Protean Ltd. has developed technology for a simple detection of various pathogens and specific DNA and RNA sequences based on isothermal amplification. The technology profits from in-house production of amplification enzymes BstI DNA polymerase and ProRT Reverse Transcriptase and fully complies with CE IVD certification standards. A patent application was filed for the technological solution of this diagnostics.
RT-LAMP (reverse transcription and loop-mediated isothermal amplification) allows amplification of nucleic acids with a high specificity, efficiency and speed under isothermal conditions - ie. at constant temperature, achievable in incubators, hybridization ovens or dry blocks. The results are reliably read based on the color change by naked eye or by mobile device. Graphical analysis software is available upon request. The test includes detection of SARS-CoV2 virus and detection of internal control (IC) for correct sampling and processing.
IVD screening of patient samples for SARS-CoV2 virus. The kit detects two independent parts of ORF1ab gene locus. The sensitivity corresponds to RT-PCR at Ct 35-38 or cca 50 viral particles per sample.
RNA purification required. Compatible with various sampling methods - saliva, gargling, nasopharyngeal swabs, BAL, sputum.
Reagents for 45 test samples. RUO.
Test sensitivity 93% Test specificity 99% Reference kit: Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR kit (3 genes) Liferiver, Shangai ZJ Bio-Tech Co.
Enzymes -20°C. Kit components RT.
Analyte specific reagent (ASR) manufactured under ISO 13485