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

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

Jorge E. Gomez Marin

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

2020

laboratory diagnosis, covid-19, SARS-CoV-2, laboratory quality control

10.22354/in.v24i3.868

Infectio

Asociación Colombiana de Infectología

Infectious and parasitic diseases, Therapeutics. Pharmacology