COVID-19 PCR Testing Kit

  • RT-LAMP technology with comparable results to laboratory standard RT-PCR.
  • Only detects inconclusive or non-negative COVID-19 infections even if still asymptomatic.
  • Only test kit to achieve 100% accuracy on FDA EUA submission testing. Report available.
  • Uses commonly available nasal or oral swab.
  • Run 8 to 96 tests at once in single 30 min cycle.
  • Simple, easy-to-determine Yellow Non-negative or Red Negative results.
  • FREE app for results with time, date, location, patient info, pics and more. Send PDF reports via email or text. (app use not required)
  • 1. Collect Sample

  • 2. Prepare Test

    2. Prepare Test

  • 3. Run Test

  • 4. Analyze Results

    4. Analyze Results

How It Works

The MD-Bio BCC19 Test utilizes a loop mediated isothermal amplification polymerase reaction (LAMP) test intended for the detection of SAR-CoV-2 viral RNA. The test uses a set of specific primers designed to uniquely detect SARS-CoV-2 RNA. The MD-Bio BCC19 Test 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 primers, and a DNA polymerase with high strand displacement and replication activity. The assay primers are targeting the SARS-CoV-2 N and E gene.

Also incorporated is a reverse transcriptase (RT) polymerase, which creates complimentary cDNA from RNA, and is in turn amplified by the DNA polymerase. These two polymerases work in tandem enabling the detection of viral DNA and RNA in the same reaction. The amplified DNA byproducts drive the pH of the reaction down to the point where it pushes the pH sensitive dyes to turn yellow, from their starting red color. Reactions displaying a visual color shift indicate that the target sequence is present.

*CLIA lab required for FDA-EUA moderate or high complexity

Ideal For:

  • Hospitals/Medical Facilities
  • Health Departments
  • Forensic Labs
  • Military
  • Prisons
  • Remote Operations
  • Airports
  • Sporting Arenas
  • Border/Screening Checkpoints
  • State or Local Agencies
  • Government Entities
  • Many More…