Panorama do controle de qualidade em laboratórios clínicos e a experiência do Instituto Adolfo Lutz / Overview of quality control in clinical laboratories and the Adolfo Lutz Institute experience

No cenário dos laboratórios clínicos é de suma importância controlar e melhorar continuamente a qualidade dos serviços para obtenção de resultados confiáveis. Para alcançar essa condição, é imprescindível acompanhar os avanços tecnológicos. Uma das causas fundamentais tem sido a introdução e o monitoramento de indicadores de qualidade, tais como as especificações de desempenho analítico, principalmente a precisão e a exatidão. São componentes-chave desse processo a utilização do controle de qualidade interno (CQI) e a participação em programas de avaliação externa da qualidade (AEQ). Este relato de experiência se propõe a apresentar algumas tendências passadas e presentes da utilização do controle de qualidade nos processos de monitoramento da fase analítica em laboratórios clínicos. Destina-se também a compartilhar a experiência do Instituto Adolfo Lutz (IAL) no desenvolvimento e na implementação de programas de controle de qualidade em ensaios sorológicos, contextualizando seu propósito e benefício dos resultados. A qualidade em laboratórios clínicos torna-se cada vez mais relevante à medida que as evidências científicas destacam o seu papel importante no processo de tomada de decisão clínica e no monitoramento de pacientes. No desempenho de suas atividades, o Centro de Imunologia do IAL tem contribuído para a melhoria da qualidade dos resultados oferecidos à população pelos laboratórios da sub-rede do estado de São Paulo.

In the clinical laboratories setting, it is extremely important to continuously control and improve the quality of services to obtain reliable results. To achieve this condition, it is essential to keep up with technological advances. One of the fundamental causes has been the introduction and monitoring of quality indicators such as the analytical performance specifications in particular accuracy and precision. The key components of this process are the use of internal quality control (IQC) and participation in external quality assessment programs (EQA). This experience report intends to present some past and present trends in the use of quality control for monitoring analytical phase in clinical laboratories. It is also intended to share the experience of the Adolfo Lutz Institute (IAL) in the development and implementation of quality control programs in serological assays, which contextualizes their purpose and benefit of the results. The quality in clinical laboratories has become increasingly relevant as scientific evidence highlights the important role it plays in the clinical decision-making and patient monitoring process. In carrying out its activities, the Center of Immunology at IAL has contributed for improving the quality of results offered to the population by laboratories of the sub-network of São Paulo State.

Ocular manifestations of monkeypox: a case report / Manifestações oculares da monkeypox: um relato de caso

ABSTRACT Monkeypox disease is a viral zoonosis with symptoms similar to those seen in the past in smallpox (variola), although clinically less severe. Following the eradication of smallpox in 1980 and the subsequent cessation of smallpox vaccination, monkeypox has emerged as the most important orthopoxvirus from a public health standpoint. Monkeypox virus occurs primarily in central and western Africa, often in tropical forests, and has increasingly manifested in urban areas. Animal hosts include various rodents and nonhuman primates. We report the case of a patient with monkeypox disease who developed ocular complaints (eye discomfort and conjunctivitis) and had detectable conjunctival lesions on biomicroscopy and fluorescein testing. Its ophthalmological manifestations are still poorly known.

RESUMO Varíola do Macaco é uma zoonose viral com sintomas semelhantes aos observados no passado em pacientes com Varíola, embora seja clinicamente menos grave. Com a erradicação da varíola em 1980 e a subsequente cessação da vacinação contra a varíola, a varíola dos macacos emergiu como o ortopoxvírus mais importante em saúde pública. O vírus monkeypox ocorre principalmente na África central e ocidental, muitas vezes nas proximidades de florestas tropicais, e tem se manifestado cada vez mais em áreas urbanas. Os hospedeiros animais incluem uma variedade de roedores e primatas não humanos. O presente estudo relata o caso de um paciente com Monkeypox que evoluiu com queixa oftalmológica de desconforto ocular e conjuntivite e, à biomicroscopia e teste da fluoresceína, detecção de lesões conjuntivais. Alterações oftalmológicas da doença são, ainda, pouco conhecidas.

Ocular manifestations of monkeypox: a case report.

Monkeypox disease is a viral zoonosis with symptoms similar to those seen in the past in smallpox (variola), although clinically less severe. Following the eradication of smallpox in 1980 and the subsequent cessation of smallpox vaccination, monkeypox has emerged as the most important orthopoxvirus from a public health standpoint. Monkeypox virus occurs primarily in central and western Africa, often in tropical forests, and has increasingly manifested in urban areas. Animal hosts include various rodents and nonhuman primates. We report the case of a patient with monkeypox disease who developed ocular complaints (eye discomfort and conjunctivitis) and had detectable conjunctival lesions on biomicroscopy and fluorescein testing. Its ophthalmological manifestations are still poorly known.

Immunogenicity After a Heterologous BNT262b2 Versus Homologous Booster in Kidney Transplant Recipients Receiving 2 Doses of CoronaVac Vaccine: A Prospective Cohort Study.

BACKGROUND: Comparative studies of third heterologous doses following the CoronaVac vaccine against coronavirus disease 2019 (COVID-19) in kidney transplant recipients are lacking. METHODS: This prospective, single-center cohort study included kidney transplant recipients without previous COVID-19. Patients received a third heterologous (BNT162b2 mRNA) or homologous dose at least 4 wk after 2 doses of the CoronaVac vaccine. Immunoglobulin G antibody response and seroprevalence for neutralizing anti-severe acute respiratory syndrome coronavirus 2 antibodies immediately before and 28 d after third doses were compared between the groups. RESULTS: There were 307 patients in the heterologous group and 777 in the homologous group. Patients in the heterologous group were older (54 versus 50 y; P < 0.0001), with a longer time since transplant (11 versus 6 y; P < 0.0001). Immediately before the third dose, immunoglobulin G seroprevalence (36% versus 34%; P = 0.597) and antibody titers (246 versus 268 AU/mL; P = 0.279) were similar. After booster, seroconversion was higher in the heterologous group (49% versus 32%; P < 0.0001), resulting in a higher seroprevalence (67% versus 55%; P = 0.0003); however, 42% of all patients remained seronegative. Antibody titers after booster in seropositive patients were higher in the heterologous group (7771 versus 599 AU/mL; P < 0.0001). These results persisted after adjusting for confounding variables. Lastly, a similar proportion of patients became seropositive for neutralizing antibodies (98% versus 94%; P = 0.098). CONCLUSIONS: In kidney transplant recipients fully vaccinated with CoronaVac, a third dose with an mRNA vaccine produced a higher seroconversion rate and antibody titers than a third homologous dose. However, both boosters achieved equivalent seroprevalence for neutralizing antibodies. The high proportion of still seronegative patients indicates the need for alternative strategies of protection.

Prediction of SARS-CoV-2-positivity from million-scale complete blood counts using machine learning.

Background: The Complete Blood Count (CBC) is a commonly used low-cost test that measures white blood cells, red blood cells, and platelets in a person's blood. It is a useful tool to support medical decisions, as intrinsic variations of each analyte bring relevant insights regarding potential diseases. In this study, we aimed at developing machine learning models for COVID-19 diagnosis through CBCs, unlocking the predictive power of non-linear relationships between multiple blood analytes. Methods: We collected 809,254 CBCs and 1,088,385 RT-PCR tests for SARS-Cov-2, of which 21% (234,466) were positive, from 900,220 unique individuals. To properly screen COVID-19, we also collected 120,807 CBCs of 16,940 individuals who tested positive for other respiratory viruses. We proposed an ensemble procedure that combines machine learning models for different respiratory infections and analyzed the results in both the first and second waves of COVID-19 cases in Brazil. Results: We obtain a high-performance AUROC of 90 + % for validations in both scenarios. We show that models built solely of SARS-Cov-2 data are biased, performing poorly in the presence of infections due to other RNA respiratory viruses. Conclusions: We demonstrate the potential of a novel machine learning approach for COVID-19 diagnosis based on a CBC and show that aggregating information about other respiratory diseases was essential to guarantee robustness in the results. Given its versatile nature, low cost, and speed, we believe that our tool can be particularly useful in a variety of scenarios-both during the pandemic and after.

Seroprevalence of hepatitis E virus infection among volunteer blood donors in Central Brazil.

A cross-sectional study was carried out in the Hematology and Hemotherapy Institute of the state of Mato Grosso do Sul (Hemosul) to evaluate the seroprevalence and risk factors of Hepatitis E Virus (HEV) exposure among volunteer blood donors in Central Brazil. Two-hundred fifty samples from the biorepository were tested for anti-HEV IgG and IgM using the Wantai HEV ELISA test. The seroprevalence of HEV exposure was 6.4% (95% CI: 3.9-10.2). Being born in another state of Brazil, mainly in the Southeast and South regions, was associated with a higher risk of HEV exposure (p < 0.001).

COVID-19 containment management strategies in a nursing home.

OBJECTIVE: To describe the first COVID-19 pandemic at Casa Ondina Lobo, a philanthropic nursing home in São Paulo city, and the containment measures against the pandemic that proved to be effective. METHODS: Several preventive measures were taken before and during the pandemic, with emphasis on universal testing by reverse transcription polymerase chain reaction for COVID-19. All residents and employees were tested twice in a D9 period. RESULTS: Among the 62 residents and 55 employees, in both testing, eight residents and nine employees tested positive for COVID-19. Of 22% of employees and 75% of residents evolved asymptomatic, emphasizing the importance of universal testing for the detection and isolation of these cases. A quarter of residents evolved without any symptoms, however, with COVID-19 signs, reinforcing the importance of monitoring vital signs. The second testing did not detect any new cases among residents, demonstrating the effectiveness of the containment measures, however, it found four new cases among employees. This emphasized their role in COVID-19 outbreaks in nursing homes. Only one patient died, a 12.5% lethality among those known to be infected and a 1.6% mortality in the total population of residents were seen. CONCLUSION: The adoption of appropriate containment measures enabled to contain an COVID-19 pandemic in studied nursing home. Universal reverse transcription polymerase chain reaction testing for COVID-19 has proved to be particularly important and effective.

Diagnóstico sorológico da infecção por HIV/aids no Brasil / Serological diagnosis of HIV/AIDS infection in Brazil

O teste imunoenzimático do tipo ELISA foi comercializado no Brasil logo após ser anunciado nos EUA e Europa, sendo imediatamente utilizado em vários laboratórios públicos e privados. Tecnologias mais recentes para a testagem de HIV, como a de quarta geração, que detecta anticorpos anti-HIV e o antígeno p24, e os testes baseados em ácido nucleico reduziram o intervalo entre a infecção e a detecção da doença. Esta breve revisão narrativa se propõe a apresentar os diferentes fluxogramas de testes para diagnóstico do HIV utilizados nacionalmente, desde os ensaios baseados apenas em anticorpos anti-HIV até os novos fluxogramas em que foram incluídos os testes moleculares. Até 1998, as autoridades sanitárias brasileiras ainda não haviam normatizado um algoritmo para a realização do diagnóstico da infecção pelo HIV. Desde então, diferentes algoritmos de testagem foram preconizados pelo Ministério da Saúde e seguidos pelos laboratórios. Considerando os diferentes cenários em que o diagnóstico do HIV tem sido realizado, há necessidade de avaliações frequentes dos ensaios, visto que a qualidade dos resultados pode ser influenciada por diversos fatores biológicos do hospedeiro e do agente.

COVID-19 containment management strategies in a nursing home

ABSTRACT Objective: To describe the first COVID-19 pandemic at Casa Ondina Lobo, a philanthropic nursing home in São Paulo city, and the containment measures against the pandemic that proved to be effective. Methods: Several preventive measures were taken before and during the pandemic, with emphasis on universal testing by reverse transcription polymerase chain reaction for COVID-19. All residents and employees were tested twice in a D9 period. Results: Among the 62 residents and 55 employees, in both testing, eight residents and nine employees tested positive for COVID-19. Of 22% of employees and 75% of residents evolved asymptomatic, emphasizing the importance of universal testing for the detection and isolation of these cases. A quarter of residents evolved without any symptoms, however, with COVID-19 signs, reinforcing the importance of monitoring vital signs. The second testing did not detect any new cases among residents, demonstrating the effectiveness of the containment measures, however, it found four new cases among employees. This emphasized their role in COVID-19 outbreaks in nursing homes. Only one patient died, a 12.5% lethality among those known to be infected and a 1.6% mortality in the total population of residents were seen. Conclusion: The adoption of appropriate containment measures enabled to contain an COVID-19 pandemic in studied nursing home. Universal reverse transcription polymerase chain reaction testing for COVID-19 has proved to be particularly important and effective.

Seroprevalence of hepatitis E virus infection among volunteer blood donors in Central Brazil

Abstract A cross-sectional study was carried out in the Hematology and Hemotherapy Institute of the state of Mato Grosso do Sul (Hemosul) to evaluate the seroprevalence and risk factors of Hepatitis E Virus (HEV) exposure among volunteer blood donors in Central Brazil. Two-hundred fifty samples from the biorepository were tested for anti-HEV IgG and IgM using the Wantai HEV ELISA test. The seroprevalence of HEV exposure was 6.4% (95% CI: 3.9-10.2). Being born in another state of Brazil, mainly in the Southeast and South regions, was associated with a higher risk of HEV exposure (p < 0.001).

Hepatitis E virus infection among patients with altered levels of alanine aminotransferase.

Hepatitis E virus (HEV) affects 20 million people worldwide, with 3.3 million cases and 56,000 deaths. The transmission is mainly by the fecal-oral route. Several studies have reported increased alanine aminotransferase (ALT) levels in association with viral hepatitis. This study evaluated the diagnosis of HEV infection among patients attending the emergency room (ER) of Hospital Beneficência Portuguesa (HBP) and Hospital São Paulo (HSP) in São Paulo, Brazil increased ALT levels (≥ 200 IU/L). From October 2018 to July 2019, 400 sera samples were collected from patients treated at the ER of HBP (n=200) and HSP (n=200). All samples were screened for HEV by RT-qPCR. 200 samples from HSP were tested for IgM of anti-Hepatitis A (HAV) and B (HBV) viruses, and total antibodies of Hepatitis C virus (HCV). Ninety samples (45 from each hospital), were tested for anti-HEV IgM antibodies. Patients aged under 1 to 91 years (mean = 46.29 ± 24.17, median = 48). ALT levels varied from 200 to 8,974 IU/l. 16 patients (4%) turned out positive for HEV by RT-qPCR (ALT levels = 299 to 698 IU/L). Of the 200 HSP patients, 18 (9%) were anti-HAV IgM reactive, 9 (4.5%) for anti-HBV IgM, and 7 (3.5%) for anti-HCV antibodies (ALT levels = 833 to 1918 IU/L). Two of 90 BPH patients (2.22%) were anti-HEV IgM reactive (ALT levels = 1502 to 3831 IU/L). This is the first Brazilian study evaluating patients with suspected HEV infection with increased ALT levels, which were higher than 12 and 60 times the normal upper limit, in the acute phase or for patients reactive for antibody detection, respectively. Liver damage could be minimized by implementing molecular diagnostic tests in the hospital routine.

Assessment of initial SARS-CoV-2 seroprevalence in the most affected districts in the municipality of São Paulo, Brazil.

BACKGROUND: São Paulo city has been one of the regions most affected by the COVID-19 pandemic in Brazil. Frequent asymptomatic and oligosymptomatic infections and poor access to diagnostic tests make serosurveys crucial to monitor the magnitude of the epidemic and to inform public health policies, such as vaccination plans. OBJECTIVES: To estimate, early in the epidemic, the seroprevalence of antibodies to SARS-CoV-2 in adults living in the six most affected districts in São Paulo city, and to assess potential associated risk factors. METHODS: This was a cross-sectional population-based survey of 1,152 households randomly selected from 72 census tracts. During the period May 4-12, 2020, 463 participants completed a questionnaire on sociodemographic characteristics and history of symptoms in the past two weeks, and provided a blood sample. Prevalence of SARS-CoV-2 antibodies was the outcome of interest and was estimated based on results of two immunoassays, Maglumi SARS-CoV-2 chemiluminescence assay Immunoglobulin (Ig) M (IgM) and IgG, and Roche electrochemiluminescence assay total Ig. Serum samples reactive to either assay were considered positive. RESULTS: Weighted overall seroprevalence was 6% (95%CI 3.9-8.3%). No association was observed between seropositivity and sex, age group or education level. Participants who reported black and brown skin color showed a 2.7 fold higher prevalence than people with white skin (p = 0.007). Among the 30 seropositive individuals, 14 (46.6%) reported no COVID-19 compatible symptoms in the past two weeks. CONCLUSION: This study represents the first assessment of SARS-CoV-2 seroprevalence in the city of São Paulo and 6% is the baseline estimate of a series of population-based seroprevalence surveys. Serological screening using sound serological assays is the key tool to monitoring temporal and geographic changes in the spread of the virus through an important epicenter of the COVID-19 pandemic in Brazil. Ultimately, it may inform prevention and control efforts.

Lower seroprevalence for SARS-CoV-2-specific antibodies among kidney transplant recipients compared to the general population in the city of Sao Paulo, Brazil.

BACKGROUND: Kidney transplant recipients have higher COVID-19 associated mortality compared to the general population. However, as only symptomatic patients seek medical attention, the current level of exposure, the main sources of acquisition, and the behavior of humoral immunity over time are poorly understood. METHODS: This cross-sectional prospective single-center study recruited kidney transplant recipients of any age living in Sao Paulo. A sample size of 401 patients was calculated considering the 17.2% seroprevalence in the municipality population from a published survey, a 95% confidence interval and an absolute error of 2%. RESULTS: Of the 2636 eligible patients, 416 were included. The seroprevalence for IgG anti-SARS-CoV-2 was 8.2%. Seroconversion rate decreased with increasing age, from 15.7% (18-35 years) to 8.3% (36-60 years) and 4.2% (>60 years, p = 0.042). Seropositivity among previously confirmed COVID-19 patients was 68.4%, followed by 9.4% in those with flu-like symptoms and only 4.6% among asymptomatic patients (p < 0.0001). Seroprevalence was significantly higher among patients reporting household contact (p = 0.018). Twenty-seven from the 34 IgG+ patients had a second test after 59 (IQR 50-63) days, and, in 33%, the IgG index became below the positivity threshold. CONCLUSIONS: In this cohort of kidney transplant recipients, the seroprevalence for IgG anti-SARS-CoV-2 was lower than that of the general population, decreased with ageing, and was associated with household contacts. In a considerable proportion of the patients, there was a significant decay in the IgG levels in a short period of time. Therefore, preventive strategies, such as prioritization for vaccination, should be urgently considered.

No association between vitamin D status and COVID-19 infection in São Paulo, Brazil

ABSTRACT In recent years the immunomodulatory actions of vitamin D, a steroid hormone, have been extensively studied. In 2020, due to the COVID-19 pandemic, the question arose as to 25(OH)D status would be related to susceptibility to SARS-CoV-2 infection, since several studies pointed out a higher prevalence and severity of the disease in populations with low levels of 25(OH)D. Thus, we investigated the 25(OH)D levels in adults "Detected" positive for SARS CoV-2 by RT-PCR (reverse transcriptase polymerase chain reaction) test, and in negative controls, "not Detected", using the Fleury Group's examination database, in Sao Paulo, Brazil. Of a total of 14.692 people with recent assessments of 25(OH)D and RT-PCR tests for COVID-19, 2.345 were positive and 11.585 were negative for the infection. The groups did not differ in the percentage of men and women, or in the age distribution. There were no differences in the distribution of 25(OH)D between the two groups (p = 0.08); mean 25(OH)D of 28.8 ± 21.4 ng/mL and 29.6 ± 18.1 ng/mL, respectively. In the specific population studied, clinical, environmental, socioeconomic and cultural factors should have greater relevance than 25(OH)D in determining the susceptibility to COVID-19.

Critical preparedness and operational response actions directed for the acute and post-acute COVID-19 pandemic in Brazil: the experience of a nationwide outpatient healthcare group.

ABSTRACT: While the new Coronavirus Disease 2019 (COVID-19) pandemic rapidly spread across the world, South America was reached later in relation to Asia, Europe and the United States of America (USA). Brazil concentrates now the largest number of cases in the continent and, as the disease speedily progressed throughout the country, prompt and challenging operational strategies had to be taken by institutions caring for COVID-19 and non-COVID-19 patients in order to assure optimal workflows, triage, and management. Although hospitals in the USA, Europe and Asia have shared their experience on this subject, little has been discussed about such strategies in South America or by the perspective of outpatient centers, which are paramount in the radiology field. This article shares the guidelines adopted early in the pandemic by a nationwide outpatient healthcare center composed by a network of more than 200 patient service centers and nearly 2,000 radiologists in Brazil, discussing operational and patient management strategies, staff protection, changes adopted in the fellowship program, and the effectiveness of such measures.

No association between vitamin D status and COVID-19 infection in São Paulo, Brazil.

In recent years the immunomodulatory actions of vitamin D, a steroid hormone, have been extensively studied. In 2020, due to the COVID-19 pandemic, the question arose as to 25(OH)D status would be related to susceptibility to SARS-CoV-2 infection, since several studies pointed out a higher prevalence and severity of the disease in populations with low levels of 25(OH)D. Thus, we investigated the 25(OH)D levels in adults "Detected" positive for SARS CoV-2 by RT-PCR (reverse transcriptase polymerase chain reaction) test, and in negative controls, "not Detected", using the Fleury Group's examination database, in Sao Paulo, Brazil. Of a total of 14.692 people with recent assessments of 25(OH)D and RT-PCR tests for COVID-19, 2.345 were positive and 11.585 were negative for the infection. The groups did not differ in the percentage of men and women, or in the age distribution. There were no differences in the distribution of 25(OH)D between the two groups (p = 0.08); mean 25(OH)D of 28.8 ± 21.4 ng/mL and 29.6 ± 18.1 ng/mL, respectively. In the specific population studied, clinical, environmental, socioeconomic and cultural factors should have greater relevance than 25(OH)D in determining the susceptibility to COVID-19.

Assessment of initial SARS-CoV-2 seroprevalence in the most affected districts in the municipality of São Paulo, Brazil

ABSTRACT Background: São Paulo city has been one of the regions most affected by the COVID-19 pandemic in Brazil. Frequent asymptomatic and oligosymptomatic infections and poor access to diagnostic tests make serosurveys crucial to monitor the magnitude of the epidemic and to inform public health policies, such as vaccination plans. Objectives: To estimate, early in the epidemic, the seroprevalence of antibodies to SARS-CoV-2 in adults living in the six most affected districts in São Paulo city, and to assess potential associated risk factors. Methods: This was a cross-sectional population-based survey of 1,152 households randomly selected from 72 census tracts. During the period May 4-12, 2020, 463 participants completed a questionnaire on sociodemographic characteristics and history of symptoms in the past two weeks, and provided a blood sample. Prevalence of SARS-CoV-2 antibodies was the outcome of interest and was estimated based on results of two immunoassays, Maglumi SARS-CoV-2 chemiluminescence assay Immunoglobulin (Ig) M (IgM) and IgG, and Roche electrochemiluminescence assay total Ig. Serum samples reactive to either assay were considered positive. Results: Weighted overall seroprevalence was 6% (95%CI 3.9-8.3%). No association was observed between seropositivity and sex, age group or education level. Participants who reported black and brown skin color showed a 2.7 fold higher prevalence than people with white skin (p = 0.007). Among the 30 seropositive individuals, 14 (46.6%) reported no COVID-19 compatible symptoms in the past two weeks. Conclusion: This study represents the first assessment of SARS-CoV-2 seroprevalence in the city of São Paulo and 6% is the baseline estimate of a series of population-based seroprevalence surveys. Serological screening using sound serological assays is the key tool to monitoring temporal and geographic changes in the spread of the virus through an important epicenter of the COVID-19 pandemic in Brazil. Ultimately, it may inform prevention and control efforts.

Current polio status in the world / Estado atual de poliomielite no mundo

ABSTRACT Poliomyelitis is still an endemic disease in Afghanistan, Nigeria, and Pakistan despite the efforts to eradicate the disease. Therefore, there is a potential risk of international spread. Since the start of the polio eradication program by the Global Polio Eradication Initiative in 1988, the incidence of polio has been reduced by 99%. In the last decade, wild poliovirus type 2 (WPV2) was eliminated and declared eradicated in 2015. Wild poliovirus type 3 (WPV3) was last reported in November 2012. These changes have allowed the removal of Sabin poliovirus type 2 from the oral poliovirus vaccine (OPV) in April 2016 and countries either introduced bivalent OPV (bOPV) containing Sabin types 1 + 3 poliovirus or added at least one dose of inactivated poliovirus vaccine (IPV) into their routine immunization schedule. Many efforts are needed to eradicate polio, and new strategies should be implemented such as the development and approval of new genetically stable OPV, and vaccines that do not require infectious processes for virus growth, such as virus-like particles (VLPs), or packing-cell technology. IPV will increasingly be produced from Sabin strains, and further attenuated or genetically modified strains. Furthermore, there is also a need for the development of antiviral drugs to treat immunodeficient patients who are long-term excretors infected with poliovirus, thus avoiding contamination of individuals susceptible to polioviruses, due to reversal of pathogenicity. If all these measures are successfully implemented, the world will be close to the global

RESUMEN La poliomielitis sigue siendo una enfermedad endémica en Afganistán, Nigeria y Pakistán a pesar de los esfuerzos por erradicar la enfermedad. Por lo tanto, existe un riesgo de propagación mundial. Desde el inicio del programa de erradicación de la poliomielitis por la Iniciativa de Erradicación Mundial de la Poliomielitis [Global Polio Eradication Initiative (GPEI)] en 1988, la incidencia de la poliomielitis se ha reducido en un 99%. En la última década, el poliovirus salvaje tipo 2 (WPV2) fue eliminado y declarado erradicado en 2015. El poliovirus salvaje tipo 3 (WPV3) se informó por última vez en noviembre de 2012. Estos cambios han permitido la eliminación del poliovirus Sabin tipo 2 de la vacuna antipoliomielítica oral (VPO) en abril de 2016, y los países introdujeron la VPO de tipo bivalente (bVPO), que contiene poliovirus Sabin tipos 1 y 3, o agregaron al menos una dosis de vacuna antipoliomielítica inactivada (VPI) al programa de inmunización de rutina. Se necesitan muchos esfuerzos para erradicar la poliomielitis y se deben implementar nuevas estrategias, como el desarrollo y aprobación de nuevas VPO genéticamente estables y vacunas que no requieren procesos infecciosos para el crecimiento del virus, como partículas pseudovirales (VLP) o tecnología de células empaquetadas (packing-cell). La VIP se producirá cada vez más a partir de cepas Sabin y otras cepas más atenuadas o modificadas genéticamente. Además, también es necesario desarrollar fármacos antivirales para tratar a pacientes inmunodeficientes que son excretores a largo plazo, evitando así la contaminación de individuos susceptibles a poliovirus, debido a la reversión de la patogenicidad. Si todas estas medidas se implementan con éxito, el mundo estará cerca de la interrupción global de la transmisión del WPV y la erradicación de la poliomielitis.

RESUMO A poliomielite ainda é uma doença endêmica no Afeganistão, na Nigéria e no Paquistão, apesar dos esforços para erradicá-la. Portanto, há risco de propagação mundial. Desde o início do programa de erradicação da poliomielite pela Iniciativa de Erradicação Global da Pólio [Global Polio Eradication Initiative (GPEI)], em 1988, a incidência da doença foi reduzida em 99%. Na última década, o poliovírus selvagem do tipo 2 (WPV2) foi eliminado e declarado erradicado em 2015. O poliovírus selvagem do tipo 3 (WPV3) foi reportado pela última vez em novembro de 2012. Essas mudanças promoveram a remoção do poliovírus Sabin tipo 2 da vacina oral antipólio (VOP) em abril de 2016, e os países introduziram a vacina oral bivalente (VOPb), que contém os poliovírus Sabin tipos 1 + 3, ou adicionaram pelo menos uma dose da vacina inativada contra o poliovírus (VIP) no calendário de imunização. É necessário muito empenho para erradicar a poliomielite. Novas estratégias devem ser implementadas, como o desenvolvimento e a aprovação de novas VOPs geneticamente estáveis e vacinas que não requerem processos infecciosos para o crescimento do vírus, como partículas pseudovirais (VLP), ou tecnologia de células de empacotamento (packing-cell). A VIP será cada vez mais produzida a partir de cepas Sabin, de outras cepas atenuadas ou geneticamente modificadas. Além disso, é imprescindível o desenvolvimento de medicamentos antivirais para tratar os pacientes imunodeficientes que são excretores de longo prazo, evitando assim a contaminação de indivíduos suscetíveis aos poliovírus, devido à reversão da patogenicidade. Se todas essas medidas forem implementadas com sucesso, o mundo estará próximo da interrupção global de transmissão do WPV e da erradicação da poliomielite.