DUAL HIV/SYPHILIS RAPID DIAGNOSTIC TESTS CAN BE USED AS THE FIRST TEST IN ANTENATAL CARE NOVEMBER 2019 POLICY BRIEF 2 Dual HIV/syphilis rapid diagnostic tests can be used as the first test in antenatal care Rationale Elimination of mother-to-child transmission (EMTCT) of HIV and syphilis is a global health priority. It is estimated that there are 1.4 million new maternal HIV infections and 988 000 new maternal syphilis infections every year. Globally, there has been marked progress toward EMTCT of HIV, with a 41% reduction in new paediatric HIV cases between 2010 and 2018. However, syphilis remains the second most common cause of stillbirth globally. As of 2016, over 660 000 cases of congenital syphilis (that is, due to mother-to-child transmission) are estimated to have occurred globally, with over 350 000 of these resulting in adverse birth outcomes (>200 000 as stillbirths and neonatal deaths). WHO recommends that pregnant women receive testing for HIV, syphilis and hepatitis B (HBsAg)* at least once during pregnancy, preferably in the first trimester. Dual HIV/ syphilis rapid diagnostic tests (RDTs) can be used as the first test for pregnant women as part of antenatal care (ANC). These simple tests can be used at the point-of-care and are cost-saving compared to standard testing in ANC. They enable more women to be diagnosed with HIV and syphilis so that they can access treatment and prevent transmission to their children. Fig. 1. Differences in coverage of testing for HIV and syphilis in pregnant women visiting ANC in 10 countries, 2016–2018 ANC = antenatal care Source: Storey A, Seghers S, Pyne-Mercier L, Peeling R, Newman Owiredu M, Taylor M. Syphilis diagnosis and treatment during antenatal care: the potential catalytic impact of the dual HIV and syphilis rapid diagnostic test. Lancet Glob Health. 2019; 7(8): e1006-e1008. 80% — 60% — 40% — 30% — 10% — 0% — 20% — 70% — 50% — 90% — 100% — Mozambique 72% >95% -24% Uganda 43% >95% -52% Zambia 56% >95% -39% Malawi 82% 94% -12% Ethiopia 45% 92% -47% Kenya 89% -3% South Africa 75% 85% -11% India 20% 59% -39% Nigeria 16% 35% -19% Indonesia 2% 28% -26% Pr ev al en ce HIV 15.0% 7.3% 14.3% 11.7% 1.2% 6.2% 23.7% 0.2% 3.0% 0.3% Women between 15–49 years Syphilis 4.6% 2.9% 3.5% 1.0% 1.1% 1.4% 2.0% 0.38% 0.8% 3.2% % ANC attendees positive for syphilis HIV testing rate Syphilis testing rate % Difference in testing rates Box 1. WHO Recommendation and implementation guidance All pregnant women should be tested for HIV, syphilis and hepatitis B surface antigen (HBsAg)* at least once and as early as possible, ideally at the first antenatal care visit (syphilis: strong recommendation, moderate-quality evidence; HBsAg*: strong recommendation, low-quality evidence). Dual HIV/syphilis rapid diagnostic tests (RDTs) can be considered as the first test in HIV testing strategies and algorithms in ANC settings. *Particularly in settings with a ≥2% HBsAg seroprevalence in the general population. *Particularly in settings with a ≥2% HBsAg seroprevalence in the general population. 3Fig. 2. WHO-recommended testing strategy for dual detection of HIV and syphilis infection for ANC settings A1: Assay 1, A2: Assay 2, A3: Assay 3, TP: Treponemal pallidum (syphilis). A1 (Assay 1) is a dual HIV/syphilis rapid diagnostic test (RDT). A2 and A3 (Assay 2 and Assay 3) are HIV RDTs or enzyme immunoassays (EIAs). When resolving discrepant results, all reactive TP (syphilis) results, including A1: TP+ or Repeat A1: TP+, should be referred for treatment and further testing according to national guidelines. When resolving discrepant results, if A1 and Repeat A1 are both TP (syphilis) nonreactive results, report syphilis-negative. Perform A1 (HIV/TP) A1: HIV-, TP- A1: HIV-, TP+ A1: HIV+, TP- A1: HIV+, TP+ A2: HIV+ A2: HIV- Repeat A1: HIV+, TP- or HIV+, TP+ Repeat A1: HIV-, TP- or HIV-, TP+ Perform A2 (HIV only) Perform A3 (HIV only) Repeat A1 (HIV/TP) A1: HIV-, TP- Report HIV-negative Report syphilis-negative A1: HIV-, TP+ Report HIV-negative Report syphilis-positive indicative of either current or past/resolved infection Report syphilis-positive, indicative of either current or past/resolved infection A1+; A2+; A3+ Report HIV-positive Report syphilis-negative A1+; A2+; A3- Report HIV-inconclusive, retest in 14 days Report syphilis-negative A1: HIV+, TP- or HIV+, TP+ A2: HIV- Repeat A1: HIV+, TP- or HIV+, TP+ Report HIV-inconclusive, retest in 14 days If A1 or Repeat A1 is TP reactive, report syphilis- positive, indicative of either current or past/ resolved infection If A1 and Repeat A1 is TP nonreactive, report syphilis-negative A1: HIV+, TP- or HIV+, TP+ A2: HIV- Repeat A1: HIV-, TP- or HIV-, TP+ Report HIV-negative If A1 or Repeat A1 is TP reactive, report syphilis- positive, indicative of either current or past/ resolved infection If A1 and Repeat A1 is TP nonreactive, report syphilis-negative Syphilis testing and treatment coverage among pregnant women are low in many countries, lower than that of antenatal HIV testing and treatment (Fig. 1). While WHO recommends testing at the point of care using RDTs, the majority of countries still rely on laboratory testing for syphilis. Use of dual HIV/syphilis RDTs offers the opportunity to immediately close the gap between HIV and syphilis testing among pregnant women, with the goal of eliminating adverse birth outcomes due to syphilis. Dual/HIV syphilis RDTs detect antibodies to both Treponemal pallidum (TP) (the cause of syphilis infection) and HIV. Like other RDTs used for HIV alone, they do not require refrigeration. Available products currently do not discriminate between active or past syphilis infection. This means that, if a person has had syphilis that is treated/ resolved, and treponemal antibodies persist, the dual/HIV syphilis RDT may produce a reactive result for syphilis. Advantages of rapid dual HIV/syphilis tests in ANC Use of a dual HIV/syphilis RDT as the first test in ANC offers the opportunity to test for both infections with a single finger prick. Results are available quickly, enabling many to start either or both HIV treatment and syphilis treatment with benzathine penicillin. In addition to increasing syphilis testing and treatment coverage, use of the dual-purpose RDT can simplify training by using one test instead of separate tests, reduce storage and transportation costs and reduce waste disposal. In both high and low HIV burden settings, use of the rapid dual test has been found to save costs, in both high and low HIV burden settings, in prevention of congenital syphilis and has not negatively affected HIV testing coverage. Countries should review and consider the dual HIV/syphilis RDTs prequalified by WHO and listed at https://www.who.int/ diagnostics_laboratory/evaluations/pq-list/hiv_syphilis/en/. Dual HIV/syphilis rapid testing strategy and algorithm for ANC The testing strategy needed for dual detection of HIV and syphilis (Fig. 2) differs from the recommended strategies for separately testing for HIV or syphilis. Countries introducing the dual HIV/syphilis RDT as the first test in ANC will need to revise their HIV testing strategy for pregnant women. It is important not to use the rapid dual HIV/syphilis test for: 1. women with HIV taking antiretroviral therapy (ART); 2. women already diagnosed with and treated for syphilis during their current pregnancy; and 3. retesting for HIV. 4 Dual HIV/syphilis rapid diagnostic tests can be used as the first test in antenatal care 4 For more information, contact: World Health Organization Department of HIV/AIDS 20, Avenue Appia 1211 Geneva 27 Switzerland E-mail: hiv-aids@who.int www.who.int/hiv WHO/CDS/HIV/19.38 © World Health Organization 2019 Some rights reserved. Licence: CC BY-NC-SA 3.0 IGO POLICY BRIEF HIV TESTING SERVICES WHO (2019). Consolidated guidelines on HIV testing services. https://www.who.int/hiv/mediacentre/news/hts-info- app/en/ WHO (2017). WHO guidelines for syphilis screening and treatment for pregnant women. https://www.who.int/ reproductivehealth/publications/rtis/syphilis-ANC-screenandtreat-guidelines/en/ WHO (2017). WHO guidelines on hepatitis B and C testing. https:// www.who.int/hepatitis/publications/guidelines- hepatitis-c-b-testing/en/ WHO (2016). WHO recommendations on antenatal care for a positive pregnancy experience. https://www.who.int/ reproductivehealth/publications/maternal_perinatal_health/anc-positive-pregnancy-experience/en/ ADDITIONAL RESOURCES Ph ot o co ve r © K ar en K as m au sk i/M CS P All women whose dual HIV/syphilis test results include a reactive TP (syphilis) result should be treated using benzathine penicillin and referred for further testing to provide final diagnosis of active syphilis. To verify HIV-positive diagnoses and prevent misdiagnosis of HIV, WHO recommends retesting all people with HIV prior to starting lifelong treatment. This form of retesting is only for HIV and not for syphilis. Therefore, for verification of an HIV-positive result, countries should only use the national HIV testing strategy and algorithm, which would not include dual HIV/syphilis RDTs. Considerations to maximize the impact of dual HIV/syphilis RDTs • Countries introducing dual HIV/syphilis RDTs as the first test in ANC will need to verify that the new test works well in combination with the other two HIV tests in the algorithm. Countries should review and consider WHO- prequalified products listed at https://www.who.int/ diagnostics_laboratory/evaluations/pq-list/hiv-rdts/ public_report/en/. • Use of the dual HIV/syphilis RDT as the first test in ANC allows for integration and improved service delivery coverage. Programmes should consider how they can integrate service delivery in ANC and other settings, such as outreach to key populations at risk for both HIV and syphilis, to maximize public health impact. Opportunities to offer HBsAg testing alongside the use of dual HIV/syphilis RDTs in pregnancy should also be considered. • As use of the dual-purpose RDTs leads to diagnosis of more syphilis cases, national programmes should prepare for additional procurement of benzathine penicillin to ensure adequate treatment supply and to prevent stock- outs. The increase in demand for benzathine penicillin can be estimated using the WHO congenital syphilis estimation tool. This tool and instructions for its use are located at https://www.who.int/reproductivehealth/ congenital-syphilis/surveillance/en/. • When introducing dual HIV/syphilis RDTs, staff, including testers, implementers, procurement specialists and other related staff, will need training and support. Programmes should plan to update training manuals, information and counselling messages, standard operating procedures, quality assurance, operational guidance and tools and procurement planning to include HIV/syphilis RDTs.
DUAL HIV/SYPHILIS RAPID DIAGNOSTIC TESTS CAN BE USED AS THE FIRST TEST IN ANTENATAL CARE NOVEMBER 2019 POLICY BRIEF 2 Dual HIV/syphilis rapid diagnostic tests can be used as the first test in antenatal care Rationale Elimination of mother-to-child transmission (EMTCT) of HIV and syphilis is a global health priority. It is estimated that there are 1.4 million new maternal HIV infections and 988 000 new maternal syphilis infections every year. Globally, there has been marked progress toward EMTCT of HIV, with a 41% reduction in new paediatric HIV cases between 2010 and 2018. However, syphilis remains the second most common cause of stillbirth globally. As of 2016, over 660 000 cases of congenital syphilis (that is, due to mother-to-child transmission) are estimated to have occurred globally, with over 350 000 of these resulting in adverse birth outcomes (>200 000 as stillbirths and neonatal deaths). WHO recommends that pregnant women receive testing for HIV, syphilis and hepatitis B (HBsAg)* at least once during pregnancy, preferably in the first trimester. Dual HIV/ syphilis rapid diagnostic tests (RDTs) can be used as the first test for pregnant women as part of antenatal care (ANC). These simple tests can be used at the point-of-care and are cost-saving compared to standard testing in ANC. They enable more women to be diagnosed with HIV and syphilis so that they can access treatment and prevent transmission to their children. Fig. 1. Differences in coverage of testing for HIV and syphilis in pregnant women visiting ANC in 10 countries, 2016–2018 ANC = antenatal care Source: Storey A, Seghers S, Pyne-Mercier L, Peeling R, Newman Owiredu M, Taylor M. Syphilis diagnosis and treatment during antenatal care: the potential catalytic impact of the dual HIV and syphilis rapid diagnostic test. Lancet Glob Health. 2019; 7(8): e1006-e1008. 80% — 60% — 40% — 30% — 10% — 0% — 20% — 70% — 50% — 90% — 100% — Mozambique 72% >95% -24% Uganda 43% >95% -52% Zambia 56% >95% -39% Malawi 82% 94% -12% Ethiopia 45% 92% -47% Kenya 89% -3% South Africa 75% 85% -11% India 20% 59% -39% Nigeria 16% 35% -19% Indonesia 2% 28% -26% Pr ev al en ce HIV 15.0% 7.3% 14.3% 11.7% 1.2% 6.2% 23.7% 0.2% 3.0% 0.3% Women between 15–49 years Syphilis 4.6% 2.9% 3.5% 1.0% 1.1% 1.4% 2.0% 0.38% 0.8% 3.2% % ANC attendees positive for syphilis HIV testing rate Syphilis testing rate % Difference in testing rates Box 1. WHO Recommendation and implementation guidance All pregnant women should be tested for HIV, syphilis and hepatitis B surface antigen (HBsAg)* at least once and as early as possible, ideally at the first antenatal care visit (syphilis: strong recommendation, moderate-quality evidence; HBsAg*: strong recommendation, low-quality evidence). Dual HIV/syphilis rapid diagnostic tests (RDTs) can be considered as the first test in HIV testing strategies and algorithms in ANC settings. *Particularly in settings with a ≥2% HBsAg seroprevalence in the general population. *Particularly in settings with a ≥2% HBsAg seroprevalence in the general population. 3Fig. 2. WHO-recommended testing strategy for dual detection of HIV and syphilis infection for ANC settings A1: Assay 1, A2: Assay 2, A3: Assay 3, TP: Treponemal pallidum (syphilis). A1 (Assay 1) is a dual HIV/syphilis rapid diagnostic test (RDT). A2 and A3 (Assay 2 and Assay 3) are HIV RDTs or enzyme immunoassays (EIAs). When resolving discrepant results, all reactive TP (syphilis) results, including A1: TP+ or Repeat A1: TP+, should be referred for treatment and further testing according to national guidelines. When resolving discrepant results, if A1 and Repeat A1 are both TP (syphilis) nonreactive results, report syphilis-negative. Perform A1 (HIV/TP) A1: HIV-, TP- A1: HIV-, TP+ A1: HIV+, TP- A1: HIV+, TP+ A2: HIV+ A2: HIV- Repeat A1: HIV+, TP- or HIV+, TP+ Repeat A1: HIV-, TP- or HIV-, TP+ Perform A2 (HIV only) Perform A3 (HIV only) Repeat A1 (HIV/TP) A1: HIV-, TP- Report HIV-negative Report syphilis-negative A1: HIV-, TP+ Report HIV-negative Report syphilis-positive indicative of either current or past/resolved infection Report syphilis-positive, indicative of either current or past/resolved infection A1+; A2+; A3+ Report HIV-positive Report syphilis-negative A1+; A2+; A3- Report HIV-inconclusive, retest in 14 days Report syphilis-negative A1: HIV+, TP- or HIV+, TP+ A2: HIV- Repeat A1: HIV+, TP- or HIV+, TP+ Report HIV-inconclusive, retest in 14 days If A1 or Repeat A1 is TP reactive, report syphilis- positive, indicative of either current or past/ resolved infection If A1 and Repeat A1 is TP nonreactive, report syphilis-negative A1: HIV+, TP- or HIV+, TP+ A2: HIV- Repeat A1: HIV-, TP- or HIV-, TP+ Report HIV-negative If A1 or Repeat A1 is TP reactive, report syphilis- positive, indicative of either current or past/ resolved infection If A1 and Repeat A1 is TP nonreactive, report syphilis-negative Syphilis testing and treatment coverage among pregnant women are low in many countries, lower than that of antenatal HIV testing and treatment (Fig. 1). While WHO recommends testing at the point of care using RDTs, the majority of countries still rely on laboratory testing for syphilis. Use of dual HIV/syphilis RDTs offers the opportunity to immediately close the gap between HIV and syphilis testing among pregnant women, with the goal of eliminating adverse birth outcomes due to syphilis. Dual/HIV syphilis RDTs detect antibodies to both Treponemal pallidum (TP) (the cause of syphilis infection) and HIV. Like other RDTs used for HIV alone, they do not require refrigeration. Available products currently do not discriminate between active or past syphilis infection. This means that, if a person has had syphilis that is treated/ resolved, and treponemal antibodies persist, the dual/HIV syphilis RDT may produce a reactive result for syphilis. Advantages of rapid dual HIV/syphilis tests in ANC Use of a dual HIV/syphilis RDT as the first test in ANC offers the opportunity to test for both infections with a single finger prick. Results are available quickly, enabling many to start either or both HIV treatment and syphilis treatment with benzathine penicillin. In addition to increasing syphilis testing and treatment coverage, use of the dual-purpose RDT can simplify training by using one test instead of separate tests, reduce storage and transportation costs and reduce waste disposal. In both high and low HIV burden settings, use of the rapid dual test has been found to save costs, in both high and low HIV burden settings, in prevention of congenital syphilis and has not negatively affected HIV testing coverage. Countries should review and consider the dual HIV/syphilis RDTs prequalified by WHO and listed at https://www.who.int/ diagnostics_laboratory/evaluations/pq-list/hiv_syphilis/en/. Dual HIV/syphilis rapid testing strategy and algorithm for ANC The testing strategy needed for dual detection of HIV and syphilis (Fig. 2) differs from the recommended strategies for separately testing for HIV or syphilis. Countries introducing the dual HIV/syphilis RDT as the first test in ANC will need to revise their HIV testing strategy for pregnant women. It is important not to use the rapid dual HIV/syphilis test for: 1. women with HIV taking antiretroviral therapy (ART); 2. women already diagnosed with and treated for syphilis during their current pregnancy; and 3. retesting for HIV. 4 Dual HIV/syphilis rapid diagnostic tests can be used as the first test in antenatal care 4 For more information, contact: World Health Organization Department of HIV/AIDS 20, Avenue Appia 1211 Geneva 27 Switzerland E-mail: hiv-aids@who.int www.who.int/hiv WHO/CDS/HIV/19.38 © World Health Organization 2019 Some rights reserved. Licence: CC BY-NC-SA 3.0 IGO POLICY BRIEF HIV TESTING SERVICES WHO (2019). Consolidated guidelines on HIV testing services. https://www.who.int/hiv/mediacentre/news/hts-info- app/en/ WHO (2017). WHO guidelines for syphilis screening and treatment for pregnant women. https://www.who.int/ reproductivehealth/publications/rtis/syphilis-ANC-screenandtreat-guidelines/en/ WHO (2017). WHO guidelines on hepatitis B and C testing. https:// www.who.int/hepatitis/publications/guidelines- hepatitis-c-b-testing/en/ WHO (2016). WHO recommendations on antenatal care for a positive pregnancy experience. https://www.who.int/ reproductivehealth/publications/maternal_perinatal_health/anc-positive-pregnancy-experience/en/ ADDITIONAL RESOURCES Ph ot o co ve r © K ar en K as m au sk i/M CS P All women whose dual HIV/syphilis test results include a reactive TP (syphilis) result should be treated using benzathine penicillin and referred for further testing to provide final diagnosis of active syphilis. To verify HIV-positive diagnoses and prevent misdiagnosis of HIV, WHO recommends retesting all people with HIV prior to starting lifelong treatment. This form of retesting is only for HIV and not for syphilis. Therefore, for verification of an HIV-positive result, countries should only use the national HIV testing strategy and algorithm, which would not include dual HIV/syphilis RDTs. Considerations to maximize the impact of dual HIV/syphilis RDTs • Countries introducing dual HIV/syphilis RDTs as the first test in ANC will need to verify that the new test works well in combination with the other two HIV tests in the algorithm. Countries should review and consider WHO- prequalified products listed at https://www.who.int/ diagnostics_laboratory/evaluations/pq-list/hiv-rdts/ public_report/en/. • Use of the dual HIV/syphilis RDT as the first test in ANC allows for integration and improved service delivery coverage. Programmes should consider how they can integrate service delivery in ANC and other settings, such as outreach to key populations at risk for both HIV and syphilis, to maximize public health impact. Opportunities to offer HBsAg testing alongside the use of dual HIV/syphilis RDTs in pregnancy should also be considered. • As use of the dual-purpose RDTs leads to diagnosis of more syphilis cases, national programmes should prepare for additional procurement of benzathine penicillin to ensure adequate treatment supply and to prevent stock- outs. The increase in demand for benzathine penicillin can be estimated using the WHO congenital syphilis estimation tool. This tool and instructions for its use are located at https://www.who.int/reproductivehealth/ congenital-syphilis/surveillance/en/. • When introducing dual HIV/syphilis RDTs, staff, including testers, implementers, procurement specialists and other related staff, will need training and support. Programmes should plan to update training manuals, information and counselling messages, standard operating procedures, quality assurance, operational guidance and tools and procurement planning to include HIV/syphilis RDTs.
DUAL HIV/SYPHILIS RAPID DIAGNOSTIC TESTS CAN BE USED AS THE FIRST TEST IN ANTENATAL CARE NOVEMBER 2019 POLICY BRIEF 2 Dual HIV/syphilis rapid diagnostic tests can be used as the first test in antenatal care Rationale Elimination of mother-to-child transmission (EMTCT) of HIV and syphilis is a global health priority. It is estimated that there are 1.4 million new maternal HIV infections and 988 000 new maternal syphilis infections every year. Globally, there has been marked progress toward EMTCT of HIV, with a 41% reduction in new paediatric HIV cases between 2010 and 2018. However, syphilis remains the second most common cause of stillbirth globally. As of 2016, over 660 000 cases of congenital syphilis (that is, due to mother-to-child transmission) are estimated to have occurred globally, with over 350 000 of these resulting in adverse birth outcomes (>200 000 as stillbirths and neonatal deaths). WHO recommends that pregnant women receive testing for HIV, syphilis and hepatitis B (HBsAg)* at least once during pregnancy, preferably in the first trimester. Dual HIV/ syphilis rapid diagnostic tests (RDTs) can be used as the first test for pregnant women as part of antenatal care (ANC). These simple tests can be used at the point-of-care and are cost-saving compared to standard testing in ANC. They enable more women to be diagnosed with HIV and syphilis so that they can access treatment and prevent transmission to their children. Fig. 1. Differences in coverage of testing for HIV and syphilis in pregnant women visiting ANC in 10 countries, 2016–2018 ANC = antenatal care Source: Storey A, Seghers S, Pyne-Mercier L, Peeling R, Newman Owiredu M, Taylor M. Syphilis diagnosis and treatment during antenatal care: the potential catalytic impact of the dual HIV and syphilis rapid diagnostic test. Lancet Glob Health. 2019; 7(8): e1006-e1008. 80% — 60% — 40% — 30% — 10% — 0% — 20% — 70% — 50% — 90% — 100% — Mozambique 72% >95% -24% Uganda 43% >95% -52% Zambia 56% >95% -39% Malawi 82% 94% -12% Ethiopia 45% 92% -47% Kenya 89% -3% South Africa 75% 85% -11% India 20% 59% -39% Nigeria 16% 35% -19% Indonesia 2% 28% -26% Pr ev al en ce HIV 15.0% 7.3% 14.3% 11.7% 1.2% 6.2% 23.7% 0.2% 3.0% 0.3% Women between 15–49 years Syphilis 4.6% 2.9% 3.5% 1.0% 1.1% 1.4% 2.0% 0.38% 0.8% 3.2% % ANC attendees positive for syphilis HIV testing rate Syphilis testing rate % Difference in testing rates Box 1. WHO Recommendation and implementation guidance All pregnant women should be tested for HIV, syphilis and hepatitis B surface antigen (HBsAg)* at least once and as early as possible, ideally at the first antenatal care visit (syphilis: strong recommendation, moderate-quality evidence; HBsAg*: strong recommendation, low-quality evidence). Dual HIV/syphilis rapid diagnostic tests (RDTs) can be considered as the first test in HIV testing strategies and algorithms in ANC settings. *Particularly in settings with a ≥2% HBsAg seroprevalence in the general population. *Particularly in settings with a ≥2% HBsAg seroprevalence in the general population. 3Fig. 2. WHO-recommended testing strategy for dual detection of HIV and syphilis infection for ANC settings A1: Assay 1, A2: Assay 2, A3: Assay 3, TP: Treponemal pallidum (syphilis). A1 (Assay 1) is a dual HIV/syphilis rapid diagnostic test (RDT). A2 and A3 (Assay 2 and Assay 3) are HIV RDTs or enzyme immunoassays (EIAs). When resolving discrepant results, all reactive TP (syphilis) results, including A1: TP+ or Repeat A1: TP+, should be referred for treatment and further testing according to national guidelines. When resolving discrepant results, if A1 and Repeat A1 are both TP (syphilis) nonreactive results, report syphilis-negative. Perform A1 (HIV/TP) A1: HIV-, TP- A1: HIV-, TP+ A1: HIV+, TP- A1: HIV+, TP+ A2: HIV+ A2: HIV- Repeat A1: HIV+, TP- or HIV+, TP+ Repeat A1: HIV-, TP- or HIV-, TP+ Perform A2 (HIV only) Perform A3 (HIV only) Repeat A1 (HIV/TP) A1: HIV-, TP- Report HIV-negative Report syphilis-negative A1: HIV-, TP+ Report HIV-negative Report syphilis-positive indicative of either current or past/resolved infection Report syphilis-positive, indicative of either current or past/resolved infection A1+; A2+; A3+ Report HIV-positive Report syphilis-negative A1+; A2+; A3- Report HIV-inconclusive, retest in 14 days Report syphilis-negative A1: HIV+, TP- or HIV+, TP+ A2: HIV- Repeat A1: HIV+, TP- or HIV+, TP+ Report HIV-inconclusive, retest in 14 days If A1 or Repeat A1 is TP reactive, report syphilis- positive, indicative of either current or past/ resolved infection If A1 and Repeat A1 is TP nonreactive, report syphilis-negative A1: HIV+, TP- or HIV+, TP+ A2: HIV- Repeat A1: HIV-, TP- or HIV-, TP+ Report HIV-negative If A1 or Repeat A1 is TP reactive, report syphilis- positive, indicative of either current or past/ resolved infection If A1 and Repeat A1 is TP nonreactive, report syphilis-negative Syphilis testing and treatment coverage among pregnant women are low in many countries, lower than that of antenatal HIV testing and treatment (Fig. 1). While WHO recommends testing at the point of care using RDTs, the majority of countries still rely on laboratory testing for syphilis. Use of dual HIV/syphilis RDTs offers the opportunity to immediately close the gap between HIV and syphilis testing among pregnant women, with the goal of eliminating adverse birth outcomes due to syphilis. Dual/HIV syphilis RDTs detect antibodies to both Treponemal pallidum (TP) (the cause of syphilis infection) and HIV. Like other RDTs used for HIV alone, they do not require refrigeration. Available products currently do not discriminate between active or past syphilis infection. This means that, if a person has had syphilis that is treated/ resolved, and treponemal antibodies persist, the dual/HIV syphilis RDT may produce a reactive result for syphilis. Advantages of rapid dual HIV/syphilis tests in ANC Use of a dual HIV/syphilis RDT as the first test in ANC offers the opportunity to test for both infections with a single finger prick. Results are available quickly, enabling many to start either or both HIV treatment and syphilis treatment with benzathine penicillin. In addition to increasing syphilis testing and treatment coverage, use of the dual-purpose RDT can simplify training by using one test instead of separate tests, reduce storage and transportation costs and reduce waste disposal. In both high and low HIV burden settings, use of the rapid dual test has been found to save costs, in both high and low HIV burden settings, in prevention of congenital syphilis and has not negatively affected HIV testing coverage. Countries should review and consider the dual HIV/syphilis RDTs prequalified by WHO and listed at https://www.who.int/ diagnostics_laboratory/evaluations/pq-list/hiv_syphilis/en/. Dual HIV/syphilis rapid testing strategy and algorithm for ANC The testing strategy needed for dual detection of HIV and syphilis (Fig. 2) differs from the recommended strategies for separately testing for HIV or syphilis. Countries introducing the dual HIV/syphilis RDT as the first test in ANC will need to revise their HIV testing strategy for pregnant women. It is important not to use the rapid dual HIV/syphilis test for: 1. women with HIV taking antiretroviral therapy (ART); 2. women already diagnosed with and treated for syphilis during their current pregnancy; and 3. retesting for HIV. 4 Dual HIV/syphilis rapid diagnostic tests can be used as the first test in antenatal care 4 For more information, contact: World Health Organization Department of HIV/AIDS 20, Avenue Appia 1211 Geneva 27 Switzerland E-mail: hiv-aids@who.int www.who.int/hiv WHO/CDS/HIV/19.38 © World Health Organization 2019 Some rights reserved. Licence: CC BY-NC-SA 3.0 IGO POLICY BRIEF HIV TESTING SERVICES WHO (2019). Consolidated guidelines on HIV testing services. https://www.who.int/hiv/mediacentre/news/hts-info- app/en/ WHO (2017). WHO guidelines for syphilis screening and treatment for pregnant women. https://www.who.int/ reproductivehealth/publications/rtis/syphilis-ANC-screenandtreat-guidelines/en/ WHO (2017). WHO guidelines on hepatitis B and C testing. https:// www.who.int/hepatitis/publications/guidelines- hepatitis-c-b-testing/en/ WHO (2016). WHO recommendations on antenatal care for a positive pregnancy experience. https://www.who.int/ reproductivehealth/publications/maternal_perinatal_health/anc-positive-pregnancy-experience/en/ ADDITIONAL RESOURCES Ph ot o co ve r © K ar en K as m au sk i/M CS P All women whose dual HIV/syphilis test results include a reactive TP (syphilis) result should be treated using benzathine penicillin and referred for further testing to provide final diagnosis of active syphilis. To verify HIV-positive diagnoses and prevent misdiagnosis of HIV, WHO recommends retesting all people with HIV prior to starting lifelong treatment. This form of retesting is only for HIV and not for syphilis. Therefore, for verification of an HIV-positive result, countries should only use the national HIV testing strategy and algorithm, which would not include dual HIV/syphilis RDTs. Considerations to maximize the impact of dual HIV/syphilis RDTs • Countries introducing dual HIV/syphilis RDTs as the first test in ANC will need to verify that the new test works well in combination with the other two HIV tests in the algorithm. Countries should review and consider WHO- prequalified products listed at https://www.who.int/ diagnostics_laboratory/evaluations/pq-list/hiv-rdts/ public_report/en/. • Use of the dual HIV/syphilis RDT as the first test in ANC allows for integration and improved service delivery coverage. Programmes should consider how they can integrate service delivery in ANC and other settings, such as outreach to key populations at risk for both HIV and syphilis, to maximize public health impact. Opportunities to offer HBsAg testing alongside the use of dual HIV/syphilis RDTs in pregnancy should also be considered. • As use of the dual-purpose RDTs leads to diagnosis of more syphilis cases, national programmes should prepare for additional procurement of benzathine penicillin to ensure adequate treatment supply and to prevent stock- outs. The increase in demand for benzathine penicillin can be estimated using the WHO congenital syphilis estimation tool. This tool and instructions for its use are located at https://www.who.int/reproductivehealth/ congenital-syphilis/surveillance/en/. • When introducing dual HIV/syphilis RDTs, staff, including testers, implementers, procurement specialists and other related staff, will need training and support. Programmes should plan to update training manuals, information and counselling messages, standard operating procedures, quality assurance, operational guidance and tools and procurement planning to include HIV/syphilis RDTs.
艾滋病毒／梅毒 双重快速诊断检测 可用作产前护理的 第一项检测 2019年11月 政策简报 2 艾滋病毒／梅毒双重快速诊断检测可用作产前护理的第一项检测 理由 消除艾滋病毒和梅毒的母婴传播是全球卫生事项的 一个重点。据估计，每年有140万个产妇感染艾滋病毒的 新病例，988 000个产妇感染梅毒的新病例。 从全球来看，在消除母婴传播艾滋病毒方面取得 了显著进展，2010年至2018年间，儿科艾滋病毒新病 例减少了41%。 然而，梅毒仍然是全球第二大死产原因。截至2016 年，据估计全球出现了660 000多例先天性梅毒（即由于 母婴传播），其中350 000多例导致了不良分娩结果（死 产和新生儿死亡超过200 000例）。 世卫组织建议孕妇在怀孕期间至少接受一次艾滋病毒、梅毒和乙型肝炎（HBsAg）* 病毒检测，最好是在妊娠前三个月。艾滋病毒／梅毒双重快速诊断检测可用作孕妇的 第一项检测，作为产前护理的一部分。这些简单的检测可以在护理点进行，与标准的 产前护理检测相比可以节省成本。双重检测能够使更多妇女被诊断出感染了艾滋病毒 和梅毒，以便她们能够获得治疗并防止传染给她们的孩子。 ANC = 产前护理 资料来源：Storey A, Seghers S, Pyne-Mercier L, Peeling R, Newman Owiredu M, Taylor M. Syphilis diagnosis and treatment during antenatal care: the potential catalytic impact of the dual HIV and syphilis rapid diagnostic test. Lancet Glob Health. 2019; 7(8): e1006-e1008. 80 % — 60 % — 40 % — 30 % — 10 % — 0 % — 20 % — 70 % — 50 % — 90 % — 100 % — 莫桑比克 72 % >95 % -24 % 乌干达 43 % >95 % -52 % 赞比亚 56 % >95 % -39 % 马拉维 82 % 94 % -12 % 埃塞俄比亚 45 % 92 % -47 % 肯尼亚 89 % -3 % 南非 75 % 85 % -11 % 印度 20 % 59 % -39 % 尼日利亚 16 % 35 % -19 % 印度尼西亚 2 % 28 % -26 % Pr ée va le nc e 艾滋病毒 15.0 % 7.3 % 14.3 % 11.7 % 1.2 % 6.2 % 23.7 % 0.2 % 3.0 % 0.3 % 15–49岁的女性 梅毒 4.6 % 2.9 % 3.5 % 1.0 % 1.1 % 1.4 % 2.0 % 0.38 % 0.8 % 3.2 % 接受ANC者梅毒阳 性的% 艾滋病毒检测率 梅毒检测率 % 检测率的差异 方框1. 世卫组织的建议 新 和实施指南 所有孕妇应尽早接受至少一次艾滋病毒、梅毒 和乙型肝炎表面抗原（HBsAg）*检测，最好是在 第一次产前检查时（梅毒：强烈推荐，中等质量证 据；HBsAg*：强烈推荐，低质量证据）。 艾滋病毒／梅毒双重快速诊断检测可被视为产 前护理环境中艾滋病毒检测策略和算法中的第一项 检测。 *特别是在普通人群中HBsAg血清阳性率≥2%的环境中。 图1. 2016-2018年10个国家中接受产前护理孕妇的艾滋病毒和梅毒检测覆盖率差异 3图2. 世卫组织推荐的产前护理中艾滋病毒和梅毒感染双重检测的检测策略 A1：化验1，A2：化验2，A3：化验3、TP：梅毒螺 旋体（梅毒）。 A1（化验1）是一种艾滋病毒／梅毒双重快速诊 断检测。 A2和A3（化验2和化验3）是艾滋病毒快速诊断检 测或酶免疫测定。 当解决不一致的结果时，所有反应性TP（梅毒） 结果，包括A1：TP+或重复A1：TP+，应根据国家 指南进行治疗和进一步检测。 当解决不一致的结果时，如果A1和重复A1都是TP （梅毒）非反应性结果，则报告梅毒阴性。 进行A1（HIV/TP） A1：VIH-, TP- A1：VIH-, TP+ A1：VIH+, TP- A1：VIH+, TP+ A2：VIH+ A2：VIH- 重复A1： VIH+, TP-或VIH+, TP+ 重复A1： VIH-, TP-或VIH-, TP+ 进行A2（仅HIV） 进行A3（仅HIV） 重复A1（VIH/TP） A1：VIH-, TP- 报告HIV - 阴性 报告梅毒 - 阴性 A1：VIH-, TP+ 报告HIV - 阴性 报告HIV - 阴性 提示当前或既往／已解决感染 报告梅毒 - 阳性 提示当前或既往／已解决感染 A1+; A2+; A3+ 报告HIV - 阳性 报告梅毒 - 阴性 A1+; A2+; A3- 报告HIV - 不确定，14 天后重新检测 报告梅毒 - 阴性 A1：VIH+, TP-或VIH+, TP+ A2：VIH- 重复A1：VIH+, TP-或 VIH+, TP+ 报告HIV - 不确定，14天后重 新检测 如果A1或重复A1是TP有反应， 报告梅毒阳性，提示当前或既 往／已解决感染 如果A1和重复A1是TP无反应， 报告梅毒阴性 A1： VIH+, TP-或VIH+, TP+ A2：VIH- 重复 A1：VIH-, TP-或 VIH-, TP+ 报告HIV-n阴性 如果A1或重复A1是TP有反应， 报告梅毒阳性，提示当前或既 往／已解决感染 如果A1和重复A1是TP无反应， 报告梅毒阴性 许多国家孕妇的梅毒检测和治疗覆盖率较低，低 于产前艾滋病毒检测和治疗的覆盖率（图1）。虽然世 卫组织推荐在护理点利用快速诊断检测进行检测，但大 多数国家仍然依赖实验室来检测梅毒。艾滋病毒／梅毒 双重快速诊断检测的采用为立即缩小孕妇中艾滋病毒和 梅毒检测之间的差距提供了机会，目标是消除梅毒导致 的不良分娩结果。 艾滋病毒梅毒双重快速诊断检测检测梅毒螺旋体 （梅毒感染的原因）和艾滋病毒的抗体。就像其它只 针对艾滋病的快速诊断检测一样，艾滋病毒梅毒双重 快速诊断检测检测不需要冷藏。目前可用的产品并不 区分活动性和既往梅毒感染。这意味着，如果一个人 患有梅毒并且已经治疗／解决，并且梅毒抗体持续存 在，那么艾滋病毒梅毒双重快速诊断检测可能产生梅 毒反应性结果。 产前护理中艾滋病毒／梅毒快速双重检测 的好处 采用艾滋病毒／梅毒双重快速诊断检测作为产前护 理中进行的第一项检测提供了一个机会，可以扎一次手 指检测两种感染。结果很快就可获得，使许多人能够开 始使用苄星青霉素单独或同时治疗梅毒和艾滋病。 除了扩大梅毒检测和治疗的覆盖率，采用双重快速 诊断检测还可以通过采用一项检测而不是分别检测来简 化培训，降低存储和运输成本，并减少废物处理。无论 是在艾滋病毒负担重还是负担轻的情况下，已经发现采 用快速双重检测可以节省成本和预防先天性梅毒，并且 不会对艾滋病毒检测覆盖率产生负面影响。 各国应审查和考虑通过了世卫组织资格预审的艾滋 病毒／梅毒双重快速诊断检测，名单见https://www.who. int/diagnostics_laboratory/evaluations/pq-list/hiv_syphilis/en/。 4 艾滋病毒／梅毒双重快速诊断检测可用作产前护理的第一项检测4 想了解更多信息，请联系： World Health Organization Department of HIV/AIDS 20, Avenue Appia 1211 Geneva 27 Switzerland 电子邮件：hiv-aids@who.int www.who.int/hiv WHO/CDS/HIV/19.38 © 世界卫生组织2019 保留某些权利 许可证：CC BY-NC-SA 3.0 IGO 政策简报 艾滋病毒检测服务 WHO (2019). Consolidated guidelines on HIV testing services. https://www.who.int/hiv/mediacentre/news/hts-info-app/en/ WHO (2017). WHO guidelines for syphilis screening and treatment for pregnant women. https://www.who.int/reproductivehealth/publications/rtis/syphilis-ANC-screenandtreat-guidelines/en/ WHO (2017). WHO guidelines on hepatitis B and C testing. https://www.who.int/hepatitis/publications/guidelines-hepatitis-c-b-testing/en/ WHO (2016). WHO recommendations on antenatal care for a positive pregnancy experience. https://www.who.int/reproductivehealth/publications/maternal_perinatal_health/anc-positive-pregnancy-experience/en/ 其它资源 封 面 图 片 © K ar en K as m au sk i/M CS P 产前护理中艾滋病／梅毒双重快速检测 策略及算法 艾滋病毒和梅毒双重检测所需的检测策略（图2） 不同于单独检测艾滋病毒或梅毒的推荐策略。将艾滋病 毒／梅毒双重快速诊断检测作为产前护理的第一项检测 的国家将需要修订其孕妇的艾滋病毒检测策略。重要的 是不要对以下情况采用艾滋病毒／梅毒快速双重检测： 1. 感染艾滋病毒并接受抗逆转录病毒疗法的妇女； 2. 本次怀孕期间已被诊断出患有梅毒并接受治疗的妇 女； 3. 再次检测艾滋病毒。 所有艾滋病毒／梅毒双重检测结果包含反应性TP （梅毒）结果的妇女应使用苄星青霉素进行治疗，并做 进一步检测，以提供活动性梅毒的最终诊断。 为了核实艾滋病毒阳性诊断和防止艾滋病毒误诊， 世卫组织建议在开始终身治疗前对所有艾滋病毒感染者 进行再次检测。这种形式的再次检测只适用于艾滋病 毒，不适用于梅毒。因此，为了核实艾滋病毒阳性结 果，各国应仅使用国家艾滋病毒检测策略和算法，其中 不包括艾滋病毒／梅毒双重快速诊断检测。 要最大限度地发挥艾滋病毒／梅毒双重快 速诊断检测的影响需考虑的因素 • 引入艾滋病毒／梅毒双重快速诊断检测作为产前护理 的第一项检测的国家将需要验证新的检测与算法中其 它两项艾滋病毒检测的结合效果是否良好。各国应审 查和考虑通过世卫组织资格预审的产品，这些产品列 于：https://www.who.int/diagnostics_laboratory/evaluations/ pq-list/hiv-rdts/public_report/en/。 • 采用艾滋病毒／梅毒双重快速诊断检测作为产前护理 中的第一项检测，有助于整合和改善服务提供覆盖 面。各种规划应考虑如何将提供服务纳入产前护理和 其它环境，例如对面临艾滋病毒和梅毒风险的重点人 群进行宣传，以最大限度地扩大公共卫生影响。还应 考虑在怀孕期间采用艾滋病毒／梅毒双重快速诊断检 测的同时提供乙型肝炎表面抗原检测的机会。 • 由于双重目的快速诊断检测的采用导致更多梅毒病例 确诊，国家规划应准备额外采购苄星青霉素，以确保 充足的治疗药物供应和防止缺货。对苄星青霉素需 求的增加可以使用世卫组织先天性梅毒估算工具进 行估算。该工具及其使用说明见https://www.who.int/ reproductivehealth/congenital-syphilis/surveillance/en/。 • 当引入艾滋病毒／梅毒双重快速诊断检测时，工作人 员，包括检测人员、实施人员、采购专业人员和其他 相关人员，将需要培训和支持。各规划应计划更新培 训手册、信息和咨询信息、标准操作程序、质量保 证、操作指南和工具以及采购计划，以纳入艾滋病 毒／梅毒快速诊断检测。
ДВОЙНЫЕ ДИАГНОСТИЧЕСКИЕ ЭКСПРЕСС-ТЕСТЫ НА ВИЧ/СИФИЛИС МОГУТ ИСПОЛЬЗОВАТЬСЯ В КАЧЕСТВЕ ТЕСТОВ ПЕРВОЙ ЛИНИИ В ХОДЕ ДОРОДОВОГО НАБЛЮДЕНИЯ НОЯБРЬ 2019 г. КРАТКИЙ ОБЗОР ПОЛИТИКИ 2 Двойные диагностические экспресс-тесты на ВИЧ/сифилис могут использоваться в качестве тестов первой линии в ходе дородового наблюдения Обоснование Элиминация передачи от матери ребенку (ЭПМР) ВИЧ- инфекции и сифилиса является глобальным приоритетом здравоохранения. По оценкам, ежегодно имеет место 1,4 миллиона новых случаев заражения беременных женщин ВИЧ-инфекцией и 988 000 новых случаев заражения сифилисом. Во всем мире был достигнут заметный прогресс в направлении ЭПМР ВИЧ-инфекции, причем в период с 2010 по 2018 г. число новых случаев ВИЧ-инфекции у детей сократилось на 41%. Однако сифилис остается второй наиболее распространенной причиной мертворождения в мире. По состоянию на 2016 г., согласно оценкам, в мире имело место более 660 000 случаев врожденного сифилиса (т. е. вследствие передачи от матери ребенку), причем более 350 000 из них привели к неблагоприятному исходу при рождении (> 200 000 случаев мертворождения и смерти новорожденных) ВОЗ рекомендует, чтобы беременные женщины проходили тестирование на ВИЧ, сифилис и гепатит B (HBsAg)* хотя бы один раз во время беременности, предпочтительно в первом триместре. Двойные диагностические экспресс-тесты (ДЭТ) на ВИЧ/сифилис могут использоваться в качестве тестов первой линии в ходе дородового наблюдения (ДН). Эти простые и недорогостоящие по сравнению со стандартными тесты могут использоваться во время дородового наблюдения (ДН). Они позволяют большему числу женщин получить доступ к диагностике на ВИЧ и сифилис и, в случае необходимости, к лечению, помогая тем самым предотвратить передачу инфекции их детям. Рис. 1. Различия в охвате тестированием на ВИЧ и сифилис беременных женщин, находящихся на ДН, 10 стран, 2016–2018 гг. ДН — дородовое наблюдение Источник: Storey A, Seghers S, Pyne-Mercier L, Peeling R, Newman Owiredu M, Taylor M. Syphilis diagnosis and treatment during antenatal care: the potential catalytic impact of the dual HIV and syphilis rapid diagnostic test. Lancet Glob Health. 2019; 7(8): e1006-e1008. 80 % — 60 % — 40 % — 30 % — 10 % — 0 % — 20 % — 70 % — 50 % — 90 % — 100 % — Мозамбик 72 % >95 % -24 % Уганда 43 % >95 % -52 % Замбия 56 % >95 % -39 % Малави 82 % 94 % -12 % Эфиопия 45 % 92 % -47 % Кения 89 % -3 % ЮАР 75 % 85 % -11 % Индия 20 % 59 % -39 % Нигерия 16 % 35 % -19 % Индонезия 2 % 28 % -26 % Ра сп ро ст ра не нн ос ть ВИЧ 15,0 % 7,3 % 14,3 % 11,7 % 1,2 % 6,2 % 23,7 % 0,2 % 3,0 % 0,3 % Женщины в возрасте 15–49 лет Сифилис 4,6 % 2,9 % 3,5 % 1,0 % 1,1 % 1,4 % 2,0 % 0,38 % 0,8 % 3,2 % Находящиеся на ДН с сифилис-положительным статусом, % Доля тестирования на ВИЧ Доля тестирования на сифилис % Различия в долях тестирования Вставка 1. Рекомендация ВОЗ и НОВАЯ руководство по внедрению Всем беременным женщинам следует проходить тестирование на ВИЧ, сифилис и поверхностный антиген вируса гепатита В (HBsAg)* хотя бы один раз и как можно раньше, предпочтительно при первом посещении в ходе дородового наблюдения (сифилис: настоятельная рекомендация, доказательства умеренного качества; HBsAg*: настоятельная рекомендация, доказательства низкого качества). Двойные диагностические экспресс-тесты (ДЭТ) на ВИЧ/ сифилис можно рассматривать в качестве тестов первой линии в рамках стратегий и алгоритмов тестирования на ВИЧ в ходе ДН. *В частности, когда в общей популяции серотип HbsAg ≥2%. 3Рис. 2. Рекомендуемая ВОЗ стратегия одновременного тестирования на ВИЧ и сифилис в ходе ДН A1: Тест 1, A2: Тест 2, A3: Тест 3, TP: Treponema pallidum (сифилис). A1 (тест 1) — двойной диагностический экспресс-тест (ДЭТ) на ВИЧ/сифилис. A2 и A3 (тест 2 и тест 3) представляют собой ДЭТ на ВИЧ или иммуноферментные анализы (ИФА). При интерпретации противоречивых результатов, если все результаты на TP (сифилис), включая A1, положительные: TP+ или повторить A1: TP+, следует направить на лечение и проводить дальнейшее тестирование в соответствии с национальными рекомендациями. При интерпретации противоречивых результатов, если A1 и повторный A1 оба являются отрицательными на TP (сифилис), регистрируют сифилис-отрицательный статут. Выполнить А1 (ВИЧ/TP) A1: ВИЧ–, TP– A1: ВИЧ–, TP+ A1: ВИЧ+, TP– A1: ВИЧ+, TP+ A2: ВИЧ+ A2: ВИЧ– Повторить А1: ВИЧ+, TP– или ВИЧ+, TP+ Повторить А1: ВИЧ–, TP– или ВИЧ–, TP+ Выполнить А2 (только ВИЧ) Выполнить А3 (только ВИЧ) Повторить А1 (ВИЧ/TP) A1: ВИЧ–, TP– Регистрируют ВИЧ- отрицательный статус Регистрируют сифилис-отрицательный статус A1: ВИЧ–, TP+ Регистрируют ВИЧ-отрицательный статус Регистрируют сифилис- положительный статус, указывающий на текущую или перенесенную/ разрешившуюся инфекцию Регистрируют сифилис-положительный статус, указывающий на текущую или перенесенную/разрешившуюся инфекцию A1+; A2+; A3+ Регистрируют ВИЧ- положительный статус Регистрируют сифилис- отрицательный статус A1+; A2+; A3– Регистрируют ВИЧ- неопре-деленный статус, повторяют тестирование через 14 дней Регистрируют сифилис- отрицательный статус A1: ВИЧ+, TP– или ВИЧ+, TP+ A2: ВИЧ– Повторить А1: ВИЧ+, TP– или ВИЧ+, TP+ Регистрируют ВИЧ-неопределенный статус, повторяют тестирование через 14 дней Если А1 или повторный А1 положительный на ТР, регистрируют сифилис- положительный статус, указывающий на текущую или перенесенную/ разрешившуюся инфекцию Если A1 и повторный A1 являются отрицательными на TP, регистрируют сифилис-отрицательный статус A1: ВИЧ+, TP– или ВИЧ+, TP+ A2: ВИЧ– Повторить А1: ВИЧ–, TP– или ВИЧ–, TP+ Регистрируют ВИЧ-отрицательный статус Если А1 или повторный А1 положительный на ТР, регистрируют сифилис- положительный статус, указывающий на текущую или перенесенную/ разрешившуюся инфекцию Если A1 и повторный A1 являются отрицательными на TP, регистрируют сифилис-отрицательный статус Во многих странах охват тестированием и лечением сифилиса среди беременных женщин более низок по сравнению с уровнем дородового тестирования и лечения ВИЧ (рис. 1). В то время как ВОЗ рекомендует проводить тестирование в ЛПУ с использованием ДЭТ, большинство стран по-прежнему полагаются на лабораторные исследования на сифилис. Использование двойных ДЭТ на ВИЧ/сифилис дает возможность немедленно сократить разрыв между тестированием на ВИЧ и сифилис среди беременных женщин с целью устранения неблагоприятного исхода родов из-за сифилиса. Двойные ДЭТ на ВИЧ/сифилис одновременно обнаруживают антитела к Treponema pallidum (TP) (причина сифилисной инфекции) и к ВИЧ. Как и другие ДЭТ, используемые только для диагностики ВИЧ, двойные ДЭТ на ВИЧ/сифилис не требуют низких температур хранения. Доступные в настоящее время тест- системы не позволяют различить активную или перенесенную в прошлом сифилисную инфекцию. Это значит, что, если у пациента имелся излеченный/разрешившийся сифилис, а трепонемные антитела сохраняются, то двойной ДЭТ на ВИЧ/сифилис может дать положительный результат на сифилис. Преимущества двойных диагностических экспресс-тестов на ВИЧ/сифилис в ходе ДН Использование двойного ДЭТ на ВИЧ/сифилис в качестве теста первой линии в ходе ДН дает возможность проверить наличие обеих инфекций с помощью одного теста. Результаты доступны быстро, что позволяет многим пациентам вовремя начать лечение ВИЧ и/или сифилиса бензатинпенициллином. В дополнение к увеличению охвата тестированием и лечением сифилиса, использование двойных ДЭТ позволяет упростить обучение персонала благодаря использованию одного теста вместо двух отдельных тестов, снизить затраты на хранение и транспортировку и сократить отходы. Было показано, что в условиях как высокого, так и низкого уровня распространенности ВИЧ использование двойного ДЭТ позволяет сэкономить на профилактике врожденного сифилиса и не оказывает негативного влияния на охват тестированием на ВИЧ. Странам следует ознакомиться с двойными ДЭТ на ВИЧ/ сифилис, прошедшими преквалификацию ВОЗ, и рассмотреть возможность их использования (перечень см. по адресу: https://www.who.int/diagnostics_laboratory/evaluations/ pq-list/ hiv_syphilis/en/). Стратегия и алгоритм двойного экспресс- тестирования на ВИЧ/сифилис для ДН Стратегия тестирования, требуемая для одновременного выявления ВИЧ и сифилиса (рис. 2), отличается от рекомендованных стратегий раздельного тестирования на ВИЧ или сифилис. Странам, вводящим двойной ДЭТ на ВИЧ/сифилис в качестве теста первой линии в ходе ДН, необходимо будет пересмотреть действующую стратегию тестирования на ВИЧ у 4 Двойные диагностические экспресс-тесты на ВИЧ/сифилис могут использоваться в качестве тестов первой линии в ходе дородового наблюдения4 Для получения дополнительной информации обращайтесь по адресу: Всемирная организация здравоохранения Департамент по ВИЧ/СПИДу 20, Avenue Appia 1211 Женева 27 Швейцария E-mail: hiv-aids@who.int www.who.int/hiv WHO/CDS/HIV/19.38 © World Health Organization 2019 Некоторые права защищены. Лицензия: CC BY-NC-SA 3.0 IGO КРАТКИЙ ОБЗОР ПОЛИТИКИ УСЛУГИ ТЕСТИРОВАНИЯ НА ВИЧ ВОЗ (2019 г.). Сводное руководство по услугам тестирования на ВИЧ. https://www.who.int/hiv/mediacentre/news/hts-info- app/en/ ВОЗ (2017 г.). Руководство ВОЗ по скринингу и лечению сифилиса у беременных женщин. https://www.who.int/reproductivehealth/publications/rtis/syphilis-ANC-screenandtreat-guidelines/en/ ВОЗ (2017 г.). Руководство по тестированию на гепатиты В и С. https:// www.who.int/hepatitis/publications/guidelines- hepatitis-c-b-testing/en/ ВОЗ (2016 г.). Рекомендации ВОЗ по оказанию дородовой помощи для формирования положительного опыта беременности. https://www.who.int/reproductivehealth/publications/maternal_perinatal_health/anc-positive-pregnancy-experience/en/ ДОПОЛНИТЕЛЬНЫЕ РЕСУРСЫ Фо то гр аф ия н а о бл ож ке © K ar en K as m au sk i/M CS P беременных женщин. Важно не использовать двойной ДЭТ на ВИЧ/сифилис: 1. для тестирования женщин с ВИЧ, получающих антиретровирусную терапию (АРТ); 2. для тестирования женщин, у которых во время текущей беременности уже диагностировали сифилис и которые уже прошли лечение от сифилиса; и 3. для повторного тестирования на ВИЧ. Все женщины, у которых результаты двойного теста на ВИЧ/сифилис дают положительный результат на ТП (сифилис), должны проходить лечение с использованием бензатинпенициллина и направляться для дальнейшего тестирования, чтобы поставить окончательный диагноз активного сифилиса. Для проверки ВИЧ-положительных диагнозов и предотвращения ошибочного диагноза ВИЧ ВОЗ рекомендует проводить повторное тестирование всех людей с ВИЧ до начала пожизненного лечения. Эта форма повторного тестирования касается только ВИЧ. Поэтому для проверки положительного результата на ВИЧ страны должны придерживаться только национальных стратегий и алгоритма тестирования на ВИЧ, которые не будут включать двойной ДЭТ на ВИЧ/сифилис. Предложения по максимальному использованию двойных ДЭТ на ВИЧ/сифилис • Странам, вводящим двойной ДЭТ на ВИЧ/сифилис в качестве теста первой линии в ходе ДН, необходимо будет проверить его сочетаемость с двумя другими тестами на ВИЧ, включенными в их алгоритм тестирования. Странам следует ознакомиться с тест системами, прошедшими преквалификацию ВОЗ, и рассмотреть возможность их использования. Перечень тест систем можно найти по адресу: https://www.who.int/diagnostics_laboratory/ evaluations/pq-list/hiv-rdts/public_report/en/. • Использование двойного теста на ВИЧ/сифилис в качестве теста первой линии в ходе ДН позволяет улучшить охват услугами тестирования. В рамках соответствующих программ следует рассмотреть, как можно интегрировать предоставление услуг беременным женщинам в ходе ДН и в других условиях, например, ключевым группам населения, подверженным риску заражения ВИЧ и сифилисом, чтобы максимизировать положительный эффект для здоровья населения. Следует также рассмотреть возможность предложения во время беременности, наряду с использованием двойных ДЭТ на ВИЧ/сифилис, тестирования на HBsAg. • Поскольку использование двойных ДЭТ приводит к диагностике большего числа случаев сифилиса, разработчики национальных программ должны подготовиться к дополнительным закупкам бензатинпенициллина, чтобы обеспечить требуемое для лечения количество и предотвратить дефицит. Увеличение спроса на бензатинпенициллин можно оценить с помощью инструмента оценки врожденного сифилиса ВОЗ. Этот инструмент и инструкция по его использованию доступы по адресу: https://www.who.int/reproductivehealth/ congenital-syphilis/ surveillance/en/. • При внедрении двойных тестов на ВИЧ/сифилис потребуются обучение и поддержка персонала, включая лаборантов, специалистов по внедрению, закупкам и других сотрудников. В рамках программ следует предусмотреть обновление учебных пособий, информационных и консультативных сообщений, стандартных рабочих протоколов, механизмов обеспечения качества, оперативных руководств и инструментов, а также планирования закупок для включения в них ДЭТ на ВИЧ/сифилис.