Consenso de grupo Ad-hoc sobre recomendaciones para la evaluación y controles de calidad para el diagnóstico molecular y serológico de la infección humana por SARS CoV-2

Abstract

We formulate recommendations from a consensus working group on the criteria to evaluate the diagnostic performance (size and criteria of selection of samples to determine sensitivity, analytical specificity, criteria for limit of detection, criteria for gold standard to evaluate serological assays) that should be taken into account during the evaluation and validation/verification of diagnostic tests for SARS CoV-2 infection. A national external quality control program should be established to guarantee the suitability and performance of these diagnostic serological and molecular tests during this pandemic, that will have deep implications for decisions on clinical and public health.

Keywords

• laboratory diagnosis
• sars cov-2
• covid 19
• laboratory quality control