Distribution agreement on a global scale on serological tests to detect exposure to COVID-19
06/25/2020
HUMAN Gesellschaft für Biochemica und Diagnostica mbH, signed a distribution agreement on a global scale for antibody related COVID-19 products. The new tests, developed and manufactured by Wantai, will be distributed by HUMAN to health care providers in more than 140 countries of the world.
Delemir Delev, Business Development Manager Wantai: “Partnering with HUMAN helps us to provide the mentioned COVID-19 tests in 140 countries of the world by one partner with long lasting distribution in these countries. Together we will help to identify more people who have developed antibodies against the COVID-19 virus.”
Serological tests are important because many patients show asymptomatic progression of the disease. Typically, such “healthy” patients never receive a molecular test since patients without symptoms do not show up at clinics and the PCR test is not suitable for later stages of the infection.
The characterization of exposure to SARS-CoV-2 is a valuable information about these patients. Serological tests are a must to determine seroprevalence in a given population and to develop strategies for “returning to work”. Along with molecular testing, they can improve the rate of positive contact tracing.
Wantai has developed the tests using S1-RBD, as a coating protein. RDB, the receptor binding domain, is the main target antigen for virus neutralizing antibodies. Wantai's total antibody tests are designed to qualitatively detect all antibody isotypes (IgM, IgA, IgG) against the RDB domain of the S1 protein.
- a total-Ab ELISA and an IgM ELISA, detecting antibodies in blood to confirm current or past exposure to COVID-19.
And
- a total Ab rapid test for the detection of IgM, IgA and IgG antibodies in just 10 µl of blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. The test requires no special equipment and can be used in a laboratory or at the point of care. One drop of capillary or venous blood is sufficient to have the test performed by a healthcare professional.
The test has been clinically evaluated in many countries, including Europe, and shows in a recent publication significantly higher sensitivity than 6 other assays from established manufacturers. The optimal specificity (>98%) was only achieved by the Wantai SARS-CoV-2 Ab ELISA (1). The publication also states that "within 10 days after onset of symptoms only the Wantai SARS-COV-2 Ab ELISA achieves a medially relevant diagnostic significance, as this is the first test for the detection of seroconversion.” Similar data are published by independent universities (2, 3, 4).
The Wantai Elisa tests can be performed on the semi-automatic and automated HUMAN Elisa instruments.
Dr. Björn Breth, Managing Director HUMAN Gesellschaft für Biochemica und Diagnostica mbH : “We look forward to working with such a renowned company as Wantai, which has been known for almost 30 years for its high quality diagnostic products for infectious diseases.”
About HUMAN
For nearly 50 years HUMAN has been serving the healthcare sector. HUMAN’s success is based on three pillars: A broad and constantly growing portfolio of in vitro diagnostic products with Quality Made in Germany, outstanding worldwide available service, support and supply capabilities and a grown culture of partnership with the distribution partners in more than 160 countries. All together HUMAN can be regarded as a global player in the in vitro diagnostics industry.
About Wantai
Beijing Wantai was founded in 1991 and developed from a small laboratory. Beijing Wantai is one of the largest Chinese manufacturers of in vitro diagnostic tests, located at Beijing.
Wantai operates domestic and international diagnostic tests businesses in the fields of human infectious diseases, and screening of blood donors. The customers are blood banks, hospitals and clinics, reference laboratories, border inspection centres, blood-processing companies and research institutes.
References
(1) Herroelen P.H. et. al. Kinetics of the humoral immune response to SARS-CoV-2: comparative analytical performance of seven commercial serology tests. medRxiv June 12, 2020
(2) Corine H. GeurtsvanKessel, et.al. Towards the next phase: evaluation of serological assays for diagnostics and exposure Assessment. medRxiv preprint doi: https://doi.org/10.1101/2020.04.23.20077156, 29. April 2020
(3) Lassaunière, R., Frische, A., Harboe, Z. B., Nielsen, A. C. Y., Fomsgaard, A., Krogfelt, K. A., & Sværke Jørgensen, C. (2020). Evaluation of nine commercial SARS-CoV-2 immunoassays. Manuscript submitted for publication
(4) Juanjuan Zhao, et. al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. 2020. Published by Oxford University Press for the Infectious Diseases Society of America.
