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MDBio BCC19 Smartphone COVID-19 RT-LAMP Test Kit for Increased Efficiency and Testing Speed

D3: Catalogue of Resources
Closed

The Detectachem MobileDetect Bio (MDBio) BCC19 Test Kit is an innovative, high efficiency and throughput laboratory test intended for detection of nucleic acids from the 2019-nCoV virus. The test is the latest innovation from DetectaChem, a private manufacturer in Houston, Texas that supplies trace explosive and drug detection platforms to the U.S. Department of Defense, Department of Homeland Security, Department of Justice, State and Local Law Enforcement as well as First Responders around the world.

The MobileDetect Bio BCC19 Test Kit utilizes an isothermal nucleic acid amplification technique wherein DNA amplification is carried out at a constant temperature of 65 °C. The assay/test uses a set of 6 primers and a DNA polymerase with high strand displacement and replication activity. The assay also incorporates a reverse transcriptase (RT) polymerase which creates complimentary cDNA from RNA which is then amplified by the DNA polymerase. These two polymerases work in tandem enabling the detection of viral DNA and RNA in the same reaction. The assay primers are designed to amplify the N portion of the COVID-19 genome. The amplified DNA byproducts have an extra proton making them slightly acidic, and as they accumulate, they drive the pH of the reaction down to the point where the solution changes from pink to yellow, and visible colorimetric detection is possible.

The interpretation and reporting of results with the BCC19 Test Kit is automated through our free MobileDetect smartphone/tablet app currently available globally on Apple and Android app stores. The MobileDetect App automatically analyzes each reaction, and objectively interprets the results as positive or negative for the operator. After analysis, the app automatically generates a PDF result report with time, date, GPS location, test ID, reaction picture and also allows users to add more pictures, custom patient information and notes. The user then can then send this result report via email or SMS to medical care providers. Benefits of this function allow for GPS heat mapping of infection data, geographic concentrations, proactive triaging for hospitals regarding incoming patients, more accurate allocation of medical supplies and more.

Total time required to perform one 8 strip test: 56 minutes:

(7.0 minutes per patient sample)

  1. Specimen collection: 5 minutes
  2. Specimen transport: 5 minutes
  3. Reagent preparation of one 8 strip: 10 minutes
  4. Heat Cycle: 30 minutes
  5. Cool down: 5 minutes
  6. Results interpretation: 1 minute

One instrument can process 120 patient samples, and 8 control samples in an 8-hour work shift by running back to back heat cycles.

834 instruments can process 100,080 patient samples total, and 8 control samples per instrument in an 8-hour work shift by running back to back heat cycles.

Have you validated this method, if so, how and what were the results of the validation?

Internal validation against known COVID-19 Synthetic RNA and Plasmid DNA controls shows repeatable detection of COVID-19 DNA or RNA. Additional CLIA lab testing against active patient samples have provided similar repeatable results. 

How quickly could this be deployed and what are the dependencies?

The MDBio BCC19 Test Kits are currently being manufactured with manageable supply chain dependencies. All components are manufactured in Houston, Texas, or sourced from US providers.

What is the likely production volume?​

Current product capability of 800,000 tests per week, with capability to accommodate up to 3,200,000 tests per week within a month timeframe. DetectaChem currently manufactures similar quantities of explosive and drug testing kits for their globally-deployed detection products.

What are the risks and barriers to using this at scale?

Availability of trained healthcare providers for sample collection, as well as availability of PCR Laboratory Facilities and trained personnel to run the assay. Availability of sampling swabs and availability of universal viral transport media.

Who are you already partnering with on this?

We have partnered with Methodist Hospital System in Houston Texas and the University of Oklahoma Medical Center in Tulsa Oklahoma to validate the BCC19 Test Kits effectiveness on known positive COVID-19 patient samples.   

Commenting is closed

Bev Matthews 4 months ago

Status label added: C: Further assessment

Tom Jordan 3 months ago

This is already in our catalogue of resources so will close this second entry down. Happy to discuss, Tom

Tom Jordan 3 months ago

Status label added: D3: Catalogue of Resources

Status label removed: C: Further assessment

Tom Jordan 3 months ago

Moderation status changed: Closed

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