Original Title: Ampliação do uso do teste do pezinho para a detecção da toxoplasmose congênita

Authors' objectives: Is newborn screening test for congenital toxoplasmosis by analysis of anti-Toxoplasma gondii IgM antibodies in blood spots collected on filter paper, safe, effective and efficient enough to change immediate and long-term practices and outcomes in patients diagnosed? Scientific evidence: According to data from a national study in Brazil, neonatal screening identified cases of infection not detected by obtaining only one or two serum samples from pregnant women for T. gondii serology, mainly when infection was acquired in late pregnancy. The immunosorbent agglutination assay (ISAGA) is the serological test for the diagnosis of CT that has shown the highest sensitivity (54-87%) and specificity (77.7-100%). There are no randomized trials evaluating antiparasitic therapy in infants, so the evidence comes from observational studies. Compared with historical controls (untreated or treated for one month), combination treatment for 12 months was associated with improved neurologic, cognitive, and auditory outcomes and prevention of new eye lesions.

Authors' results and conclusions: The CONITEC’s members present at the 85th Ordinary Meeting, on February 5th, 2020, unanimously decided to recommend the expansion of newborn screening (heel prick test) for congenital toxoplasmosis. The Deliberation Record No. 507/2020 was signed.

Authors' recommendations: Scientific evidence: According to data from a national study in Brazil, neonatal screening identified cases of infection not detected by obtaining only one or two serum samples from pregnant women for T. gondii serology, mainly when infection was acquired in late pregnancy. The immunosorbent agglutination assay (ISAGA) is the serological test for the diagnosis of CT that has shown the highest sensitivity (54-87%) and specificity (77.7-100%). There are no randomized trials evaluating antiparasitic therapy in infants, so the evidence comes from observational studies. Compared with historical controls (untreated or treated for one month), combination treatment for 12 months was associated with improved neurologic, cognitive, and auditory outcomes and prevention of new eye lesions. Budget impact analysis: In the first scenario, considering the cost of BRL 8.19 per birth obtained in the economic evaluation, the budget impact would be around BRL 23.9 million. Considering a maternal-fetal transmission rate of 18.5% identified in a Brazilian epidemiological study, the budget impact was estimated to be approximately BRL 55 million, after five years, and considering a lower transmission rate of 3.5%, it would be approximately BRL 54 million. In the last scenario, considering the prevalence of congenital toxoplasmosis of 6/10,000 live births, the budget impact was estimated to range from BRL 55.44 to BRL 55.56 million. International recommendations: Toxoplasmosis prevention strategies, adopted by the several public health systems, are not uniform across different countries. The neonatal screening has been adopted in Poland, Denmark and some cities in the United States – these three countries have low prevalence of congenital toxoplasmosis. Countries with high incidence of infection, such as France, Austria and Slovenia, implemented prenatal screening. The United Kingdom, where congenital toxoplasmosis is rare, has no universal serologic screening program. Considerations: Congenital toxoplasmosis is an important health problem, prevalent in Brazil (5-23 infected children for every 10,000 live births), and often associated with severe sequelae. CT is diagnosed by detection of IgM in the neonatal period in more than 80% of cases. Early treatment may reduce the damage caused by the disease. The analysis of anti-T. gondii IgM for neonatal screening has already been applied in different regions in Brazil, and the cost-benefit ratio of early diagnosis is favorable in the absence of a well-implemented prenatal screening.

Project Status: Completed

URL for project: http://conitec.gov.br/images/Consultas/Relatorios/EN2020/20200915_Report516_Newbor-Screening_CongenitalToxoplasmosis.pdf

Year Published: 2020

URL for published report: http://conitec.gov.br/images/Relatorios/2020/Relatorio_Teste_Pezinho_Deteccao_Toxoplasmose_Congenita_516_2020_FINAL.pdf

URL for additional information: http://conitec.gov.br/recomendation-reports

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Brazil

Organisation Name: National Committee for Technology Incorporation (CONITEC)

Contact Address: Esplanada dos Ministérios, Bl. G, Ed. Sede, 8º andar, CEP: 70058-900

Contact Name: Clarice Moreira Portugal

Contact Email: clarice.portugal@saude.gov.br

Copyright: 2021 Conitec