SARS-CoV-2 Mutation Panel

Intended Use:

The kit is only used for in vitro diagnosis by professionals in BSL-2 laboratories. It is used for rapid identification of SARS-CoV-2 variant Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2) and B.1.617.1 / B.1.617.3 and qualitative detection of SARS-CoV-2 in samples including nasopharyngeal swab, oropharyngeal swab, saliva, bronchoalveolar lavage fluid and sputum.

Principle of the Procedures:

The kit used one-step reverse transcription polymerase chain reaction (One-step RT-PCR) combined with “multicolor probe melting curve analysis” (MMCA®) technique to simultaneously detect ten characteristic mutation sites of the four variants.All mutation sites included in each variant are tabulated as below. The detection results were determined according to the Tm value of the ten mutation sites.

Instument:

The kit can be operated by the real-time PCR thermal cycler with FAM, HEX, ROX and CY5 channels. Among them, SLAN 96S, SLAN 96P, SLAN 48P is highly recommended. ABI QuantStudio™ series, MA-6000, LightCycler 480 and Bio-Rad CFX96 need to be tested prior to use.

The kit has obtained CE certificate. The kit is applying for Chinese export white list and can be exported as RUO(Research Use Only).