COVID19 Lateral Flow Kits and Fluorescent Immunoassay Tests

96.9%

SENSITIVITY

97.4%

SPECIFICITY

IgG & IgM

Combined

Whole Blood

QUICK FACTS THAT SET US APART

• We hand selected the technology that presented the best clinical data to the China FDA (NMPA) as well as decades of government investment and R & D, which presides over the territory where the COVID-19 pandemic emerged, and where all companies went first for approval for their COVID19 testing solutions. This insight is irreplaceable and the Watmind system was developed for the purpose of point of need laboratory testing which was not a focus of the USA until the pandemic occurred. We currently conduct all clinical research in the USA. 

• Purchased products can be delivered to your address within 21 days upon purchase order execution for freshly manufactured Microfluidic Reagent Chips (Bio-Chips) and M2 and M5 Portable Analyzers. 

• For first orders, we can discuss a US-based escrow to allow release of funds upon receipt of product to ease any concerns. After the first order, we will require payment in full upon purchase order receipt to start the manufacturing process due to our parent companies cost of goods and production.

• We have donated thousands of Disposable Test Kits and Microfluidic Reagent Chips (Bio-Chips aka Laboratories on a Chip) to various institutions nationally as well as the M2 and M5 Analyzers for validation and peer reviewed trials assessing protocols to segregate COVID19 both at-risk populations and high risk, essential, & elective workforce  to establish deployable COVID-19 containment protocols using our integrated Serology systems as the first line of detection and maintenance.

• These ongoing data are showing the unique capability of the Watmind system to prevent on-site COVID19 exposure and outbreaks in real world trials. RT-PCR does not work for Surveillance as it detects the virus after it becomes infectious. Watmind can detect the virus in the blood during the incubation period prior to the subjects conversion to being infectious. This is very unique to this technology and defines the essential requirement for true surveillance.

• We are willing to engage with academic institutions or non-profit organizations to assist with validation or protocol design or grants applications and other research applications such as vaccine development and monitoring. 

COMPLIANCE:

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.