The kit "CoV-2-dif-O" for qualitative detection of the SARS-CoV-2 coronavirus RNA with differentiation of the B.1.1.529 "Omicron" strain by real-time PCR has been registered
The kit "CoV-2-dif-O" for qualitative detection of the SARS-CoV-2 coronavirus RNA with differentiation of the B.1.1.529 "Omicron" strain by real-time PCR has been registered.
Detection of the coronavirus RNA is performed by real-time reverse transcription polymerase chain reaction and allows for detection of RNA of the genetic variant "Omicron" of SARS-CoV-2 coronavirus, due to the ability to determine the characteristic mutations in the N-gene. Registration of a new test system will allow for monitoring the circulation of the "Omicron" virus variety in order to take the necessary anti-epidemic and clinical measures.
The peculiarity of the new test is that detection of the SARS-CoV-2 coronavirus RNA and differentiation of the Omicron strain proceed in one PCR test tube, which reduces the analysis time and allows to study the maximum number of samples within one test. Various packaging forms make working with the test as convenient as possible for all types of laboratories. Separately, it is worth noting the "Cito" packaging, which makes it possible to perform the assay without RNA isolation. Thus, the time of the assay is 1.5 hours, which significantly increases the laboratory production capacity, reduces the cost of performing the assay, and also reduces the risk of obtaining incorrect results.
Andrey Toropovskiy, CEO of TestGene: "For detection of SARS-CoV-2, a highly conserved fragment of the nucleocapsid protein gene (N) is used. Differentiation of the Omicron variant is based on detection of the characteristic mutation – deletion 31-33 of the N gene. The method is recommended for use with patients with clinical symptoms of a respiratory disease, especially those arriving from epidemiologically disadvantaged regions, as well as contact people".
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