96.9%
SENSITIVITY
SENSITIVITY
SPECIFICITY
Combined
Whole Blood
Accurate test results in 10 minutes
Only two steps to operate
1 Kit tests IgM & IgG antibodies
Avoid false negative rates of RT-PCR test
Fingertip blood sample can minimize infection risk
Real-time & on-site spot test, no need for laboratory conditions
QUICK FACTS THAT SET US APART
Center for Molecular Biology of Heidelberg University (ZMBH), Heidelberg, Germany.
Department of Infectious Diseases, Virology, Heidelberg University Hospital, Heidelberg, Germany.
Department of Infectious Diseases, Division of Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
German Cancer Research Center (DKFZ), Heidelberg, Germany.
DKFZ-ZMBH Alliance, Heidelberg, Germany.
Denzler et.al “Among the 32 investigated AgPOCTs, we identified four reliably well performing AgPOCTs, which detected the Ct28 sample (~1.7*10⁵ copies/ ml) as SARS-CoV-2 positive in all replicates (Group I). Watmind “represents the test winner in our study and is also among the best three AgPOCTs out of 122 tested products with a sensitivity of 82 % in samples with Ct values ranging from 17 to 35 corresponding to viral loads of >10⁸ to 10³ SARS-CoV-2 genome copies per ml (Scheiblauer et al., 2021).”
On March 16, 2020, the FDA updated its “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
Under the announced FDA policy, upon filing our submittal on March 27, 2020 (See Confirmation Here) we are authorized to market and distribute COVID-19 IgM / IgG Rapid Test kits to any licensed healthcare practitioner in the United States for diagnostic use. While the policy does not apply to at-home testing, the policy does allow testing in laboratories or by healthcare workers at the point-of-care.
In summary, WatMIND has the highest combined IgG/IgM sensitivity and specificity scores presented to the NMPA to date, diagnostic kits and devices are currently being sold in Europe (CE mark) and many other countries.
We are available to discuss any further questions, and Watmind USA has the full direct-to-factory support from Shenzen Watmind Medical Technology Co., the developer and supplier of this technology. We are fully authorized by WatMIND to distribute the testing platform in territories including North America, the UK and the Middle East.