The National Reference Center (CNR) has published the first list of 23 reliable serological tests. They must make it possible to detect antibodies in an individual's blood and thus determine whether he has already contracted the virus in the past. The patient could potentially be protected from future re-infection even if immunity has not yet been proven. The French National Authority for Health recommends that they be intended for French people who have had symptoms lately and who had not been tested, and for people working in nursing homes or closed accommodation, such as barracks. This list should regulate the "market for serological tests". For several days, many French people rushed to the laboratories to carry out these tests, whose price varies between 30 euros and 60 euros. Approved tests can be prescribed by doctors and will now be reimbursed by Social Security. They will also be available for nursing staff from next week. The government should still clarify who the other beneficiaries will be.
There are two types of approved serological tests
The list includes two different types of tests. ELISA tests, on the one hand and Rapid diagnostic tests (TDR) on the other hand. The name ELISA designates tests carried out in laboratories using a blood sample then analyzed using reagents. ELISA works on the reaction between the antigen (contained in the test) and the antibody (in the blood), the combination of which is identified by an enzyme which colors and establishes the result. HAS recommends this type of test to confirm a diagnosis of Covid-19, to conduct epidemiological studies, or to test personnel, even asymptomatic, who work in medico-social institutions or in confined environments (nursing homes, boarding schools, aircraft carriers, etc.).
Rapid diagnostic tests similar to pregnancy tests
Rapid Diagnostic Tests (RDTs) are carried out by taking a drop of blood from the fingertip, then inserted into a device similar to a pregnancy test. The passage of blood through different reagents makes it possible to establish or not the presence of antibodies. The result is available in fifteen minutes. Indicated in the same cases as ELISA, this test has an advantage: cities with only medical biology laboratories without a highly developed technical platform will be able to use it in order to best screen their population.
The tests validated by the National Reference Center (CNR):
ELISA tests
COVID-19 IgG ELISA KAPCOVID19G – DIAsource ImmunoAssays
ELISA SARS-CoV-2 (IgG) – EUROIMMUN
Elecsys Anti-SARS-CoV-2 – ROCHE Diagnostics
NovaLisa SARS-CoV-2 (COVID-19) IgG – NOVATEC Immunodiagnostica
SARS-CoV-2 IgG Architect – Abbott Ireland
VIDAS SARS-COV-2 IgG – bioMérieux
Virotech SARS-CoV-2 IgG (Elisa) – Virotech diagnostics
Rapid screening tests (RDTs)
2019-nCoV IgG / IgM Rapid Test Cassette – BIOMAXIMA
2019-nCoV IgG / IgM detection kit – Nanjing Vazyme Medical technology Co. Ltd (distributed by Clinisciences)
2019-nCoV IgG / IgM detection kit – Nanjing Vazyme Medical technology Co. Ltd (distributed by S&I Equipement)
2019-nCoV IgG / IgM detection kit – Nanjing Vazyme Medical technology Co. Ltd (distributed by MDL medical)
2019-nCoV IgG / IgM detection kit – Nanjing Vazyme Medical technology Co. Ltd (distributed by SAM SARL)
BIOSYNEX COVID-19 BSS IgG / IgM – Biosynex Swiss
Base Point Covid-19 IgG / IgM rapid test device – Guanzhou Wondfo Biotech
COVID-19 IgG / IM rapid test device – Guanzhou Wondfo Biotech
COVID-19 IgG / IgM Rapid Test Cassette – Inzek International Trading
Diagnostic kit for IgM / IgG Ab to SARS-CoV-2 – Zhuhai LIVZON Diagnostics
NG-Tests IgG-IgM Covid -19 – NG-Biotech
SARS-CoV-2 Antibody Test – Guanzhou Wondfo Biotech (distributed by WEMADE)
SARS-CoV-2 Antibody Test – Guanzhou Wondfo Biotech (distributed by Shana Xie)
SARS-CoV-2 Antibody Test – Guanzhou Wondfo Biotech (distributed by Axamed Lab)
Standard Q COVID-19 IgM / IgG Combo Test – SD BIOSENSOR
careUS COVID-19 IgM / IgG – WELLS BIO
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