Vela Operations Singapore Pte Ltd

(Co Reg No. 201106974H)

50 Science Park Road
#05-07, The Kendall
Singapore 117406
Phone: +65 6672 6060
Fax: +65 6672 6066
Web: www.veladx.com

29 Nov 2021 Memo-21-124a

ViroKey® SARS-CoV-2 RT-PCR Test v2.0 detects SARS-CoV-2 variants

We evaluated the performance of the ViroKey® SARS-CoV-2 RT-PCR Test v2.0 for Taqman
primer/probe reactivity with SARS-CoV-2 Variants of Concern (VOC) by in silico analysis. The ViroKey®
SARS-CoV-2 RT-PCR Test v2.0 is able to detect the first four VOC strains below for both targets (Orf1a
and N genes) with no nucleotide mismatch, thus the mutations of these variants are unlikely to impact
the performance of the ViroKey® SARS-CoV-2 RT-PCR Test v2.0.

Earliest documented
No WHO label Pango lineage GISAID clade/ lineage
samples
1 Alpha B.1.1.7 GRY (formerly GR/501Y.V1) UK

2 Beta B.1.351 20H/501Y.V2 South Africa

3 Gamma P.1 20J/501Y.V3 Brazil

4 Delta B.1.617.2 G/452R.V3 India

5 Omicron B.1.1.529 GR/484A Multiple countries

The recently classified Omicron VOC harbours a large number of the mutations, and one of which is a
stretch of nine (9) nucleotide deletion at the 3’ end of the N gene probe. This likely affects the detection
of the N gene by the ViroKey® SARS-CoV-2 RT-PCR Test v2.0. However, as the ViroKey® SARS-CoV-2
RT-PCR Test v2.0 is a dual-target design and as the detection of the ORF1a in Omicron VOC is not
affected, its overall sensitivity should not be impacted. Likely, if sample with Omicron VOC is tested with
the ViroKey® SARS-CoV-2 RT-PCR Test v2.0, it will be detected by ORF1a, while likely N gene will not
be detected. This result signature may indicate the presence of the N gene mutation and, potentially, the
Omicron VOC. Sequencing may be performed on such sample to confirm the presence of the Omicron
VOC.

Additionally, we also performed the same evaluation for SARS-CoV-2 variants in the table below. For the
Eta variant, there is one (1) nucleotide mismatch in the forward primer of the N gene. The probe and
reverse primer, as well as ORF1a target showed no mismatch. Allowing for 1 nucleotide mismatch in just
one of the primer/probe for N gene, the ViroKey® SARS-CoV-2 RT-PCR Test v2.0 is able to amplify the
Eta variant. For the remaining variants, no nucleotide mismatch was observed for both targets (Orf1a
and N genes), thus the mutations of these variants are unlikely to impact the performance of the
ViroKey® SARS-CoV-2 RT-PCR Test v2.0.
Page 1 of 2
 Vela Operations Singapore Pte Ltd
(Co Reg No. 201106974H)
50 Science Park Road
#05-07, The Kendall
Singapore 117406
Phone: +65 6672 6060
Fax: +65 6672 6066
Web: www.veladx.com

Earliest documented
No WHO label Pango lineage GISAID clade/ lineage
samples
1 Eta B.1.525 G/484K.V3 Multiple countries

2 Iota B.1.526 GH/253G.V1 USA

3 Kappa B.1.617.1 G/452R.V3 India

4 Lambda C.37 GR/452Q.V1 Peru

5 Mu B.1.621 GH Colombia

Thank you.

Yours sincerely,

Boon King Teh

Head, Quality Assurance & Regulatory Affairs

Page 2 of 2