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during seroconversion, as measured by the optical density signal in EIAs or intensity of the
band/dot in a rapid test, dramatically increase over days.
Specimens from HIV-infected individuals typically give rise to strong, and often maximum,
signals in most screening tests whereas false reactive specimens infrequently do (Parry,
2003). However, this is not a reliable basis on which to make a diagnosis of HIV infection,
and confirmatory testing is essential. For this reason a patient should never be told that
he/she is HIV positive based on screening test result alone, especially if the signal (optical
density or band/spot) is weak. False reactive results can occur due to human error, in
individuals with acute Epstein-Barr virus or human cytomegalovirus infection, autoimmune
disorders, hypergammaglobulinemias, multiple myeloma, hemophilia, and hemodialysis
patients. In general, the percentage of false reactive EIA results decreases as the prevalence
of HIV infection in particular population increases (Shapiro, 1999).

Requirements for HIV screening tests

Only Conformité Européenne (CE) marked tests i.e. tests that meet the legal requirements
before they can be sold within the European Community, are allowed for diagnostic testing in
EU. It is important to note that the CE marking gives the assurance that the specified
diagnostic test complies to set manufacturing standards, but there are still differences in
sensitivity and specificity between tests from different manufactures. Although all approved
CE marked HIV screening tests have good sensitivities (99.78%–100%) and specificities
(99.5%–99.93%) (Perry, 1999; Perry, 2003), it is still recommended to consider validation
data obtained by external bodies such as the Microbiological Diagnostics Assessment
Service of the United Kingdom’s Healt
h Protection Agency w
( ww.hpa-
midas.org.uk/index.asp) and to perform an initial own in-house evaluation before finally
selecting a test even though performance claims made in the package inserts are usually
upheld by further studies (Wesolowski, 2006). The testing procedure should not deviate in
any segment from the manufactures’ instructions.

HIV confirmatory testing

As mentioned earlier any reactive or indeterminate screening test result should be confirmed
with more specific test which preferably tests with different method/antigens. Confirmation of
reactive screening test result should be performed in a specialist laboratory with experience
in HIV confirmation. For several reasons, an essential part of HIV confirmatory testing is to
distinguish between HIV-1 and HIV-2 infections. Testing of a follow-up specimen is a critical
safeguard against human error thus a subsequent second blood sample should be always
tested for confirmation of HIV infection to exclude mislabelling, misidentification and
clinic/laboratory mix-up. The patient can be told after confirmation of the first blood that

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he/she is most probably HIV infected but final assurances can only be given after a second
confirmatory blood.
Line-Immuno Assay (LIA) or Western blot (WB) which distinguishes between the different
antibodies against the individual HIV-1 and HIV-2 antigenic components is the preferred final
confirmation assay (IV, C). Confirming initially reactive result with two different confirmation
tests which have high specificities virtually excludes a false positive result (UNAIDS/WHO,
1997). Although exceptional cases of false positive results of a single WB or LIA have been
described in literature (Tarjan, 1998; Mylonakis, 2000; Seme, 2006), the two-test
confirmatory strategy has never been recommended. The interpretation of results of
confirmatory tests should not deviate in any manner from the manufactures’ instructions.
Some laboratories employ two further EIAs or rapid tests to resolve the HIV status of initially
reactive or indeterminate screening test result. Although this strategy will suffice for the
majority of cases, there still will be cases where the reactions are weak in all the tests. In
such cases it is recommended to use more specific tests such as a LIA or WB for final
confirmation of HIV infection.
Nucleic acid amplification tests (NAAT) for HIV i.e. HIV-1 viral load or proviral DNA testing as
well as HIV-1 p24 antigen testing with a neutralisation step can be employed to diagnose
seroconversion where the initial screening test gives a weak positive or negative results, but
where seroconversion is highly suspected. However, when using HIV-1 viral load tests for
such purposes, it should be borne in mind that these tests are not licensed for HIV-1
diagnosis, although there is supporting literature showing that they are clinically helpful and
compare favourably with HIV DNA testing (Hecht, 2002). Additionally, both false-positive and
false-negative HIV-1 viral load test results occasionally occur (Rich, 1999; Sherman, 2005;
Marinovich, 2006). Especially, low values of HIV-1 RNA (less than 5000 copies/ml) should be
interpreted with caution and probably not viewed as positive unless it is confirmed on a
subsequent test (IIb). If HIV-1 viral load test is negative, infection with HIV-2 or infection with
the outlier group of HIV-1 should be excluded (CDC, 2006a). Such specimens should be
referred to specialist laboratory with experience in HIV confirmation of such cases. Additional
testing in such specialist laboratory is also recommended when HIV-1 WB results include the
unusual indeterminate pattern of gag (p55, p24, p17) plus pol (p66, p51, p31) bands in the
absence of env (gp160, gp120, gp41) bands (CDC, 2006a).
As recommended, laboratories should test initially by a fourth generation screening assay
and confirm reactive result using a test which does not contain HIV-1 p24 antigen (usually
third generation test). If there is a discrepancy between the third and fourth generation test
results then a separate HIV-1 p24 antigen test with neutralization of the positive result or a
NAAT testing can be performed to diagnose possible early seroconversion. Alternatively, if
on the follow-up sample in addition to fourth generation screening assay the third generation

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screening test also becomes clearly positive then a diagnosis of seroconversion can be
made without further testing. However, it is recommended to finally confirm HIV infection
using LIA or WB.

Requirements for laboratories performing HIV screening tests

Each European country needs to belong to a laboratory accreditation body, e.g. Clinical
Pathology Accreditation (CPA) (www.cpa-uk.co.uk) in the UK. The body commissioning
services also have to ensure that the laboratory which performs their testing has obtained
and retained the necessary accreditation and one is entitled to ask for a copy of the latest
accreditation certificate. All laboratories should be able to provide their latest external quality
control scores to their users upon request. It is important to note that even though a
laboratory is accredited one can still have inadequate confidence in whether requirements for
quality are met. It is therefore imperative that any users of the laboratory concerned put any
concerns or mistakes which have taken place in writing so that these adverse incidences can
be recorded. This is to ensure that adequate mechanisms are put in place to prevent the
same mistakes from occurring again.

Use of rapid/point of care tests (POCT)

Rapid tests are especially popular in outreach clinic (point of care) screening settings
because they have the advantage of giving immediate test results that enable timeous post-
test discussion. Moreover, patients generally prefer this type of service especially if it
involves minimal sample taking, such as non-blood samples or a finger prick samples. Some
laboratories also use these tests when a quick result is required, such as excluding HIV after
hours, for post exposure prophylaxis.
Although the sensitivity and specificity of CE marked POCTs are comparable with EIAs, one
should remember that they do not test for HIV-1 p24 antigen and therefore can be false
negative early during seroconversion (WHO, 2004; Greenwald, 2006; CDC, 2007). Thus, it is
recommended that if the patient has a seroconversion like illness at time of POCT testing
and a negative test result, then the test should either be repeated using fourth generation
EIAs or repeated using POCT a week later (CDC, 2007).
Rapid tests that use sample types other than blood, such as oral fluid or urine, might be
subject to more sampling variation and this will influence the sensitivity and should probably
not be used as the screening tests. They are useful in certain settings, such as needle-
phobic patients, for epidemiological purposes and for screening children of adults who are
HIV positive when they attend clinic with their parents, and where referral to a paediatric
phlebotomist is impractical (Greenwald, 2006).

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Point of care testing is not managed in many cases by the laboratories and their quality
assurance programmes. Currently these test sites, when not affiliated to a laboratory, do not
fall under a licensing body and great care should be taken to ensure that testing fulfils the
highest standards. It is recommended that all testing sites that use POTC must have a
quality assurance programme consisting of quality control and external quality assessment in
place before offering testing as set out by the WHO and CDC (WHO, 2004; CDC, 2007).
They must also have a multi-test confirmation algorithm and a pre-test and post-test
discussion service in place. It would be best practice if rapid testing site’s testing
responsibilities falls under the management of the local laboratory. If this is not logistically
possible then the local laboratory, which has experience in quality assurance schemes,
should at least be consulted to provide leadership and advice (CDC, 2007).

Offering anonymous testing

Many STI/GUM facilities use a clinic number as the patient identifier instead of a name and
surname. Anonymous testing in this manner makes HIV testing more acceptable and may
encourage certain individuals to present earlier in their infection (Thorvaldsen, 2001). Other
health care facilities that do not routinely provide such an option, should consider a similar
option for those individuals who have a fear of being identified. Occupational health of
hospitals/medical care institutions should always use anonymous testing for their health care
workers to prevent laboratory staff accidentally identifying fellow staff. With anonymous
testing only the name should be anonymised and there should be at least two identifiers,
such clinic number and date of birth, to eliminate the possibility of misidentification either in
the clinic or in the laboratory.
Anonymous testing surveillance is a good source of public health data. It involves HIV
screening of blood which is collected for other purposes e.g. syphilis serology in STI/GUM
facilities and is performed without the patients’ consent (Kessel, 2001). Any such HIV
screening, however, should be so that the researcher cannot trace a result back to a patient.
It goes without saying that ethical approval from one’s local ethics board is required under
these circumstances (Kessel, 2001).

Duration of storage of samples after testing

Plasma/serum samples should be stored post testing according to local regulations. The
Royal College of Pathologists expects samples to be stored for up to 48 hours after the
report has been released, except when the HIV testing was done on transplant patients
(keep for 11 years) and following needle stick injuries (keep for a minimum of 2 years) (RCP,
2005). From a practical point of view, some laboratories opt to store all their plasma/serum
for 2 years since they do not always know which samples were from patients who received a

12
needle stick injury. However, if feasible it is recommended to store all plasma/serum samples
as long as it is possible.

Documenting HIV test results

All laboratories performing HIV testing should have a system in place which complies with
their accreditation bodies’ regulations of recording and documenting HIV test results. POCT
sites will have to develop a system, of not only documenting the actual test result, i.e.
negative, positive or intermediate in the patient’s notes, but also have a test result log that
documents information such as who performed the test, test kit lot number, expiry date etc.
(CDC, 2007).
It is advisable that there is also an electronic record of the actual test with the result
preferably linked to the patient’s test results in the pathology recording system. Consider also
documenting other useful information such as whether an HIV test was declined and referral
to follow-up care, if applicable.

HOW TO INTERPRET HIV TEST RESULTS

Recommendations:
 The health care provider who orders HIV tests should be familiar with basic laboratory
terminology such as sensitivity, specificity and positive predictive value of tests. (IV, C)
 The health-care provider should be aware of what HIV testing algorithm and especially
what HIV screening test their local laboratory is using. (IV, C)
 Patients whose specimens test negative on the initial HIV screening should be regarded
as non-infected unless the patient presents with symptoms of primary HIV infection. (IV,
C)
 It is recommended that patients have a baseline HIV test done at presentation and if
necessary be repeated at 3 months from the time of high risk exposure. (IIb, B)
 Individuals with a high risk exposure to HIV should not be fully reassured until at least 3
months have passed during which they remain seronegative. (IV C)
 Recalling patients for a 6 month follow-up should be considered for occupational
exposures especially if post exposure prophylaxis was given, where the tested subject
has an impaired ability to develop antibodies and where there is simultaneous infection
with another viral pathogen. (IV, C)
 The health-care provider should advise repeat HIV testing at least annually to all persons
who tested HIV negative but who are likely to be at high risk for HIV. (IV, C)

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 The second specimen should be taken at least one week later in the case of an
indeterminate or weakly-reactive screening test. Plasma sample is the preferred second
specimen. (IV, C)
 If a good positive screening test cannot be confirmed by other tests and test negative on
repeat testing with the same assay consider the possibility that another sample has
wrongly been sent out as negative i.e. a testing mix-up. (IV, C)
 Be cautious when you have weak reactions in all or some of the assays. (IV, C)
 Patients who are retested repeatedly following subsequent sexual exposures should have
more intensive counselling to establish the reason and solution for their repeated risk.
They should be made aware of the availability of post exposure prophylaxis. (IV, C)

It is recommended that the health care provider who orders HIV tests be familiar with basic
laboratory terminology such as sensitivity, specificity and positive predictive value of tests
(IV, C). This is not only helpful to interpret the test result correctly, but also to give an
unambiguous answer to the patient during post-test discussion. When interpreting test
results the requesting health care provider should always be kept in mind that no diagnostic
test is 100% accurate, and although the HIV testing have sensitivities and specificities close
to 100%, false positive and false negative results can still occur. Because the prevalence of
HIV in majority of European countries is low, as a general rule false positive HIV screening
tests tend to occur, whilst false negative HIV screening tests (unless a person is in the
window period) are extremely rare. The health-care provider should be aware of what HIV
testing algorithm and especially what HIV screening test their local laboratory is using, e.g.
whether it is a third or fourth generation screening test.

Interpreting negative HIV test results

Patients can be reassured that they are HIV-1 and HIV-2 negative upon obtaining a negative
test result unless the presents with signs and symptoms of primary HIV infection (IV, C). This
is due to the extreme sensitivity of the current HIV screening tests and due to the fact that an
HIV positive person produces huge quantities of antibodies against the various HIV antigens.
The only caveat, however, is the question of whether the patient is at the time of the testing
still in the diagnostic window period i.e. the period before HIV-1 p24 antigen and/or anti-HIV
antibodies are produced. During the diagnostic window period the patient might already be
viraemic (HIV RNA and/or HIV DNA positive) and therefore highly infectious. However, if
there are any clinical signs or symptoms of primary HIV infection present, then the requesting
health care provider should keep in mind that the chance of having a positive HIV test
become increasingly likely as time (days) passes since anti-HIV antibody titres during

14
seroconversion dramatically increases over days. Thus, it is recommended that if the patient
has a seroconversion like illness at time of HIV testing and a negative test result then the test
should be repeated using fourth generation EIAs a week later. The early stage of
seroconversion (first week) is the period of HIV infection in which the differences in the
testing performance of different HIV screening tests are the most pronounced (Parry, 2003).
It is estimated that HIV seroconversion occurs in about 50% of cases around 1 month
following exposure when a third generation screening test is used (Busch, 1995) and 4 to 8
days earlier when a fourth generation screening test is used (Parry, 2003). Another study has
shown that seroconversion occurred in all the study participants within 1 month following
exposure (Lindbäck, 2000). It is recommended that following the initial negative test the
patient is asked to come back for a repeat test at least 3 months after the last exposure or
sooner should symptoms or signs of primary HIV infection appear (Lindbäck, 2000). Repeat
testing of asymptomatic individuals should be according to repeat exposure. Once a patient
has been tested beyond 3 months following a definite exposure and there have been no
subsequent exposures then the patient does not have to be repeat tested.
Case studies of prolonged (only HIV-1 p24 antigen positive for months) or no seroconversion
for up to a year have been described in literature (Farzadegan, 1988; Montagnier, 1997;
Michael, 1997; Reimer, 1997; Rice, 1999; Preiser, 2000). However, these reports were all
tested with older generations of HIV screening tests and many of these long window period
cases tested HIV RNA negative on retesting, suggesting infection was caused by a re-
exposure at a later date. Some older literature also refers to cases where the HIV antibodies
disappeared in patients with advanced AIDS (Pedersen, 1987; Sullivan, 1999). Even though
these cases are very rare they should all be detected by the HIV-1 p24 antigen component of
a current fourth generation screening test.
The CDC guidelines state that one might consider a further follow-up at 6 months if there has
been exposure to a known HIV positive person (CDC, 2001), which in most settings is
impractical and creates a lot of anxiety. In perspective the risk of contracting HIV from a
subsequent episode of unsafe sexual exposure is far greater than the remote possibility of a
prolonged seroconversion. Recalling patients for a 6 month follow-up should be still
considered where the tested subject has an impaired ability to develop antibodies or where
there is a microbiologically proven simultaneous infection with another pathogen such as
human cytomegalovirus (CMV) or hepatitis C virus (HCV). Of note, there has been a case of
prolonged seroconversion in a health care worker who was simultaneously infected with HCV
following a needle stick injury. It was thought that the simultaneous HCV infection influenced
the HIV seroconversion time (Ridzon, 1997).
Recalling patients for a 6 month follow-up should also be considered for occupational
exposures especially if post exposure prophylaxis was given. There is a theoretical, but as

15
yet unproven, risk that during post exposure prophylaxis, HIV replication can be inhibited
enough to prolong the window period. For this reason, the advice sometimes given is to
rather retest, not at 3 months following exposure, but rather at 3 months post stopping post
exposure prophylaxis e.g. at 4 months. However, this makes follow-up difficult, since the
patient is usually asked to return for HCV testing at 3 and 6 months. It would be acceptable
to test for HIV at the same intervals e.g. at 3 months instead of 4 months providing the
patient is informed about primary HIV infection symptoms and one is reasonably sure that
the patient will keep their 6 month follow-up appointment.

If a patient presents with clinical symptoms suggestive of HIV infection or AIDS and the HIV
screening tests are repeatedly negative, then referral of the specimen to a specialist testing
laboratory with experience in HIV confirmation of such cases is recommended (IV, C). There
is a theoretical risk that a patient with a diverse HIV-1 strain not belonging to the M-group will
not be detected by the current HIV screening tests. This possibility should be kept in mind
should the patient have had exposure in or from someone from Central and West Africa and
have a low CD4 count or AIDS defining illnesses.

It is recommended that the health care provider advises repeat HIV testing at least annually
to all persons who tested HIV negative but who are likely to be at high risk for HIV (CDC,
2006b). Persons likely to be at high risk include injection-drug users and their sex partners,
persons who exchange sex for money or drugs, sex partners of HIV-infected persons, and
men who have sex with men or heterosexual persons who themselves or whose sex partners
have had more than one sex partner since their most recent HIV test. Health-care providers
should also encourage patients and their prospective sex partners to be tested before
initiating a new sexual relationship (CDC, 2006b). Patients who are retested repeatedly
following subsequent sexual exposures should have more intensive counselling to establish
the reason and solution for their repeated risk. They should be made aware of the availability
of post exposure prophylaxis. (IV, C)

Interpreting positive HIV test results

A patient should not be told under any instances they are HIV positive based on an initial
result of screening tests alone. As described earlier, two further confirmatory tests will
establish with a high decree of certainty whether the person is truly infected with HIV. Before
final diagnosis, a second blood specimen needs to be tested to exclude mislabelling,
misidentification and clinic/laboratory mix-ups. As described earlier, the patient can be told
after confirmation of the first blood that he/she is most probably HIV infected, but must also
be told that a final confirmation test is still required from second blood specimen. Most

16
patients are understandably anxious following the initial positive test and therefore it is
important that the confirmatory testing algorithm has an acceptable turnaround time. It should
be kept in mind that any weak positive results which are sent to a reference laboratory will
take a substantially longer turnaround time and the patient should be made aware of this.
Although the overall prevalence of HIV-2 infection is low in Europe and is mostly found in
individuals who have had exposure in or with someone from West Africa or the former
African Portuguese colonies, it is important that HIV confirmatory testing distinguish between
HIV-1 and HIV-2 infections. Since the viral load assays and treatment need to be tailored for
people with HIV-2 infections, the final laboratory HIV report, which usually contains at least
three test results, must clearly indicate whether the patient has an HIV-1 or HIV-2 or dual
confirmed infection. The health care provider should also be aware if the referral laboratory is
not able to distinguish between HIV-1 and HIV-2 infections.

Interpreting indeterminate and unconfirmed HIV test results

All HIV screening tests are prone to producing occasional indeterminate and weakly-reactive
results that very often do not prove to be consistent with HIV infection. Thus, care must be
taken not to cause alarm if such indeterminate and unconfirmed results are identified. Such
non-specific reactions in the HIV screening assays tend to occur almost as frequently as
positive reactions when testing populations with a low prevalence. The signal of the test is
usually weak (close to the cut-off when using EIAs or faint bands/spot in POCTs) and mostly
represents a non-specific reaction which may or may not be repeatable. Some HIV screening
tests tend to produce these reactions more frequently than others, especially if the cut-off for
a positive reaction is close to the normal distribution of an uninfected population or there is a
lot of background “noise” generated by the test.
Repeat testing with the same screening test is usually performed when the initial test gave
indeterminate or weakly-reactive result. If repeat testing in duplicate with the same EIA gives
a negative reaction then the test can be considered non repeatable and reported as negative
(always refer to the package insert of the screening test used). If repeat testing in duplicate
with the same EIA gives a weak positive result again the sample should be sent to the
reference laboratory for further testing and/or follow-up sample should be requested.
If a good positive screening test cannot be confirmed by other tests and test negative on
repeat testing with the same assay consider the possibility that another sample has wrongly
been sent out as negative i.e. a testing mix-up.
As described earlier, if the fourth generation EIA is positive but the third generation EIA
and/or confirmatory LIA/WB tests is negative then the high possibility of seroconversion
exists. The best strategy in such a case is to obtain follow-up a specimen. If on the follow-up
sample in addition to fourth generation EIA the third generation EIA also becomes clearly

17
positive then a diagnosis of seroconversion can be made without further testing.
Alternatively, the initial specimen can be tested using a separate HIV-1 p24 antigen test with
neutralization or a NAAT test to diagnose early seroconversion. Remember all results should
still be confirmed on a follow-up specimen.
As suggested earlier, for all POCTs it is recommended that in case of a reactive result
(strong or weak) blood is drawn and sent to the laboratory for further testing.

In cases where the initial screening test cannot be confirmed with either the first or second
confirmatory test, a result of “indeterminate” should be given and a second blood sample
should be requested. The general recommendation is to separate the first and second blood
sample by at least 2 weeks (Rogstad, 2006), but in practice a rise in anti-HIV antibody titres,
as reflected in EIA signal strength (optical density/cut-off) or number of bands on the LIA/WB,
is dramatic over days during seroconversion. In most instances a good laboratory should be
able to distinguish a false reactive signal from seroconversion using two specimens spaced
one week apart as it is unfair towards an anxious patient to insist on waiting for two weeks.
There are no clear patterns of antibody reactivity that predict a higher likelihood of
seroconversion in patients with indeterminate WB results (Davey, 1992).
It is recommended that a plasma sample be used for the second sample so that NAAT
testing can be performed should it still be uncertain whether the patient is HIV infected
without the need to ask for another sample. Thus NAAT or HIV-1 viral load tests can be use
to diagnose HIV infections when the indeterminate and unconfirmed HIV test results occur
since they are positive 7-10 days before the routine HIV screening tests during
seroconversion and the HIV RNA levels are usually very high by the time anti-HIV antibodies
start to appear. However, as described earlier, both false-positive and false-negative HIV-1
viral load test results occasionally occur and thus care should be taken during interpretation.

In cases where the initial signal observed in the screening test does not increase in strength
over a 1-2 week period and where the signal is not caused by HIV-1 p24 antigen the result of
testing should be reported as non-specific. A second or third sample should be sent to a
reference laboratory for further testing which most likely will involve NAAT testing should
there be any doubt as to whether the reaction is non-specific.

PRE-TEST DISCUSSION, INFORMED CONSENT AND

CONFIDENTIALITY

18
Recommendations:
 HIV testing should be undertaken only with the individual’s specific informed verbal
consent which should be documented. (IV, C)
 If a patient declines or defers HIV testing, this decision should be documented in the
medical record. (IV, C)
 Pre-test discussion is the most appropriate way to obtain informed consent. The patient
should understand the purpose, risks and benefits of being tested and of not being tested,
and must give informed consent voluntarily. (IV, C)
 Provision of an information leaflet about HIV testing can provide or replace much of the
information needed prior to obtaining informed consent. (III, B)
 Patients identified as being at high risk for HIV or those with particular concerns should be
offered more in depth pre-test discussion. (IV, C)
 The individual who declines or defers HIV testing on grounds related to confidentiality can
be offered anonymous testing. (IV, C)

During HIV testing in European STI/GUM settings informed consent, counselling and
confidentiality must be clearly observed (IV, C). The best way to ensure this is by pre-test
discussion (IV, C). The pre-test discussion is a recently introduced term which replaced the
term pre-test counselling which has been used in the past to describe a person needing to
see a professional with specific training and expertise in relation to HIV and/or counselling
prior to undertaking an HIV test (Rogstad, 2006). The main purpose of pre-test discussion is
to establish informed consent for the HIV test. The patient should understand the purpose,
risks and benefits of being tested and of not being tested, and must give informed consent
voluntarily (Rogstad, 2006) (IV, C).

Informed consent
Except for unlinked anonymous surveillance or rare cases described below, patients should
only be tested for HIV infection with their informed consent (IV, C). Informed consent must be
obtained before an HIV test is performed and should always be given individually, in private,
and in the presence of a health care provider (WHO, 2007). If a patient declines or defers
HIV testing, this decision should be documented in the medical record (IV, C). Declining an
HIV test should not result in reduced quality or denial of services that do not depend on
knowledge of HIV status (WHO, 2007) (IV, C).
Verbal communication is sufficient for the purpose of obtaining informed consent thus
policies that require consent to be given in writing are encouraged to be reviewed (WHO,
2007) (IV, C). Verbal consent should be always documented in the medical record (IV, C).

19
It is recommended that a part of information required to be given prior to informed consent
(see below) be prepared in the form of an information leaflet that everybody should receive
(Rogstdad, 2003) (III, B). However, it remains essential to ensure that the individual
understands the information given on the information leaflet and that consent to testing is
obtained (Rogstdad, 2006). The information leaflet should be prepared in an easy to
understand informative way and translated in the various languages of the commonly
encountered populations within the service area (CDC, 2006b) (IV, C).

Main topics to be covered in pre-test discussion

In pre-test discussion, the health care provider offering HIV testing should at a minimum
provide the patient with the following information and/or to discuss following topics
(Thorvaldsen, 2001; Rogstad, 2006; WHO, 2007) (IV, C):
 purpose and reasons why HIV testing is being recommended;
 the fact that the patient has the right to decline or defer the test and that such
decision will not affect the patient's access to services that do not depend upon
knowledge of HIV status;
 clinical and prevention benefits of HIV testing including: health benefits of current
treatments, the fact that knowing HIV status can allay anxiety, that a positive test may
motivate people to reduce risk activities and provide the opportunity to reduce the risk
of transmission of the infection to others e.g. infants, sexual partners etc.;
 options for anonymous testing;
 risks of being tested and of not being tested;
 the risk assessment, sexual history and history of other types of risk behaviour
including date of last risk activity;
 the possibility that a later HIV test may be positive if a negative one follows only
shortly after an exposure (window period) and other technical shortcomings of the
HIV testing;
 implications of testing for mortgages, insurance, occupational risks, and
confidentiality;
 details of how the result will be given including the fact that the test result will be
treated confidentially and will not be shared with anyone other than heath care
providers directly involved in providing services to the patient;
 possible personal, social and medical implications of a positive result, including
relevant laws in jurisdictions that mandate the disclosure of HIV status to sexual
and/or drug injecting partners if applicable;

20
  where appropriate to explore support and coping mechanisms of receiving a positive
result;
 obtaining informed consent for the test;
 information about HIV transmission and risk reduction if necessary (e.g. knowledge of
condom use, including practical demonstration for both genders if needed);
 an opportunity to ask the health care provider questions.

Individuals who may require more in depth pre-test discussion

In addition to listed information and topics mentioned above, a more in depth pre-test
discussion should be available for those requiring or requesting it or to those at high risk of a
positive result. Groups who may require more in depth pre-test discussion include (Rogstad,
2006) (IV, C):
 those at high risk of HIV infection and their sexual partners (men who have sex with
men; injecting drug users; people from countries with a high prevalence of HIV
infection);
 patients with another blood borne or sexually transmitted infection;
 patients with a psychiatric history/high level of anxiety/sexual or relationship issues;
 individuals who have been the victims of sexual assault/rape;
 individuals who currently or who may in the future perform exposure prone
procedures;
 individuals involved in commercial sex work;
 women who are or may become pregnant;
 adolescents below the legal age of majority.

In addition to information listed above, pre-test discussion for women who are or may
become pregnant should include: the risks of transmitting HIV to the infant; measures that
can be taken to reduce mother-to-child transmission, including antiretroviral prophylaxis and
infant feeding counselling and the benefits to infants of early diagnosis of HIV infection
(WHO, 2007) (IV, C). For more details on pre-discussion for pregnant women consult recent
CDC guidelines (CDC, 2006a; CDC, 2006b).

Special considerations apply also in the case of adolescents who are below the legal age of
majority. The pre-test discussion should be adapted to the patient’s age, developmental
stage and literacy level (WHO, 2007). Since the legal framework, including the age of
consent for sexual intercourse and offering treatment services to adolescents, varies
between countries please consult relevant national guidelines e.g. in UK National guideline

21
for the management of suspected sexually transmitted infections in children and young
people (Thomas, 2002). If national gudeline is not available you can consult recent
WHO/UNAIDS Guidance on provider-initiated testing and counselling in health facilities
(WHO, 2007).

Testing without informed consent

Few circumstances where informed consent cannot be obtained should represent only
exceptions to general rule (Thorvaldsen, 2001). The major exception arises when the patient
is unconscious or seriously ill and therefore unable to give consent but knowledge of the
patient’s HIV status is regarded as essential for the protection of the patient’s life or the
preservation of his health (Thorvaldsen, 2001; Rogstad, 2006; WHO, 2007). In such
circumstances, informed consent should be sought from the patient’s next-ofkin, guardian or
other caregiver (WHO, 2007) (IV, C). In the absence of such a person, health care providers
should act according to the best interests of the patient concerned (WHO, 2007) (IV, C).
However, once the patient regain consciousness then he/she should be told that he/she has
been tested, the reason for doing so and the result. Their result should not be passed on to
anyone not involved in their care e.g. a relative without their permission (Rogstad, 2006). In
all cases the health care provider must be able to justify their actions and must take into
consideration recent medical advances, consensus opinion and guidance from professional
bodies (Rogstad, 2006).
Recent United Kingdom National Guidelines on HIV testing 2006 (Rogstad, 2006) also
mention a complex problem with informed consent for adolescents and children in situation
where health care provider strongly believes that the judgement of parents/guardian is
distorted, for example, because he or she may be the cause of the child's infection. The
health care provider can test a child without obtaining informed consent preferably after
discussion with an experienced colleague when they are convinced that the medical interests
of the child/adolescent override the wishes of those with parental responsibility. They, must
however be prepared to justify that decision if necessary (Rogstad, 2006).

Occupational exposure and informed consent

Health care providers frequently suffer from a needle stick injury or other occupational
exposures (Elder, 2006; Tarantola, 2006) (IIa). The complex problem with informed consent
after occupational exposure is described in detail in the recently published United Kingdom
National Guidelines on HIV testing 2006 (Rogstad, 2006). Briefly, in the case where a health
care provider has suffered an occupational exposure to blood or body fluids and it is
considered necessary to test the patient for HIV, the patient's informed consent should be
obtained before the test is undertaken. However, in some rare circumstances e.g. if the

22
patient is unconscious and does not regain full consciousness within 48 hours, if patient
refuses testing, is unable to give or withhold consent because of mental illness or disability,
the health care provider can exceptionally, after reconsideration of the severity of risk,
arrange HIV testing without patient’s consent (Rogstad, 2006). In such cases the health care
provider may opt to test an existing blood sample, taken for other purposes, but consultation
with an experienced colleague should be sought first and he/she must be prepared to justify
that decision (Rogstad, 2006). If the health care provider decides to test without consent,
then he/she must inform the patient of his/her decision at the earliest opportunity. In such
cases confidentiality is paramount: only the patient and those who have been exposed to
infection may be told about the test and its result. In these exceptional circumstances neither
the fact that test has been undertaken, nor its result, should be entered in the patient's
personal medical record without the patient's consent (Rogstad, 2006).
For therapeutic options (post-exposure prophylaxis) after possible occupational exposure to
HIV please consult the recent review from Cochrane Library (Young, 2007).

Confidentiality
As a general rule, in pre-test discussion patients should be informed that their confidentiality
will be respected and protected including confidentiality of positive results (Thorvaldsen,
2001, Rogstad, 2006). However, patients should also be advised that confidentiality is not
absolute and that health care provider may be legally bound to disclose HIV status
information in exceptional circumstances (Rogstad, 2006). It is recommended that this
information is included in the information leaflet if appropriate (IV, C). The individual who
declines or defers HIV testing on grounds related to confidentiality can be offered
anonymous testing (Thorvaldsen, 2001) (IV, C).

METHODS OF GIVING RESULTS AND POST-TEST DISCUSSION

Recommendations:
 Detailed procedures how the patient will receive the result, with particular attention to the
means by which a positive result will be delivered should be established. (IV,C)
 Arrangements for communicating the results should be discussed and agreed with the
patient at the time of testing. (IV, C)
 Strict confidentiality of the receipt of the HIV test and the HIV test result must be
maintained, regardless of the method used. (IV, C)
 Face-to-face post-test discussion is the preferred method of providing patients with their
results, but some patients might prefer an alternative method of receiving their result, such

23
 as SMS texting or a mailed report. (IV, C)
 Post-test discussion for individuals with positive or inconclusive test results should be
always done face-to-face. (IV, C)
 Stress to patients the importance of returning to receive their test results and establish a
plan for doing so. (IV, C)
 Every effort should be made to trace positive patients who are not attending for results.
(IV, C)
 All patients should be advised to disclose their HIV infection status to their regular sexual
and needle sharing partners. (IV, C)
 Post-test discussion is an opportune time to re-enforce the issue of safer sex practices.
(IV, C)

Post-test counselling used to be an integral part of HIV testing. However, recent initiatives in
United Kingdom to expand testing to all individuals in HIV high prevalence health care
settings (Depart. of Health, 2007; Hamill, 2007) and the approach adopted in USA recently,
which involves HIV diagnostic testing and opt-out HIV screening as part of routine clinical
care, have put less emphasis on post-test discussion (CDC, 2006b). In the broader sense it
is a step in the right direction to “normalise” HIV testing and to remove perceived barriers to
testing. The CDC advises that HIV test results should be provided in the same manner as
results of other diagnostic or screening tests (CDC, 2006b). They do, however, make a
distinction between HIV diagnostic screening to detect HIV infection earlier and HIV
counselling and testing conducted primarily as a prevention intervention for uninfected
persons at high risk, like patients in STI/GUM settings (CDC, 2006b).

Methods of giving results

It is essential that detailed procedures are established for how the patient will receive the
result, with particular attention to the means by which a positive result will be delivered (IV,
C). Arrangements for communicating the results should be discussed and agreed with the
patient at the time of testing. Face-to-face post-test discussion is the preferred method of
providing patients with their results, but it is not always possible due to constraints in
resources (IV, C). Identifying patients who should preferably have their results discussed in
person, such as those who are anxious, with mental health issues or risk of suicide, those
likely to be positive or vulnerable persons such as those who are underage, is strongly
encouraged (Rogstad, 2006).
Some patients might prefer an alternative method of receiving their result, which will not
involve another clinic visit, such as SMS texting or a mailed report. Providing test results by

24
telephone, SMS text or written results is an good option to low risk patients providing that the
clinic has a standard operating procedure (SOP) in place to deal with all possible scenarios,
including indeterminate and positive results. Patients should be informed that if they receive
a letter, SMS text or telephone call to come back to the testing site to discuss their results
that they must realise that this is to discuss indeterminate and unconfirmed results in the
majority of cases. However, the importance of returning to discuss their test results and a
plan for doing so should be established (IV, C). Alternatively, low-risk patients can simply be
informed that they will only be contacted if their test was reactive (indeterminate,
unconfirmed or positive).
It is preferable to have a written letter signed by the responsible health care provider, rather
than a copy of the actual result, and this should be addressed to a specific individual, not ‘to
whom it may concern’ if patients request or require written confirmation of their results
(Rogstad, 2006) (IV, C). A written protocol is recommended to set out the criteria for those
who receive results in this way, and how this is done (Rogstad, 2006) (IV, C).

Post-test discussion after point of care testing

Point of care testing has the advantage over conventional testing in the sense that the
patient will still be present for a face-to-face consultation when the result is known. If a
positive rapid test result is obtained but has not been confirmed yet, then the patient should
be told that he/she is likely to have HIV infection (based on a strong band/spot) or that there
is a possibility that he/she might have HIV (based on a faint band/spot). It should be
explained that the result is preliminary and that false positive results are possible.
Alternatively, tested individuals can be stratified in those at high risk and low risk and
possibility of HIV infection should be expressed as “highly likely” and “quite likely”,
respectively (Greenwald, 2006). Information on how additional/confirmatory testing will be
performed including time frame should be also given (CDC, 2004).

Post-test discussion for individuals who are negative

Post-test discussion for individuals who are negative should involve a basic explanation of
the test result, and the need for re-testing if there has been a recent exposure and if the
patient is still within the window period. Methods of prevention and provision of condoms can
be reiterated, especially if it was not performed at the initial clinic visit.

Post-test discussion for individuals with inconclusive test results

Post-test discussion for individuals with inconclusive test results should be always done face-
to-face (IV, C). A patient should have been warned when the sample was initially taken about

25
the possibility of an indeterminate test result, which usually turns out to be a non-specific
reaction. They should therefore not be completely uninformed at this stage, but the
significance and the further steps should be re-explained in a straightforward manner. The
importance of continual follow-up until the inconclusive result is resolved and the use of
condoms should be stressed.

Post-test discussion for individuals who are positive

Individuals who are HIV positive will have to receive a face-to-face post-test counselling (IV,
C). They might have received the news of a “reactive” result through the above mentioned
means, but they will be prompted to present as soon as possible for further discussions on
issues such as: what does the test result mean, the need for a second sample and the need
to practice safer sex and partner notification. It is good practice to give patients whom you
suspect to have a bigger chance of being positive a follow-up appointment to come and
collect their result. It is recommended to avoid communicating positive results at times when
ongoing support may be difficult, e.g. immediately before weekends and public holidays
(Thorvaldsen, 2001)
Appointments for face-to-face post-test discussion for individuals who are positive and who
were not expected to be positive should be given as soon as they are notified of a “reactive”
result. Appropriate support should be available on-site to address the psychological
implication of an unexpected HIV infection.

Non attendance for positive results

Every effort should be made to trace positive patients who are not attending for results (IV,
C). This is usually made by telephone calls, letters or home visits. Contacting the patient’s
GP for information regarding address or telephone number changes is also acceptable
providing the HIV result is not divulged to the GP practice without the patient’s consent. It is
recommended to have an agreed process following failure of a patient to return for a positive
result.

Voluntary disclosure, partner notification and contact tracing

All patients should be advised to disclose their HIV infection status to their regular sexual
partners (IV, C). They should also disclose their HIV status to any new sexual and needle
sharing partner even though they are encouraged to use condoms during sexual intercourse.
A further issue that needs to be addressed is that of notification of previous sexual and
needle sharing partners. This usually is done on a case by case basis working back from the
present partner up to the time when they had a negative test. Patients should be asked to
contact the partners themselves or if they so prefer to provide the details of the partner(s)

26
who will then be contacted by the clinic who will need to inform the contacts of an HIV
exposure whilst trying not to disclose the index patient’s details (IV, C).

HIV TESTING IN SPECIAL GROUPS/SITUATIONS

Recommendations:
 Recipients of preventive HIV vaccines might have vaccine-induced antibodies that are
detectable by HIV screening tests. Those individuals should be encouraged to contact or
return to their trial site or an associated trial site for the confirmatory testing necessary to
determine their HIV status. (IV, C)
 HIV testing and counselling is recommended to all men seeking circumcision as an HIV
prevention intervention. (IV, C)
 Due to illegal status of HIV self-tests in some European countries and several concerns
the use of such tests can not be recommended at present. (IV, C)

Testing of participants in HIV vaccine trials

Recipients of preventive HIV vaccines might have vaccine-induced antibodies that are
detectable by HIV screening tests. Persons whose test results are HIV positive and who are
identified as vaccine trial participants might not be infected with HIV and should be
encouraged to contact or return to their trial site or an associated trial site for the
confirmatory testing necessary to determine their HIV status (CDC, 2006b) (IV, C).

Testing of men undergoing circumcision as an HIV prevention intervention

Recent studies have shown up to 60% efficacy of male circumcision in preventing HIV
transmission from women to men (Auvert, 2005; Bailey, 2007; Gray, 2007). Accordingly,
WHO and UNAIDS have issued a series of recommendations endorsing male circumcision
as an intervention for the prevention of HIV (WHO/UNAIDS, 2007). The recommendations
focus primarily on the implementation of male circumcision in high prevalence settings where
circumcision rates are currently low. Consistent with these recommendations, HIV testing
and counselling should be recommended to all men seeking circumcision as an HIV
prevention intervention (IV, C).

HIV self-testing
Self-testing for HIV is a procedure in which all stages of the HIV test take place in the
patient’s home (Frith, 2007). The patient obtains the sample, such as an oral-fluid swab, and
the result develops in 15-20 min. Self-tests for HIV need to be distinguished from home

27
sample-collection test kits in which the patient takes his/her own blood sample at home, then
sends it to a laboratory for testing and receives the results by telephone (Frith, 2007). Such
tests have had FDA approval since 1996. Due to illegal status of HIV self-tests in some
European countries and several concerns (accuracy, the nonability of people to provide
adequate samples for testing, possibility of abuse, lack of pre-test and post-test counselling)
the use of HIV self-test can not be recommended, at present (IV, C).

28
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