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Journal of Clinical Microbiology, October 2007, p. 3184-3190, Vol. 45, No. 10
0095-1137/07/$08.00+0 doi:10.1128/JCM.00789-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.
Evolution of an International External Quality Assurance Model To Support Laboratory Investigation of Streptococcus pneumoniae, Developed for the SIREVA Project in Latin America, from 1993 to 2005
Marguerite Lovgren,1*
James A. Talbot,1,
Maria Cristina Brandileone,2
Silvana T. Casagrande,2
Clara Inés Agudelo,3
Elizabeth Castañeda,3
Mabel Regueira,4
Alejandra Corso,4
Ingrid Heitmann,5
Aurora Maldonado,5
Gabriela Echániz-Avilés,6
Araceli Soto-Noguerón,6
María Hortal,7
Teresa Camou,7
Jean-Marc Gabastou,8
José Luis Di Fabio,8 the SIREVA Study Group,
National Centre for Streptococcus, Edmonton, Alberta, Canada,1 Instituto Adolfo Lutz, São Paulo, Brazil,2 Instituto Nacional de Salud, Bogotá, Colombia,3 Instituto Nacional de Enfermedades Infecciosas ANLIS Carlos Malbrán, Buenos Aires, Argentina,4 Instituto de Salud Pública, Santiago de Chile, Chile,5 Instituto Nacional de Salud Pública, Cuernavaca, Mexico,6 Departamento de Laboratorios de Salud Pública, Montevideo, Uruguay,7 Area of Technology and Health Services Delivery, Unit of Essential Medicines, Vaccines and Health Technology, Pan American Health Organization/ World Health Organization, Washington, DC8
Received 12 April 2007/ Returned for modification 29 May 2007/ Accepted 1 August 2007
In 1993 the Pan American Health Organization initiated a laboratory-based surveillance system, called the SIREVA project, to learn about Streptococcus pneumoniae invasive disease in Latin American children. In 1994, National Laboratories in six countries were trained to perform serotyping and antibiotic susceptibility testing using broth microdilution to determine the MIC for specified antibiotics. An international External Quality Assurance (EQA) program was developed to monitor and support ongoing laboratory performance. The EQA program was coordinated by the National Centre for Streptococcus (NCS), Edmonton, Canada, and included external proficiency testing (EPT) and a validation process requiring regular submission of a sample of isolates from each laboratory to the NCS for verification of the serotype and MIC. In 1999, the EQA program was decentralized to use three of the original laboratories as regional quality control centers to address operational concerns and to accommodate the growth of the laboratory network to more than 20 countries including the Caribbean region. The overall EPT serotyping accuracies for phase I (1993 to 1998) and phase II (1999 to 2005) were 88.0 and 93.8%, respectively; the MIC correlations within ±1 log2 dilution of the expected result were 83.0 and 91.0% and the interpretive category agreements were 89.1 and 95.3%. Overall, the validation process serotyping accuracies for phases I and II were 81.9 and 88.1%, respectively, 80.4 and 90.5% for MIC agreement, and 85.8 and 94.3% for category agreement. These results indicate a high level of testing accuracy in participating National Laboratories and a sustained increase in EQA participation in Latin America and the Caribbean.
* Corresponding author. Mailing address: National Centre for Streptococcus, Rm. 1B3.26 WMC, Provincial Public Health Laboratory, 8440-112 St., Edmonton, T6G 2J2 Alberta, Canada. Phone: (780) 407-8977. Fax: (780) 407-8984. E-mail: m.lovgren{at}provlab.ab.ca
Published ahead of print on 8 August 2007.
Contributing members of the study group are listed in the Acknowledgments.
Present address: Capital Health, Edmonton, Alberta, Canada.
Journal of Clinical Microbiology, October 2007, p. 3184-3190, Vol. 45, No. 10
0095-1137/07/$08.00+0 doi:10.1128/JCM.00789-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.
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