Project Proposal for Monitoring the Quality of Diagnosis in the Dengue

Laboratory Network of the Americas: Adjustments and Modifications

Dr. Mariana LeoneRegional Dengue Program

PAHO/WHO WDC

Operational Methodology

• The EQA program will be implemented in four phases:– Phase I: Project analysis– Phase II: Proficiency testing of the PAHO/WHO-CC– Phase III: Development and distribution of

proficiency tests for RELDA participating laboratories

– Phase IV: Global analysis of the results, publication, recommendations, and evalutation for the continuity and sustainability of the program

Phase I: Project Analysis

• Samples:– Who will prepare the samples?

• The samples should be prepared by one laboratory, and they should then distribute the samples to the rest

– Will the samples be tested first?• Yes, a pre-phase of proficiency testing should be performed

– Apart from dengue virus, what other viruses or conditions will the samples contain?• Some of the samples will have other conditions or viruses

(autoimmune disease, presence of other arboviruses)• Amount of sample needed to run NS1, PCR, and serological tests

Phase I: Project Analysis

• Samples:– How will these sample panels be shipped?

• Special media requirements (dry ice, refrigeration, etc)• Special shipping requirements in regards to safety and

prevention of possible contamination (for specimens that are BSL3 vs BSL4)

• Permit requirements for shipping to different countries, and for customs

• It will be important to assign this responsibility to one individual

– Number of sample panels distributed

Phase II and Phase III

• Laboratory Techniques– NS1, PCR, and serologic methods will be

performed on the samples• Consolidation of the results and analysis– Should be performed by trained biostastician

Phase IV

• Development of follow up plans addressing these possible problems – 1.- Pre-testing: specimen compromised during

preparation, transport, or after receipt by improper storage or handling

– 2.- Testing: reagents, test methods, quality control, competency of staff

– 3.- Post-testing: report format, interpretation

Bibliography

1.- Domingo C, Alves M, de Ory F, Teichmann A, Schmitz H, Müller R et al. International external quality control assessment for the serological diagnosis of dengue infections. BMC Infect Dis. 2015;15(1).2.- Domingo C, Niedrig M, Teichmann A, Kaiser M, Rumer L, Jarman R et al. 2nd International External Quality Control Assessment for the Molecular Diagnosis of Dengue Infections. PLoS Negl Trop Dis. 2010;4(10):e833.3.- Donoso Mantke O. Quality control assessment for the serological diagnosis of dengue virus infections. Journal of Clinical Virology. 2004;29(2):105-112.4.- Guzmán M, Pelegrino J, Pumariega T, Vázquez S, González L, Kourí G et al. Control externo de la calidad del diagnóstico serológico del dengue en laboratorios de países de las Américas, 1996-2001. Rev Panam Salud Publica. 2003;14(6).5.- Pok K, Squires R, Tan L, Takasaki T, Abubakar S, Hasebe F et al. First round of external quality assessment of dengue diagnostics in the WHO Western Pacific Region, 2013. Western Pacific Surveillance and Response Journal. 2015;6(2):73-81.

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