Rapid serological test for the determination of SARS-CoV-2 immunization

COVID-PRESTO®

COVID-PRESTO® is a Rapid Diagnostic Test and a Rapid Diagnostic Orientation Test for the serological diagnosis of COVID-19 IgG and IgM antibodies.

Within 10 minutes, a drop of capillary blood obtained from a fingertip can be used to determine whether a person who has been in contact with the new SARS-CoV-2 virus has developed an immune reaction, which is a priori protective, as is generally the case in coronavirus infections.

COVID-PRESTO® has undergone several evaluations in France, including that of the Centre National de Référence (CNR, Lyon site), which validated it and has since used it in its routine activity.

COVID-PRESTO® meets the eligibility criteria of the Haute Autorité de Santé and is registered on the list of authoritative serological tests by the Ministry of Health.

All evaluations concluded very satisfactory performance for use in mass screening to determine the level of population immunity in asymptomatic individuals or those with symptoms beyond 10 to 20 days*.

COVID-PRESTO® has been monitored since its conception by a Steering Committee made up of French experts in infectious diseases, virology, associations and pharmacy.

Each COVID-PRESTO® batch is controlled by a French reference hospital laboratory (Hôpital La Croix Rousse/HCL, affiliated to the CNR).

COVID-PRESTO® is assembled, packaged and released from ESAT**TECH’AIR in Villiers-le-Bel (95) which employs 140 disabled employees with a view to developing a socially responsible and socially responsible economy.

The box contains all the components to perform 25 tests, i.e.:
– 25 test cassettes
– 1 vial of buffer + 1 backup vial
– 25 safety lancets
– 25 pre-calibrated 10µl pipettes
– 1 user manual

COVID-PRESTO® has been referenced among the suppliers of the central purchasing office of the Ile-de-France region, in order to public-private actors. Its President, Valérie Précresse, announced on May 15, 2020, during her visit to the AAZ manufacturing site, that the Ile-de-France Region had ordered 150,000 COVID-PRESTO® tests in order to offer them to caregivers and vulnerable people in the region.

COVID-PRESTO® has also been chosen by many medical and hospital analysis laboratories (including those of AP-HP) for use as a TDR and by many other communities), EPHAD, pharmacies… with a view to its use as a TROD.
* Variable delay depending on the studies
** Establishment and Service of Help through Work

Demonstration video

Instructions for use

Legal Information

COVID-PRESTO® is intended for the determination of SARS-COV-2 immunization for use by healthcare professionals.

This test is reliable for the detection of IgG and IgM antibodies to the new coronavirus 1 to 3 weeks after the onset of symptoms.

Read the instructions in the package insert carefully.

Manufactured and distributed by : AAZ-LMB 43 rue de Bellevue 92100 Boulogne-Billancourt, FRANCE

This in vitro diagnostic medical device is a regulated health product which, under these regulations, bears the CE mark.