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1. Clinical Evaluation Report
1.Investigators
Name Department Responsibility
Yang Xiaoshan R&D Operator
Sun Yingying R&D Operator
Hu Shikai QA Review
Lan jixian Director Approve
2.Study Protocol
2.1 Objectives
Diagnostic Kit for Antigen to 2019-nCOV(Colloidal Gold), hereinafter called SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) , is a
rapid immune-chromatographic assay for the qualitative detection of SARS-CoV-2 Antigen in population oropharynx swabs and nasopharyngeal swabs.
The test is a screening test, and all positives must be confirmed using an other test methods such as nucleic acid or 2019-ncov clinical symptoms. The test
is intended for healthcare professional use only. Also, this test is used for in vitro diagnosis without the need of additional instrument.
The purpose of this experiment is to study the detection of clinical samples with the SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method),
including sensitivity, and specificity.
2.2 Administrative Information
The protocol should be read carefully, the protocol and ‘Test Procedure’ supplied with the reagents must be followed exactly unless explicitly stated.
The assays during the period of the evaluation should be double checked by another technician.
The results for both SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) and any alternative assay methods must be properly identified.
The data should be clearly legible and initialed by Principal Investigator.
All original raw data must be made available for further information.
2.3 Study Design

2. 2.3.1 Time Scale of evaluation
From March 1, 2020 to December 3 2020.
2.3.2 Specimen to be tested
These test samples are population nasopharyngeal swabs and oropharyngeal nswabs samples from Guangzhou Eight People’s Hospital and Shanghai
Public Health Clinical Center.
2.3.3 Acceptance criteria
Compared with COVID-19 Coronavirus Real Time PCR Kit (RT-PCR), the coincidence rate of test result shall be ≥80%.All of the above positive
samples were negative, indicating that the reagent test was associated with Influenza A H1N1, Influenza A H3N2, Influenza B Yamagata, Influenza B
Victoria, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Rhinovirus A, Rhinovirus B, Adenovirus 1, Adenovirus 2, Adenovirus 3,
Adenovirus 4, Adenovirus 5. Type, adenovirus type 7, EBV, measles virus, human cytomegalovirus, rotavirus, norovirus, mumps virus, varicella-zoster
virus, Mycoplasma pneumoniae, coronavirus HKU1, OC43, NL63, 229E and MERS positive samples do not cross-react.
2.3.4 Experimental site
Xiamen Jiqing Biomedical Technology Co., Ltd
2.3.5 Materials and Methods
2.3.5.1 Reagents
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) manufactured by Xiamen JiqingBiomedicalTechnology Co., Ltd
Lot No: JQ2003001 ; Expiry date: 220301
Lot No: JQ2003002 ; Expiry date: 220303
Lot No: JQ2003003 ; Expiry date: 220305
COVID-19 Coronavirus Real Time PCR Kit (RT-PCR), by Jiangsu Bioperfectus Technologies Co.,Ltd CAT.NO.:JC10223-1NW
2.3.5.2 Method
1) Detection of clinical samples
237 clinical case samples which include 107confirmed case samples and 130 confirmed excluded case samples. Clinical samples are tested with the
SARS- CoV-2 Antigen Detection Kit (Colloidal Gold Method) in parallel with the COVID-19 Coronavirus Real Time PCR Kit (RT-PCR). For the
inconsistent result, the result shall be confirmed with 2019-nCoV clinical symptoms .
2) Analytical sensitivity (detected and collected positive samples)
With the SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method), Test the collected 107 positive samples, including positive samples of internal QC

3. panel for SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method). Conduct the test with COVID-19 Coronavirus Real Time PCR Kit (RT-PCR) in
parallel. Observe and record the results .
3) Interference and cross-reaction (Test samples with all types of potential interferences) Cross-reaction studies
Table 2.1 Test samples
Serial Number Names Source (of information) Sample Name
Lot
Number/Model Concentration
1 Influenza A (H1N1) zeptometrix
Influenza A H1N1 (New Cal/20/99)
Culture Fluid (1mL) #0810036CF 3.70×107
TCID50/mL
2 Influenza A H3N2 zeptometrix
Influenza A H3N2 (Brisbane/10/07)
Culture Fluid (1mL) #0810138CF 1.04×106
TCID50/mL
3 Influenza B Yamagata zeptometrix
Influenza B (Yamagata/16/88) Culture
Fluid (1 mL) #0810518CF 5.33×107
TCID50/mL
4 Influenza B. Victoria zeptometrix
Influenza B (Victoria/2/87) Culture
Fluid (1mL) #0810571CF 9.02×106
TCID50/mL
5 Respiratory syncytial virus type A zeptometrix
Respiratory Syncytial Virus Type A
(RSV-A) Culture Fluid (1mL) #0810040ACF 1.16×109
TCID50/mL
6 Respiratory syncytial virus type B zeptometrix
Respiratory Syncytial Virus Type B
(RSV-B) Culture Fluid (1mL) #0810040CF 6.50×108
TCID50/mL
7 Rhinovirus A zeptometrix Rhinovirus Type 1A Culture Fluid (1mL) #0810012CFN 5.21×108
TCID50/mL
8 Rhinovirus B zeptometrix Rhinovirus B14 Culture Fluid (1mL) #0810284CF 2.74×107
TCID50/mL
9 Adenovirus type 1 zeptometrix Adenovirus Type 1 Culture Fluid (1mL) #0810050CF 4.05×107
TCID50/mL
10 Adenovirus type 2 zeptometrix Adenovirus Type 2 Culture Fluid (1mL) #0810110CF 6.13×107
TCID50/mL
11 Adenovirus type 3 zeptometrix Adenovirus Type 3 Culture Fluid (1mL) #0810062CF 2.01×108
TCID50/mL
12 Adenovirus type 4 zeptometrix Adenovirus Type 4 Culture Fluid (1mL) #0810070CF 7.30×107
TCID50/mL
13 Adenovirus type 5 zeptometrix Adenovirus Type 5 Culture Fluid (1mL) #0810020CF 1.05×108
TCID50/mL

4. Serial number Names Source (of information) Sample Name
Lot
Number/Model Concentration
14 Adenovirus type 7 zeptometrix Adenovirus Type 7A Culture Fluid (1mL) #0810021CF 5.32×107
TCID50/mL
15 EBV zeptometrix Epstein-Barr Virus (EBV) Culture Fluid(1mL) #0810008CF 7.80×106
TCID50/mL
16 Measles virus zeptometrix Measles Virus Culture Fluid (1mL) #0810025CF 2.24×107
TCID50/mL
17 Human cytomegalovirus (HCV) zeptometrix
Cytomegalovirus (CMV) (Strain: AD-
169) Culture Fluid (1mL) #0810003CF 3.35×107
TCID50/mL
18 Rotavirus zeptometrix Rotavirus Culture Fluid ( mL) #0810041CF 6.04×107
TCID50/mL
19 Norovirus (virus) zeptometrix
Norovirus Group I (Recombinant)
Culture Fluid (1mL) #0810086CF 7.02×107
TCID50/mL
20 Mumps virus zeptometrix Mumps Virus (Isolate 1) Culture Fluid (1mL) #0810079CF 6.54×106
TCID50/mL
21
Chickenpox-herpes zoster virus
(HSV) zeptometrix
Varicella Zoster Virus (VZV) Strain: 82
Culture Fluid (1mL) #0810167CF 3.21×107
TCID50/mL
22 Mycoplasma pneumoniae zeptometrix
Mycoplasma pneumoniae M129, titered
(1mL) #0801579CF 7.80×106
TCID50/mL
23 Coronavirus HKU1 zeptometrix coronavirus HKU1 Culture Fluid (1mL) #0800305CF 3.62×107
TCID50/mL
24 Coronavirus OC43 zeptometrix coronavirus OC43 Culture Fluid (1mL) #0800328CF 8.68×106
TCID50/mL
25 Coronavirus NL63 zeptometrix coronavirus NL63 Culture Fluid (1mL) #0800366CF 9.62×106
TCID50/mL
26 Coronavirus 229E zeptometrix coronavirus 229E Culture Fluid (1mL) #0800311CF 6.22×106
TCID50/mL
27
Middle East Respiratory Syndrome
Coronavirus(MERS-Cov)
zeptometrix MERS-Cov Culture Fluid (1mL) #0800312CF 8.45×106
TCID50/mL
a. Research on interfering substances
During the use of the SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method), as the test specimens are nasopharyngeal and oropharyngeal
secretions, the results may be affected by substances such as blood, saliva (mucin), allergy symptom relieving drugs/antivirals (a-interferon, zanamivir,
ribavirin, oseltamivir, paramivir, lopinavir, ritonavir, abiraterol), and Interference with substances such as antibiotics (levofloxacin, azithromycin, ceftriaxone,

5. meropenem) and systemic antimicrobials (tobramycin).
Test samples
(1) Blood(20ul/ml): Use a throat swab to soak a healthy person's whole blood to simulate the amount of blood in the nose or mouth.
(2) Saliva (mucin, 50mg/ml): preparation of artificial saliva, swabbed with an oropharyngeal swab and tested.
Table 2.2: Saliva formulation
KCl Ca3(PO4)2 K2HPO4 K2SO4 Na2SO4 Mucin bovine serum protein distilled water
2.4g 0.02g 1.4g 0.9g 0.8g 50mg 5g 1000mL
A small amount of 0.5‰ sodium azide for corrosion protection.
(3) Drug interference
The concentration of the test drug is determined by the Chinese Pharmacopoeia (2005 edition) or the drug dosage in the drug instruction, the following
drugs are added to the negative samples and weak positive samples (minimum detection limit reference product L2) at 10 times the blood concentration to
study the effect of the following drugs on the test results.
Table2.3 Drug use
Drug classification Name of drug consumption
Interference test
concentration
Allergy symptom relief medications Histamine hydrochloride 0.1mg/time 0.25mg/L
Antiviral drug
a-interferon 0.5ml/time 1.25 ml/L
Zanamivir 10mg/time 25mg/L
Ribavirin (loanword) 0.3g/time 375mg/L
Oseltamivir 75mg/time 187.5mg/L
Paramivir (name) 300mg/time 750mg/L
Lopinavir (antibiotic) 200mg/time 500mg/L
Ritonavir 50mg/time 125mg/L
Abidor (name) 0.2g/time 0.5g/L
Antibiotics
Levofloxacin (antibiotic) 0.5g/time 1.25g/L
Azithromycin (antibiotic) 1g/time 2.5g/L
Ceftriaxone 1g/time 2.5g/L
Meropenem (loanword) 200mg/time 500mg/L
Systemic antimicrobials Tobramycin 0.1ml/time 0.25ml/L
Note: The above doses are based on an adult weighing 60 kg, with a blood volume of 4000 mL and a lower tissue fluid content than blood. (The volume of blood in the human
body is about 7-8% of body weight, e.g., if 60 kg, the volume of blood is about 4000 to 4800 mL.)
4) Validation and Interpretation of Assay
An assay can only be interpreted if the criteria for the performance, outlined in the Product Insert, have been met.
In case of problems, testing should be discontinued and the approver should be contacted as soon as possible .

6. 5) Data Storage and Reporting
All data will be filed both on hard copy and in electronically files. Data will be stored for long time. All laboratory results are strictly
confidential. Copies of raw data were retained under the internal R&D for future reference.
All data will be summarized in a final report, including material and methods section, results tables, discussion and conclusion per item. The
final report will be authorized and signed by the principal investigator.
3.Study Report
3.1 Introduction
SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) is based on the principle of Immunochromatography sandwich for determination of
SARS-CoV-2 antigen extracted from the nasopharyngeal swab or oropharyngeal swab specimen. When the extracted specimen is added into the test
device, the specimen is absorbed into the device by capillary action, mixes with the SARS-CoV-2 antibody colloidal conjugate and flows across the pre-
coated membrane.
When the SARS-CoV-2 antigen level in the specimen is at or above the target cutoff (the detection limit of the test), the antigen bound to the
antibody colloidal conjugate are combined by SARS-CoV-2 antibody immobilized in the Test Region (T) of the device, and this produces a colored test
band that indicates a positive result. When the SARS-CoV-2 antigen level in the specimen is zero or below the target cutoff, there is not a visible colored
band in the Test Region (T) of the device. This indicates a negative result.
To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.
The test is a screening test, and all positives must be confirmed using an alternate test such as COVID-19 Coronavirus Real Time PCR Kit (RT-PCR).
The test is intended for healthcare professional use only.
3.2 Purpose
The purpose of this experiment is to study the detection of clinical samples with theSARS-CoV-2 Antigen Detection Kit
(Colloidal Gold Method), including sensitivity, and specificity.
3.3 Materials and methods
3.3.1 Materials
SARS-CoV-2 Antigen Rapid Test manufactured by Xiamen Jiqing Biomedical Technology Co., Ltd
Lot No: JQ2003001 ; Expiry date: 220301
Lot No: JQ2003002 ; Expiry date: 220303

7. Lot No: JQ2003003 ; Expiry date: 220305
COVID-19 Coronavirus Real Time PCR Kit (RT-PCR) manufactured by Jiangsu Bioperfectus Technologies Co.,Ltd CAT.NO:JC10223-
1NW
Lot No: H20200301; Expiry date: 20210320
Lot No: H20201006; Expiry date: 20211010
3.3.2 Method
1) Detection of clinical samples
237 clinical case samples which include 107confirmed case samples （ with Covid-19 symptoms within 2-7 days of onset of symptoms ） and 130
confirmed excluded case samples（without a specific exposure risk in the SARS-CoV-2 ）. Clinical samples are tested with the SARS- CoV-2 Antigen
Detection Kit (Colloidal Gold Method) in parallel with the COVID-19 Coronavirus Real Time PCR Kit (RT-PCR). For the inconsistent result, the result
shall be confirmed with 2019-nCoV clinical symptoms .
2) Analytical sensitivity (detected and collected positive samples)
With the SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method), Test the collected 107 positive samples, including positive samples of internal QC
panel for SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method). Conduct the test with COVID-19 Coronavirus Real Time PCR Kit (RT-PCR) in
parallel. Observe and record the results .
3) Interference and cross-reaction (Test samples with all types of potential interferences) Cross-reaction studies
Table 3.1. Test samples
Serial Number Names Source (of information) Sample Name
Lot
Number/Model Concentration
1 Influenza A (H1N1) zeptometrix Influenza A H1N1 (New Cal/20/99) Culture Fluid (1mL) #0810036CF 3.70×107TCID50/mL
2 Influenza A H3N2 zeptometrix Influenza A H3N2 (Brisbane/10/07) Culture Fluid (1 mL) #0810138CF 1.04×106TCID50/mL
3 Influenza B Yamagata zeptometrix Influenza B (Yamagata/16/88) Culture Fluid (1mL) #0810518CF 5.33×107TCID50/mL
4 Influenza B. Victoria zeptometrix Influenza B (Victoria/2/87) Culture Fluid (1mL) #0810571CF 9.02×106TCID50/mL
5 Respiratory syncytial virus type A zeptometrix
Respiratory Syncytial Virus Type A (RSV-A)
Culture Fluid (1mL) #0810040ACF 1.16×109TCID50/mL

8. 6 Respiratory syncytial virus type B zeptometrix
Respiratory Syncytial Virus Type B (RSV-B)
Culture Fluid (1mL) #0810040CF 6.50×108TCID50/mL
7 Rhinovirus A zeptometrix Rhinovirus Type 1A Culture Fluid (1mL) #0810012CFN 5.21×108TCID50/mL
8 Rhinovirus B zeptometrix Rhinovirus B14 Culture Fluid (1mL) #0810284CF 2.74×107TCID50/mL
9 Adenovirus type 1 zeptometrix Adenovirus Type 1 Culture Fluid (1mL) #0810050CF 4.05×107TCID50/mL
10 adenovirus type 2 zeptometrix Adenovirus Type 2 Culture Fluid (1mL) #0810110CF 6.13×107TCID50/mL
11 Adenovirus type 3 zeptometrix Adenovirus Type 3 Culture Fluid (1mL) #0810062CF 2.01×108TCID50/mL
12 Adenovirus type 4 zeptometrix Adenovirus Type 4 Culture Fluid (1mL) #0810070CF 7.30×107TCID50/mL
13 Adenovirus type 5 zeptometrix Adenovirus Type 5 Culture Fluid (1mL) #0810020CF 1.05×108TCID50/mL
14 Adenovirus type 7 zeptometrix Adenovirus Type 7A Culture Fluid (1mL) #0810021CF 5.32×107TCID50/mL
15 EBV zeptometrix Epstein-Barr Virus (EBV) Culture Fluid (1mL) #0810008CF 7.80×106TCID50/mL
16 Measles virus zeptometrix Measles Virus Culture Fluid (1mL) #0810025CF 2.24×107TCID50/mL
17 Human cytomegalovirus (HCV) zeptometrix
Cytomegalovirus (CMV) (Strain: AD-169)
Culture Fluid (1mL) #0810003CF 3.35×107TCID50/mL
18 Rotavirus zeptometrix Rotavirus Culture Fluid (1mL) #0810041CF 6.04×107TCID50/mL
19 Norovirus (virus) zeptometrix Norovirus Group I (Recombinant) Culture Fluid (1mL) #0810086CF 7.02×107TCID50/mL
20 Mumps virus zeptometrix Mumps Virus (Isolate 1) Culture Fluid (1mL) #0810079CF 6.54×106TCID50/mL
21
Chickenpox-herpes zoster virus
(HSV) zeptometrix
Varicella Zoster Virus (VZV) Strain: 82 Culture
Fluid (1mL) #0810167CF 3.21×107TCID50/mL
22 Mycoplasma pneumoniae zeptometrix Mycoplasma pneumoniae M129, titered (1mL) #0801579 7.80×106TCID50/mL
23 Coronavirus HKU1 zeptometrix coronavirus HKU1 Culture Fluid (1mL) #0800305CF 3.62×107TCID50/mL
24 Coronavirus OC43 zeptometrix coronavirus OC43 Culture Fluid (1mL) #0800328CF 8.68×106TCID50/mL
25 Coronavirus NL63 zeptometrix coronavirus NL63 Culture Fluid (1mL) #0800366CF 9.62×106TCID50/mL
26 Coronavirus 229E zeptometrix coronavirus 229E Culture Fluid (1mL) #0800311CF 6.22×106TCID50/mL
27
Middle East Respiratory Syndrome
Coronavirus(MERS-Cov)
zeptometrix MERS-Cov Culture Fluid (1mL) #0800312CF 8.45×106TCID50/mL
a. Research on interfering substances
During the use of theSARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method), as the test specimens are nasopharyngeal and oropharyngeal
secretions, the results may be affected by substances such as blood, saliva (mucin), allergy symptom relieving drugs/antivirals (a-interferon, zanamivir,
ribavirin, oseltamivir, paramivir, lopinavir, ritonavir, abiraterol), and Interference with substances such as antibiotics (levofloxacin, azithromycin, ceftriaxone,
meropenem) and systemic antimicrobials (tobramycin).
Test samples
(1) Blood（20ul/ml）: Use a throat swab to soak a healthy person's whole blood to simulate the amount of blood（20ul/ml） in the nose or mouth.

9. (2) Saliva (mucin, 50ug/ml): preparation of artificial saliva, swabbed with an oropharyngeal swab and tested.
Table 3.2: Saliva formulation
KCl Ca3(PO4)2 K2HPO4 K2SO4 Na2SO4 Mucin bovine serum protein distilled water
2.4g 0.02g 1.4g 0.9g 0.8g 50mg 5g 1000mL
A small amount of 0.5‰ sodium azide for corrosion protection.
(3) Drug interference
The concentration of the test drug is determined by the Chinese Pharmacopoeia (2005 edition) or the drug dosage in the drug instruction, the following
drugs are added to the negative samples and weak positive samples (minimum detection limit reference product L2) at 10 times the blood concentration to
study the effect of the following drugs on the test results.
Table3.3 Drug use
Drug Classification Name of Drug Cnsumption Interference Test Concentration
Allergy symptom relief medications Histamine hydrochloride 0.1mg/time 0.25mg/L
Antiviral drug
a-interferon 0.5ml/time 1.25 ml/L
Zanamivir 10mg/time 25mg/L
Ribavirin (loanword) 0.3g/time 375mg/L
Oseltamivir 75mg/time 187.5mg/L
Paramivir (name) 300mg/time 750mg/L
Lopinavir (antibiotic) 200mg/time 500mg/L
Ritonavir 50mg/time 125mg/L
Abidor (name) 0.2g/time 0.5g/L
Antibiotics
Levofloxacin (antibiotic) 0.5g/time 1.25g/L
Azithromycin (antibiotic) 1g/time 2.5g/L
Ceftriaxone 1g/time 2.5g/L
Meropenem (loanword) 200mg/time 500mg/L
Systemic antimicrobials Tobramycin 0.1ml/time 0.25ml/L
Note: The above doses are based on an adult weighing 60 kg, with a blood volume of 4000 mL and a lower tissue fluid content than blood. (The volume of blood in the
human body is about 7-8% of body weight, e.g., if 60 kg, the volume of blood is about 4000 to 4800 mL.)
3.4 Acceptance criteria
Compared with COVID-19 Coronavirus Real Time PCR Kit (RT-PCR), the coincidence rate of test result shall be ≥80%.All of the above positive
samples were negative, indicating that the reagent test was associated with Influenza A H1N1, Influenza A H3N2, Influenza B Yamagata, Influenza B
Victoria, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Rhinovirus A, Rhinovirus B, Adenovirus 1, Adenovirus 2, Adenovirus 3,

10. Adenovirus 4, Adenovirus 5. Type, adenovirus type 7, EBV, measles virus, human cytomegalovirus, rotavirus, norovirus, mumps virus, varicella-zoster
virus, Mycoplasma pneumoniae, coronavirus HKU1, OC43, NL63, 229E and MERS positive samples do not cross-react.
3.5 Experimental results
A total of 237 samples of various types of samples are tested (see Attachment 1 Test result of 237 population swabs and nasopharyngeal swabs
samples for detail). Compared with the COVID-19 Coronavirus Real Time PCR Kit (RT-PCR), theSARS-CoV-2 Antigen Detection Kit (Colloidal
Gold Method) (See Table 3.4 for details) shows sensitivity of Sensitivity: 94.39% (95% CI:90.57%-98.21%), Specificity:100% (95% CI: 96.91%-
100.00%), Accuracy: 97.47% (95% CI:95.69%-99.25%).
Table 3.4 Test result of clinical samples
Clinical Sample
COVID-19 Coronavirus Real Time PCR Kit (RT-PCR)
Total
Positive Negative
SARS-CoV-2 Antigen Rapid Test
Positive 101 0 101
Negative 6 130 136
Total 107 130 237
Sensitivity: 94.39% (95% CI:90.57%-98.21%)
Specificity:100% (95% CI: 96.91%-100.00%)
Accuracy: 97.47% (95% CI:95.69%-99.25%)
3.5.2 Interference and cross-reaction (Test samples with all types of potential interferences) Cross-reaction studies
All of the under positive samples were negative(See Table 3.5 for details), indicating that the reagent test was associated with Influenza A H1N1,
Influenza A H3N2, Influenza B Yamagata, Influenza B Victoria, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Rhinovirus A, Rhinovirus B,
Adenovirus 1, Adenovirus 2, Adenovirus 3, Adenovirus 4, Adenovirus 5. Type, adenovirus type 7, EBV, measles virus, human cytomegalovirus, rotavirus,
norovirus, mumps virus, varicella-zoster virus, Mycoplasma pneumoniae , coronavirus HKU1, OC43, NL63 , 229E and MERS positive samples do not
cross-react.
SARS-CoV-2 Antigen Rapid Test with influenza A H1N1, influenza A H3N2, influenza A H5N1, influenza B Yamagata, influenza B Victoria,
respiratory syncytial virus type A, respiratory syncytial virus type B, rhinovirus A, rhinovirus B, adenovirus type 1, adenovirus type 2, adenovirus type 3.
Adenovirus type 4, adenovirus type 5, adenovirus type 7, EBV, measles virus, human cytomegalovirus, rotavirus, norovirus, mumps virus, varicella-
zoster virus, andMycoplasma pneumoniae, coronavirus HKU1, OC43, NL63, 229E and MERS antigen-positive samples do not cross-react.

11. Table 3.5 Results of other virus crossover studies
Lots
Results
Sample H2003001 H2003002 H2003003
Influenza A (H1N1) -- -- --
Influenza A H3N2 -- -- --
Influenza B Yamagata -- -- --
Influenza B. Victoria -- -- --
Respiratory syncytial virus type A -- -- --
Respiratory syncytial virus type B -- -- --
Rhinovirus A -- -- --
Rhinovirus B -- -- --
Adenovirus type 1 -- -- --
Adenovirus type 2 -- -- --
Adenovirus type 3 -- -- --
Adenovirus type 4 -- -- --
Adenovirus type 5 -- -- --
Adenovirus type 7 -- -- --
EBV -- -- --
Measles virus -- -- --
Human cytomegalovirus (HCV) -- -- --
Rotavirus -- -- --
Norovirus (virus) -- -- --
Mumps virus -- -- --
Chickenpox-herpes zoster virus (HSV) -- -- --
Mycoplasma pneumoniae -- -- --
Coronavirus HKU1 -- -- --
Coronavirus OC43 -- -- --
Coronavirus NL63 -- -- --
Coronavirus 229E -- -- --
MERS -- -- --
Note: "-" indicates a negative result.
3.5.2.1 Research on interfering substances
From the results of the under table, it is clear that the reagent assay was not interfered with by allergic symptoms (histamine hydrochloride), remission

12. medications antivirals (a-interferon, zanamivir, ribavirin, oseltamivir, paramivir, lopinavir, ritonavir, abidrol), antibiotics (levofloxacin, azithromycin,
ceftriaxone, meropenem), and systemic antimicrobials (tobramycin).
TheSARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) samples are unaffected by blood and saliva(See Table 3.6 for details).
The results of theSARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) were independent of allergic symptoms (histamine hydrochloride),
antivirals (a-interferon, zanamivir, ribavirin, oseltamivir, paramivir, lopinavir, ritonavir, abiraterol), antibiotics (levofloxacin, azithromycin, ceftriaxone,
meropenem), systemic antimicrobials (Tobramycin) interference., which contain potentially interfering substances(See Table 3.6 for details).
Table 3.6 Results of studies on the effects of blood and saliva
Interfering Substance Main Active Ingredient Consumption Sample
Lots Number
H200301 H2003002 H200303
Hematology / 20ul/ml
negative -- -- --
weak postive + + +
Saliva Mucin 50ug/ml
negative -- -- --
weak postive + + +
Table3.7 Results of Drug interference studies
Drug Classification Name of Drug Consumption Test Samples
Lots Number
H2003001 H2003002 H2003003
Allergy symptom relief
medications
Histamine hydrochloride 0.25mg/L
negative -- -- --
weak postive + + +
Antiviral drug
a-interferon 1.25 mg/L
negative -- -- --
weak postive + + +
Zanamivir 25mg/L
negative -- -- --
weak postive + + +
Ribavirin (loanword) 375mg/L
negative -- -- --
weak postive + + +
Oseltamivir 187.5mg/L
negative -- -- --
weak postive + + +
Paramivir (name) 750mg/L
negative -- -- --
weak postive + + +
Lopinavir (antibiotic) 500mg/L
negative -- -- --
weak postive + + +

13. Drug Classification Name of Drug Consumption Test Samples
Lots Number
H2003001 H2003002 H2003003
Ritonavir 125mg/L negative -- -- --
weak postive + + +
Abidor (name) 0.5g/L
negative -- -- --
weak postive + + +
Antibiotics
Levofloxacin (antibiotic) 1.25g/L
negative -- -- --
weak postive + + +
Azithromycin (antibiotic) 2.5g/L
negative -- -- --
weak postive + + +
Ceftriaxone 2.5g/L
negative -- -- --
weak postive + + +
Meropenem (loanword) 500mg/L
negative -- -- --
weak postive + + +
Systemic antimicrobials Tobramycin 0.25ml/L
negative -- -- --
weak postive + + +
3.6 Experimental conclusion
A total of 237 samples of various types of samples are tested. Compared with the COVID-19 Coronavirus Real Time PCR Kit (RT-PCR), the SARS-
CoV-2 Antigen Detection Kit (Colloidal Gold Method) shows sensitivity of 94.39% (95% CI:90.57%-98.21%), Specificity:100% (95% CI: 96.91%-100.00%),
Accuracy: 97.47% (95% CI:95.69%-99.25%).
All of the under positive samples were negative(See Table 3.5 for details), indicating that the reagent test was associated with Influenza A H1N1,
Influenza A H3N2, Influenza B Yamagata, Influenza B Victoria, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, Rhinovirus A, Rhinovirus B,
Adenovirus 1, Adenovirus 2, Adenovirus 3, Adenovirus 4, Adenovirus 5. Type, adenovirus type 7, EBV, measles virus, human cytomegalovirus, rotavirus,
norovirus, mumps virus, varicella-zoster virus, and Mycoplasma pneumoniae, coronavirus HKU1, OC43, NL63, 229E and MERS positive samples do not
cross-react.
SARS-CoV-2 Antigen Rapid Test with influenza A H1N1, influenza A H3N2, influenza A H5N1, influenza B Yamagata, influenza B Victoria,
respiratory syncytial virus type A, respiratory syncytial virus type B, rhinovirus A, rhinovirus B, adenovirus type 1, adenovirus type 2, adenovirus type 3.
Adenovirus type 4, adenovirus type 5, adenovirus type 7, EBV, measles virus, human cytomegalovirus, rotavirus, norovirus, mumps virus, varicella-zoster
virus, and Mycoplasma pneumoniae, coronavirus HKU1, OC43, NL63, 229E and MERS antigen-positive samples do not cross-react.

14. Attachment 1 Test result of 237 population oropharyngeal swab or nasopharyngeal swabs samples
Sample Nr.
SARS-CoV-2
Antigen
Rapid Test
COVID-19 Coronavirus
Real Time PCR Kit
Sample Nr.
SARS-CoV-2
Antigen
Rapid Test
COVID-19 Coronavirus
Real Time PCR Kit
Sample Nr. SARS-CoV-2
Antigen Rapid
Test
COVID-19 Coronavirus
Real Time PCR Kit
Ct Result Ct Result Ct Result
2020030001 3+ 21 positive 2020040001 2+ 23 positive 2020050001 - / negative
2020030002 - / negative 2020040002 3+ 22 positive 2020050002 - / negative
2020030003 - / negative 2020040003 1+ 25 positive 2020050003 - / negative
2020030004 - / negative 2020040004 - / negative 2020050004 - / negative
2020030005 - / negative 2020040005 - / negative 2020050005 2+ 22 negative
2020030006 3+ 23 positive 2020040006 - / negative 2020050006 3+ 19 negative
2020030007 2+ 25 positive 2020040007 - / negative 2020050007 3+ 21 negative
2020030008 3+ 21 positive 2020040008 - / negative 2020050008 3+ 20 negative
2020030009 1+ 27 positive 2020040009 - / negative 2020050009 - / negative
2020030010 - / negative 2020040010 - / negative 2020050010 - / negative
2020030011 - / negative 2020040011 - / negative 2020050011 - / negative
2020030012 - / negative 2020040012 - / negative 2020050012 - / negative
2020030013 - 30 positive 2020040013 3+ 20 positive 2020050013 2+ 24 positive
2020030014 3+ 22 negative 2020040014 3+ 19 positive 2020050014 - / negative
2020030015 - / negative 2020040015 2+ 23 positive 2020050015 - / negative
2020030016 - / negative 2020040016 2+ 24 positive 2020050016 - / negative
2020030017 - / negative 2020040017 3+ 21 positive 2020050017 - / negative
2020030018 3+ 23 negative 2020040018 - / negative 2020050018 - / negative
2020030019 1+ 26 positive 2020040019 - / negative 2020050019 2+ 25 positive
2020030020 - / negative 2020040020 3+ 22 positive 2020050020 1+ 26 positive
Note: “-” indicates the negative result, “1+, 2+, 3+” indicate positive result, the intensity increases from “1+” to “3+”. Ct Value：Cycle threshold

15. Attachment 1 Test result of 237 population oropharyngeal swab or nasopharyngeal swabs samples
Sample Nr.
SARS-CoV-2
Antigen
Rapid Test
COVID-19 Coronavirus
Real Time PCR Kit
Sample Nr.
SARS-CoV-2
Antigen
Rapid Test
COVID-19 Coronavirus
Real Time PCR Kit
Sample Nr. SARS-CoV-2
Antigen Rapid
Test
COVID-19 Coronavirus
Real Time PCR Kit
Ct Result Ct Result Ct Result
2020030021 3+ 20 positive 2020040021 + 29 positive 2020050021 - / negative
2020030022 - / negative 2020040022 3+ 21 positive 2020050022 3+ 22 positive
2020030023 - / negative 2020040023 3+ 20 positive 2020050023 - / negative
2020030024 - / negative 2020040020 - / negative 2020050024 - / negative
2020030025 2+ 28 positive 2020040025 - / negative 2020050025 3+ 23 positive
2020030026 3+ 21 positive 2020040026 - / negative 2020050026 - / negative
2020030027 3+ 19 positive 2020040027 3+ 22 positive 2020050027 - / negative
2020030028 3+ 21 positive 2020040028 2+ 21 positive 2020050028 3+ 20 positive
2020030029 2+ 24 positive 2020040029 3+ 20 positive 2020050029 - / negative
2020030030 - / negative 2020040020 - / negative 2020050030 - / negative
2020030031 - / negative 2020040031 - / negative 2020050031 - / negative
2020030032 - / negative 2020040032 - / negative 2020050032 3+ 19 positive
2020030033 3+ 21 positive 2020040033 2+ 23 positive 2020050033 3+ 21 positive
2020030034 + 29 positive 2020040034 3+ 21 positive 2020050034 - / negative
2020030035 3+ 18 positive 2020040035 2+ 23 positive 2020050035 - / negative
2020030036 3+ 19 positive 2020040036 + 30 positive 2020050036 - / negative
2020030037 - / negative 2020040037 - / negative 2020050037 - / negative
2020030038 3+ 21 positive 2020040038 - / negative 2020050038 + 31 positive
2020030039 + 28 positive 2020040039 - / negative 2020050039 3+ 22 positive
2020030040 - / negative 2020040040 - / negative 2020050040 2+ 23 positive
Note: “-” indicates the negative result, “1+, 2+, 3+” indicate positive result, the intensity increases from “1+” to “3+”. Ct Value：Cycle threshold

16. Attachment 1 Test result of 237 population oropharyngeal swab or nasopharyngeal swabs samples
Sample Nr.
SARS-CoV-2
Antigen
Rapid Test
COVID-19 Coronavirus
Real Time PCR Kit
Sample Nr.
SARS-CoV-2
Antigen Rapid
Test
COVID-19 Coronavirus
Real Time PCR Kit
Sample Nr. SARS-CoV-2
Antigen Rapid
Test
COVID-19 Coronavirus
Real Time PCR Kit
Ct Result Ct Result Ct Result
2020030041 + 29 positive 2020040041 2+ 23 positive 2020050041 - / negative
2020030042 - / negative 2020040042 - 32 positive 2020050042 - / negative
2020030043 - / negative 2020040043 1+ 27 positive 2020050043 + 29 positive
2020030044 3+ 21 positive 2020040040 - / negative 2020050044 - / negative
2020030045 - / negative 2020040045 - / negative 2020050045 - / negative
2020030046 3+ 20 positive 2020040046 - / negative 2020050046 - / negative
2020030047 - 31 positive 2020040047 1+ 28 positive 2020050047 + 31 positive
2020030048 3+ 18 positive 2020040048 3+ 19 positive 2020050048 3+ 20 positive
2020030049 1+ 27 positive 2020040049 3+ 21 positive 2020050049 - / negative
2020030050 - / negative 2020040050 - / negative 2020050050 - / negative
2020030051 - / negative 2020040051 - / negative 2020050051 - / negative
2020030052 - / negative 2020040052 - / negative 2020050052 - / negative
2020030053 - / negative 2020040053 2+ 26 positive 2020050053 - / negative
2020030054 - / negative 2020040054 - / negative 2020050054 - / negative
2020030055 - / negative 2020040055 - / negative 2020050055 3+ 18 positive
2020030056 - / negative 2020040056 3+ 20 positive 2020050056 2+ 23 positive
2020030057 - / negative 2020040057 - / negative 2020050057 1+ 27 positive
2020030058 + 29 positive 2020040058 - / negative 2020050058 - / negative
2020030059 2+ 22 positive 2020040051 - / negative 2020050059 - / negative
2020030060 - / negative 2020040060 - / negative 2020050060 - / negative
Note: “-” indicates the negative result, “1+, 2+, 3+” indicate positive result, the intensity increases from “1+” to “3+”. Ct Value：Cycle threshold

17. Attachment 1 Test result of 237 population oropharyngeal swab or nasopharyngeal swabs samples
Sample Nr.
SARS-CoV-2
Antigen
Rapid Test
COVID-19 Coronavirus
Real Time PCR Kit
Sample Nr.
SARS-CoV-2
Antigen Rapid
Test
COVID-19 Coronavirus
Real Time PCR Kit
Sample Nr. SARS-CoV-2
Antigen Rapid
Test
COVID-19 Coronavirus
Real Time PCR Kit
Ct Result Ct Result Ct Result
2020030061 - / negative 2020040061 3+ 21 positive 2020110011 2+ 26 positive
2020030062 - / negative 2020040062 - 32 positive 2020110012 3+ 22 positive
2020030063 - / negative 2020040063 3+ 21 positive 2020110013 3+ 21 positive
2020030064 3+ 21 positive 2020040064 - / negative 2020110014 2+ 25 positive
2020030065 + 29 positive 2020040065 - / negative 2020110015 1+ 29 positive
2020030066 - / negative 2020040066 - / negative 2020120001 - 31 positive
2020030067 3+ 24 positive 2020050061 3+ 21 positive 2020120002 3+ 21 positive
2020030068 - 32 positive 2020050062 - / negative 2020120003 3+ 22 positive
2020030069 - / negative 2020050063 - / negative 2020120004 2+ 24 positive
2020030070 3+ 21 positive 2020110001 3+ 26 positive 2020120005 1+ 26 positive
2020030071 - / negative 2020110002 1+ 24 positive 2020120006 - / negative
2020030072 - / negative 2020110003 2+ 25 positive 2020120007 - / negative
2020030073 - / negative 2020110004 3+ 25 positive 2020120008 - / negative
2020030074 - / negative 2020110005 3+ 21 positive 2020120009 - / negative
2020030075 - / negative 2020110007 1+ 26 positive 2020120010 - / negative
2020030076 1+ 26 positive 2020110008 2+ 22 positive 2020120011 - / negative
2020030077 - / negative 2020110009 2+ 24 positive 2020120012 - / negative
2020030078 3+ 21 positive 2020110010 2+ 26 positive 2020120013 - / negative
2020120014 - / negative
2020120015 - / negative
Note: “-” indicates the negative result, “1+, 2+, 3+” indicate positive result, the intensity increases from “1+” to “3+”. Ct Value：Cycle threshold