Before introducing a new Point-of-Care test, health managers should carefully weigh up the potential benefits and risks, just as they would do before introducing any new medical test, service or treatment. This should be done in a systematic, comprehensive manner so that there is consensus on the need for a test, as well as agreement on the selection of a test and of how it will be implemented.

There may be pressure to introduce a new POC test, which can mean that a proper initial assessment gets missed. This pressure should be resisted.

Ideally, a national technical working group would undertake the initial assessment with representation from experts in STIs, laboratory testing, disease surveillance, procurement and supplies, and public health program management. In the Pacific, there is also a regional STI technical working group that can provide advice, and countries can learn from the experience of their neighbours.

The initial assessment involves a series of overlapping considerations:

1.1 Review your local STI situation

This task requires an understanding of:

Knowing the magnitude and dynamic of your own STI epidemic is the key to tailoring public health responses to benefit those most in need. Such descriptive information may also influence the decision to use an STI POC test

Key questions to ask include:

Key Questions Related Questions Why ask the Qs?
Is the STI an important public health problem in your country? How many cases? What is the infection rate?

Are case numbers and infection rates increasing or decreasing over time?

Does the STI cause serious morbidity and mortality?

What is the burden of disease? How does this compare to other health conditions?

How do these figures compare to other countries in the region? 		Helps in setting priorities

Helps identify what we do and don’t know

** Existing data suggests that chlamydia is a problem throughout the Pacific whereas syphilis affects some countries more than others
Do we know who is affected by this STI and where they are? Which people are most affected? Which geographic areas are most affected? Are there high-risk groups or vulnerable populations?

Are these patterns changing over time?

Do we know why these people are at risk of being infected with this STI? 		Helps in targeting health responses including thinking about where and who might benefit from a POC test

** Most Pacific countries have data to show that young people aged 15-30 years are most affected
How useful are the available data? Are data accurate? Why or Why not?

Do data reflect the real STI situation in the whole population or a particular subgroup?

If there are no local data, are there data from other countries in the region that can be used as a best guess to describe the likely patterns of disease? 		Identifies weaknesses in existing data that may need to be addressed before the introduction of a POC test or that may be improved by introducing a POC test

Key activities in reviewing the local STI situation include:

  1. Compile existing health data on the STI from a range of local, national, regional and international sources to build the best picture of the STI epidemic that you can. Sometimes you need to go looking for data, as surveillance systems may not collect information from every health facility. For instance, figures from rural and remote clinics may not be included in national surveillance data.
  2. Find out who are the best sources of local knowledge. This can save an enormous amount of time in gathering up-to-date quantitative data. Also, qualitative information such as interviews with key health staff can be helpful to make sense of quantitative data.
  3. Critique the quality of the data and interpret the findings
  4. Decide on whether to continue with the initial assessment based on your review. For instance, if STIs are not a major problem in your setting health managers may decide that introducing a new POC test would not be the best use of resources and may not proceed with the initial assessment. If STIs are a major problem for everyone or among some risk groups, then health managers may begin to explore the advantages that a POC test could bring and would continue with the initial assessment. If no data are available, take the opportunity to discuss with key decision makers about how to improve the STI reporting system either before proceeding with the introduction of a POC test or exploring the ways in which introducing a POC test may strengthen the health information system.

Key sources of information include:

A lesson about the importance of engaging with local partners at the outset

Save the Children PNG have partnered with the provincial government to implement the Lusa Numini sexual health improvement project in the Eastern Highlands. From the outset there has been meaningful engagement with local government in design, management and implementation. This has helped to ensure that program activities were aligned with national and provincial policies and informed by local health data; it has also meant that sustainability considerations have been well thought through and planned for. The provincial government has a strong sense of ownership for the project and this support has flowed through to local communities.

Local

Regional

Documents and materials

1.2 Review your local STI response

This task requires an understanding of local:

Before integrating POC testing for STIs into your country, the overall STI control strategy and existing services should be reviewed and strengthened if necessary. In particular, the set-up and performance of current testing programs needs to be assessed to help decide if there is a place for a new POC test. Legislation, regulations and politics are also important and differ across and within countries. These structural factors may make it easy to implement a new POC test or they may complicate and slow implementation. It is better to understand these aspects as early as possible. Mapping the local response can also help later to guide program decisions about who should be tested and how the test should be implemented.

Key questions to ask include:

Key Questions Related Questions Why ask the Qs?
What is the current national (or local) STI control strategy? What elements of the Regional Comprehensive Package are being implemented?
  • Promotion of safer sexual behaviour and health seeking behaviour
  • Expanded counselling and testing among high risk groups
  • Syndromic management of symptomatic cases
  • Effective STI treatment drugs available
  • Improved partner management
  • Expanded counselling and testing of antenatal women
  • Universal infant prophylaxis
 The Comprehensive Package provides a benchmark against which to assess the local response

Introducing a POC test without having the minimum control strategies in place will not lead to improved outcomes
What do we know about the existing system for testing for STIs? Is STI testing available? Are tests free of charge? What type of tests? Which facilities conduct testing? How long does it take from specimen collection to return of test results?

What is the current capacity to do STI testing through laboratory based services? Is this servicing the need? What is the caseload? How many tests could be performed?

What is the quality of current testing? Is there a program of ongoing quality control? Are national protocols being followed? Has there been an evaluation of the testing system? Is there a need for a formal review?

What proportion of people can access testing? Are there inequities in access to testing? What are the barriers to testing? Is privacy and confidentiality respected by staff? Are clinics accessible, user-friendly, and client centred?

Can young people access testing without parental consent? Where do people want to access tests?

What proportion of people who had a positive test received their test result and were able to access timely treatment?

Who can order an STI test and prescribe treatment at different levels of the health system?

Will introduction of a POC test improve coverage and access? Will it improve patient care and outcomes? 		Mapping the strengths and weaknesses of the existing system can identify settings where a POC test may or may not be useful
Is nationally approved (or WHO recommended) treatment available for those diagnosed with an STI? What factors limit the availability of this treatment? E.g. procurement, storage, distribution, prescription, training etc.

Are there treatment guidelines? Have these been validated?

Do health staff follow treatment guidelines?

Are condoms on display and freely available? 		Effective, acceptable, accessible treatment must be available before introducing a POC test
How might policy, legislative and regulatory frameworks impact on the introduction of a POC test? Are certain behaviours illegal?

Can the test be used in the country?

Which health staff can perform tests? Is counselling required?

Which health staff can prescribe and dispense treatment?

Which bodies are responsible for regulating testing and treatment, and for overseeing the implementation and management of a new POC test?

 Appropriate policy, legislation and regulation are basic elements of ensuring that a new POC test will improve diagnostic services & patient outcomes
Is the political environment supportive? Is there interest and leadership on STIs within the health sector?

Are legislative or regulatory changes required?

Will systems to maintain the quality of POC testing be supported? 		Helps determine if the minimum level of support for implementation and ongoing management is in place

Key activities in reviewing the local STI response include:

  1. Describe relevant national legislation, the policy setting, and the existing STI control strategy by speaking to key staff and sourcing relevant local documents
  2. Assess existing elements of the STI control strategy against national and regional standards – review what is on paper compared to what actually occurs as there may be differences (e.g. in urban vs. rural areas)
  3. Evaluate the existing testing program performance based on its objectives and targets
  4. Build a picture of the strengths and weaknesses of the existing testing system to determine if it can be strengthened and the resources that would be required to do this (This will allow you to make comparisons with the benefits and resources required to introduce a POC test in the next section of the toolkit.)

A lesson about the impact of HIV legislation in PNG

The HIV/AIDS Management and Prevention (HAMP) Act in PNG ensures that people living with HIV and AIDS have the same rights as others in the community. In particular, the HAMP Act protects the privacy and confidentiality of people with HIV. The legislation was passed before the introduction of widespread HIV testing in PNG, and has ensured that healthcare workers adhere to national standards in providing Voluntary Confidential Counselling and Testing. This has been an important enabler to accessing testing without fear of stigma and discrimination- especially for vulnerable and marginalized groups most at risk of HIV and other STIs.

A lesson about overcoming legal and organizational constraints in Fiji

In 2009, Fiji began training Nurses, Nursing Practitioners and Medical officers to deliver comprehensive case management of STIs (CMS) based on a regional package that included the latest WHO treatment recommendations. During the training a number of challenges were raised:

These regulatory and system issues were serious enough to hamper the roll out of the CMS package in Fiji. In response, the Minister of Health gave powers to a national STI working group (supported by regional partners) to address these issues. As a result, Fiji has new STI treatment guidelines, drugs will be made available at all health care facilities, and nurses can now diagnose and treat STIs.

The Fiji experience highlights a number of key points:

Key sources of information include:

Local

Regional

Documents and materials

1.3 Decide if a POC test will be beneficial

This task requires an understanding of the:

By reviewing both the local STI situation and the response, you can determine if an STI POC test might offer advantages over the current system of testing. Note that weighing up the advantages and disadvantages of a POC test can be complex and should involve a range of stakeholders to make sure that all aspects are considered.

Key questions to ask include:

Key Questions Related Questions Examples
Are basic STI policies, legislation and services in place? Where do POC tests fit in the overall Comprehensive Package of STI Control for your country?

Do national policies and legislation need to be amended before a POC test can be introduced?

Is treatment available and have drug supply systems been optimized?		 If you have a chlamydia POC test but azithromycin is not available, there is no use testing people who cannot then be treated

If the basic elements are not in place, then it may be reasonable to delay introduction of POC testing until the relevant areas have been addressed
Is the existing system functioning adequately? Is the quality of testing ok? Is coverage high?

Would it be simpler and cheaper to strengthen the existing system rather than introducing a new test? Can system constraints be overcome?		 Small islands serviced by one or a few health facilities with a laboratory capable of performing STI tests may not benefit from a POC test. The accuracy of diagnoses may actually suffer if POC tests are introduced in this setting
Can you identify reasons why a POC test will not be appropriate? Are there settings in your country where a POC test is clearly not helpful and may result in harm?

Will POC testing alter the clinical management of patients?

Are barriers to testing such that a POC test will not change access to and utilization of STI testing?		 People aged over 40 years are usually much less likely to have gonorrhea or chlamydia so POC tests are less reliable in this population

Testing young children can raise problems if the limitations of POC tests are not well understood

Men with urethritis will be treated regardless of POC test results for gonorrhea and chlamydia (though they may benefit from testing for HIV and syphilis)

Women with pelvic inflammatory disease often test negative on POC tests but need treatment regardless of the test result

The use of POC tests in non-clinical settings such as use at home is generally unreliable

If presumptive treatment of some groups such as women attending antenatal care is the national strategy, then there may not be a place for a POC test since testing would not alter patient management

High levels of stigma, discrimination and partner violence may limit the clinical benefits of a POC test
Can your health system support the introduction of a POC test and maintain a high-quality testing program? Can your system cope with POC tests applied in some settings where they offer clear advantages but not in other settings where there are no or few advantages?

Will a POC test program be managed effectively with tests used only in the settings for which they have been approved?		 If tests begin to be used in settings for which they were not intended – "leakage" - then the reliability of the test result is reduced
Can you justify why a POC test should be introduced? Do you anticipate that it will improve access to testing, coverage of treatment, and patient outcomes for the intended population?

Key activities in deciding if a POC test will be beneficial in your setting include:

  1. Assess if basic STI policies, legislation, regulation, and services are in place and review what you know about the current system of STI testing and its performance
  2. Consult with health workers working at different levels in the health system to understand potential socio-cultural barriers to STI testing
  3. Determine if a POC test will offer advantages over the current testing system and which settings and populations it might best be used for
  4. Compare the benefits and resources required to strengthen the existing testing system with those required to introduce a new POC test

A lesson about "leakage" of POC tests

Laboratory based testing of pregnant women for syphilis has long been used to prevent adverse outcomes for the baby. The introduction of new combination HIV and syphilis POC tests sound promising but may lead to over diagnosing syphilis in areas where yaws is endemic (such as PNG and Vanuatu) as the syphilis POC test cannot distinguish between yaws and syphilis. If this same test is then used to screen blood for HIV and syphilis, the same over diagnosis of syphilis will occur. This could then result in many blood units being falsely discarded, wasting a precious resource because of the application of a test to a setting where it was never intended to be used. It may also result in negative social consequences for individuals who may be mistakenly labelled as being infected with syphilis.

(Note that if a laboratory relies solely on the same kind of specific treponemal test used in these combination HIV and syphilis POC tests and does not do any additional tests, then the results will also lead to falsely discarding blood units.)

Key sources of information include:

Local

Regional

Documents and materials

1.4 Decide which POC test to use & where it will be used

This task requires an understanding of:

Test performance and operational features are both important in selecting a POC test that is suitable for your primary care setting. The World Health Organization has developed the ASSURED criteria as a benchmark for essential characteristics of POC tests: Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free, and Deliverable. As a minimum, any POC test needs to fulfil these criteria for the population in which the test will be used.

Key questions to ask when appraising the range of POC tests available include:

ASSURED criteria Qualities of an Optimal Point-of-Care Test
Affordable Minimal cost to those being tested

Balanced with competing health priorities

Ideally, tests procured through WHO
Sensitive and Specific For the population being tested with the POC test:
· There should be few false-negative tests (high sensitivity)
· There should be few false-positive tests (high specificity)
· Results should be applicable to clinical decision making
· There should be a strong correlation compared with standard laboratory procedures
User-friendly Minimal training

Minimal or no use of blood

Simple, easy to perform

Easy to interpret test results & minimal variability in test results – controls built into the test may help with interpretation of the result
Rapid and Robust Rapid availability of test results (<30 minutes for results) to enable treatment during first visit

Stability of testing equipment in a variety of different environments (e.g. does not require refrigerated storage)

Low maintenance
Equipment-free Minimal elements (e.g. reagents, kits, ancillary equipment)

Portability of testing equipment
Deliverable to those who need it Political, legal, regulatory and organizational framework permits test introduction and sound management

Tests can be distributed to testing sites and health workers can administer tests without compromising clinical services

Acceptable to people being tested (e.g. they are willing to be tested, they can access testing sites, they wait to receive test results, few negative social consequences of being tested)
Peeling RW, Holmes KK, Mabey D, Ronald A Rapid tests for sexually transmitted infections (STIs): the way forward Sex Transm Infect 2006;82(Suppl V):v1–v6

Lessons learned from STI programs run by primary healthcare services in remote Indigenous Australian communities

STI programs in remote Australia have implemented comprehensive STI control programs that are similar to the Regional Comprehensive Package: clinical strategies of testing, prompt treatment, syndromic management, and contact tracing were combined with measures to improve program management, surveillance, monitoring and evaluation, condom availability, and community health promotion and education.

A review of the impact of these programs found that it was possible to test a high proportion of the local community for STIs with periodic community testing, ongoing opportunistic testing in health services or a combination of both strategies. In 3 of 4 programs the prevalence of STIs was reduced:

Testing strategy Features of settings where the testing strategy is often used Point of care testing Laboratory testing Advantages Disadvantages
None +
Presumptive treatment
(usually considered an emergency strategy) 		Remote

Poor laboratory access

High disease burden

Simple, effective treatment 		None None Comprehensive treatment coverage

No lab requirements

No loss to follow up 		Costs

Overtreatment

Adverse effects

Drug resistance

May miss women with pelvic inflammatory disease (PID)
None +
Syndromic treatment 		No lab requirements

No loss to follow up
 Misses asymptomatic and women with PID
POC test as a diagnostic tool for symptomatic or high-risk patients · As above

Plus a setting where:
· The consequences for missed cases are not severe
· Tests are easy to use
· There are validated testing algorithms		 Single or multiple tests None Improved diagnostics with clear testing algorithms

Reduces overtreatment

Reduces loss to follow up		 PPV low if prevalence low

False negatives may be a concern

Operator dependent

Test storage & logistic needs

Access to external quality assurance may be challenging

Time taken to do tests & impact on clinical services

Symptomatic patients should always be given syndromic treatment regardless of test results
POC test for screening & confirmation for asymptomatic patients (opportunistic screening or a formal screening program)
POC test as an initial screening tool

(diagnostic, opportunistic screening or a formal screening program)		 A setting where:
· The time to send specimen to lab and return result is minimal
· The consequences of being labelled as ‘positive’ are severe 		Single Yes
(Confirmation) 		May reduce loss to follow up

Reduces overtreatment (fewer false positives) 		False negatives can still be a problem if consequences of missed cases severe

Time to obtain result
Laboratory based testing A setting where:
· There are sound systems for sending specimens & receiving results
· The time to send specimens to the lab is minimal
· Patients are likely to return for results 		None Yes
(Screening + Confirmation) 		Quality assurance is simpler because fewer sites / staff

Allows HCWs to focus on services 		Time to obtain result

May be more costly

Excel worksheet of test formulas

SETTING Estimated prevalence of STI in population (%)
Estimated number of people to be tested
(e.g. no. births in Port Vila Hospital in 2009)
TEST PARAMETERS
(from manufacturer, WHO or literature review)		 Lower 95% CI Point Estimate Upper 95% CI
Sensitivity (%)
Specificity (%)

TEST PERFORMANCE
(compared to gold standard laboratory tests)		 Positive predictive value
(How likely a person is to have the disease if they test positive)
Negative predictive value
(How likely a person is not to have the disease if they test negative)
Estimated number of cases missed
(False negatives: implications = ongoing spread of STI, medical consequences of untreated infection, costs)
Estimated number of cases treated unnecessarily
(False positives: implications = side effects of treatment, social consequences, costs)

Use of POC tests for syphilis

Most of the currently available POC tests for syphilis that have been ASSURED are single treponemal specific antibody tests that cannot distinguish between current active infection and past infection. In settings where the disease is uncommon (has a low prevalence) there may be an unacceptable number of false positive tests so lots of treatment of people who don’t have active syphilis. This is usually not a major medical concern because the treatment (penicillin) is safe and adverse reactions rare. However, people with false positive results may face serious social implications such as violence from a partner who thinks they have been unfaithful. These social dimensions are important to consider when assessing the suitability of introducing a POC test.

False positive test results for syphilis are likely to be an even greater problem in Vanuatu and PNG than in other settings because these countries still have yaws - people with yaws are likely to test positive on a treponemal antigen test for life even after they have been treated.So basing treatment on the result of a single POC test for a treponemal antigen may mean that many people tested end up being treated. In this setting, a different POC test may need to be used or else medical and laboratory records will need to be good enough to trace previous test results so that people aren’t repeatedly tested and treated.

Key activities in selecting a POC test include:

  1. Consider where a POC test would be used – define the population, and decide whether the test would be used for screening or diagnosis
  2. Assess the suitability of the range of POC tests that are commercially available for this population using the ASSURED criteria. If possible refer to WHO assessments. If they are not available, draw on domestic, regional and international expertise in assessing point-of-care tests
  3. Consult with health workers working at different levels in the health system to understand potential socio-cultural barriers to STI testing
  4. Consider whether a formal assessment of costs is required and what expertise is available locally and regionally to undertake this assessment

Lessons from trialing POC tests for chlamydia in Vanuatu

Wan Smolbag in Vanuatu conducted a study to assess the performance of two POC tests for chlamydia. Their observations illustrate the importance of assessing performance and operational characteristics of POC tests in the local setting:

Through the trial, Wan Smolbag found that the POC tests were acceptable to 18-29 year old men and women and even found that self-collected samples were just as good as samples collected by health workers. This has implications for how tests should be implemented. On the other hand, the legislative environment meant that only people aged 18 years or older could consent to being tested even though the age of sexual consent is 15 years.

Key sources of information include:

Local

Regional

Documents and materials

Next: 2.0 Piloting an STI POC test

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