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