Quality
AMDI follows strict regulatory compliance and quality standards to ensure the safety and effectiveness of our products. AMDI's Quality Management System is certified by Intertek to be in compliance with ISO 13485:2016, Medical Devices Quality Management System Requirements.
The Autolab

The Autolab Microfluidic Disc contains chambers and channels where the patient sample is driven by inertial forces to interact with chemical and biological reagents.
The Autolab Instrument contains all of the functions necessary to run the microfluidic disc: a motor spins the disc and acts as an inertial pump, a laser opens up fluidic valves to control flow, thermal elements control different biological and chemical reactions, and a camera takes images of the sample reaction.
Meet the Autolab-20 Neutralizing Antibody Test (A20 NAb Test)*
The Autolab-20 is a portable, rapid diagnostic device that can perform all functions of an immunoassay. The A20 NAb Test measures protective antibodies against SARS-CoV-2 present in a fingerstick of whole blood in less than 15 minutes.
The heart of the A20 NAb Test is a protein microarray embedded in a microfluidic disc. The microarray is printed with recombinant viral antigens that serve as binding probes for human IgG antibodies against SARS-CoV-2 present in a patient sample. This reaction is visualized by developing the microarray with a fluorescent secondary antibody designed to bind to all human IgG antibodies captured on the microarray. The multiplexing nature of the microarray allows antigens against both current and future variants to be printed on the array, keeping pace with the virus as it evolves.
To see the A20 microfluidic disc in action, watch the video below:
Meet the Autolab-30 RT LAMP Test (A30 LAMP)*
The Autolab-30 is a portable, rapid diagnostic device that contains all of the necessary functions to run molecular diagnostic assays and detect infectious pathogens such as SARS-CoV-2. The A30 LAMP test combines whole virus isolation, virion lysis, and monitoring of real-time amplification for detection of SARS-CoV-2.
The A30 microfluidic disc contains a matrix that selectively binds and isolates infectious SARS-CoV-2 virus particles from a patient sample. A combination of chemicals and heat release genomic RNA from the virus. This RNA is then sent through a series of fluidic channels to an amplification chamber, where a loop mediated isothermal amplification (LAMP) reaction produces double stranded DNA.
To see the A30 disc in action, see the video below:
*This product has not been evaluated by the FDA or other regulatory authorities.