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Overview: Decombio Technology, Inc. was incorporated in the State of California. They specialise in assembling, packaging and distributing colloidal gold diagnostic instruments in North Americas. Their product received acknowledgment from the U.S. FDA, with permission to distribute.
Test Name: Noval Coronavirus (SARS- COV-2) IgM/IgG Combo Rapid Test
Testing Type: Immunochromatographic Lateral Flow Assay
Technology:
- Take fingertip blood, serum, or plasma
- Pipette the sample and drop one drop of 10 ul into the sample hole.
- Add two drops of sample diluent to the sample hole.
Test Sample Type: Whole blood, serum, or plasma
Time to Result: 20 Minutes
Testing Location: Anywhere
Complementary Products: None – each test includes all the components
Effectiveness: Specificity: 89.72% (IgM or IgG), Sensitivity (current, <10 days): 66.67% (IgM or IgG), Sensitivity (past, >20 days since symptoms): 90.91% (IgM or IgG) – Independently verified by the Covid-19 testing project
Current Status: FDA approved and in the final stages of EUA approval
Business Model: N/A
Organization: Consists of multidisciplinary team of researchers and physicians at UCSF, UC Berkeley, Chan Zuckerberg Biohub, and Innovative Genomics Institute.
Other: Noval Corona Virus (SARS- COV-2) IgM/IgG Combo Rapid Tests were validated by several institutions, including the UCSF’s Marson Lab of Chang and Zuckerberg Foundation.
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