Dec. 14th, 2020, UK reported a new variant strain of SARS-CoV-2 (known as 20B/501Y.V1, VOC 202012/01, or B.1.1.7 lineage) to WHO which emerged with an unusually large number of mutations. This variant has since been detected in numerous countries around the world, including the United States (US) and Canada. According to the new research from the Department of Health of UK, based on the data of whole genome sequencing, epidemiology and modeling, the infectiousness of variant strain of SARS-CoV-2 is almost 40-70% higher than other discoverable modification scientist recognized.

This variant of B.1.1.7 has been detected in China after UK reported, so rapid response and detection is one of the vital prevention and control measure. Till this report, there are 14 Chinese IVD enterprise successfully developed the B.1.1.7 testing kits as follows:

Sansure Biotech Inc. 

Booth No. of CACLP 2021: N7-T002

The reagent produced by Sansure used the major mutation site in S gene to test N501Y which will enhance the affinity and might cause the escaping of HV 69/70 deletion occurred in human immunity.

Guangdong Hybribio

Booth No. of CACLP 2021: N5-T008

Currently, the independent researched nucleic acid testing kit (PCR method) produced by Hybribio is designed for the suspected infection by 2019-nCoV that may induce severe coronavirus pneumonia (CNP) by using the targeting genes of ORFlab and N targeting genes, with B2M gene as internal control.

Shanghai BioGerm Medical Technology Co., Ltd.

Booth No. of CACLP 2021: N5-T034

The 2019-nCoV Nucleic Acid Detection Kit produced by BioGerm increased the typing result based on original product utilizing the principle of ARMS-PCR to test SNP aiming for B.1.1.7 of the spike protein at position N501Y and 69-70del designed the primer probe to produce the Fluorescence amplification signal on target, to produce the non- Fluorescence amplification signal on wild type target then realizing the differential diagnosis on wild type strain and Mutant virus strain.

Shanghai GeneoDx Bio

Booth No. of CACLP 2021: N3-S016

The reagent of SARS-CoV-2 produced by GeneoDx is designed for inducing severe coronavirus pneumonia (CNP) by using the targeting genes of ORFlab and N targeting genes to detect RNA exist on mutation strain. It adopted PCR（allele-specific PCR，ASPCR）to realizing the differential diagnosis on wild strain and mutant type (501Y).

Jiangsu Macro micro-test Medical Technology Co., Ltd.

Booth No. of CACLP 2021: N5-H252

The reagent of SARS-CoV-2 produced by Macro Micro-test Medical can diagnose the N501Y and P681H for B.1.1.7.

BGI Group Guangdong

Booth No. of CACLP 2021:

Beijing BGI-GBI Biotech Co., Ltd.: N1-T021

Beijing BGI Patho-Genesis Co., Ltd.: N3-T053

BGI Patho-Genesis used the method of ARMS-qPCR designed the special amplification combined the fluorescent probe signal regarding to B.1.1.7 on N501Y to rapidly identify the wild and mutant strain.

Xiamen Zeesan Biotech Co., Ltd.

Booth No. of CACLP 2021: N5-T010

Combined with Engineering Research Center for molecular diagnostics, Ministry of education, Xiamen University, Zeesan Bio used the independent PI of MMCA? technology produced the SARS-CoV-2 kits on B.1.1.7 lineage which supplied 2 kinds of diagnosis solution, AIO and batch testing scheme for real-time or huge number of screening.

Ustar Biotechnologies

Booth No. of CACLP 2021: N3-T029

Based on the POCT nucleic acid AIO analyzer with independent patent, Ustar operated the CPA isothermal amplification real-time fluorescence method. Each detecting tube has 2 independent reaction chambers, one chamber is for special amplification and target sequence on ORFlab and N gene, the other is for detecting the deficiency of high infectious of B.1.1.7 lineage of N501Y and HV 69-70. The product performed the whole process of nucleic acid extraction and amplification in closed chamber.

Zybio Inc.

Booth No. of CACLP 2021: N8-T007

The reagent produced by Zybio used the major mutation site in S gene to test N501Y which will enhance the affinity and might cause the escaping of HV 69/70 deletion occurred in human immunity.

Zhejiang Orient Gene Biotech Co., Ltd.

Booth No. of CACLP 2021: N5-T035

The SARS-CoV-2 testing kit produced by Orient Gene Bio is designed for detecting the deficiency of high infectious of B.1.1.7 lineage of N501Y and HV 69-70 with PCR method. And the 2 mutant detecting kits of K417N and E484K can identify the mutation strain of variant from South Africa. Both kinds of the kits can be used on gross of the PCR analyzer.

Jiangsu Bioperfectus Technologies Co., Ltd.

Booth No. of CACLP 2021: N7-T033

Adopting the principle of ARMS to select the mutant position on S gene to detect the N501Y which will enhance the affinity. COVID-19 Coronavirus Real Time PCR Kit is an In Vitro Diagnostic (IVD) reagent applying on fluorescent PCR technology and aiming at qualitatively detect Open Reading Frame gene region (ORF1a/b) and viral nucleocapsid region (N) of SARS-CoV-2 RNA from upper and lower respiratory tract specimens. 

Guangzhou Wondfo Biotech Co., Ltd.

Booth No. of CACLP 2021: N8-T003

The reagent produced by Wondfo used the major mutation site in S gene to test N501Y which will enhance the affinity and might cause the escaping of HV 69/70 deletion.

Maccura Biotechnology Co., Ltd.

Booth No. of CACLP 2021: N8-T014

The reagent kit researched by Maccura is designed for the detection of ORFlab and N targeting genes of 2019-nCoV, also identification of N501Y which will enhance the affinity on S gene. The kit applies the principle of TT-ARMS (Tagged-Tail ARMS) to detect the mutation of N501Y on S gene is suitable for major variation region on S gene which needs 2 primers to specific binding with target without extra specific probe.

Vipotion Bio

The reagent produced by Vipotion used the major mutation site in S gene to test N501Y which will enhance the affinity and might cause the escaping of HV 69/70 deletion occurred in human immunity to detect the deficiency of high infectious of B.1.1.7 lineage.