Comparação de dois imunoensaios para dosagem do hCG sérico utilizados no monitoramento da doença trofoblástica Gestacional
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2016-08-29
Autores
Souza, Juliana Maria Quinalha [UNESP]
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Universidade Estadual Paulista (Unesp)
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Introdução: A Doença Trofoblástica Gestacional (DTG) compreende dois tipos clínicos: mola hidatiforme (MH) e neoplasias trofoblásticas gestacionais (NTG). A dosagem do hCG é o parâmetro mais importante para detecção da persistência de trofloblasto ativo na parede do útero ou em outros locais do organismo. Objetivo: Comparar concentrações séricas do hormônio hCG em pacientes com DTG utilizando duas variações do método de quimioluminescência comercialmente disponíveis em nosso centro. Métodos: Este estudo incluiu pacientes com DTG avaliadas e acompanhadas no Centro de Doenças Trofoblásticas da Faculdade de Medicina de Botucatu (CDTB) – UNESP, de novembro de 2014 a outubro de 2015. Amostras de soro das pacientes foram testadas para dosagem de hCG em duas variações do método de quimioluminescência ARCHITECT® i2000 SR e IMMULITE® 2000 Xpi. Concentrações séricas de hCG foram comparadas contra a hipótese nula e a concordância clínica foi determinada em dois momentos: admissão da paciente e evolução pela curva de hCG de acordo com os valores de hCG entre os dois equipamentos. Resultados: 73 pacientes com DTG foram incluídas no estudo. Destas, 45 tinham MH e remissão espontânea, enquanto 28 tiveram NTG. Uma boa concordância nos valores médios de hCG entre IMMULITE® 2000 Xpi e ARCHITECT® i2000 SR quando hCG <100 mUI/mL. Para valores de hCG >100 mUI/mL, houve diferença significativa entre ensaios (p<0,05), com valores medidos pelo ARCHITECT® i2000 SR sendo maior que aqueles medidos pelo IMMULITE® 2000 Xpi em pacientes com MH e remissão espontânea ( Immulite = 0.79Architect ; p < 0,01 ) ; R2 = 90 % ) e NTG ( Immulite = 0,51Architect ; p < 0,01 ) ; R2 = 98 % ). As condutas clínicas no momento da admissão das pacientes foram concordantes em 100% dos casos [73/73(100%); kappa1; p<0,001] e pela evolução da curva de hCG, a concordância observada foi de 98% [71/72(98%); kappa 0,93; p<0,001].Conclusão: O uso do equipamento IMMULITE® é recomendado para monitoramento de pacientes com DTG, entretanto, ARCHITECT® apresentou desempenho analítico e coerência clínica em relação aos resultados de hCG, o que faz deste equipamento uma boa alternativa.
Introduction: Gestational trophoblastic disease (GTD) is a group of disorders spanning the conditions that range from hydatidiform mole (HM) to gestational trophoblastic neoplasia (GTN). Determining human chorionic gonadotrophin (hCG) serum levels is crucial for the early detection and optimal management of GTN. Objective: To compare serum hCG levels in patients with GTD using 2 commercially available hCG immunoassays. Methods: Serum samples were obtained from patients with GTD attending the Botucatu Trophoblastic Diseases (Botucatu Medical School, São Paulo State University- Unesp) from November 2014 to October 2015. Serum hCG levels were measured with both IMMULITE® 2000 XPi and ARCHITECT® i2000 chemiluminescence tests. Serum hCG levels were compared against the null hypothesis. Agreement with clinical management was determined by comparing baseline hCG measures as well as the hCG curves obtained with both assays. Results: Seventy-three patients with GTD were included in the analysis. Of these, 45 had HM and experienced spontaneous remission, while 28 had GTN. There was a perfect (zero difference) agreement in mean hCG levels between IMMULITE® 2000 XPi and ARCHITECT® i2000 when hCG < 100 mUI/mL. For hCG values greater than 100 mUI/mL, there was a significant difference between assays (p < 0.05), with levels measured via ARCHITECT® i2000 being higher than those measured with IMMULITE® 2000 XPi in patients with spontaneous remission (Immulite = 0.79Architect; p < 0.01); R2 = 90%) and GTN (Immulite = 0,51Architect; p < 0,01); R2 = 98%). Baseline test results agreed in all cases (73/73(100%); kappa1;p<0,001] and hCG curve agreement was 98% [71/72(98%); kappa0,93;p<0,001].Conclusion: IMMULITE® has been the assay recommended for diagnosing and monitoring patients with GTD. However, our results suggest that as ARCHITECT® and IMMULITE® show similar performance in measuring hCG levels and determining clinical management, ARCHITECT® may be used an alternative.
Introduction: Gestational trophoblastic disease (GTD) is a group of disorders spanning the conditions that range from hydatidiform mole (HM) to gestational trophoblastic neoplasia (GTN). Determining human chorionic gonadotrophin (hCG) serum levels is crucial for the early detection and optimal management of GTN. Objective: To compare serum hCG levels in patients with GTD using 2 commercially available hCG immunoassays. Methods: Serum samples were obtained from patients with GTD attending the Botucatu Trophoblastic Diseases (Botucatu Medical School, São Paulo State University- Unesp) from November 2014 to October 2015. Serum hCG levels were measured with both IMMULITE® 2000 XPi and ARCHITECT® i2000 chemiluminescence tests. Serum hCG levels were compared against the null hypothesis. Agreement with clinical management was determined by comparing baseline hCG measures as well as the hCG curves obtained with both assays. Results: Seventy-three patients with GTD were included in the analysis. Of these, 45 had HM and experienced spontaneous remission, while 28 had GTN. There was a perfect (zero difference) agreement in mean hCG levels between IMMULITE® 2000 XPi and ARCHITECT® i2000 when hCG < 100 mUI/mL. For hCG values greater than 100 mUI/mL, there was a significant difference between assays (p < 0.05), with levels measured via ARCHITECT® i2000 being higher than those measured with IMMULITE® 2000 XPi in patients with spontaneous remission (Immulite = 0.79Architect; p < 0.01); R2 = 90%) and GTN (Immulite = 0,51Architect; p < 0,01); R2 = 98%). Baseline test results agreed in all cases (73/73(100%); kappa1;p<0,001] and hCG curve agreement was 98% [71/72(98%); kappa0,93;p<0,001].Conclusion: IMMULITE® has been the assay recommended for diagnosing and monitoring patients with GTD. However, our results suggest that as ARCHITECT® and IMMULITE® show similar performance in measuring hCG levels and determining clinical management, ARCHITECT® may be used an alternative.
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Doença trofoblástica gestacional, Imunoensaios, hCG sérico, Gestational trophoblastic disease, Immunoassays, Serum hCG