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A.Description

The series of products are designed according to the key mutation sites of each mutant strain. Using multiple ARMS fluorescent PCR method, it can realize multiple rapid identification and detection of coronavirus variants in throat swab samples, and simultaneously amplify the conservative sequence N gene of the coronavirus.

B.Intended Use

In order to better identify the mutant strains of the coronavirus and effectively assist in the prevention and control of the epidemic, Bioteke organized the R&D team to develop the new coronavirus mutant detection kit. On the one hand, it can realize the screening of coronavirus infection, on the other hand, it can be used as a monitoring internal standard for mutation detection, which greatly improves the accuracy of sample test results.

C.Advantages

1. Coronavirus universal (N) gene detection + synchronous detection (S) of key mutation sites can simultaneously achieve coronavirus infection screening and mutant identification.

2. High detection sensitivity, up to 500copies/mL; for composite infected persons,it can detect variant strains as low as 0.1% to 0.01%.

3. Strong specificity, no cross-reactions such as non-specific amplification among different mutations.

4. Compatible with Bioteke rapid nucleic acid extraction technology, nucleic acid-free extraction technology and rapid fluorescence quantitative PCR instrument, and the detection results can be obtained within 45 minutes.

D.Testing data

According to the difference of the Ct value of the mutant and wild-type responses, the samples with mutant virus content as low as 0.1% to 0.01% in the heterogeneous infection can be identified.

Figure 1. Test Results of wild and heterotropic mutant (0.01%) samples at concentration 1 × 107copies/ml

Figure 2. Test Results of wild and heterotropic mutant (0.1%) samples at concentration 1 × 107copies/ml

Figure 3 Test Results of mutant samples at concentration 1 × 103copies/mL 

E.Product Qualifications（By Dec.2nd,2022）