Ad-hoc group consensus recommendations on the evaluation and quality control of molecular and serological diagnostics tests for SARS CoV-2 human infection*

A consensus working group formulates recommendations 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 considered 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 on clinical and public health decisions.