Scope and efficiency of the newborn screening program in identifying hemoglobin S
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1 REV BRAS HEMATOL HEMOTER. 2014;36(1):14-18 Revista Brasileira de Hematologia e Hemoterapia Brazilia Joural of Hematology ad Hemotherapy Origial article Scope ad efficiecy of the ewbor screeig program i idetifyig hemoglobi S Maria Lúcia Ivo*, Olida Maria Rodrigues de Araujo, Aa Rita Barbieri, Ruy Alberto Caetao Corrêa Filho, Eleir Rose Jardim Cury Potes, Carlos Augusto de Oliveira Botelho Uiversidade Federal de Mato Grosso do Sul (UFMS), Campo Grade, MS, Brazil ARTICLE INFO ABSTRACT Article history: Received 16 July 2012 Accepted 16 October 2013 Keywords: Neoatal screeig Hemoglobi S Hemoglobiopathies Backgroud: I 2001, the Brazilia Miistry of Health added hemoglobiopathies to the Natioal Neoatal Screeig Program to be implemeted i three steps. I order to meet the proposed goals, it is crucial to establish periodic assessmets of this program with the aim of moitorig its implemetatio. Objective: To assess the scope ad the efficiecy of the stages of the Natioal Newbor Screeig Program i idetifyig hemoglobi S. Methods: A cross-sectioal study was developed with the results of the heel prick test usig the high performace liquid chromatography method for babies bor i Mato Grosso do Sul from 2006 to The followig variables were ivestigated: year, umber of live births, total screeig, coverage ratio, prevalece, time betwee the child birth ad the blood collectio; age at diagosis; age at the time of the first cosultatio; ad time betwee the diagosis ad the first appoitmet. Results: Over the five years of the study, the mea coverage rate was 91.77%. The prevaleces of hemoglobi FAS ad hemoglobi FS were 1.65% ad 0.011%, respectively. Blood samples from 43.48% of childre were collected from the secod to the seveth day. The age at diagosis was withi the first 28 days i 87.80% of the screeed childre. The lowest mea idices for the first cosultatio ad the time betwee the diagosis ad the first appoitmet (58.8 ad 46.4 days, respectively) occurred i Coclusios: The scope of the Natioal Neoatal Screeig Program for hemoglobiopathies is good, with a large umber of idividuals beig tested. Efficiecy is a suitable idicator to assess the program steps. Three poits are recommeded: the traiig of the idividuals ivolved, studies to assess the assistace provided to the affected child, ad geetic couselig to the mothers Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular. All rights reserved. *Correspodig author at: Uiversidade Federal de Mato Grosso do Sul, Campus Uiversitário, Cidade Uiversitária S/N, Caixa Postal 549, Campo Grade, MS, Brazil. ivoms@terra.com.br (M.L. Ivo) /$ - see frot matter 2014 Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular. Published by Elsevier Editora Ltda. All rights reserved. DOI: /
2 REV BRAS HEMATOL HEMOTER. 2014;36(1): Itroductio Hemoglobiopathies are recessively iherited geetic diseases, icludig sickle cell disease ad thalassemias. 1 The presece of hemoglobi S (Hb S), prevailig i sickle cell disease, cosists i a chage that characterizes it as a structural hemoglobiopathy, whereas thalassemia is a sythesis hemoglobiopathy. Idividuals with Hb S have predomiated i the screeigs performed i the state of Mato Grosso do Sul (MS). 2,3 I order to explai these fidigs, further research is eeded. However, this study corroborates research developed i Dourados, MS, usig molecular biology techiques to cofirm the diagosis of some hemoglobiopathies. 4 Hb S ca be foud i the heterozygous state (sickle cell trait), which is cosidered asymptomatic, that is without disease; i a homozygous state (Hb SS or sickle cell aemia), or i associatio with other chages (Hb S/β-thalassemia, Hb SC, HB SD ad others). 5,6 Because of the cliical complexity ad high death rate worldwide, these geetic chages, specifically sickle cell aemia, have cotributed to the creatio of commuitybased programs. 7 I 2001, the Brazilia Miistry of Health, through the Act 822/01, added the hemoglobiopathies to the Natioal Neoatal Screeig Program (Programa Nacioal de Triagem Neoatal) to be implemeted i three steps i 12 Brazilia States. 8 Uder the resposibility of the Istituto de Pesquisas, Esio e Diagóstico da Associação de Pais e Amigos dos Excepcioais (IPED-APAE), the program is i its Step II i the State of Mato Grosso do Sul. Coverage has bee icreasig i the State; i 2002, the program already screeed 92.06% of ewbors. 2 Sice the, there have bee o records of coverage of less tha 87.41%. 2 For the screeig program to be able to reach the proposed goals, 8 it is essetial to establish periodic assessmets, ad divulge the results to the public health authorities itedig to improve the system. The assessmet of the scope ad the efficiecy of the program leads to its moitorig, aimig at better meetig the populatio s eeds. 9 Accordigly, this study aims ot oly at assessig the comprehesiveess (coverage) of the program, but also at idetifyig the steps (efficiecy) that eed to be improved. Thus, the efficiecy of the steps of the screeig program was chose as a appraisal idicator. The objective of this work was to assess the scope ad the efficiecy of the steps of the hemoglobi S screeig program i the State of Mato Grosso do Sul, from 2006 to Methods This is a cross-sectioal study of the screeig results for hemoglobiopathies of 181,973 childre i the 78 muicipalities of the State of Mato Grosso do Sul. Iformatio was obtaied from 923 registered collectio statios of the screeig program IPED-APAE i the period from 2006 to The variables studied to assess the scope were: year, umber of live births, 10 total screeig, coverage rate, ad prevalece of hemoglobiopathies, with the exceptio of thalassemia. The variables studied to aalyze the efficiecy of the program were: the time betwee the child s birth ad the exam, the age at diagosis, the child s age at the time of the first cosultatio, ad the time betwee the diagosis ad the first appoitmet. This study focused o sickle cell diseases as this proved to be the most commo hemoglobiopathies. The date of the first cosultatio was take from the records of IPED-APAE. The time betwee the diagosis ad the first appoitmet was calculated from the date of the diagosis, ad from the date of the first cosultatio. The screeig steps at IPED-APAE are performed i accordace with the techical criteria defied i the Maual of Techical Stadards ad Operatioal Routies of the screeig program. 8 The process starts with blood collectio for tests o filter paper (Schleicher & Schuell 903), usig the heel prick techique i Family Health Cliics, materity wards or hospitals, by a member of the ursig team or a traied techicia. After collectig ad dryig the sample, it is placed i a evelope for biological materials ad set to a testig laboratory. Muicipalities with ambulaces goig to Campo Grade (the State capital) ship the samples directly to the screeig laboratory for ewbor diseases. I the laboratory, the blood samples are classified i respect to the quality of the blood sample, ad the data relatig to the age of the child at the time of the collectio is recorded. The criteria adopted to discard the blood sample are: usuitable sample (visual), isufficiet blood for all tests, ad early sample (obtaied withi the first 48 hours after birth). Samples discarded due to the above criteria are retured to the place of origi for the collectio of aother sample. This study icluded valid samples oly. Hemoglobi screeig is performed usig the VARIANTbs High Performace Liquid Chromatography (HPLC) system. This is a qualitative screeig that idetifies the presece of ormal (Hb F ad A) ad abormal hemoglobis (Hb S, D, C, ad E). This methodology is recogized as the gold stadard by the Brazilia Miistry of Health. The results of the tests are available as web reports set to the health cliics via the iteret, prited, or set by . Newbors with results suggestive of hemoglobiopathies are scheduled for their first cosultatio with a hematologist at APAE-IPED. Subsequetly, a cliical follow-up is carried out durig the first year of life, ad after this period the childre are referred to the Campo Grade Regioal Hospital to cofirm the diagosis. This research was approved by the Research Ethics Committee of the Uiversidade Federal de Mato Grosso do Sul (protocol #1.822/2010/UFMS). For the statistical aalysis, descriptive measures were calculated usig the Statistical Aalysis Software (SAS) versio 9.0 for Widows. The followig formula was used to calculate the coverage of the screeig program: coverage = umber of screeed babies / umber of live births 100. Prevalece rates were estimated by poit ad 95% cofidece itervals (95% CI). Results Based o the umber of live births, the coverage rate varied over the five-year period (Table 1); the highest coverage occurred i 2006 (94.26%), ad the lowest i 2010 (89.69%). Of the total of 181,973 samples screeed by the program, 3,040 were diagosed with Hb S i differet geotypic associatios; 20 cases were diagosed with Hb FS; eight had results for Hb
3 16 REV BRAS HEMATOL HEMOTER. 2014;36(1):14-18 Table 1 - Overall screeigs ad coverage rate of ewbors ivestigated at IPED APAE, Mato Grosso do Sul, 2006 to Year Live birth () Screeed ewbors () Coverage rate (%) before 48 hours of life; 1,322 (43.48%), betwee the secod ad seveth day, ad 1,401 (46.1%), betwee the eighth ad 30th day. A further 46 (1.5%) childre preseted positive results for Hb FAS, yet there was o record of their age at the time of collectio ,309 37, ,378 34, ,045 37, ,979 36, ,587 35, Total 198, , IPED-APAE: Istituto de Pesquisas, Esio e Diagósticos da Associação de Pais e Amigos dos Excepcioais. FSC, oe for Hb FSD, ad 3,011 were Hb FAS, the asymptomatic form of the disease. Whe examiig the prevalece amog 181,973 childre screeed (Table 2), Hb S was the most frequet hemoglobiopathy, with Hb FAS beig the most prevalet i The prevalece of the homozygous form, sickle cell aemia, was 0.011% with oe case i 9,098 childre screeed. Table 2 - Prevalece of hemoglobiopathies estimated as percetages of total ad 95% cofidece iterval i childre screeed at IPED-APAE, Mato Grosso do Sul, Total 3, , to Data related to the occurrece of cases of sickle cell trait Hemoglobiopathy Year Childre screeed Cases Prevalece (%) a 95% CI b Hb FAS , , , , , All 181,973 3, Hb FS All 181, Hb FSC All 181, Hb FSD All 181, Table 3 - Occurrece of cases of sickle cell trait ad sickle cell disease accordig to age i days at time of sample collectio for eoatal screeig at IPED-APAE, Mato Grosso do Sul, 2006 to Age days Hb FAS Hb FS Hb FSC Hb FSD Total , , , , > No records ad sickle cell disease, accordig to age i days at the time of diagosis, idicate that amog the childre screeed, 2,669 were betwee 0 ad 28 days at diagosis, ad 371 were older. Amog the ewbors, 24 had sickle cell disease geotypes (18 with Hb FS, five with Hb FSC, ad oe with Hb FSD), ad 2,645 had the sickle cell trait geotype (Hb FAS). Amog the childre older tha 28 days at diagosis, five cases had the disease (two with Hb FS, ad three with Hb FSC), ad 366 had Hb FAS. As for the age of childre at the time of the first appoitmet, i 2009, the mea age was days ( = 7; media = 81; rage: days), whereas i 2010, there was a decrease i age at the first cosultatio, with a mea of 58.8 days ( = 8; media = 40.5; rage: days) (Table 4). Table 4 - Age of the childre i days, at time of the first cosultatio after diagosis i the eoatal screeig program at IPED-APAE, Mato Grosso do Sul, 2006 to Year Mea Media Miimum Maximum a Estimates of prevalece rate by poit. b Estimates of prevalece by cofidece level of 95%. I respect to the time from birth to the blood samplig for eoatal screeig, Table 3 shows that, of the childre screeed with hemoglobi S, 161 (5.3%) uderwet the test
4 REV BRAS HEMATOL HEMOTER. 2014;36(1): The highest mea umber of days betwee the diagosis of sickle cell disease ad the first cosultatio was i 2006 ( = 8; mea: 86.8; media = 63.5; rage: days). I 2010, the average umber of days betwee the diagosis ad the first appoitmet was the lowest ( = 8; mea: 46.4; media = 28; rage: days). Discussio The mea coverage of screeig program i this study was 91.77% betwee 2006 ad 2010, with the highest rate i 2006 (94.26%). I a study coducted i the Brazilia Federal District, the coverage rate was 83.4% i 2006, 11 ad i Bahia State, the average coverage rate was 88.9% i the period from 2007 to The program s atioal goal is to achieve a coverage of 100%. 8 The differeces amog the Brazilia regios ca be justified by the structure ad the orgaizatio of services. The uptake of live births, the umber of collectio statios, the shipmet of samples i a suitable timeframe, ad the articulatio betwee the steps, are of utmost importace for the program s success. As for the equity of access, the local services should be aware of iche populatios, because of the risk of failig to collect samples give the cultural, social, ad ecoomic heterogeeity of Mato Grosso do Sul, which borders Bolivia ad Paraguay, ad has the secod largest idigeous populatio i the coutry. 13 Regardig the prevalece of the hemoglobiopathies, the results show that, of 181,973 childre screeed, 3,040 (1.67%) preseted Hb S i differet geotypic associatios. This fidig cofirms those described i the literature, i.e., i Brazil, Hb S is the commoest hemoglobiopathy, marked by a high prevalece, ad potetial morbidity. 14 These results corroborate the epidemiological survey developed i Mato Grosso do Sul, from 2000 to 2005, i which, amog the childre screeed, 2,624 (1.38%) preseted Hb S i differet geotypic associatios. 2 I the preset study, the highest prevalece for Hb FAS was 1.87% i This fidig places Mato Grosso do Sul, together with Sata Cataria (0.9%), 15 amog the Brazilia states with the lowest prevalece of sickle cell disease. These results are differet from those of Bahia, which preseted oe case for every 650 live births screeed ( = 257); Bahia is the State with the highest prevalece of sickle cell disease. 16 Attetio should be paid to the results related to the time betwee the birth ad eoatal screeig, which revealed early collectios i 5.3% of the cases. I Brazil, the Miistry of Health reported that, i 2011; 62.11% of the tests were performed by the seveth day of life, disregardig the results i cases of early collectio. 17 Whe aalyzig the age i days at the time of collectio, it was foud that 43.48% occurred from the secod to seveth day, as recommeded by the screeig program. 8 Globally, the results of studies i respect to the age at the time of collectio are fairly diversified. Research coducted i the Gaza Strip, i the Palestiia Territories, showed that 61% of the collectios occurred betwee the 11th ad 17th day of life. 18 I Brazil, i Porto Alegre city, the average was 11 days; 19 i Sergipe State 17 days, with 50% of samples beig collected i childre older tha 28 days; 20 i Campia Grade city, the average was 29.8 days, 21 ad i Marília, São Paulo State, the average was 27 days. 22 A weak poit i this study lies i the absece of a record of the age at the time of collectio for 46 childre positive for Hb FAS. Cocerig the age i days at diagosis, 87.80% of the results were ready while the subjects were eoates (up to 28 days). I discussig this figure, it was observed that early diagosis favors itervetios ad, therefore, positively iflueces the outcome of the disease. 23 I recet years, the expectatios related to morbidity ad mortality from sickle cell disease have chaged dramatically, partly due to the higher accuracy of tests, early diagosis, ad greater kowledge about the disease. Aother reaso is the icreased sesitivity of the public health istitutios i Brazil, motivated by social movemets focused o the black populatio, ad by the societies of Hb S gee carriers. 5 Regardig the age of the child at the first cosultatio, ad the time betwee the diagosis ad the first appoitmet, 2010 had the lowest idices amog the years studied, which led to a shorter time to diagosis. Accordig to the literature, the earlier the diagosis ad treatmet of sickle cell disease, the less likely patiets will have complicatios, thereby icreasig the survival ad the quality of life. 24 Routie prevetive measures for patiets with sickle cell disease should be iitiated withi the first two moths of life, as at the first cosultatio; parets ad guardias should be couseled about prophylaxis agaist ifectios, immuizatios, ad also taught to idetify the complicatios of the disease, reducig morbidity ad mortality. 25 The screeig program defies the itervals betwee the steps, so as to provide the patiet with early diagosis ad timely treatmet. Therefore, the gap betwee the birth ad the iitiatio of the treatmet should be short, so that the program ca be effective i prevetig sequels, i promotig social iclusio, ad i reducig sufferig. 23 Coclusio The scope of the screeig program for hemoglobiopathies i the state of Mato Grosso do Sul is successful, with a mea coverage of 91.77%, thereby providig diagoses of Hb S for the populatio. Efficiecy, the idicator employed i this study, idetified two steps that eed to be improved: the time of the sample collectio, which i may cases is too early, ad age at diagosis of more tha 28 days. Thus, the authors of this study would like to make three recommedatios: cotiuous traiig of those ivolved, further studies to assess the assistace provided to affected childre, ad the provisio of geetic couselig to mothers. Coflicts of iterest The authors declare o coflicts of iterest.
5 18 REV BRAS HEMATOL HEMOTER. 2014;36(1):14-18 Ackowledgmets The authors wish to thak IPED-APAE, Campo Grade, MS for makig data regardig ewbor screeig of the muicipalities of Mato Grosso do Sul availability, ad Fudação de Apoio ao Desevolvimeto do Esio, Ciêcia e Tecologia do Estado de Mato Grosso do Sul (FUNDECT) for the research grat. REFERENCES 1. Orlado GM, Naoum PC, Siqueira FA, Boii-Domigos CR. Diagóstico laboratorial de hemoglobiopatias em populações difereciadas. Rev Bras Hematol Hemoter. 2000;22(2): Holsbach DR, Ivo ML, Hoer MR, Rigo L, Botelho CA. Ocorrêcia de hemoglobia S o estado de Mato Grosso do Sul, Brasil. Bras Patol Med Lab. 2008,44(4): Sakamoto TM, Ivo ML, Brum MA, Potes ER, Boii-Domigos CR, Ferreira Juior MA. Aemia e hemoglobiopatias em gestates atedidas em hospital público. Rev Eferm UFPE o lie. 2012;6(7): Souza RA, Pratesi R, Foseca SF. Programa de Triagem Neoatal para Hemoglobiopatias em Dourados, MS uma aálise. Rev Bras Hematol Hemoter. 2010;32 (2): Naoum PC, Naoum FA. Doeça das células falciformes. São Paulo: Sarvier, Ivo ML, Carvalho EC. Assistêcia de efermagem a portadores de aemia falciforme, à Luz do Referecial de Roy. Rev Lat Am Efermagem. 2003;11(2): Compri MB, Polimeo NC, Stella MB, Ramalho AS. Programa Comuitário de hemoglobiopatias hereditárias em população estudatil brasileira. Rev Saude Publica. 1996;30(2): Brasil. Miistério da Saúde. Portaria GM/MS º 822, de 6 de juho de Istitui, o âmbito do Sistema Úico de Saúde, o Programa Nacioal de Triagem Neoatal/PNTN. Diário Oficial da Uião. Brasília, DF, p.33, col.2, 7 ju Citra EA, Lofrao-Porto A. Avaliação do programa de triagem eoatal em Cáceres, Mato Grosso, o período de 2006 a Brasília Med. 2011;48(4): Miistério da Saúde. Iformações de Saúde. Sistema de Iformações sobre Nascidos Vivos (SINASC). [cited 2011 Oct 03]. Available from: exe?siasc/cv/vms.def 11. Diiz D, Guedes C, Barbosa L, Tauil PL, Magalhães I. Prevalêcia do traço falciforme e da aemia falciforme em recém-ascidos do Distrito Federal, Brasil, 2004 a Cad Saude Publica. 2009;25(1): Amorim T, Pimetel H, Fotes MIMM, Purificação A, Lessa P, et al. Avaliação do Programa de Triagem Neoatal a Bahia etre 2007 e As lições da doeça falciforme. Gaz Med Bahia. 2010;80(3): Cazola LH, Pícoli RP, Tamaki EM, Potes ERJC, Ajalla ME. Atedimetos a brasileiros residetes a froteira Brasil- Paraguai pelo Sistema Úico de Saúde. Rev Paam Salud Publica. 2011;29(3): de Araújo MC, Serafim ES, Castro Jr WA, Medeiros TM. Prevalêcia de hemoglobias aormais em recém-ascidos da cidade de Natal, Rio Grade do Norte, Brasil. Cad Saúde Pública. 2004;20(1): Backes CE, Mallma FG, Dassi T, Bazzo ML, Satos-Silva MC. Triagem eoatal como um problema de saúde pública. Rev Bras Hematol Hemoter. 2005;27(1): Almeida AM, Godiho TM, Teles MS, Rehem AP, Jalil HM, Fukuda TG, et al. Avaliação do Programa de Triagem Neoatal a Bahia o ao de Rev Bras Saúde Mater Ifat. 2006;6(1): Teste do peziho. Triagem Neoatal. Sistemas de Admiistração de Saúde (SAS). [cited 2012 Jue 08]. Available from: oticia/5494/162/triagem-eoatal-alcaca-83-de-coberturaacioal.html 18. Abu Shahla AN, Abed Y, Abu Shahla NK. Screeig programme for pheylketouria i the Gaza Strip: evaluatio ad recommedatios. J Trop Pediatr. 2004;50(2):101-5; discussio Daudt LE, Zechmaister D, Portal L, Camargo Neto E, Silla LM, Giugliai R. Triagem eoatal para hemoglobiopatias: um estudo piloto em Porto Alegre, Rio Grade do Sul, Brasil.Cad Saúde Pública. 2002;18(3): Ramalho RJ, Ramalho AR, Oliveira CR, Aguiar-Oliveira MH. Evolução do programa de triagem eoatal para o hipotireoidismo cogêito e feilcetoúria o Estado de Sergipe de 1995 a Arq Bras Edocriol Metabol. 2004;48(6): Ramos AJ, Rocha AM, Costa AD, Beicio AV, Ramos AL, Silva CR, et al. Avaliação do programa de rastreameto de doeças cogêitas em Campia Grade - PB, Brasil. Arq Bras Edocriol Metab. 2003;47(3): Medoça AC, Garcia JL, Almeida CM, Megid TB, Fabro Juior A. Muito além do Teste do Peziho. Rev Bras Hematol Hemoter. 2009;31(2): Bloter J, Camacho LA, Cruz MM. Aálise de desempeho do Programa de Triagem Neoatal do Estado do Rio de Jaeiro, Brasil de 2005 a Cad Saude Publica. 2011;27(12): Ramalho AS, Maga LA, Paiva-e-Silva. A Portaria MS o 822/01 e a triagem eoatal das hemoglobiopatias. Rev Bras Hematol Hemoter. 2002;24(4): Rodrigues DO, Ferreira MC, Pereira PM, Bustamate MT, Campos EM, Oliveira CM. Diagóstico histórico da triagem eoatal para doeça falciforme. Rev APS, Juíz de Fora. 2010;13(1):34-45.
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