Description
This tool can be used to identify COVID-19 positive patients who may have been infected by SARS-CoV-2 variants of concern (VOC), such as the Beta (B.1.351 – South Africa) lineage or Delta (B.1.167.2 – India) lineage.
*Research Use Only
Key Features
Detects key SARS-CoV-2 variants
Individual panels to detect key mutations for identification of key variants of concern and variants of interest identified by the WHO.
Fast results
Can be used for quick identification of COVID-19 positive patients who may be infected by variants of concern or interest before sequencing.
Reliable
performance
High sensitivity and specificity. Limit of detection at 2-3 copies per microliter. Uses N gene as internal control for COVID-19 diagnosis validation
Lab ready
Compatible with current industry-standard RT-PCR instruments and data analysis software without any additional installations.
Quality assured
Manufactured and distributed under ISO13485 quality management system.
SARS-CoV-2 Variants Description
The World Health Organization (WHO) has defined a SARS-CoV-2 isolate as a variant of interest (VOI) if it is phenotypically changed compared to a reference isolate of has a genome with mutations that lead to amino acid changes associated with established or suspected phenotypic implications; AND has been identified to cause community transmission/multiple COVID-19 cases/clusters, or has been detected in multiple countries.
A VOI is further classified as a variant of concern (VOC) if, through a comparative assessment, it has been demonstrated to be associated with:
- Increase in transmissibility of detrimental change in COVID-19 epidemiology;
- Increase in virulence or change in clinical disease presentation; or
- Decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics.
WHO-designated variants of concern (VOCs) and selected variants of interest (VOIs), as of 4 August 2021.
| WHO Label | Pango Lineage | First identified | Mutation Panel Targets | Other spike protein substitutions |
| Delta | B.1.617.2 | India | L452R | D614G, P681R |
| Beta | B.1.351 | South Africa | E484K | D80A, D215G, 241/243del, K417N, N501Y, D614G, A701V |
| Gamma | P.1 | Brazil | E484K | L18F, T20N, P26S, D138Y, R190S, K417T, N501Y, D614G, H655Y, T1027I, V1176F |
| Eta | B.1.525 | Multiple countries | E484K | Q52R, A67V, 69/70del, 144del, D614G, Q677H, F888L |
| Epsilon | B.1.427/B.1.429 | USA, California | L452R | S13I, W152C, D614G |
Ordering Information
| Product | Pack Size | Contents | Catalogue No. |
| CoVClear Mutation Panel Reagent Pack | 200 tests/kit | Reaction Master Mix, Enzyme Mix, Positive Control (WT+N), Negative Control | FGS0032R |
| CoVClear Mutation Panel E484K | 200 tests/kit | Primer-Probe Mix (E484K+N), Positive Control (E484K+N) | FGS0035R |
| CoVClear Mutation Panel L452R | 200 tests/kit | Primer-Probe Mix (L452R+N), Positive Control (L452+N) | FGS0036R |
Research Use Only (RUO).
