In the developing world, laboratory services for sexually transmitted infections STIs are either not available, or where limited services are available, patients may not be able to pay for or physically access those services. Rapid syphilis tests that can be used with whole blood approach the ASSURED criteria and can now be deployed in areas where no previous screening has been possible. Although rapid tests for chlamydia and gonorrhoea lack sensitivity, more tests are in development.
The prize was never claimed and was withdrawn in In stark contrast, ultra sensitive and specific assays such as nucleic acid amplified tests were developed and became widely and effectively used in the developed world to screen for these infections and facilitate treatment. Not surprisingly, the prevalences of curable STIs remain very high in much of the developing world, where women and children continue to bear a disproportionate share of the disease burden.
Diagnostic testing is particularly critical for STIs, including HIV, as most infected individuals are often asymptomatic but, nonetheless, infectious. Sensitive diagnostic tests are required for early detection to guide treatment, to prevent the development of reproductive sequelae, and to interrupt onward transmission.
Reasons for the failure to prevent and control STIs in the developing world are complex, but a major barrier to effective health care in Africa is the lack of access to reliable, affordable, accurate laboratory
Rapid tests for sexually transmitted infections list.
Selected from the World Development Report, 5 page For syphilis, the evaluation of diagnostics that would increase access to prenatal screening was selected.
For genital chlamydial and gonococcal infection, priority was given to the evaluation of diagnostics that can be used for screening of high risk populations as well as for increasing the specificity of syndromic management. This review provides the background for the work on STI diagnostics featured in this supplement, and proposes 10 specific strategies or pathways for the way forward. The consequences of syphilis in pregnancy are so severe that universal screening of pregnant women for syphilis is national policy in most countries.
Simple rapid tests such as Rapid tests for sexually transmitted infections list rapid plasma reagin RPR or venereal diseases research laboratory VDRL tests are used for prenatal screening.
Women must return to receive test results as the testing is batched to save time and reagents, or specimens may be sent to a central laboratory for processing.
Despite recent successes in increasing coverage for antenatal services in developing countries, most pregnant women fail to get screened for syphilis. The syndromic approach works particularly well for men with urethral discharge and genital ulcers, but evaluations showed that the algorithm for vaginal discharge lacks both sensitivity and specificity for the identification of women with Chlamydia trachomatis and Neisseria gonorrhoeae infection.
Since facilities for culture, antigen detection or nucleic acid amplification tests are not available outside of major urban centres, it is not possible to diagnose gonorrhoea or C trachomatis infection in women at peripheral health services in most developing countries. Hence the syndromic approach is widely promoted and used.
Although simple to use and inexpensive, the poor performance of the syndromic approach to the management of cervical infection is well documented and often can lead to problems in unnecessary treatment and difficulties with partner notification.
Women may be at risk of stigma and violence from their sexual partners if they are asked to refer their partners for STI treatment when they do not have an STI. Articles in this supplement describe the results of evaluations of two rapid tests for gonorrhoea and one for chlamydia.
Clinical care for STIs in the developing world is compromised if regulatory control of diagnostics in both the public and private sector is not done effectively. Many countries do not have sufficient infrastructure to determine the quality of diagnostic tests.
A CE mark on a product only addresses manufacturing quality and does not imply acceptable test performance. A questionnaire sent to WHO member states inquired about regulation of in vitro diagnostics other than those used for blood bankingand if clinical trials were required for regulatory approval. However, no standard exists for diagnostic evaluation or approval in developing countries.
Diagnostic trials had been conducted in as few as 15 patients unpublished TDR data. The evaluation was conducted in just over patients, of whom only three were positive for syphilis! Physicians often select tests based on information provided in the product insert or from published data.
Information on the performance of tests sold in developing countries is often biased because of flaws in the design and conduct of evaluations. The consequences of low quality diagnostics for STIs include wasted precious resources and mismanagement of patients, potentially leading serious sequelae in the infected individual and failure to interrupt the chain of transmission in the population. Rapid tests for HIV infection have shown the potential for such tests to be rapidly and widely introduced in both developed and developing countries.
Having been evaluated by WHO and shown to be both sensitive and specific, they became available at affordable prices through the WHO bulk procurement programme, and were approved for use in the USA by the Food and Drug Administration. The demand for an immediate result, and the advantages in terms of patient management, are so great that
Rapid tests for sexually transmitted infections list tests are now routinely used in voluntary counselling and testing centres and antenatal clinics worldwide.
However, there are 10 areas where more work is needed before STI tests can be widely used. Improved tests for syphilis that can distinguish between active and past treated infection are still needed.
These prototypes will soon be ready for evaluation. Clearly there is a need for more sensitive, simpler and cheaper rapid tests for C trachomatis and N gonorrhoeae. Too often, research findings are not effectively translated into control strategies, policies and programmes.
These activities form a basic road map for the introduction of new tools that can be used for diagnostics, vaccines and medicines. As a result of the SDI regional consultations, 12 countries have initiated the development of a road map for the introduction of syphilis screening in their country.
Such a road map can be broadly used for the introduction of other technologies for a variety of infectious diseases. It is therefore critical that countries set up external quality assurance EQA schemes to ensure that the quality of the tests has not been compromised during storage and that health workers are proficient at performing the tests.
These national schemes can be developed in conjunction with quality assurance schemes for other diagnostic testing and should be supported technically by a network of expert laboratories, inside and outside of the country. This requires the development of a business plan for obtaining sufficient funds to cover set up costs and identify means of sustaining the programme.
Capacity for introduction of new tools varies significantly between countries, and between rural and urban Rapid tests for sexually transmitted infections list within countries.
The success of increasing access to syphilis screening depends on the level of political commitment, the existence of a robust health infrastructure to facilitate the implementation, and the availability of screening tools.
In resource limited settings, health
Rapid tests for sexually transmitted infections list providers have to prioritise their scarce monetary and human resources to accommodate many competing demands. Instead of setting up a new infrastructure for decentralised STI diagnostic services, every effort should be made to take advantage of new or existing initiatives, such as antenatal care programmes, Prevention of Mother to Child Transmission programmes for HIV, and HIV Voluntary Counselling and Testing programmes.
In recent years, the internet has emerged as a risk environment for STIs and many STI testing services are available from the internet. The type of tests and the quality of testing used on these internet services are unknown. Few countries regulate STI tests sold through these venues. STI control programmes need to exploit the popularity of the internet to provide scientific information to health care professionals and the lay public on how STIs should be diagnosed and treated, and make the public aware of the consequences of misdiagnosis.
The availability of new tools that can be used to increase coverage for prenatal screening has sparked interest in planning for the global elimination of congenital syphilis. Another treponematosis, yaws, has been eliminated from some regions, but not globally. However, it returned with a vengeance as sexual behaviours and patterns of sexual mixing changed.