Research Data of Stability

Coronavirus-19 (COVID-19)
Antibody (IgM/IgG) Rapid Test Kit
(Colloidal gold
immunochromatography)

Wuhan UNscience Biotechnology Co., Ltd.

 Contents

Preface ................................................................................................ 1

1. Overview of accelerated stability study ..................................... 2

1.1. Content of accelerated stability study ................................. 2

1.2. Reagents preparation ........................................................... 2

1.3. Test content and result judgement ....................................... 2

1.4. Detection method ................................................................ 4

1.5. Operation method of this kit................................................ 5

2. Test result .................................................................................... 5

3. Conclusion of accelerated stability study ................................. 13

 Preface

Stability is the ability of in vitro diagnostic reagents to maintain consistency over time,
is the basic attribute that reagents must possess, and is an important index to ensure
the effectiveness of reagents during the detection. Stability study refers to design
reasonable stability research test items to investigate the changes of the main quality
indicators of the product with time under different condition, and the test items are
based on the physical and chemical properties of the products. Stability study can
provide the basis for the determination of the preservation conditions and validity
period of the product and the relevant points for attention in the operation method.

For this study, the main references are Guidelines for the Study of Chemical Stability,
EU Regulations on in vitro Diagnostic Reagents (IVD), Review of New Biological
Products, Key Points for Technical Review of Registration of Coronavirus-19
(COVID-19) Antibody (IgM/IgG) Rapid Test Kit (Trial), Guidelines for Evaluating
the Analytical Performance of in vitro Diagnostic Reagents, etc. Furthermore, the
accelerated stability research is carried out with the technical requirements of the
product and the actual storage and transportation as the basis of the research method.
The validity period of this kit is tentatively set for 18 months, and it should be
accelerated at 37℃ for 21 days according to relevant domestic industry standards.

1
1. Overview of accelerated stability study

1.1. Content of accelerated stability study

1.1.1. Accelerated stability study

The COVID-19 IgG/IgM Rapid Test Kit (Colloidal gold immunochromatography)

produced by our company is a reagent stored at room temperature (2~30℃). The
COVID-19 IgG/IgM Rapid Test Kit (Colloidal gold immunochromatography) (Lot
Number: 20200226, 20200228, 20200302) was placed at 37℃ constant temperature
conditions, then take the Positive reference coincidence rate, Negative reference
coincidence rate, Lowest detection limit, Repeatability, Analysis specificity test at
0,5,15,21 days respectively, record and analyze the experimental results.

1.2. Reagents preparation

1.2.1. Instruction of reagents

The batch information of COVID-19 IgG/IgM Rapid Test Kit (Colloidal gold
immunochromatography) produced by our company is as follows:

Lot. NO. 20200226 20200228 20200302

Date of production Feb. 26, 2020 Feb. 28, 2020 Mar. 2, 2020

Specification 40T/kit 40T/kit 40T/kit

1.3. Test content and result judgement

1.3.1. Positive reference of product compliance rate

Positive reference of product compliance rate: The positive reference of product

compliance rate should be 5/5.

2
1.3.2. Negative reference of product compliance rate

Negative reference of product compliance rate: The negative reference of product

compliance rate should be 10/10.

1.3.3. Minimum detection limit

Minimum detection limit: The minimum detection limit of reference product S1

should be negative, S2A, S2B and S3 should be positive.

1.3.4. Repeatability

Repeatability: Three reference products are tested for repeatability. Each test is
repeated 10 times and should be positive.

1.3.5. Analysis specificity

a. Cross-reaction:

This product does not have cross reaction with positive samples of
parainfluenza virus antibody, influenza A virus antibody, influenza B virus
antibody, Chlamydia pneumoniae antibody, Mycoplasma pneumoniae
antibody, adenovirus antibody, respiratory syncytial virus antibody, hepatitis B
surface antibody, type C Hepatitis virus antibody, Treponema pallidum
antibody, human immunodeficiency virus antibody, EB virus antibody,
measles virus antibody, cytomegalovirus antibody, enterovirus 71 antibody,
mumps virus antibody, chicken pox-zoster virus antibody.

b. Interfering substances:

a) When the bilirubin concentration is ≤250 μmol/L, the hemoglobin

content is ≤9 g/L, the triglyceride content is ≤15 mmol/L, the
rheumatoid factor content is ≤ 80IU/mL, and the antinuclear
antibody (ANA) titer is ≤ 1: 240, anti-mitochondrial antibody
(AMA) ≤80U/mL, mouse IgG content ≤1000μg/mL, will not
interfere with the detection results of this product.

3
 b) Histamine hydrochloride, alpha-interferon, zanamivir, ribavirin,
oseltamivir, peramivir, lopinavir, ritonavir, abidol, levofloxacin,
azithromycin, Ceftriaxone, meropenem, and tobramycin, they will
have no effect on the test results of product.

1.4. Detection method

1.4.1. Compliance rate of positive reference

Test with 5 positive reference, observe the result on the test strip, the positive
reference of product compliance rate should be accordance with the requirements of
1.3.1.

1.4.2. Compliance rate of negative reference

Test with 10 negative reference, observe the result on the test strip, the negative
reference of product compliance rate should be accordance with the requirements of
1.3.2.

1.4.3. Lowest detectable limit

Test with minimum detection reference product for 3 times, observe the result on the
test strip, the minimum detection limit of reference product should be accordance with
the requirements of 1.3.3.

1.4.4. Repeatability

Three reference products are tested for repeatability. Each test is repeated 10 times,
observe the result on the test strip, the repeatability of reference product should be
accordance with the requirements of 1.3.4.

1.4.5. Analysis specificity

Separately test with samples of parainfluenza virus antibody, influenza A virus

antibody, influenza B virus antibody, Chlamydia pneumoniae antibody, Mycoplasma
pneumoniae antibody, adenovirus antibody, respiratory syncytial virus antibody,

4
hepatitis B surface antibody, type C Hepatitis virus antibody, Treponema pallidum
antibody, human immunodeficiency virus antibody, EB virus antibody, measles virus
antibody, cytomegalovirus antibody, enterovirus 71 antibody, mumps virus antibody,
chicken pox-zoster virus antibody, and sample with 250 μ mol/L bilirubin
concentration, 9 g/L hemoglobin content, 15 mmol/L triglyceride content, 80IU/mL
rheumatoid factor, and 1: 240 titer of antinuclear antibody (ANA), 80U/mL
anti-mitochondrial antibody (AMA), 1000 μ g/mL mouse IgG, histamine
hydrochloride, alpha-interferon, zanamivir, ribavirin, oseltamivir, peramivir, lopinavir,
ritonavir, abidol, levofloxacin, azithromycin, Ceftriaxone, meropenem, and
tobramycin, the test result should be accordance with the requirements of 1.3.5.

1.5. Operation method of this kit

The instruction manual and the applicable instrument instruction must be read
completely before the test is carried out. The test strip should be recovered to room
temperature (15 ℃ ~30 ℃ ) before use. The test should be carried out at room
temperature.
1. Open the aluminum foil bag of the test strip and take out the test strip.
2. Add sample (20 μL serum/plasma or 20 μL whole blood) into the sample well, and
add sample diluent (40 μL for serum/plasma or 100 μL for whole blood) into the
sample well. Wait for the colored line(s) to appear and read the test result at 10
minutes .

2. Test result
Table1: COVID-19 Positive reference of product compliance rate test result
Lot Number: 20200226
Accelerate
Results of 5 tests (IgM/IgG)
time
0d +/- +/+ +/- -/+ -/+
Results of 5 tests (IgM/IgG)
5d
+/- +/+ +/- -/+ -/+
15d Results of 5 tests (IgM/IgG)

5
 +/- +/+ +/- -/+ -/+
Results of 5 tests (IgM/IgG)
21d
+/- +/+ +/- -/+ -/+
Lot Number: 20200228
Accelerate
Results of 5 tests (IgM/IgG)
time
0d +/- +/+ +/- -/+ -/+
Results of 5 tests (IgM/IgG)
5d
+/- +/+ +/- -/+ -/+
Results of 5 tests (IgM/IgG)
15d
+/- +/+ +/- -/+ -/+
Results of 5 tests (IgM/IgG)
21d
+/- +/+ +/- -/+ -/+
Lot Number: 20200302
Accelerate
Results of 5 tests (IgM/IgG)
time
0d +/- +/+ +/- -/+ -/+
Results of 5 tests (IgM/IgG)
5d
+/- +/+ +/- -/+ -/+
Results of 5 tests (IgM/IgG)
15d
+/- +/+ +/- -/+ -/+
Results of 5 tests (IgM/IgG)
21d
+/- +/+ +/- -/+ -/+

Table 2: COVID-19 Negative reference of product compliance rate test result

Lot Number: 20200226
Accelerate
Results of 10 tests (IgM/IgG)
time
-/- -/- -/- -/- -/-
0d
-/- -/- -/- -/- -/-
Results of 10 tests (IgM/IgG)
5d -/- -/- -/- -/- -/-
-/- -/- -/- -/- -/-
Results of 10 tests (IgM/IgG)
15d -/- -/- -/- -/- -/-
-/- -/- -/- -/- -/-
Results of 10 tests (IgM/IgG)
21d -/- -/- -/- -/- -/-
-/- -/- -/- -/- -/-
Lot Number: 20200228

6
 Accelerate
Results of 10 tests (IgM/IgG)
time
-/- -/- -/- -/- -/-
0d
-/- -/- -/- -/- -/-
Results of 10 tests (IgM/IgG)
5d -/- -/- -/- -/- -/-
-/- -/- -/- -/- -/-
Results of 10 tests (IgM/IgG)
15d -/- -/- -/- -/- -/-
-/- -/- -/- -/- -/-
Results of 10 tests (IgM/IgG)
21d -/- -/- -/- -/- -/-
-/- -/- -/- -/- -/-
Lot Number: 20200302
Accelerate
Results of 10 tests (IgM/IgG)
time
-/- -/- -/- -/- -/-
0d
-/- -/- -/- -/- -/-
Results of 10 tests (IgM/IgG)
5d -/- -/- -/- -/- -/-
-/- -/- -/- -/- -/-
Results of 10 tests (IgM/IgG)
15d -/- -/- -/- -/- -/-
-/- -/- -/- -/- -/-
Results of 10 tests (IgM/IgG)
21d -/- -/- -/- -/- -/-
-/- -/- -/- -/- -/-

Table 3: COVID-19 minimum detection limit test result (IgM/IgG)

Lot Number: 20200226
Accelerate Results of 3 tests Results of 3 tests Results of 3 tests Results of 3
time of S1 of S2A of S2B tests of S3
0d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+
5d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+
15d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+
21d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+
Lot Number: 20200228
Accelerate Results of 3 tests Results of 3 tests Results of 3 tests Results of 3
time of S1 of S2A of S2B tests of S3
0d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+
5d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+
15d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+

7
 21d -/- -/- -/-
-/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+
Lot Number: 20200302
Accelerate Results of 3 tests Results of 3 tests Results of 3 tests Results of 3
time of S1 of S2A of S2B tests of S3
0d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+
5d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+
15d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+
21d -/- -/- -/- -/+ -/+ -/+ +/- +/- +/- +/+ +/+ +/+

Table 4: COVID-19 repeatability test result (IgM/IgG)

Lot Number: 20200226
Accelerate Results of 10 tests Results of 10 tests Results of 10 tests
time of S2A of S2B of S3
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
0d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
5d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
15d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
21d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
Lot Number: 20200228
Accelerate Results of 10 tests Results of 10 tests Results of 10 tests
time of S2A of S2B of S3
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
0d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
5d -/+ -/+ +/- +/- +/+ +/+

8
 -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
15d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
21d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
Lot Number: 20200302
Accelerate Results of 10 tests Results of 10 tests Results of 10 tests
time of S2A of S2B of S3
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
0d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
5d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
15d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
21d -/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+
-/+ -/+ +/- +/- +/+ +/+

Table 5: COVID-19 analysis specificity test result (IgM/IgG)

Lot Number: 20200226
Sample Accelerated for 0d: Accelerated for 5d: Accelerated for 15d: Accelerated for 21d:

analysis specificity result analysis specificity result analysis specificity result analysis specificity result

9
Parainfluenza virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Influenza A virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Influenza B virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Chlamydia pneumoniae -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Mycoplasma pneumoniae -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Adenovirus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Respiratory syncytial virus -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Hepatitis B surface antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Type C Hepatitis virus -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Treponema pallidum antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Human immunodeficiency -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

virus antibody

EB virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Measles virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Cytomegalovirus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Enterovirus 71 antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Mumps virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Chicken pox-zoster virus -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

250 μmol/L Bilirubin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

concentration

9 g/L Hemoglobin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

15 mmol/L Triglyceride -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

80IU/mL Rheumatoid factor -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Antinuclear antibody (ANA) -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

with titer of 1:240

80U/mL Anti-mitochondrial -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody (AMA)

1000μg/mL Mouse IgG -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

content

Histamine hydrochloride -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Alpha-interferon -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Zanamivir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Ribavirin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Oseltamivir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Peramivir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Lopinavir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Ritonavir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Abidol -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

10
 Levofloxacin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Azithromycin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Ceftriaxone -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Meropenem -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Tobramycin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Lot Number: 20200228

Sample Accelerated for 0d: Accelerated for 5d: Accelerated for 15d: Accelerated for 21d:

analysis specificity result analysis specificity result analysis specificity result analysis specificity result

Parainfluenza virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Influenza A virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Influenza B virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Chlamydia pneumoniae -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Mycoplasma pneumoniae -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Adenovirus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Respiratory syncytial virus -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Hepatitis B surface antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Type C Hepatitis virus -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Treponema pallidum antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Human immunodeficiency -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

virus antibody

EB virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Measles virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Cytomegalovirus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Enterovirus 71 antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Mumps virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Chicken pox-zoster virus -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

250 μmol/L Bilirubin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

concentration

9 g/L Hemoglobin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

15 mmol/L Triglyceride -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

80IU/mL Rheumatoid factor -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Antinuclear antibody (ANA) -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

with titer of 1:240

80U/mL Anti-mitochondrial -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody (AMA)

1000μg/mL Mouse IgG -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

content

Histamine hydrochloride -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

11
 Alpha-interferon -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Zanamivir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Ribavirin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Oseltamivir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Peramivir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Lopinavir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Ritonavir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Abidol -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Levofloxacin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Azithromycin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Ceftriaxone -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Meropenem -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Tobramycin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Lot Number: 20200302

Sample Accelerated for 0d: Accelerated for 5d: Accelerated for 15d: Accelerated for 21d:

analysis specificity result analysis specificity result analysis specificity result analysis specificity result

Parainfluenza virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Influenza A virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Influenza B virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Chlamydia pneumoniae -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Mycoplasma pneumoniae -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Adenovirus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Respiratory syncytial virus -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Hepatitis B surface antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Type C Hepatitis virus -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

Treponema pallidum antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Human immunodeficiency -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

virus antibody

EB virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Measles virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Cytomegalovirus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Enterovirus 71 antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Mumps virus antibody -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Chicken pox-zoster virus -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody

250 μmol/L Bilirubin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

concentration

9 g/L Hemoglobin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

15 mmol/L Triglyceride -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

12
80IU/mL Rheumatoid factor -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Antinuclear antibody (ANA) -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

with titer of 1:240

80U/mL Anti-mitochondrial -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

antibody (AMA)

1000μg/mL Mouse IgG -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

content

Histamine hydrochloride -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Alpha-interferon -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Zanamivir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Ribavirin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Oseltamivir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Peramivir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Lopinavir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Ritonavir -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Abidol -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Levofloxacin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Azithromycin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Ceftriaxone -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Meropenem -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

Tobramycin -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/- -/-

3. Conclusion of accelerated stability study

The company has carried on the accelerated stability study on its COVID-19 IgG/IgM
Rapid Test Kit (colloidal gold immunochromatography).
By accelerating stability study, the properties of the reagents (Lot Number: 20200226,
20200228, 20200302) were maintained after accelerated for 21 days at 37℃.

ERICK Digitally signed

ESTEBAN by ERICK ESTEBAN
PAREDES CEDENO
PAREDES Date: 2020.06.30
20:19:45 -05'00'
CEDENO

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