Homogeneity study of the internal quality control sera for immunodiagnosis of HIV/AIDS

• Main Authors: Márcia Jorge Castejon, Rosemeire Yamashiro, Camila Cardoso de Oliveira, José Carlos Olivieri, Carmem Aparecida de Freitas Oliveira, Mirthes Ueda
• Format: Article
• Language: English
• Published: Sociedade Brasileira de Patologia Clínica 2014-02-01
• Series: Jornal Brasileiro de Patologia e Medicina Laboratorial
• Subjects: material de referência; HIV; controle de qualidade; técnicas imunoenzimáticas
• Online Access: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1676-24442014000100046&lng=en&tlng=en

Introduction: The present study reports the data from the first homogeneity assessment of samples composing the serum panels produced at the Immunology Center of Instituto Adolfo Lutz, São Paulo. These samples have been distributed to the public laboratories and those partaking in the Brazilian Unified Health System, and to the participants in the Internal Quality Control Program for human immunodeficiency virus (HIV) antibody (Ab) testing. Objective: To assess the homogeneity of serum samples in panels from different lots for HIV/acquired immunodeficiency syndrome (AIDS) immunodiagnosis by using the statistical method to ensure quality of the reference material. Method: Sera homogeneity was evaluated by means of enzyme-linked immunoassay/enzyme immunoassay (ELISA/EIA) for detection of HIV Ab, and the one-way analysis of variance was employed for analyzing the data. No statistically significant differences were found among the several serum vials. Conclusion: The sera dispensed in the vials were homogeneous in the respective lots.