WHO RECOMMENDS COUNTRIES MOVE AWAY FROM THE USE OF WESTERN BLOTTING AND LINE IMMUNOASSAYS IN HIV TESTING STRATEGIES AND ALGORITHMS NOVEMBER 2019 POLICY BRIEF WHO recommends countries move away from the use of western blotting and line immunoassays in HIV testing strategies and algorithms2 WHO Recommendation Western blotting and line immunoassays should not be used in HIV testing strategies/algorithms. (strong recommendation, low quality evidence). Rationale for the new recommendation Globally one in five people with HIV still do not know their status. Many people with HIV who do not know their status are from key populations and other vulnerable groups that often find it difficult to access health services, including HIV testing. Further efforts are needed to expand HIV testing The World Health Organization (WHO) recommends replacing western blotting and line immunoassays with simpler tests in HIV testing services. These simpler tests include rapid diagnostic tests (RDTs) that can be used at the point-of-care, and enzyme immunoassays (EIAs). These tests get results to the client faster, produce accurate results more often, cost less, can be performed by various cadres of health providers, and can thus facilitate greater access and uptake of HIV testing services among those who need it most. services for these populations and others. At the same time, testing itself should be optimized to produce quick and reliable results. Worldwide, most people are diagnosed with HIV using testing strategies that include RDTs only. However, in some countries western blotting and line immunoassays, which are longstanding laboratory-based technologies, are still used as the second or third test in national testing algorithms to confirm HIV infection. This is common in a number of countries within the European region and other high-income settings as well as in parts of the South-East Asia, Western Pacific and Eastern Mediterranean regions. In these regions, knowledge of HIV status is generally low, hampering uptake of antiretroviral therapy (ART) among people with HIV or prevention services for those at high ongoing risk. Moving away from western blotting and rolling-out HIV rapid diagnostic testing algorithms in Kyrgyzstan In 2016, Kyrgyzstan revised their national HIV testing policy and included a simplified HIV testing strategy aligned with WHO recommendations. Through this policy, western blotting was phased out across the country, and replaced with testing strategies/algorithms using a combination of HIV rapid diagnostic tests (RDTs) and enzyme immunoassays (EIAs). Because of this shift, HIV testing is being integrated into primary care, as well as in community settings. Since the introduction of this new strategy, the turnaround time between testing and receiving final HIV diagnoses reduced from 4-6 weeks to 1-2 weeks. Cost of HIV testing services reported by the national programme have also considerably decreased. Continued efforts are needed to provide fast and accurate diagnoses so more people with HIV can access treatment, and those who are HIV negative can benefit from prevention services. Source: Republican AIDS Centre of Kyrgyzstan, WHO Regional Office for Europe, 2019. 3Disadvantages of western blotting and line immunoassays For western blotting/line immunoassays, specimens are collected in a health facility by venepuncture, processed and then sent to a laboratory, where highly skilled staff perform the test. The laboratory then sends the test results to the referring facility, which contacts the client, so they can deliver the result. Compared with RDTs, which provide same-day diagnosis, it takes longer to provide the final HIV status to the client with testing strategies or algorithms that include western blotting/line immunoassays. Interpretation of the test result and final HIV status with western blotting/line immunoassays can also be complex. Indeterminate results are common, leaving affected clients without a definitive diagnosis and the need to return for retesting. HIV testing services delivered with western blotting/line immunoassays will not be able to increase access to and uptake of HIV treatment and prevention services among those in greatest need. The time to conduct western blotting/line immunoassays, interpret the results and to return test results to clients is resource intensive, from both a cost and human resource perspective. These same factors also lead to delayed or no ART initiation resulting in lost to follow-up along the testing and treatment pathway. Evidence favours discontinuation of western blotting/line immunoassays for HIV diagnosis WHO commissioned a systematic review to compare testing strategies that include western blotting/line immunoassays with those that only use a combination of HIV RDTs and/ or EIAs. The review found similar accuracy (sensitivity and specificity), but that testing algorithms with western blotting/line immunoassays led to more HIV-indeterminate results, requiring more clients to return for retesting 14 days later. Nearly half of all indeterminate results identified were among people with HIV, and therefore they were unable to start ART quickly. A client’s perspective on western blotting I took a rapid [HIV] test and it turned out to be reactive. The counselor explained I had to take a “western blot” test [to confirm my diagnosis], which is only available at the hospital. It took five weeks to get the final results and it was a nightmare, I even regretted taking the HIV test! Source: Association de Lutte Contre le Sida (ALCS), Morocco WHO recommends countries move away from the use of western blotting and line immunoassays in HIV testing strategies and algorithms4 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/19.30 © World Health Organization 2019 Some rights reserved. Licence: CC BY-NC-SA 3.0 IGO POLICY BRIEF HIV TESTING SERVICES • Many HIV RDTs or EIAs can replace western blotting and line immunoassays. The critical task is to verify that the new test selected works well in combination with the other two tests in the algorithm. Most important is to maximize the specificity of the products chosen as the second and third tests in a strategy/algorithm. Countries should review and consider products listed by WHO prequalification: https://www.who.int/diagnostics_laboratory/ evaluations/pq-list/hiv-rdts/public_report/en/. • The move away from western blotting/line immunoassays will facilitate task sharing with health providers, as well as community workers, enabling more people in need of HIV testing to be served with fewer resources. Efforts will be needed to support and reorient the role of laboratories, so they can take on broader roles around supportive supervision and other aspects of quality assurance. • The transition away from western blotting/line immunoassays will require national policy change and training of staff. These changes should be linked to broader efforts to scale-up rapid ART initiation and access to HIV prevention services. Consultation with communities and other stakeholders will be critical. • Promoting, and providing messages to communities, on the shift to faster, more accurate test results may help to increase demand for HIV testing services, particularly among key populations and populations where the burden of undiagnosed HIV is the greatest. Implementation considerations For those with conclusive test results, whether positive or negative, including western blotting led to longer turnaround time between testing and receiving a final HIV diagnosis, increased loss to follow-up and delayed linkage to treatment. Testing strategies that included western blotting/line immunoassays were costlier and less preferred by both clients and providers. Use of HIV RDTs and EIAs alone were strongly preferred as they were accurate, convenient and enabled clients to get their results faster. Based on this evidence, WHO recommended against the use of western blotting/line immunoassays in routine HIV testing services. Countries should move away from western blotting or line immunoassays. Use of testing strategies that do not include western blotting/line immunoassays is highly feasible and already implemented in most settings. Testing strategies that only include RDTs require less infrastructure and can be performed by various cadres of health workers, including trained lay providers and community health workers. The switch to non-western blot/line immunoassay containing strategies can facilitate immediate initiation of ART and streamline the offer of pre-exposure prophylaxis (PrEP), as well as support the expansion and decentralization of HIV testing services including community-based testing. This is also likely lead to greater equity and uptake among people with HIV who do not know their status. Many countries have made the shift away from western blotting/line immunoassays, a few of them in recent years. The countries where western blotting/line immunoassays remain the standard of care should plan to make the switch. These countries may need support to make the transition to updated testing strategies/ algorithms and to select replacement assays. Reviewing and selecting assays to take the place of western blotting/line immunoassays requires time and resources in the short term but will achieve greater impact for clients and reduce future costs. Ph ot os : C ov er © A rt em G et m an /U N DP U kr ai ne ; p ag e 3 © A nn a Ka ri/ W HO
WHO RECOMMENDS COUNTRIES MOVE AWAY FROM THE USE OF WESTERN BLOTTING AND LINE IMMUNOASSAYS IN HIV TESTING STRATEGIES AND ALGORITHMS NOVEMBER 2019 POLICY BRIEF WHO recommends countries move away from the use of western blotting and line immunoassays in HIV testing strategies and algorithms2 WHO Recommendation Western blotting and line immunoassays should not be used in HIV testing strategies/algorithms. (strong recommendation, low quality evidence). Rationale for the new recommendation Globally one in five people with HIV still do not know their status. Many people with HIV who do not know their status are from key populations and other vulnerable groups that often find it difficult to access health services, including HIV testing. Further efforts are needed to expand HIV testing The World Health Organization (WHO) recommends replacing western blotting and line immunoassays with simpler tests in HIV testing services. These simpler tests include rapid diagnostic tests (RDTs) that can be used at the point-of-care, and enzyme immunoassays (EIAs). These tests get results to the client faster, produce accurate results more often, cost less, can be performed by various cadres of health providers, and can thus facilitate greater access and uptake of HIV testing services among those who need it most. services for these populations and others. At the same time, testing itself should be optimized to produce quick and reliable results. Worldwide, most people are diagnosed with HIV using testing strategies that include RDTs only. However, in some countries western blotting and line immunoassays, which are longstanding laboratory-based technologies, are still used as the second or third test in national testing algorithms to confirm HIV infection. This is common in a number of countries within the European region and other high-income settings as well as in parts of the South-East Asia, Western Pacific and Eastern Mediterranean regions. In these regions, knowledge of HIV status is generally low, hampering uptake of antiretroviral therapy (ART) among people with HIV or prevention services for those at high ongoing risk. Moving away from western blotting and rolling-out HIV rapid diagnostic testing algorithms in Kyrgyzstan In 2016, Kyrgyzstan revised their national HIV testing policy and included a simplified HIV testing strategy aligned with WHO recommendations. Through this policy, western blotting was phased out across the country, and replaced with testing strategies/algorithms using a combination of HIV rapid diagnostic tests (RDTs) and enzyme immunoassays (EIAs). Because of this shift, HIV testing is being integrated into primary care, as well as in community settings. Since the introduction of this new strategy, the turnaround time between testing and receiving final HIV diagnoses reduced from 4-6 weeks to 1-2 weeks. Cost of HIV testing services reported by the national programme have also considerably decreased. Continued efforts are needed to provide fast and accurate diagnoses so more people with HIV can access treatment, and those who are HIV negative can benefit from prevention services. Source: Republican AIDS Centre of Kyrgyzstan, WHO Regional Office for Europe, 2019. 3Disadvantages of western blotting and line immunoassays For western blotting/line immunoassays, specimens are collected in a health facility by venepuncture, processed and then sent to a laboratory, where highly skilled staff perform the test. The laboratory then sends the test results to the referring facility, which contacts the client, so they can deliver the result. Compared with RDTs, which provide same-day diagnosis, it takes longer to provide the final HIV status to the client with testing strategies or algorithms that include western blotting/line immunoassays. Interpretation of the test result and final HIV status with western blotting/line immunoassays can also be complex. Indeterminate results are common, leaving affected clients without a definitive diagnosis and the need to return for retesting. HIV testing services delivered with western blotting/line immunoassays will not be able to increase access to and uptake of HIV treatment and prevention services among those in greatest need. The time to conduct western blotting/line immunoassays, interpret the results and to return test results to clients is resource intensive, from both a cost and human resource perspective. These same factors also lead to delayed or no ART initiation resulting in lost to follow-up along the testing and treatment pathway. Evidence favours discontinuation of western blotting/line immunoassays for HIV diagnosis WHO commissioned a systematic review to compare testing strategies that include western blotting/line immunoassays with those that only use a combination of HIV RDTs and/ or EIAs. The review found similar accuracy (sensitivity and specificity), but that testing algorithms with western blotting/line immunoassays led to more HIV-indeterminate results, requiring more clients to return for retesting 14 days later. Nearly half of all indeterminate results identified were among people with HIV, and therefore they were unable to start ART quickly. A client’s perspective on western blotting I took a rapid [HIV] test and it turned out to be reactive. The counselor explained I had to take a “western blot” test [to confirm my diagnosis], which is only available at the hospital. It took five weeks to get the final results and it was a nightmare, I even regretted taking the HIV test! Source: Association de Lutte Contre le Sida (ALCS), Morocco WHO recommends countries move away from the use of western blotting and line immunoassays in HIV testing strategies and algorithms4 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/19.30 © World Health Organization 2019 Some rights reserved. Licence: CC BY-NC-SA 3.0 IGO POLICY BRIEF HIV TESTING SERVICES • Many HIV RDTs or EIAs can replace western blotting and line immunoassays. The critical task is to verify that the new test selected works well in combination with the other two tests in the algorithm. Most important is to maximize the specificity of the products chosen as the second and third tests in a strategy/algorithm. Countries should review and consider products listed by WHO prequalification: https://www.who.int/diagnostics_laboratory/ evaluations/pq-list/hiv-rdts/public_report/en/. • The move away from western blotting/line immunoassays will facilitate task sharing with health providers, as well as community workers, enabling more people in need of HIV testing to be served with fewer resources. Efforts will be needed to support and reorient the role of laboratories, so they can take on broader roles around supportive supervision and other aspects of quality assurance. • The transition away from western blotting/line immunoassays will require national policy change and training of staff. These changes should be linked to broader efforts to scale-up rapid ART initiation and access to HIV prevention services. Consultation with communities and other stakeholders will be critical. • Promoting, and providing messages to communities, on the shift to faster, more accurate test results may help to increase demand for HIV testing services, particularly among key populations and populations where the burden of undiagnosed HIV is the greatest. Implementation considerations For those with conclusive test results, whether positive or negative, including western blotting led to longer turnaround time between testing and receiving a final HIV diagnosis, increased loss to follow-up and delayed linkage to treatment. Testing strategies that included western blotting/line immunoassays were costlier and less preferred by both clients and providers. Use of HIV RDTs and EIAs alone were strongly preferred as they were accurate, convenient and enabled clients to get their results faster. Based on this evidence, WHO recommended against the use of western blotting/line immunoassays in routine HIV testing services. Countries should move away from western blotting or line immunoassays. Use of testing strategies that do not include western blotting/line immunoassays is highly feasible and already implemented in most settings. Testing strategies that only include RDTs require less infrastructure and can be performed by various cadres of health workers, including trained lay providers and community health workers. The switch to non-western blot/line immunoassay containing strategies can facilitate immediate initiation of ART and streamline the offer of pre-exposure prophylaxis (PrEP), as well as support the expansion and decentralization of HIV testing services including community-based testing. This is also likely lead to greater equity and uptake among people with HIV who do not know their status. Many countries have made the shift away from western blotting/line immunoassays, a few of them in recent years. The countries where western blotting/line immunoassays remain the standard of care should plan to make the switch. These countries may need support to make the transition to updated testing strategies/ algorithms and to select replacement assays. Reviewing and selecting assays to take the place of western blotting/line immunoassays requires time and resources in the short term but will achieve greater impact for clients and reduce future costs. Ph ot os : C ov er © A rt em G et m an /U N DP U kr ai ne ; p ag e 3 © A nn a Ka ri/ W HO
WHO RECOMMENDS COUNTRIES MOVE AWAY FROM THE USE OF WESTERN BLOTTING AND LINE IMMUNOASSAYS IN HIV TESTING STRATEGIES AND ALGORITHMS NOVEMBER 2019 POLICY BRIEF WHO recommends countries move away from the use of western blotting and line immunoassays in HIV testing strategies and algorithms2 WHO Recommendation Western blotting and line immunoassays should not be used in HIV testing strategies/algorithms. (strong recommendation, low quality evidence). Rationale for the new recommendation Globally one in five people with HIV still do not know their status. Many people with HIV who do not know their status are from key populations and other vulnerable groups that often find it difficult to access health services, including HIV testing. Further efforts are needed to expand HIV testing The World Health Organization (WHO) recommends replacing western blotting and line immunoassays with simpler tests in HIV testing services. These simpler tests include rapid diagnostic tests (RDTs) that can be used at the point-of-care, and enzyme immunoassays (EIAs). These tests get results to the client faster, produce accurate results more often, cost less, can be performed by various cadres of health providers, and can thus facilitate greater access and uptake of HIV testing services among those who need it most. services for these populations and others. At the same time, testing itself should be optimized to produce quick and reliable results. Worldwide, most people are diagnosed with HIV using testing strategies that include RDTs only. However, in some countries western blotting and line immunoassays, which are longstanding laboratory-based technologies, are still used as the second or third test in national testing algorithms to confirm HIV infection. This is common in a number of countries within the European region and other high-income settings as well as in parts of the South-East Asia, Western Pacific and Eastern Mediterranean regions. In these regions, knowledge of HIV status is generally low, hampering uptake of antiretroviral therapy (ART) among people with HIV or prevention services for those at high ongoing risk. Moving away from western blotting and rolling-out HIV rapid diagnostic testing algorithms in Kyrgyzstan In 2016, Kyrgyzstan revised their national HIV testing policy and included a simplified HIV testing strategy aligned with WHO recommendations. Through this policy, western blotting was phased out across the country, and replaced with testing strategies/algorithms using a combination of HIV rapid diagnostic tests (RDTs) and enzyme immunoassays (EIAs). Because of this shift, HIV testing is being integrated into primary care, as well as in community settings. Since the introduction of this new strategy, the turnaround time between testing and receiving final HIV diagnoses reduced from 4-6 weeks to 1-2 weeks. Cost of HIV testing services reported by the national programme have also considerably decreased. Continued efforts are needed to provide fast and accurate diagnoses so more people with HIV can access treatment, and those who are HIV negative can benefit from prevention services. Source: Republican AIDS Centre of Kyrgyzstan, WHO Regional Office for Europe, 2019. 3Disadvantages of western blotting and line immunoassays For western blotting/line immunoassays, specimens are collected in a health facility by venepuncture, processed and then sent to a laboratory, where highly skilled staff perform the test. The laboratory then sends the test results to the referring facility, which contacts the client, so they can deliver the result. Compared with RDTs, which provide same-day diagnosis, it takes longer to provide the final HIV status to the client with testing strategies or algorithms that include western blotting/line immunoassays. Interpretation of the test result and final HIV status with western blotting/line immunoassays can also be complex. Indeterminate results are common, leaving affected clients without a definitive diagnosis and the need to return for retesting. HIV testing services delivered with western blotting/line immunoassays will not be able to increase access to and uptake of HIV treatment and prevention services among those in greatest need. The time to conduct western blotting/line immunoassays, interpret the results and to return test results to clients is resource intensive, from both a cost and human resource perspective. These same factors also lead to delayed or no ART initiation resulting in lost to follow-up along the testing and treatment pathway. Evidence favours discontinuation of western blotting/line immunoassays for HIV diagnosis WHO commissioned a systematic review to compare testing strategies that include western blotting/line immunoassays with those that only use a combination of HIV RDTs and/ or EIAs. The review found similar accuracy (sensitivity and specificity), but that testing algorithms with western blotting/line immunoassays led to more HIV-indeterminate results, requiring more clients to return for retesting 14 days later. Nearly half of all indeterminate results identified were among people with HIV, and therefore they were unable to start ART quickly. A client’s perspective on western blotting I took a rapid [HIV] test and it turned out to be reactive. The counselor explained I had to take a “western blot” test [to confirm my diagnosis], which is only available at the hospital. It took five weeks to get the final results and it was a nightmare, I even regretted taking the HIV test! Source: Association de Lutte Contre le Sida (ALCS), Morocco WHO recommends countries move away from the use of western blotting and line immunoassays in HIV testing strategies and algorithms4 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/19.30 © World Health Organization 2019 Some rights reserved. Licence: CC BY-NC-SA 3.0 IGO POLICY BRIEF HIV TESTING SERVICES • Many HIV RDTs or EIAs can replace western blotting and line immunoassays. The critical task is to verify that the new test selected works well in combination with the other two tests in the algorithm. Most important is to maximize the specificity of the products chosen as the second and third tests in a strategy/algorithm. Countries should review and consider products listed by WHO prequalification: https://www.who.int/diagnostics_laboratory/ evaluations/pq-list/hiv-rdts/public_report/en/. • The move away from western blotting/line immunoassays will facilitate task sharing with health providers, as well as community workers, enabling more people in need of HIV testing to be served with fewer resources. Efforts will be needed to support and reorient the role of laboratories, so they can take on broader roles around supportive supervision and other aspects of quality assurance. • The transition away from western blotting/line immunoassays will require national policy change and training of staff. These changes should be linked to broader efforts to scale-up rapid ART initiation and access to HIV prevention services. Consultation with communities and other stakeholders will be critical. • Promoting, and providing messages to communities, on the shift to faster, more accurate test results may help to increase demand for HIV testing services, particularly among key populations and populations where the burden of undiagnosed HIV is the greatest. Implementation considerations For those with conclusive test results, whether positive or negative, including western blotting led to longer turnaround time between testing and receiving a final HIV diagnosis, increased loss to follow-up and delayed linkage to treatment. Testing strategies that included western blotting/line immunoassays were costlier and less preferred by both clients and providers. Use of HIV RDTs and EIAs alone were strongly preferred as they were accurate, convenient and enabled clients to get their results faster. Based on this evidence, WHO recommended against the use of western blotting/line immunoassays in routine HIV testing services. Countries should move away from western blotting or line immunoassays. Use of testing strategies that do not include western blotting/line immunoassays is highly feasible and already implemented in most settings. Testing strategies that only include RDTs require less infrastructure and can be performed by various cadres of health workers, including trained lay providers and community health workers. The switch to non-western blot/line immunoassay containing strategies can facilitate immediate initiation of ART and streamline the offer of pre-exposure prophylaxis (PrEP), as well as support the expansion and decentralization of HIV testing services including community-based testing. This is also likely lead to greater equity and uptake among people with HIV who do not know their status. Many countries have made the shift away from western blotting/line immunoassays, a few of them in recent years. The countries where western blotting/line immunoassays remain the standard of care should plan to make the switch. These countries may need support to make the transition to updated testing strategies/ algorithms and to select replacement assays. Reviewing and selecting assays to take the place of western blotting/line immunoassays requires time and resources in the short term but will achieve greater impact for clients and reduce future costs. Ph ot os : C ov er © A rt em G et m an /U N DP U kr ai ne ; p ag e 3 © A nn a Ka ri/ W HO
世界卫生组织建议各国在 艾滋病检测策略和程序中 不再使用蛋白免疫印迹法和 线状免疫分析法 2019年11月 政策简报 世界卫生组织建议各国在艾滋病检测策略和程序中不再使用蛋白免疫印迹法和线状免疫分析法2 世卫组织的建议 艾滋病检测策略／程序中不应使用蛋白免疫印迹 法和线状免疫分析法。 （强烈建议，低质量证据）。 新建议的理由 在全球范围内，仍有五分之一的艾滋病感染者不了 解自身的情况。许多不知道自己状况的艾滋病毒感染者 来自重点人群和其他弱势群体，他们往往难以获得包括 艾滋病检测在内的卫生服务。 需要进一步努力扩大对这些人群和其他人的艾滋 病检测服务。同时，检测本身应该得到优化，以产生 快速可靠的结果。 世界卫生组织（世卫组织）建议在艾滋病检测服务中以更简单的检测取代蛋白免 疫印迹法和线状免疫分析法。这些更简单的检测包括可在卫生服务点使用的快速诊断 检测和酶免疫分析法。这些检测可以更快地向客户提供结果，而且产生准确结果的频 率更高，成本更低，并可以由各种核心卫生人员实施，因此可以促进提高艾滋病检测 服务在最有需要者中的可及性和利用率。 在世界各地，大多数得到诊断的艾滋病毒感染者使 用的检测策略只包括快速诊断检测。然而，在一些国 家，蛋白免疫印迹法和线状免疫分析法这两种基于实 验室的长期技术仍然被用作国家检测程序中用以确认 艾滋病毒感染的第二次或第三次检测。这在欧洲区域 和其他高收入环境中的一些国家以及东南亚、西太平 洋和东地中海区域的部分地区很常见。在这些区域， 对艾滋病毒状况的了解普遍低下，阻碍了艾滋病毒感 染者接受抗逆转录病毒治疗，也阻碍了对面临持续高 风险人群的预防服务。 蛋白免疫印迹法和线状免疫分析法的 缺点 关于蛋白免疫印迹法／线状免疫分析法，须在医疗 机构中通过静脉穿刺收集和处理标本，然后送到实验 室，由高度熟练的人员进行检测。实验室随后将检测结 果送回医疗机构，由医疗机构与客户联系以交付结果。 吉尔吉斯斯坦不再使用蛋白质印迹法并推出艾滋病快速诊断检测程序 2016年，吉尔吉斯斯坦修订了国家艾滋病检测政策，纳入了符合世卫组织建议的简化艾滋病检测策略。 通过这一政策，在全国范围逐步淘汰了蛋白免疫印迹法，并代之以一种综合使用艾滋病快速诊断检测和酶免 疫分析法的检测策略／程序。由于这一转变，艾滋病检测正被纳入初级保健服务和社区环境。 自从实行这一新策略以来，检测与获得最终艾滋病毒诊断之间的周转时间从4-6周减少到1-2周。国家规 划报告的艾滋病检测服务费用也大幅下降。 （检测机构）需要继续努力以提供快速准确的诊断，以便更多的艾滋病毒感染者能够接受治疗，同时 艾滋病毒阴性的人也可以从预防服务中受益。 来源：吉尔吉斯斯坦共和国艾滋病中心、世卫组织欧洲区域办事处，2019年 新 3与在同一天提供诊断结果的快速诊断检测相比， 使用包括蛋白免疫印迹法／线状免疫分析法的检测策 略或程序向客户提供最终的艾滋病毒状态需要更长时 间。用蛋白免疫印迹法／线状免疫分析法来解释检测 结果和最终艾滋病毒状态也可能很复杂。结果不确定 的情况很常见，致使受影响的客户得不到明确诊断， 需要返回进行复检。 使用蛋白免疫印迹法／线状免疫分析法提供的艾滋 病检测服务将无法在最有需要者中提高艾滋病治疗和预 防服务的可及性和利用率。从成本和人力资源两方面来 看，进行蛋白免疫印迹法／线状免疫分析法、解释结果 并将检测结果返回给客户的过程是资源密集型的。这些 相同的因素还会导致延迟或根本不启动抗逆转录病毒治 疗，致使在检测和治疗过程中出现失访。 有证据支持停止使用蛋白质印迹法／线性 免疫分析进行艾滋病毒诊断 世卫组织委托进行了一项系统审查，以便对包括蛋 白免疫印迹法／线状免疫分析法的检测策略与仅使用艾 滋病快速诊断检测和／或酶免疫分析法相结合的检测策 略进行比较。审查发现了相似的准确性（敏感性和特异 性），但是使用蛋白免疫印迹法／线状免疫分析法的 检测程序导致了更多的艾滋病毒不确定结果，要求更 多的客户在14天后返回进行复检。在确认的所有不确 定结果中，将近一半是艾滋病毒感染者，因此他们无 法迅速开始抗逆转录病毒治疗。 一名客户对蛋白免疫印迹法的看法 我参加了一个快速的[艾滋病]检测，结果 为阳性。咨询人员解释说，我必须接受“蛋白 免疫印迹”检测[来确认我的诊断结果]，这种 检测只在医院提供。花了五个星期才得到最 终结果，这真是一场噩梦，我甚至后悔进行 了艾滋病检测！ 来源：摩洛哥防治艾滋病协会 对于已经有确切的阳性或阴性检测结果的人，如果 将蛋白免疫印迹法包括在内会导致延长检测与获得最终 艾滋病毒诊断之间的周转时间，增加失访的比率，并延 迟向治疗服务的转介。 世界卫生组织建议各国在艾滋病检测策略和程序中不再使用蛋白免疫印迹法和线状免疫分析法4 • 许多艾滋病快速诊断检测或酶免疫分析法可以替代蛋白免疫印迹法和线状免疫分析法。关键任务是验证所 选的新检测法能否与程序中的其他两个检测法良好结合。最重要的是，要最大限度提高被选为策略／程序 中新的第二种和第三种检测产品的特异性。各国应审查和考虑由世卫组织预认证的产品：http://www.WHO. int/diagnostics_laboratory/evaluations/pq-list/HIV-rdts/public_report/en/。 • 放弃蛋白免疫印迹法／线状免疫分析法将有助于与卫生服务提供者以及社区工作者分担任务，从而能够以 更少的资源使更多需要艾滋病检测的人获得服务。需要努力支持和调整实验室的作用，使其能够围绕支持 性监督和质量保证的其他方面发挥更广泛的作用。 • 不再使用蛋白免疫印迹法／线状免疫分析法将需要改变国家政策的和培训员工。这些变化应与扩大启动快 速抗逆转录病毒治疗和扩大获取艾滋病预防服务的更广泛努力相结合。与社区和其他利益攸关方进行协商 将至关重要。 • 向社区宣传和提供信息，说明转向更快、更准确的检测结果可有助于增加对艾滋病检测服务的需求，特别 是在重点人群和未得到诊断的艾滋病负担最重的人群中。 实施注意事项 将蛋白免疫印迹法／线状免疫分析法包括在内的检 测策略成本更高，客户和供应商都不太喜欢，而远远更 喜欢只使用艾滋病快速诊断检测和酶免疫分析法，因为 它们准确、方便，并使客户能更快获得结果。 基于这一证据，世卫组织不建议在常规艾滋病检测 服务中使用蛋白免疫印迹法／线状免疫分析法。各国应 停用蛋白免疫印迹法或线状免疫分析法。 使用不包括蛋白免疫印迹法／线状免疫分析法的检 测策略是高度可行的，并且已经在大多数环境中得到实 施。只包含快速诊断检测的检测策略需要的基础设施较 少，并且可以由各种核心卫生工作者实施，包括训练有 素的非专业人员和社区卫生工作者。转向不包含蛋白免 疫印迹法／线状免疫分析法的策略可以促进立即启动 抗逆转录病毒治疗，简化暴露前预防的提供，并支持 艾滋病检测服务的扩展和分散，包括实行基于社区的 检测。这还可能促使在不知道自己状况的艾滋病毒感 染者中加强公平和提高受检率。 许多国家已经放弃了蛋白免疫印迹法／线状免疫分 析法，其中一些国家于近几年停用。仍以蛋白免疫印迹 法／线状免疫分析法作为医护标准的国家应该作出转变 计划。这些国家可能需要得到一些支持与帮助才能过渡 到经更新的检测策略／程序并选择替代检测的方法。审 查和选择用于替代蛋白免疫印迹法／线状免疫分析法的 检测法在短期内可能需要时间和资源，但会对客户产生 更深远的影响并降低未来成本。 照 片 ： 封 面 © A rt em G et m an /开 发 署 ， 乌 克 兰 ； 第 3页 © A nn a Ka ri/ 世 卫 组 织 要获得更多信息，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/19.30 © 世界卫生组织2019 保留某些权利 许可：CC BY-NC-SA 3.0 IGO 政策简报 艾滋病毒检测服务