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Abstract：
BACKGROUND: Accurate diagnosis is pivotal for implementing strategies for surveillance, control, and elimination of schistosomiasis. Despite their low sensitivity in low-endemicity areas, microscopy-based urine filtration and the Kato-Katz technique are considered as reference diagnostic tests for Schistosoma haematobium and Schistosoma mansoni infections, respectively. We aimed to collate all available evidence on the accuracy of other proposed diagnostic techniques.
METHODS: In this systematic review and meta-analysis, we searched PubMed, Embase, the Cochrane Library, and LILACS for studies published from database inception to Dec 31, 2022, investigating the sensitivity and specificity of diagnostic tests for S haematobium and S mansoni infections against Kato-Katz thick smears or urine microscopy (reference tests) involving adults (aged ≥18 years), school-aged children (aged 7 to 18 years), or preschool-aged children (aged 1 month to 7 years). We extracted raw data on true positives, true negatives, false positives, and false negatives for the diagnostic tests and data on the number of participants, study authors, publication year, journal, study design, participants\' age and sex, prevalence of Schistosoma infection, and treatment status. To account for imperfect reference tests, we used a hierarchical Bayesian latent class meta-analysis to model test accuracy.
RESULTS: Overall, we included 121 studies, assessing 28 different diagnostic techniques. Most studies (103 [85%] of 121) were done in Africa, 14 (12%) in South America, one (1%) in Asia, and one (1%) in an unknown country. Compared with the reference test, Kato-Katz thick smears, circulating cathodic antigen urine cassette assay version 1 (CCA1, 36 test comparisons) had excellent sensitivity (95% [95% credible interval 88-99]) and reasonable specificity (74% [63-83]) for S mansoni. ELISA-based tests had a performance comparable to circulating cathodic antigen, but there were few available test comparisons. For S haematobium, proteinuria (42 test comparisons, sensitivity 73% [62-82]; specificity 94% [89-98]) and haematuria (75 test comparisons, sensitivity 85% [80-90]; specificity 96% [92-99]) reagent strips showed high specificity, with haematuria reagent strips having better sensitivity. Despite limited data, nucleic acid amplification tests (NAATs; eg, PCR or loop-mediated isothermal amplification [LAMP]) showed promising results with sensitivity estimates above 90%. We found an unclear risk of bias of about 70% in the use of the reference or index tests and of 50% in patient selection. All analyses showed substantial heterogeneity (I2>80%).
CONCLUSIONS: Although NAATs and immunological diagnostics show promise, the limited information available precludes drawing definitive conclusions. Additional research on diagnostic accuracy and cost-effectiveness is needed before the replacement of conventional tests can be considered.
BACKGROUND: WHO and Luxembourg Institute of Health.
METHODS: In this systematic review and meta-analysis, we searched PubMed, Embase, the Cochrane Library, and LILACS for studies published from database inception to Dec 31, 2022, investigating the sensitivity and specificity of diagnostic tests for S haematobium and S mansoni infections against Kato-Katz thick smears or urine microscopy (reference tests) involving adults (aged ≥18 years), school-aged children (aged 7 to 18 years), or preschool-aged children (aged 1 month to 7 years). We extracted raw data on true positives, true negatives, false positives, and false negatives for the diagnostic tests and data on the number of participants, study authors, publication year, journal, study design, participants\' age and sex, prevalence of Schistosoma infection, and treatment status. To account for imperfect reference tests, we used a hierarchical Bayesian latent class meta-analysis to model test accuracy.
RESULTS: Overall, we included 121 studies, assessing 28 different diagnostic techniques. Most studies (103 [85%] of 121) were done in Africa, 14 (12%) in South America, one (1%) in Asia, and one (1%) in an unknown country. Compared with the reference test, Kato-Katz thick smears, circulating cathodic antigen urine cassette assay version 1 (CCA1, 36 test comparisons) had excellent sensitivity (95% [95% credible interval 88-99]) and reasonable specificity (74% [63-83]) for S mansoni. ELISA-based tests had a performance comparable to circulating cathodic antigen, but there were few available test comparisons. For S haematobium, proteinuria (42 test comparisons, sensitivity 73% [62-82]; specificity 94% [89-98]) and haematuria (75 test comparisons, sensitivity 85% [80-90]; specificity 96% [92-99]) reagent strips showed high specificity, with haematuria reagent strips having better sensitivity. Despite limited data, nucleic acid amplification tests (NAATs; eg, PCR or loop-mediated isothermal amplification [LAMP]) showed promising results with sensitivity estimates above 90%. We found an unclear risk of bias of about 70% in the use of the reference or index tests and of 50% in patient selection. All analyses showed substantial heterogeneity (I2>80%).
CONCLUSIONS: Although NAATs and immunological diagnostics show promise, the limited information available precludes drawing definitive conclusions. Additional research on diagnostic accuracy and cost-effectiveness is needed before the replacement of conventional tests can be considered.
BACKGROUND: WHO and Luxembourg Institute of Health.
摘要：
背景：准确的诊断对于实施监测策略至关重要，control,和消除血吸虫病。尽管它们在低流行地区的敏感性较低，基于显微镜的尿液过滤和Kato-Katz技术被认为是血吸虫和曼氏血吸虫感染的参考诊断测试。分别。我们旨在整理有关其他拟议诊断技术准确性的所有可用证据。
方法：在本系统综述和荟萃分析中，我们搜索了PubMed,Embase,Cochrane图书馆,和LILACS从数据库开始到2022年12月31日发表的研究，调查S-hematomium和S-mansoni感染的诊断测试对成人（年龄≥18岁）的Kato-Katz厚涂片或尿液显微镜检查（参考测试）的敏感性和特异性，学龄儿童（7至18岁），或学龄前儿童（1个月至7岁）。我们提取了真实阳性的原始数据，真正的底片，假阳性,以及诊断测试的假阴性和参与者数量的数据，研究作者,出版年份,journal,研究设计，参与者的年龄和性别，血吸虫感染的患病率，和治疗状态。为了解释不完善的参考测试，我们使用分层贝叶斯潜在类元分析来建模测试准确性。
结果：总体而言，我们纳入了121项研究，评估28种不同的诊断技术。大多数研究（121项研究中的103项[85%]）是在非洲进行的，14（12%）在南美洲，一个（1%）在亚洲，和一个（1％）在一个未知的国家。与参考测试相比，加藤-卡茨厚厚的涂片,循环阴极抗原尿盒测定版本1(CCA1,36项试验比较)对SMansoni具有优异的灵敏度(95%[95%可信区间88-99])和合理的特异性(74%[63-83]).基于ELISA的测试具有与循环阴极抗原相当的性能，但是几乎没有可用的测试比较。对于S血吸虫，蛋白尿(42个测试比较，灵敏度73%[62-82]；特异性94%[89-98]）和血尿（75个测试比较，灵敏度85%[80-90]；特异性96%[92-99])试剂条显示出高特异性，与血尿试剂条具有更好的灵敏度。尽管数据有限,核酸扩增试验(NAAT；例如，PCR或环介导等温扩增[LAMP]）显示出有希望的结果，灵敏度估计超过90％。我们发现，在使用参考或指数测试时，偏差的风险不清楚，约为70％，在患者选择时，偏差的风险为50％。所有分析均显示出显著的异质性(I2>80%)。
结论：尽管NAAT和免疫诊断显示出希望，有限的信息无法得出明确的结论。在考虑替代常规测试之前，需要对诊断准确性和成本效益进行更多研究。
背景：世卫组织和卢森堡卫生研究所。
方法：在本系统综述和荟萃分析中，我们搜索了PubMed,Embase,Cochrane图书馆,和LILACS从数据库开始到2022年12月31日发表的研究，调查S-hematomium和S-mansoni感染的诊断测试对成人（年龄≥18岁）的Kato-Katz厚涂片或尿液显微镜检查（参考测试）的敏感性和特异性，学龄儿童（7至18岁），或学龄前儿童（1个月至7岁）。我们提取了真实阳性的原始数据，真正的底片，假阳性,以及诊断测试的假阴性和参与者数量的数据，研究作者,出版年份,journal,研究设计，参与者的年龄和性别，血吸虫感染的患病率，和治疗状态。为了解释不完善的参考测试，我们使用分层贝叶斯潜在类元分析来建模测试准确性。
结果：总体而言，我们纳入了121项研究，评估28种不同的诊断技术。大多数研究（121项研究中的103项[85%]）是在非洲进行的，14（12%）在南美洲，一个（1%）在亚洲，和一个（1％）在一个未知的国家。与参考测试相比，加藤-卡茨厚厚的涂片,循环阴极抗原尿盒测定版本1(CCA1,36项试验比较)对SMansoni具有优异的灵敏度(95%[95%可信区间88-99])和合理的特异性(74%[63-83]).基于ELISA的测试具有与循环阴极抗原相当的性能，但是几乎没有可用的测试比较。对于S血吸虫，蛋白尿(42个测试比较，灵敏度73%[62-82]；特异性94%[89-98]）和血尿（75个测试比较，灵敏度85%[80-90]；特异性96%[92-99])试剂条显示出高特异性，与血尿试剂条具有更好的灵敏度。尽管数据有限,核酸扩增试验(NAAT；例如，PCR或环介导等温扩增[LAMP]）显示出有希望的结果，灵敏度估计超过90％。我们发现，在使用参考或指数测试时，偏差的风险不清楚，约为70％，在患者选择时，偏差的风险为50％。所有分析均显示出显著的异质性(I2>80%)。
结论：尽管NAAT和免疫诊断显示出希望，有限的信息无法得出明确的结论。在考虑替代常规测试之前，需要对诊断准确性和成本效益进行更多研究。
背景：世卫组织和卢森堡卫生研究所。
