Watmind USA sells its products globally. Within the US, we are currently authorized to sell only to High Complexity CLIA laboratories overseeing Governmental Agencies, Hospitals, Point Of Care, and Licensed Medical Professionals.
SARS-COV2
COVID-19
IgG 97.35% Sensitivity
IgG 97.81% Specificity
IgM 99.12% Sensitivity
IgM 98.54% Specificity
Whole blood test results from our Disposable Test Kit (DTK)
CE & FDA REGISTERED
M2 & M5 QUANTITATIVE SEROLOGY MACHINES
The portable rapid M2/M5 quantitative serology machine allows us to protect critical infrastructure in a mobile environment by providing real-time quantitative readout in 15 minutes on a subject’s exact exposure history. This allows us to track down exposed contacts accurately thus preventing work site viral contamination and assessing infectious risk and immunity of the subject. This is for critical Federal work environments such as Armed Services, First Responders, Governmental Agencies, Energy, Power, Engineering, IT, Healthcare, Public Health, Water, Transportation, Telecommunications, etc.
M2 & M5 MICROFLUIDIC REAGENT CHIP
OUR SARS-COV2 TEST ADVANTAGES
(Supporting clinical, scientific, and laboratory raw data available upon request)
RAPID DISPOSABLE TEST KITS (DTK'S)
Accurate test results in 10 minutes
EASY
Only two steps to operate
PRACTICAL
1 Kit tests IgM & IgG antibodies
ACCURATE
Avoid false negative rates of RT-PCR test
SAFE
Fingertip blood sample can minimize infection risk
CONVENIENT
Real-time & on-site spot test, no need for laboratory conditions
IgG & IgM Ab are recommended by US FDA guidelines for COVID-19
According to global clinical experience, there is a high rate of false negatives using nucleic acid RT-PCR tests. In order to reduce misdiagnosis, these tests are in most global clinical guidelines for COVID-19 Diagnosis & Treatment.
WATMIND USA COVID-19 TEST RESULT INTERPRETATION
WHO WE ARE
Watmind USA is the exclusive licensed distributor of Shenzen Watmind Medical Technology Co, LTD. For over 6 years, Watmind has been a global leader in microfluidic chemiluminescent technology and associated serology systems.
Based in California, Watmind USA has a dedicated team of professional healthcare experts in the fields of genomic science, biology and medical device sales.
Our Watmind USA group has decades of international experience in information technologies, regulatory & compliance, research & development, pharmaceutical, medical device, public health, government relations, hospital and laboratory management.
At Watmind USA, we are proud to be offering the best in class solutions during this time of public health crisis.
THE WatMIND USA COVID-19 CONTAINMENT PROTOCOL©
Our medical team has developed the following suggested protocol utilizing our Test Kits & Machine system to best contain the SARS-COV2 virus. This suggested protocol is subject to change pending data and suggestions from our licensed healthcare professionals.
WATMIND USA COVID-19 COMPLIANCE
WatMIND USA has registered our company and products with the FDA.
Additional FDA Information
On March 16, 2020, the FDA updated its “Policy for Diagnostic Tests for Coronavirus Disease-2019″ during the Public Health Emergency. (document download)
On March 26, WatMIND USA received its submittal confirmation from the FDA. Under the announced FDA policy, upon filing its submittal, WatMIND USA was authorized to market and distribute “WatMIND USA COVID-19 IgM / IgG Rapid Test Kits” to any licensed healthcare practitioner in the United States for diagnostic use while it awaits a final decision on its FDA EUA application. 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.
This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43 or 229E.
*Note (This site is for promotional and informational purposes only. Please contact WatMIND USA for more detailed information on our tests’ performance characteristics and their on-going evaluation by healthcare experts addressing the COVID-19 emergency.)
