FDA greenlights Healthineers’s Covid-19 antibody test

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The last few days have seen the FDA grant emergency authorisation to four novel Covid-19 tests, two of which are for Siemens Healthineers’ total antibody test. One of the test’s EUAs permits it to be run on the Atellica immunoassay analyser, which can run up to 440 tests per hour and return a result in 10 minutes, the German group says; the other covers the test when it is run on the Advia Centaur range of systems. Healthineers’ claims for the accuracy of these tests are on a par with those made by Roche and Abbott for their respective antibody tests. Healthineers has already shipped a million tests and says it has capacity to produce more than 50 million per month. Of these three groups Abbott was first to market with the launch of its antibody test on April 15, giving it a six-week advantage over Healthineers. Separately, the FDA bestowed an EUA on another home-use kit for detecting nucleic acid from the coronavirus in self-collected nasal swab specimens. The LetsGetChecked kit, sold by Privapath Diagnostics, offers results within 24 hours.

Accuracy figures for selected Covid-19 antibody tests sold in the US
Company Test name Date of US EUA EU status Sensitivity or PPA (%) Specificity or NPA (%)
Siemens Healthineers Atellica IM Sars-CoV-2 Total (COV2T) May 29 CE marked 100* 99.8
Siemens Healthineers Advia Centaur Sars-CoV-2 Total (COV2T) May 29 CE marked 100* 99.8
Roche Elecsys anti-Sars-CoV-2 antibody test May 2 CE marked 100* 99.8
Abbott Laboratories Abbott Sars-CoV-2 IgG test Apr 26 CE marked 100** 99.5
*at >14 days post PCR confirmation of disease. **at >14 days post symptom onset. Source: FDA.

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