Specifications setting out the performance assessment methods applicable to serological tests detecting anti-SARS-CoV-2 antibodies
➔ The only diagnostic test currently recommended for early diagnosis of COVID-19 is the RT-PCR molecular test used to detect the SARS-CoV-2 coronavirus genome.
➔ Serological tests are not recommended in the context of early diagnosis of COVID-19 infec-tion during the first week following the onset of symptoms.
➔ Serological tests are unable to determine how contagious an individual is.
➔ Serological tests are only able to determine whether an individual has produced antibodies in response to SARS-CoV-2 virus infection.
➔ Antibody production kinetics against the virus remain poorly characterised to date primarily in asymptomatic subjects. The potential period of protection is also poorly elucidated.
➔ It is critically important to be able to validate serological tests based on their initial analytical and clinical performances as of now, prior to their purchase and use in routine practice.
➔ For this reason, the HAS has provided these specifications setting out the quality and require-ment level criteria for all serological tests detecting specific antibodies targeted against SARS-CoV-2 with a view to facilitating their development and assessment.
➔ The minimum threshold values estimated by the HAS are 98% for clinical specificity, and 90% or 95% according to test use for clinical sensitivity.
➔ The HAS recommends obtaining the findings of the performance assessments conducted based on the information contained in these specifications prior to any purchase and use of serological tests.
➔ The strategy of use of these tests will be specified in a future review.
- Place des tests sérologiques rapides (TDR, TROD, autotests) dans la stratégie de prise en charge de la maladie COVID-19 - Rapport d'évaluation technologique
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