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We will thrive by manufacturing the best IVD products

To:

Valued customers

C.C

:

N/A

Subject:

Notification of internal test results for SARS-CoV-2 variants (Version 7.17)

1. We, SD Biosensor, Inc., wish you happiness and success.
2. We, SD Biosensor, Inc., would like to inform you that STANDARD™ Q products for SARS-CoV-2 diagnostic are notaffected by “Alpha(B.1.1.7), Beta(B.1.351), Gamma(P.1), Delta(B.1.617.2), Kappa(B.1.617.1) , Epsilon(B.1.429),
Iota(B.1.526), Lambda(C.37), Zeta(P.2), Mu(B.1.621), Omicron(B.1.1.529, BA.1, BA.2, BA.3, BA.4.1, BA.5, BA.2.75,
BF.7, BF.14, BJ.1, BQ.1.1, BA.4.6, BA.2.75.2, BA.2.12.1, BA.5.1, BA.5.2, BA.2.3.20, XBB, BA.2.10, BM.1.1.1, BS.1,
BQ.1, BA.4.4, BA.5.2.6, BN.1, CH.1.1, CJ.1, XBF, XBB.1, XBB.1.5, XBC, XBB.1.16, XBB.1.9.1, XBB.1.16.1,
XBB.1.9.2, XBB.2.3, EG.5.1, BA.2.86, GW.5.1.1, FW.1.1, JN.1, GE.1.2.1, JN.1.1, JD.1.1, BA.2.86.1, JG.3, EG.5.1.6,
HV.1, GS.4.1, XBB.1.16.15, FL.1.5.1, EG.5.1.3, GE.1, JN.6, JN.2, JN.3, HK.6, EG.5.1.1, JF.1, EG.10.1, XBB.1.16.6,
XBB.1.16.11, HK.3, BA.2.87.1, JN.1.18, JN.1.22, JN.1.4, JN.1.7, JN.1.8, KP.2, KP.3, KP.1.1, XDQ, JN.1.7.1,
JN.1.11.1, XDK, JN.1.16, LB.1 and KP.2.3) SARS-CoV-2 variants”.
The list of applicable STANDARD™ Q products is as follows.
No.
Product Name
1
STANDARD™ Q COVID-19 Ag Test
2
STANDARD™ Q COVID-19 Ag Home Test
3
STANDARD™ Q COVID-19 Ag Nasal Test
4
STANDARD™ Q COVID/Flu Ag Combo Test
5
STANDARD™ Q COVID-19 Ag Saliva Test
6
STANDARD™ i-Q COVID-19 Ag Home Test
7
STANDARD™ Q COVID-19 Ag Test 2.0
8
STANDARD™ i-Q COVID/Flu Ag Combo Test
9
STANDARD™ Q Flu/RSV/SARS-CoV-2 Ag Combo Test

Reference No.
Q-NCOV-01G
Q-NCOV-03G
Q-NCOV-04G
Q-CVFL-01C
Q-NCOV-02G
EQ-NCOV-03G
Q-NCOV-07G
EQ-CVFL-01C
Q-CVFR-01G

We verified this through internal test, and detailed information about it is below.
Mutations commonly found in the Alpha (B.1.1.7), Beta(B.1.351), Gamma(P.1), Delta(B.1.617.2), Kappa(B.1.617.1),
Epsilon(B.1.429), Iota(B.1.526), Lambda(C.37), Zeta(P.2), Omicron(BA.1, BA.2, BA.3, BA.4.1, BA.5, BF.7, BJ.1)
variants as well as the variants listed in part 1, analytical sensitivity, have been wet-lab tested using recombinant
proteins, in the combinations indicated in the table in part 1 and no impact was observed in test performance. The
mutations commonly found in the respective strains and in the Mu(B.1.621), Omicron(B.1.1.529, BA.2.75, BF.14,
BQ.1.1, BA.4.6, BA.2.75.2, BA.2.12.1, BA.5.1, BA.5.2, BA.2.3.20, XBB, BA.2.10, BM.1.1.1, BS.1, BQ.1, BA.4.4,
BA.5.2.6, BN.1, CH.1.1, CJ.1, XBF, XBB.1, XBB.1.5, XBC, XBB.1.16, XBB.1.9.1, XBB.1.16.1, XBB.1.9.2, XBB.2.3,
EG.5.1, BA.2.86, GW.5.1.1, FW.1.1, JN.1, GE.1.2.1, JN.1.1, JD.1.1, BA.2.86.1, JG.3, EG.5.1.6, HV.1, GS.4.1,
XBB.1.16.15, FL.1.5.1, EG.5.1.3, GE.1, JN.6, JN.2, JN.3, HK.6, EG.5.1.1, JF.1, EG.10.1, XBB.1.16.6, XBB.1.16.11,
HK.3, BA.2.87.1, JN.1.18, JN.1.22, JN.1.4, JN.1.7, JN.1.8, KP.2, KP.3, KP.1.1, XDQ, JN.1.7.1, JN.1.11.1, XDK,
JN.1.16, LB.1 and KP.2.3) variant (see the table in part 2, in-silico analysis) have been analyzed in-silico, and no impact
on performance is expected.
0. Monitoring information
0.1 Circulating mutations in nucleocapsid (N) protein
On a monthly basis, viral genomic sequences of the circulating strains will be gathered using GISAID. The
most recent 2000 complete and high coverage entries will be analyzed at least monthly against the reference
sequence (Wuhan-Hu-1/2019), and all non-synonymous mutations in the N protein will be identified. The
percentage of single mutations and mutation combinations in the N protein will be analyzed. All mutations
present in > 5% of the circulating isolates will be defined as “Relevant Mutations”.
0.2 Variants of Concern/Interest globally
Additionally, Variants of Concern (VoCs) and Variants of Interest (VoIs) by the WHO and the European Centre
for Disease Prevention and Control (ECDC), as well as Variants Being Monitored (VBMs), VOIs, VOCs andVariants of High Consequence (VOHCs) by the US CDC will be monitored regularly. Isolates from all variants
listed above will be monitored on GISAID. The most recent 2000 complete and high coverage entries per

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variant will be analyzed against the reference sequence (Wuhan-Hu-1/2019), and all non-synonymous
mutations in the N protein will be identified. The percentage of single mutations and mutation combinations in
the N protein will be analyzed. All mutations present in > 5% of the variant will be defined as “Relevant
Mutations” as well.
1. Analytical sensitivity
1.1 Purpose of test
The purpose of this test is to verify that the sensitivity of STANDARD™ Q products is not affected by SARSCoV-2 variants by using synthetic recombinant proteins.
1.2 Specimen of test1) Specimen (Positive)
Since STANDARD™ Q products target nucleocapsid protein (hereafter, N protein), recombinant N proteinof 34 variants were synthesized and used as positive specimen.
#
Pango lineage
GISAID ACCESSION ID. EPI_ISL
WHO label
1-1
B
402125N/A
1-2
B.1.1.7
835226Alpha
1-3
B.1.351
660190Beta
1-4
P.1
792680Gamma
1-5
B.1.617.1
1360306
Kappa
1-6
B.1.617.1
1789542Kappa
1-7
B.1.617.1
1620161Kappa
1-8
B.1.617.1
1545312Kappa
1-9
B.1.617.1
1823120Kappa
1-10
B.1.617.1
1904467
Kappa
1-11
B.1.617.1
1660436Kappa
1-12
B.1.617.1
1913208Kappa
1-13
B.1.617.1
1969991Kappa
1-14
B.1.617.2
1970310Delta
1-15
B.1.617.2
1660458
Delta
1-16
B.1.617.2
1807318Delta
1-17
B.1.617.2
1913205
Delta
1-18
A.23.1925892
N/A
1-19
B.1.429
1771435
Epsilon1-20
B.1.526.2
1080752
N/A
1-21
B.1.526
1227165
Iota
1-22
B.1.617.3
1704494
N/A
1-23
C.36
1936140
N/A
1-24
C.37
1111296
Lambda1-25
P.2
1182578
Zeta
1-26
B.1.616
1239370
N/A
1-27
C.1.2
3164100
N/A
1-28
BA.1
6640917
Omicron
1-29
BA.21)
7190366
Omicron
1-30
BA.4.12)12043292
Omicron1-31
BA.5
11903045
Omicron
1-32
BA.5.3.13)
12307612a
Omicron
1-33
BF.7
12810243
Omicron1-34
BJ.1
14167044
Omicron1) In the case of BA.3 variant, wet-testing is omitted since the mutation sites of N protein are same as BA.2.
2) BA.4.1 (hCoV-19/South Africa/NCV1112/2022) was first designated as BA.4 on April 14, 2022, and re-designated on
May 22, 2022 (from pango-designation issue #548).
3) BA.5.3.1 is rearranged from BA.5 (12307612). Its prevalence is 0.39% for last 6 months (2022.07.18-2023.01.12)
from covspectrum (Cov spectrum.org).
* Previously circulating Variants of Concerns** Previously circulating Variants of Interest*** Formerly Monitored Variants2) Specimen (Negative)ID*Negative human swab

PCR result
Negative* Negative human swabs were collected from healthy donors and were confirmed to be negative by PCR(US FDA EUA approved, STANDARD M nCoV Real-Time Detection kit, CFX96).

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3) Test strip
3 LOTs of test strips were used for the test.
1.3 Method of test
1) Each of the recombinant N proteins was diluted in successive concentrations.
2) The dilutions were spiked with a swab.
3) The spiked swab was tested in the same method as the IFU.
4) Dilutions of the recombinant N proteins were tested repeatedly 20 times for each LOT of test strips.
1.4 Result of test
The recombinant N protein of 34 variants showed a similar limit of detection to the Wuhan-Hu-1 recombinant
N protein (#1-1) used as a positive control. Therefore, it was confirmed that the sensitivity of the STANDARD™
Q product was not affected by the 34 variants.
2. In-silico analysis
2.1 Purpose of test
The purpose of this test is to theoretically verify that STANDARD™ Q products are not affected by SARSCoV-2 variants.
2.2 Method of test
1) Compare the region where the variant was mutated (hereinafter, mutation site) with the region that
STANDARD™ Q targets to detect SARS-CoV-2 (hereinafter, epitope region).
2) If the mutation site corresponds to the epitope region, it is predicted that there is a possibility of affecting
the STANDARD™ Q product, and the evaluation result is marked with ‘P’.
3) If the mutation site does not correspond to the epitope region, it is predicted that there is no possibility ofaffecting the STANDARD™ Q product, and the evaluation result is marked with ‘N’.
2.3 Result of test
As a result of in-silico analysis of 141 variants (Table 1), the mutation sites of 3 variants (#1-14: 1239370, #131: 1969991, #1-62: 14167044) corresponded to the epitope region. However, it was confirmed that #1-14,#1-31, #1-62 did not affect the sensitivity of SARS-CoV-2 products through the test for analytical sensitivity(#2-26, #2-13, #2-34). It is important to note that the N protein sequences evaluated in the in-silico analysis
include mutations and patterns of mutations commonly present in relevant and newly emerging Omicron
variants. Therefore, although not all omicron variants are listed in following table, relevant circulating omicron
variants are covered within the scope of this analysis.
GISAID
Dominant Mutation site
Result#Pango lineage
ACCESSION(amio acid number)(P or N)ID. EPI_ISL
2-1
2-2
2-3
2-4
2-5
2-6
2-7
2-8
2-9
2-10
2-11
2-12
2-13
2-14
2-15
2-16
2-17
2-18
2-19
2-20
2-21
2-22
2-23
2-24
2-25
2-26
2-27
2-28
2-29
2-30

F-QP-0002-0001

B
A.23.1
AT.1
AT.1
B.1.1.7
B.1.351
B.1.427
B.1.429
B.1.429
B.1.525
B.1.526.1
B.1.526.2
B.1.526
B.1.616
B.1.617.1
B.1.617.2
B.1.617.3
B.1.621
C.36
C.37
P.1
P.2
P.3
B.1.617.1
B.1.617.1
B.1.617.1
B.1.617.1
B.1.617.1
B.1.617.1
B.1.617.1

4021259258922385327
12592838352266601901060793
1771435
1194304
243251822049201080752
12271651239370
1360306
15089961704494
1582980
193614011112967926801182578
1213573
17895421620161154531218231201904467
1660436
1913208

N/A (as standard)
202
67, 203, 204
203, 2043, 203, 204, 235
205
205
205, 234
205
12, 205
205, 234
13, 202
199, 234
325
203, 377
63, 203, 215, 377
67, 203, 377
205
203, 204, 212
13, 203, 204, 214, 366
80, 203, 204
119, 203, 204, 234
203, 204
203, 377, 385
3, 203, 377
203, 204
203, 236, 377
3, 13, 203, 243, 377
3, 63, 203, 377
30, 203, 377

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N/A
N
N
N
N
N
N
N
N
N
N
N
N
P
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N

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2-31
2-32
2-33
2-34
2-35
2-36
2-37
2-38
2-39
2-40
2-41
2-42

B.1.617.1
B.1.617.2
B.1.617.2
B.1.617.2
B.1.617.2
AY.1
AY.2
AY.3
AY.3.1B.1.621C.1.2
B.1.1.529
BA.1(B.1.1.529.1)
BA.2(B.1.1.529.2)
BA.3(B.1.1.529.3)
B.1.640.1
B.1.640.2
XD*(Delta and BA.1)
XE*(BA.1 and BA.2)
XF*(Delta and BA.1)

1969991
19703101660458
1807318
1913205
3244751312356533522212920875
347757126956106647959

203, 310, 377
63, 203, 377. 385
63, 203, 377
63, 203, 204, 205, 206, 207, 208, 377, 385
63, 203, 215, 377
63, 203, 215, 377
63,203,377
63, 203, 215, 377
63, 203, 215, 377
205
13, 204, 384, 203
13, 31(del), 32(del), 33(del), 203, 204

P
N
N
N
N
N
N
N
N
N
N
N

664091713, 31(del), 32(del), 33(del), 203, 204

N7190366

13, 31(del), 32(del), 33(del), 203, 204, 413

N7526186

13, 31(del), 32(del), 33(del), 203, 204, 413

N67008137181977

63, 205, 378
22, 205

NN

9879437

63, 203, 215, 377

N

2-51

BA.1.19754508

2-52

BA.2.212417574

2-53

BA.2.12108420222-54

BA.2.12.1

11490263

2-55

BA.4.1a)12043292

2-56

BA.5

11903045

2-57

BA.5.3.1b)

12307612**

2-58

BA.2.75

13826295***

2-59

BA.2.75

13711333***

2-60

BF.7

12810243

2-61

BF.14

13490388

2-62

BJ.1

141670442-63

BQ.1.115155651

2-64

BA.4.612475182

2-65

BA.2.75.2

14290506

2-66

BA.2.12.1

9801346

2-67

BA.5.111941796

2-68

BA.5.211763535

2-69

BA.2.3.20

15031190

2-70

XBB

14891630

2-71

BA.2.108092783.2

2-43
2-44
2-45
2-46
2-47
2-48
2-49
2-50

F-QP-0002-0001

91777438894978

13, 31(del), 32(del), 33(del),203, 204, 413
13, 31(del), 32(del), 33(del),203, 204
P13L, E31(del),R32(del), S33(del), R203K, G204R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), P151S,
R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), E136D,
R203K, G204R, S413R
P13L E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, G204R, R203K, S413R
P13L, G30(del), E31(del), R32(del), S33F,
R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, T282I, S413R
P13L, E31(del), R32(del), S33(del), E136D,
R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del), P151S,
R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,

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N
N
N
N
N
N
N
N
N
N
N
N
N
P
N
N
N
N
N
N
N
N
N

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2-72

BM.1.1.1

13949278

2-73

BS.1

14853841

2-74

BQ.1

14294806

2-75

BA.4.412012915

2-76

BA.5.2.6

12845553

2-77

BN.1

15027018

2-78

CH.1.115316879

2-79

CJ.1

15157635

2-80

XBF

15414358

2-81

XBB.1

14917652

2-82

XBB.1.5

15687648

2-83

XBC

15057246

2-84

XBB.1.16

16835403

2-85

XBB.1.9.1

17300463

2-86

XBB.1.9.1C)

16093023

2-87

XBB.1.16.1

17206435

2-88

XBB.1.9.2

16508753

2-89

XBB.2.3

16382405

2-90

EG.5.1

17308785

2-91

BA.2.86

18125259

2-92

GW.5.1.1

18543379

2-93

FW.1.1

18536082

2-94

JN.1

18659732

2-95

GE.1.2.1

18756527

2-96

JN.1.1

18853765

2-97

JD.1.1

18854003

2-98

BA.2.86.1

18857718

2-99

JG.3

18854004

2-100

EG.5.1.6

18839472

2-101

HV.1

18852130

2-102

GS.4.1

18782653

2-103

XBB.1.16.15

18851465

2-104

FL.1.5.1

18850174

F-QP-0002-0001

G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), T135I,
R203K, G204R
P13L, E31(del), R32(del), S33(del), E136D,
R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del), P151S,
R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
D63G, R203M, D377Y
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, T362I, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del),R203K, G204R, L219F (10.22%), S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31del, R32del, S33del, R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), P80S,
R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32 (del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, G30(del), E31(del), R32(del), S33A,
R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R

Rev.00 (2023.10.16.)

N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N

SD Biosensor, Inc.

6 / 8We will thrive by manufacturing the best IVD products

2-105

EG.5.1.3

18851485

2-106

GE.1

18860090

2-107

JN.6

18849705

2-108

JN.2

18842882

2-109

JN.3

18853544

2-110

HK.6

18840974

2-111

EG.5.1.1

18852843

2-112

JF.1

18850018

2-113

EG.10.1

18824608

2-114

XBB.1.16.6

18847872

2-115

XBB.1.16.11

18851629

2-116

HK.3

18860010

2-117

18849988

2-118

18849985

2-11918849986

2-120

18849990

2-121

BA.2.87.1

18849987

2-122

18849989

2-123

18849991

2-124

18849984

2-125

18845398

2-126

JN.1.18

19013232

2-127

JN.1.22

18661795

2-128

JN.1.4

18848538

2-129

JN.1.718900863

2-130

JN.1.818607284

2-131

KP.2

19150387

2-132

KP.3

19150395

2-133

KP.3

19150366

2-134

KP.1.1

19150383

2-135

XDQ

19178922

2-136

JN.1.7.1

19176764

2-137

JN.1.11.1

19032226

F-QP-0002-0001

P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), T148A,
G178D, R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del), T148A,
R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del),T148A, R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del),T148A, R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del),T148A, G178D, R203K, G204R
P13L, E31(del), R32(del), S33(del),Q43H, T148A, R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del),T148A, R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del),T148A, G178D, R203K, G204R, S413R
P13L, G30(del), E31(del), R32(del),S33D, T148A, R203K, G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204P(10.63%), Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R

Rev.00 (2023.10.16.)

N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N

SD Biosensor, Inc.

7 / 8We will thrive by manufacturing the best IVD products

2-138

XDK

19056040

2-139

JN.1.16

19188775

2-140

n/a

n/a

2-141

LB.1

19280900

2-142

KP.2.319280924

P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
S23P, A35T, L39F, A50V, R68P, G204P,
A218S, G243C, T366I, P368S, R385K,
S412N
P13L, E31(del), R32(del), S33(del), R203K,
G204R, Q229K, S413R
P13L, E31(del), R32(del), S33 (del), R203K,
G204R, Q229K, S413R

N
N
N
N
N

* XD, XE, XF are characterized by combining with the other two lineages (Delta + Omicron) by considering all mutation site
including both spike protein and nucleocapsid protein. However, if only the sequence of nucleocapsid protein is considered,a single lineage can be characterized.
**Accession number of 12307612 is BA.5 sub lineage with very small portion (7.86 by GISAID, 2022.06.16.)*** E31, R32 and S33 amino acid deletions of BA.2.75 occur in 74.15%, 74.15% and 72.79% respectively (Covspectrum.org, 2022.07.22).
a) BA.4.1 (hCoV-19/South Africa/NCV1112/2022) was first designated as BA.4 on April 14, 2022, and re-designated on May
22, 2022 (from pango-designation issue #548).
b) BA.5.3.1 is rearranged from BA.5 (12307612). Its prevalence is 0.39% for last 6 months (2022.07.18-2023.01.12)
from covspectrum (Cov spectrum.org).
C) XBB.1.9.1 was not designated in Covspectrum and GISAID on 4th April (Version.7.10), so we searched for XBB.1.9.1
based on cov-lineages/pango-designation, issue #1819. But, issue #1819 was closed as not planed issue. The informationof XBB.1.9.1 was corrected based on Covspectrum, GISAID and cov-lineages/pango-designation, issue #1704(https://github.com/cov-lineages/pango-designation/issues/1704).

3. Final conclusion of the test
As a result of analytical sensitivity and In-silico analysis, it is verified that STANDARD™ Q products are notaffected by “Alpha(B.1.1.7), Beta(B.1.351), Gamma(P.1), Delta(B.1.617.2), Kappa(B.1.617.1), Epsilon(B.1.429),
Iota(B.1.526), Lambda(C.37), Zeta(P.2), Omicron(BA.1, BA.2, BA.3, BA.4.1, BA.5, BF.7, BJ.1) SARS-CoV-2
variants”. In addition, as a result of In-silico analysis, it is verified that STANDARD™ Q products are not affectedby “Mu(B.1.621), Omicron(B.1.1.529, BA.2.75, BF.14, BQ.1.1, BA.4.6, BA.2.75.2, BA.2.12.1, BA.5.1, BA.5.2,
BA.2.3.20, XBB, BA.2.10, BM.1.1.1, BS.1, BQ.1, BA.4.4, BA.5.2.6, BN.1, CH.1.1, CJ.1, XBF, XBB.1, XBB.1.5,
XBC, XBB.1.16, XBB.1.9.1, XBB.1.16.1, XBB.1.9.2, XBB.2.3, EG.5.1, BA.2.86, GW.5.1.1, FW.1.1, JN.1,
GE.1.2.1, JN.1.1, JD.1.1, BA.2.86.1, JG.3, EG.5.1.6, HV.1, GS.4.1, XBB.1.16.15, FL.1.5.1, EG.5.1.3, GE.1, JN.6,
JN.2, JN.3, HK.6, EG.5.1.1, JF.1, EG.10.1, XBB.1.16.6, XBB.1.16.11, HK.3, BA.2.87.1, JN.1.18, JN.1.22, JN.1.4,
JN.1.7, JN.1.8, KP.2, KP.3, KP.1.1, XDQ, JN.1.7.1, JN.1.11.1, XDK, JN.1.16, LB.1 and KP.2.3) SARS-CoV-2
variants”.
In version.7.17, the in-silico analysis of XDQ (19178922), JN.1.7.1 (19176764), JN.1.11.1 (19032226), XDK(19056040), JN.1.16 (19188775), LB.1 (19280900) and KP.2.3 (19280924) variants were conducted. Thesevariants have almost the same or identical N-protein sequence as BA.2 (EPI_ISL_7190366), with 99.76% to100% homology. The test kit's performance remains unchanged because the mutation sites in these variants do
not occur within the epitope region.
Additionally, the test kit's performance is unaffected by 12 amino acid mutations (S23P, A35T, L39F, A50V, R68P,
G204P, A218S, G243C, T366I, P368S, R385K, S412N). Among the major variants of SARS-CoV-2, variants withsuch amino acid mutations are extremely rare, and their prevalence has not been reported. Continuous
monitoring of SARS-CoV-2 variants is ongoing, and if any variants with these amino acid mutations are identified,the in-silico analysis of the variants will be updated in the report.
4. Interpretation of test result
The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.
4.1 Negative test result
A negative test result means that it is unlikely that you have COVID-19. However, even if your test is negative,
continue to observe all hygiene and safety measures. If you suspect that you have an infection, contact you
doctor/primary care physician.
4.2 Positive test result
A positive test result means that it is very likely that you have COVID-19. Please contact your doctor/primarycare physician or your local health authority immediately and adhere to the local guidelines regarding selfisolation. Your doctor may require you to undergo a PCR test to confirm the result.

F-QP-0002-0001

Rev.00 (2023.10.16.)

SD Biosensor, Inc.

8 / 8We will thrive by manufacturing the best IVD products

3. We will continue our efforts to comply with high quality management standards and to maintain a consistent highquality management system to ensure customer’s satisfaction and product safety.

Sincerely,

SD Biosensor, Inc.

Writer:Young-Ju Kwon

REF NO.

:

Address(Head office)WebsiteFactory
Manager

QMR: Jong-Kwan Ko

BA200-20240726-QA2

Date: 2024.07.26.

:

C-4th&5th, 16, Deogyeong-daero 1556beon-gil,Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690,
REPUBLIC OF KOREA

Address

74,
Osongsaengmyeong
4-ro,Osong-eup,: Heungdeok-gu, Cheongju-si, Chungcheongbuk-do,
28161, REPUBLIC OF KOREA:

www.sdbiosensor.com

Tel

F-QP-0002-0001

Reviewer : Jong-Kwan Ko(Manufacturing site)

Rev.00 (2023.10.16.): Yoon-Seok Jin: (Tel) +82-80-970-9700, (Fax) +82-31-300-0499

SD Biosensor, Inc.