New: Medicovid SARS-CoV-2 IgG/IgM rapid antibody test

04.03.2021

For validation purposes, in the first six months of 2020 a total of 943 tests were undertaken: on 566 patients with Covid-19 with a positive PCR test for coronavirus or antibodies detected in the laboratory and with 377 subjects with a negative PCR test. In addition, 513 suspected cases of Covid-19 were examined in Wuhan and 430 in Europe - 252 patients from Paris (France) and 178 from Germany and Poland (Cologne/Neuss, Münster, Munich, Freiburg, Wrocław). The French study was supervised and validated by the Pasteur Institute, Paris and the results were published separately, because the test proved to be the best qualitatively when compared with other rapid tests. The American FDA has also validated the rapid tests and regularly publishes the results of tests with inadequate quality [1]. Medicovid is not listed here.


The test is manufactured by Xiamen Biotime Biotechnology Co Inc. (Fuijan, CN) and marketed by Medice in the EU (package with 10 test kits, PZN 16759193; package with 25 test kits, PZN 16652319) and is available to medical and healthcare specialists; it allows a rapid diagnosis at the point of care, showing whether the individual examined had already been infected with Covid-19 and has acquired immune status and so constitutes a component of the 3rd pillar of pandemic management consisting of containment, mitigation and immunization. Even so, many of those affected in the first six months of 2020 were not given a PCR test in the given time window because test capacities were unavailable and since that time they are unsure if they have had Covid-19[2]. Also, epidemiological issues such as the prevalence of pandemic infection in the population are still unclear [3] and only investigated in scientific, regionally restricted studies, for example in Madrid on behalf of the Spanish Ministry of Health - also with this test [3].


Administration of the Medicovid test is really simple, and yet certification requires it to be carried out by medical professionals:


One drop of blood (10 uL), whole blood obtained from a vein or serum is applied to a test strip in opening S. Immediately afterwards, 2 drops of buffer solution are applied on the test strip into opening D. After circa 10 to 15 minutes, the bands can be read on the test strip. C shows the positive control and is the indicator and controlling condition demonstrating that the test is valid. A band at M shows, starting with a concentration of 50ng/ml, that IgM is present as an acute antibody and is evidence of early-stage infection (circa 10±5 days). A band at G is visible from an IgG antibody concentration of 20ng/ml and greater and so, combined with IgM, confirms a later stage in the infection (>14 days) or, with only IgG, confirms an infection from some weeks previously.


With the attached certificate on the immune status of tested individuals, patients receive an easy-to-understand summary of their results which can be presented if necessary to a retirement home or at events.


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[1] Zertifizierung erfolgte von SGS-Institut von Fresenius Labormedizin, das auch die ISO-Zertifizierung durchführte (report SGS/CN/SZX-IT18171-07/001, 7 March 2020). The test is listed at https://ec.europa.eu/docsroom/documents/40805?locale=de and https://www.finddx.org/covid-19/pipeline/?section=show-all


[2] Medicovid EU trial 2020, paper in submission


[3] Coronavirus in Spain (14 May 2020): https://english.elpais.com/society/2020-05-14/antibody-study-shows-just-5-of-spaniards-have-contracted-the-coronavirus.html


[4] List of tests not recommended, held by the American Food and Drug Administration (FDA) https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#nolonger


[5] Robert Koch Institute (RKI) statement, Prof. Drosten (Berlin): PCR testing given unmistakable symptoms or risk groups (20 March 2020) https://www.pharmazeutische-zeitung.de/coronavirus-tests-gezielter-einsetzen-116406


[6] Prof. Drosten, Director of the Virological Institute at the Charité (Berlin, 29 March 2020) in https://www.watson.de/deutschland/coronavirus/444975360-virologe-neue-tests-sollen-zeigen-ob-ihr-immun-gegen-corona-seid