Differential test distinguishing between multiple SARS-CoV-2 lineages includinga novel SARS-CoV-2 variants, i.e. B.1.1.7 (first described in the UK), B.1.351 (first described in South Africa), P.1 (first described in Brazil), B.1.258 (first described in Czech Republic) that are characterized by a higher viral loads and increased transmissibility (i. e., more efficient and rapid transmission), and other SARS-CoV-2 variants (i.e. B.1.1, B.1.160, B.1.170, B.1.177, B.1.258.17). Differentiation of multiple SARS-CoV-2 variants is based on the presence or absence of deletion in NSP6 (NSP6 S106-F108del; internal designation del9) and deletion in the Spike protein (S H69/V70del; internal designation del6). Since B.1.351 and P.1 both share del9 and lack del6, this assay cannot differentiate between the two variants.
Innovative dual TaqMan® probes
Multiplexed version together with RNase P assay as an internal control
SARS-CoV-2 B.1.1.7 full genomic RNA spiked with human RNA used as a positive control
100% clinical accuracy for all tested markers
100% analytical sensitivity with 2 copies/rxn for all targets (SARS-CoV-2 E and RdRP gene, del9 and del6)
Validated on real clinical samples of SARS-CoV-2 lineages B.1.1.7, B.1.351, B.1.258confirmed by sequencing
rTEST COVID-19 qPCR Multivariant kit is a qualitative in vitro confirmatory test designed to detect the presence of SARS-CoV-2 genetic material in biological samples obtained primarily from the human upper airways (nose and nasopharynx). This kit allows the differentiation of multiple SARS-CoV-2 variants based on the presence or absence of 9-base pair deletion in NSP6 that is translated from Orf1 (NSP6 S106-F108del; del9) and 6-base pair deletion in the Spike protein (S H69/V70del; del6).
The kit contains two mixes of primers and hydrolysis probes (TaqMan®) targeting either SARS-CoV-2 specific E and RdRP genes or del9 and del6 whose presence determines the SARS-CoV-2 variants. Both mixes allow the detection of the human RNase P gene. The TaqMan® probes for E gene and del9 are conjugated to Yakima Yellow, the TaqMan® probes for RdRP gene and del6 are conjugated to FAM and the TaqMan® probe for RNase P is conjugated to Cy5. This enables multiplexed detection of either the SARS-CoV-2 E and RdRP gene or del9, del6, and human RNase P, which serves as an internal control to validate proper sample collection, RNA extraction, and performance of the test. The 5X One-step Probe CoV Mix (ROX) reagent includes ROX passive reference dye as an inert additive providing a constant fluorescent signal for sample normalization in the real-time PCR assay. Due to the unique molecular structure of the supplied ROX dye, the solution is compatible with all ROX-dependent (both high-ROX and low-ROX) and ROX-independent real-time PCR cyclers.
The kit is intended exclusively for use in a diagnostic laboratory with the appropriate equipment, safety standards and properly trained personnel. One package of the kit is sufficient for 400 testing reactions and is intended for the characterization of multiple variants of SARS-CoV-2 in patient samples that previously tested SARS-CoV-2 positive in the primary test. It is mandatory to run two parallel reactions to detect standard E and RdRP gene in one reaction and del9 and del6 in another one.
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