Declaration

Date : December 1st, 2021

Dear Sir or Madam

We, PCL Inc., located at 701 Star Valley 99 Digital-ro 9-gil, Geumcheon-gu Seoul 08510,
Rep. of Korea, as the legal manufacturer of the PCL COVID-19 Ag detection kits1, hereby declare
as follows;

In Silico Analysis2 Results:

As PCL COVID-19 Ag detection kits are designed to detect the nucleocapsid (N) protein of SARS-
COV-2, in-silico analysis was performed to confirm that SARS-COV-2 variants recited in Table 1
as below have no effect on the diagnostic performance of our product.

[Table 1]

SARS-COV-2 variants
Alpha B.1.1.7 Epsilon B.1.427, B.1.429
Beta B.1.351 Eta B.1.525
Gamma P.1 Iota B.1.526
Delta B.1.617.2 , B.1.617.3 Theta P.3
Kappa B.1.617.1 Zeta P.2
Delta Plus AY.1, AY.2, AY.3 Lambda – C.37
Omicron B.1.1.529

Nucleocapsid (N) protein of SARS-CoV-2 consists a total of 5 domains: N-terminal domain (NTD),
RNA-binding domain (RBD), disordered central linker (LINK), dimerization domain, and C-
terminal domain (CTD) as shown in the figure below.

1
PCL COVID-19 Ag detection kits are referred to either [COV04S] PCL COVID19 Ag Gold or [COV05] PCL COVID19 Ag
Rapid FIA in herewith.

2
NCBI database (https://www.ncbi.nlm.nih.gov/labs/virus/vssi/#/), GenBank (http://www.ncbi.nlm.nih.gov/genbank/), PANGO
Lineages: Latest epidemiological lineages of SARS-CoV-2 (https://cov-lineages.org/index.html), Outbreak.info
(https://outbreak.info/) are refereed to investigate.

Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Korea
PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com
The following is the SARS-CoV-2 isolate information (reference isolate Wuhan-Hu-1; Accession
number: NC_045512.2) acquired from the NCBI database and GenBank, which includes the SARS-
Cov-2 variants of Table 1. Mutation sites were compared with multi-alignment of the N protein
sequences of each variant, and the variations are recited specifically.

Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Korea
PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com
The following reference is an analysis of N protein tertiary structure, confirming that amino acid
mutations from N protein falls under the N-terminal domain (NTD) or linker region, which does not
interfere the binding with ACE2 (Angiotensin-converting enzyme 2) and do not affect its tertiary
structural changes.

S protein mutations in the variants are known to affect the receptor-binding domain (RBD) of SARS-
CoV-2 binding with ACE2 (Angiotensin-converting engine2). Meanwhile, N protein mutations does
not affect with ACE2 binding of SARS-CoV-2, because the mutations primarily occur in the N-
terminal domain (NTD) or linker region.

It is known that the N antigen remains conserved among these variants. Our in-silico analysis
confirms that N protein mutations of the SARS-Cov-2 variants of Table 1 do not affect detecting the
nucleocapsid (N) protein of SARS-CoV-2 by PCL COVID-19 Ag detection kits.

Furthermore, Epitope Position & it’s Amino Acid Sequence of PCL COVID-19 Ag detection kits are
recited in Table 2 as below, which verifies that any SARS-Cov-2 variants of Table 1 does not relate
to the Epitope Position of Table 2.

[Table 2]

Ref. No Test Kit Name Target Epitope Position Amino Acid Sequence
COV04S PCL COVID19 SARS- 44-54, 44-54 ; G L P N N T A S W F
Ag Gold CoV-2 149-178 T
COV05 PCL COVID19 149-178 : R N P A N N A A I
Ag Rapid FIA VLQLPQGTTLPKG
FYAEGSRG

Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Korea
PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com
References:

1. https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-
info.html?CDC_AA_refVal=https%3A%2F%2Fptop.only.wip.la%3A443%2Fhttps%2Fwww.cdc.gov%2Fcoronavirus%2F2019-
ncov%2Fcases-updates%2Fvariant-surveillance%2Fvariant-info.html
2. Kumar, S., Stecher, G., Li, M., Knyaz, C. & Tamura, K. MEGA X: Molecular evolutionary
genetics analysis across computing platforms. Mol. Biol. Evol. 35, 1547–1549.
https://doi.org/10.1093/molbev/msy096 (2018).
3. HALL, T. Biological sequence alignment editor (BioEdit), version 7.2. 5. 2013.
4. CUBUK, Jasmine, et al. The SARS-CoV-2 nucleocapsid protein is dynamic, disordered, and
phase separates with RNA. Nature communications, 2021, 12.1: 1-17.
5. NARAYANAN, Sai, et al. SARS-CoV-2 Genomes From Oklahoma, United States. Frontiers in
Genetics, 2021, 11: 1867.
6. ELASWAD, A., et al. Mutational spectra of SARS-CoV-2 isolated from animals PeerJ. 8:
e10609. Published online, 2020.
7. SINGH, Jasdeep, et al. Structure-Function Analyses of New SARS-CoV-2 Variants B. 1.1. 7, B.
1.351 and B. 1.1. 28.1: Clinical, Diagnostic, Therapeutic and Public Health Implications. Viruses,
2021, 13.3: 439.
8. https://www.path.org/articles/new-variants-will-covid-19-tests-still-
work/?gclid=Cj0KCQjwwLKFBhDPARIsAPzPi-I4MfaGMIy2-Q8i_V1RClKguTDtJtVU-
GbR6bg6SqhyViMGhJeJD8saAnn6EALw_wcB

Sincerely,

Mr. Seung Ji Kim [Patent Attorney]

Rm701, Star Valley, 99 Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Korea
PCL Inc. TEL : +82-2-2144-3960 FAX : +82-2-2144-3910 URL : www.pclchip.com