Ustar 20223 PDF

Ustar Biotechnologies (Hangzhou) Ltd.
INTRODUCTION
Ustar Biotechnologies was established in 2005, dedicated to the research,

development, manufacturing and sales of innovative POCT molecular diagnostic
products. Our vision is to make molecular tests available to anyone, anywhere, as
stated in our company slogan: “Molecular testing, anywhere!”
Ustar’s efforts were recognized by national government and organizations, won many
national grants and awards, and our COVID-19 nucleic acid tests were approved by
the Chinese FDA under the emergency use authorization.
We were also recognized by international organizations: We participate in the Bill &

Melinda Gates Foundation’s “Grand Challenges in Global Health” program, and won
2 major grants from the Foundation for developments of POCT molecular diagnostics
for Mycobacterium tuberculosis and Polio.
In addition to the grants, the Bill & Melinda Gates Foundation also invested Ustar by a
“Program Related Investment (PRI)”, and become one of Ustar’s shareholders.
Ustar has filed 48 patents, and has been granted 35 of them, including many from
world intellectual property organization (PCT).
Our platform technologies and products were also recognized by WHO, FIND
(Foundation for Innovative and New Diagnostics) and UNITAID (information available
upon request).
Ustar has developed novel molecular technology platforms for the diagnosis of
infectious diseases.
We have developed 2 nucleic acid diagnostic systems for the detection of

COVID-19:
1. Traditional real-time RT-PCR. We developed the RT-PCR reagents that can be

used at any existing real-time fluorescence PCR instruments the customers may
have. Or we can provide low cost instruments, 48 or 96 reaction formats available.
We can also provide small, low cost RNA auto-extraction instrument.
2. An integrated, automated system, The EasyNAT2.0 platform, consists of an

instrument and a disposable cartridge. “Sample-in, result-out”. Assay to result
time is 80 minutes, including sample lysis, RNA extraction, target amplification and
real time fluorescent detection. All performed in a closed cartridge, automatically.
All reagents, including enzymes, are pre-loaded. The user need only add samples.
After the addition of samples, the entire process will be performed automatically in
a closed cartridge, therefore reduces the operator’s risk of infection, and the risk
of false positive caused by aerosol cross-contamination. The reagents are
glassified (dehydrated), and can be transported at ambient temperatures. The
operation is very simple. The operator can use this system with 30 minutes of
training. It is a low throughput machine: 2 samples at one time, can deal with
around 10 patients a day per instrument.
Products 2 were developed according to WHO’s “ASSURED” guidance:
Affordable: The consumable and the machine costs are just fractions of
comparable products
Sensitive: Around 95% compared with clinical diagnosis
Specificity: Nearly 100% in the clinical studies and Lab analysis
User Friendly: Manual operation is very simple, requires about 30 minute training
Rapid: The entire process is approximately 80 minutes, including sample
lysis, RNA extraction, amplification & Detection
Equipment-free: there are instruments to reduce manual operations. But they are
small and low costs.
Deliverable: No cold train needed. The glassified reagents (including enzymes)
can be transported at any ambient temperature.
In addition, the system is safe to use: all assay procedures occurs in a closed
cartridge. No aerosol is generated or leaked during the operation, therefor greatly
reduces the operator's risk of infection, and prevent false positive by cross
contamination.
Our COVID-19 nucleic acid tests have obtained regulatory approvals from the
Chinese FDA (registration number: 国械注准 20203400241) and Singapore
government(Authorization number: MDPA2020-10).
The US FDA EUA application is accepted (EUA #: PEUA200021) and WHO EUL
application is under review process (ref: a0B1r00001DfEDt).
Company Qualification
ISO 13485
CE
CFDA
FSC
中华人民共和国
PEOPLE'S REPUBLIC OF CHINA
朕疗器械产品出口销售证明
CERTIFICATE FOR EXPORTATION OF MEDICAL
PRODUCTS
证书编号：浙杭食药监械出20200173号
Certificate NO.: 浙杭食药监械出20200173号
产品名称：新型冠状病毒2019-nCoV核酸检测试剂盒（恒温扩增－实时荧光法），
见附件（共1页）
Product(s): Di agnostic Kit for Novel-Coronavirus(2019-nCoV) RNA
(Isot hermal Amplificat ion-Real Time Fluorescence Ass ay), See Att achment
( 1 Page)
规格型号：见附件（共1 页）
Model: See Attachment ( 1 Page)
产品注册或备案凭证号：国械注准20203400241
Registration certificate (s): 国械注准20203400241
生产企业：杭州优思达生物技术有限公司
Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
生产企业住所：浙江省杭州市滨江区南环路3766号 801-808室
Address of manufacturer: No:801-808,F/8, 3766 Nanhuan Rd, Binjiang Dist,
Hangzhou, Zhejiang, China 310053
生产许可或备案凭证号：浙食药监械生产许20120044号
Manufacturing License (s): 浙食药监械生产许20120044号
兹证明上述产品巳准许在中国生产和销售。该产品出口不受限制，出口医疗器械
的企业应当保证其出口的医疗器械符合进口国（地区）的要求。
This is to certify that the above products have been registered to be
manufactured and sold in China. The exportation of the product (s) is
not restricted. The exporter should assure that exporting medical
devices meeting requirements of the importing country(region).
证明有效日期至： 2021年11月28日
This certification valid until: 2021/11/28
备注：／
Remark: /
Material Safety Data Sheet Page 1 / 1
Acc. To ISO/DIS 11014
Printing data 03/23/2020 Reviewed on 03/23/2020

Headquarter:
Fl 8, 3766 Nanhuan Rd, Binjiang Dist, Hangzhou, Zhejiang, China 310053
Manufacturer:
Bldg C, Fl 1-2 and Bldg A, Fl 5, 399 Qiuyi Rd, Changhe Street, Binjiang Dist, Hangzhou, China
310052
Tel: 86-571-88939358; 86-4008707025

Email: sales@bioustar.com; service@bioustar.com
Website: www.bioustar.com/en
Product Name:
Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time
Fluorescence Assay)
The following components are included:

COVID-19-Cartridge
COVID-19-RNA Extraction Solution
COVID-19-Positive Control (MSDS not required)
COVID-19-Negative Control (MSDS not required)
Disclaimer:
Information presented herein is accurate and reliable to the best of our knowledge and belief, but
is not guaranteed to be so. Nothing herein is to be construed as recommending any practice or any
product in violation of any patent or in violation of any law or regulation. It is the user’s
responsibility to determine for himself or herself the suitability of any material and/or procedure
for a specific purpose and to adopt such safety precautions as may be necessary. To determine the
safety impact of this product refers to the attached MSDS's for the products listed above.
Trade name: COVID-19-RNA Extraction Solution
1 Identification of substance
▪ Product details
▪ Trade name: COVID-19-RNA Extraction Solution
▪ Manufacturer/Supplier:
Bldg C, Fl 1-2 and Bldg A, Fl 5, 399 Qiuyi Rd,
Changhe Street, Binjiang Dist, Hangzhou, China 310052
Tel.: 86-571-8893 9358
Email: sales@bioustar.com
▪ Information department:
Technical Support
Fl 8, 3766 Nanhuan Rd, Binjiang Dist,
Tel.: 86-400-8707 025
Email: service@bioustar.com
▪ Emergency information:
Chemtrec: 4001-204937 (China, 24hours)
Chemtrec: +1 703-527-3887 (International, 24hours)
2 Composition/Data on components
▪ Chemical characterization
▪ Description:
Mixture of the substances listed below with nonhazardous additions.
▪ Dangerous components:
67-63-0 Isopropyl alcohol 30-70%
593-84-0 Guanidine thiocyanate 10-25%
50-01-1 Guanidine hydrochloride 10-25%
9005-64-5 Tween-20 1-5%
9002-93-1 Triton X-100 1-5%
3 Hazards identification
▪ Hazard description: Harmful

▪ Information pertaining to particular dangers for man and environment:
(Contd. on page 2)
(Contd. of page 1)
Harmful by inhalation, in contact with skin and if swallowed.
Contact with acids release very toxic gas.
▪ Classification system:
The classification was made according to the latest editions of international
substances lists, and expanded upon from company and literature data.
▪ NFPA ratings (scale 0 - 4)
Health = 2
Fire = 3
Reactivity = 0
▪ WHMIS-ratings (scale 0 - 4)
Health = 2
Fire = 3
Reactivity = 0
4 First aid measures
▪ General information:
Immediately remove any clothing soiled by the product.
▪ After inhalation:
Supply fresh air; consult doctor in case of complaints.
▪ After skin contact:
Immediately wash with water and soap and rinse thoroughly.
▪ After eye contact:
Rinse opened eye for several minutes under running water. Then call a doctor
immediately.
▪ After swallowing:
Call a doctor immediately.
5 Fire fighting measures
▪ Suitable extinguishing agents:

CO2, extinguishing powder or water spray.
Fight larger fires with water spray or alcohol resistant foam.
▪ Protective equipment:
Do not inhale explosion gases or combustion gases.
6 Accidental release measures
▪ Person-related safety precautions:

Ensure adequate ventilation.
▪ Measures for environmental protection:
Do not allow to enter sewers/ surface or ground water.
▪ Measures for cleaning/collecting:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal
binders, sawdust).
▪ Additional information:
See Toxicological information (item 11).
7 Handling and storage
▪ Handling:
▪ Information for safe handling:
Keep receptacles tightly sealed.
Ensure good ventilation/exhaustion at the workplace.
▪ Information about protection against explosions and fires:
No special measures required.
▪ Storage:
▪ Requirements to be met by storerooms and receptacles:
No special requirements.
▪ Information about storage in one common storage facility:
Do not store together with acids.
▪ Further information about storage conditions:
Store in cool, dry conditions in well sealed receptacles.
8 Exposure controls and personal protection
▪ Additional information about design of technical systems:

No further data; see Handling and storage (item 7).
▪ Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical
values that have to be monitored at the workplace.
(Contd. on page 4)
(Contd. of page 3)
▪ General protective and hygienic measures:
Keep away from foodstuffs, beverages and feed.
Wash hands before breaks and at the end of work.
Avoid contact with the eyes and skin.
▪ Protection of hands: Protective gloves
▪ Material of gloves:
The selection of the suitable gloves does not only depend on the material, but
also on further marks of quality and varies from manufacturer to manufacturer.
▪ Penetration time of glove material:
The exact break trough time has to be found out by the manufacturer of the
protective gloves and has to be observed.
▪ Eye protection: Goggles recommended during refilling.
9 Physical and chemical properties
▪ General Information
Form: Fluid.
Color: Colorless.
Odor: Alcohol-like.
▪ Change in condition
Melting point/Melting range: Undetermined.
Boiling point/Boiling range: Undetermined.
▪ Flash point: Not applicable.
▪ Auto igniting: Product is not selfigniting.
▪ Danger of explosion: Product does not present an explosion
hazard.
▪ Density: 1.1 g/ml at 20°C
▪ Solubility in / Miscibility
with Water: Fully miscible.
▪ pH-value: 6.4
10 Stability and reactivity
▪ Thermal decomposition / conditions to be avoided:

Heat, flames, and sparks. Extremes of temperature and direct sunlight.
(Contd. on page 5)
(Contd. of page 4)
▪ Dangerous reactions: Reacts with acids, alkalis and oxidizing agents.
▪ Dangerous products of decomposition: Danger of toxic pyrolysis products.
Carbon oxides.
11 Toxicological information
▪ Acute toxicity:
▪ Primary irritant effect:
▪ On the skin: Irritant to skin and mucous membranes.
▪ On the eye: Strong irritant with the danger of sever eye injury.
▪ Sensitization: No sensitizing effects known.
▪ Additional toxicological information:
The product shows the following dangers according to internally approved
calculation methods for preparations:
Flammable, harmful, irritant
12 Ecological information
▪ General notes:
Water hazard class 2 (Self-assessment): hazardous for water.
Do not allow product to reach ground water, water course or sewage system.
Danger to drinking water if even small quantities leak into the ground.
13 Disposal considerations
▪ Product:
▪ Recommendation:
Must not be disposed of together with household garbage. Do not allow
product to reach sewage system.
▪ Unclean packages:
▪ Recommendation: Disposal must be made according to official regulations.
▪ Recommended cleansing agent: Water, if necessary with cleansing agents.
14 Transport information
▪ DOT regulations:
▪ Hazard class: 8, 3
▪ Identification number: UN2920
▪ Packing group: I
▪ Proper shipping name (technical name): CORROSIVE LIQUID,
FLAMMABLE, N.O.S.
▪ Label 8, 3
▪ Land transport ADR/RID (cross-border):

▪ ADR/RID class: 8, 3
▪ UN-Number: 2920
▪ Packaging group: I
▪ Description of goods: 2920 CORROSIVE LIQUID,
FLAMMABLE, N.O.S.
▪ Maritime transport IMDG:

▪ IMDG Class: 8, 3
▪ UN Number: 2920
▪ Label 8, 3
▪ Marine pollutant: No
▪ Proper shipping name: CORROSIVE LIQUID,
FLAMMABLE, N.O.S.
▪ Air transport ICAO-TI and IATA-DGR:

▪ ICAO/IATA Class: 8, 3
▪ UN/ID Number: 2920
▪ Label 8, 3
▪ Proper shipping name: CORROSIVE LIQUID,
FLAMMABLE, N.O.S.
15 Regulations
▪ Sara(Superfund Amendments and Reauthorization Act)

▪ Section 313 (Specific toxic chemical listings):
None of the ingredients is listed.
▪ TSCA (Toxic Substances Control Act):

▪ Proposition 65
▪ Chemicals known to cause cancer:
▪ Chemicals known to cause reproductive toxicity for females:
▪ Chemicals known to cause reproductive toxicity for males:
▪ Chemicals known to cause developmental toxicity:
▪ Cancerogenity categories
▪ EPA (Environmental Protection Agency):
▪ IARC (International Agency for Research on Cancer):
▪ NTP (National Toxicology Program):
▪ TLV (Threshold Limit Value established by ACGIH):
▪ MAK (German Maximum Workplace Concentration):
▪ NIOSH-Ca (National Institute for Occupational Safety and Health):
▪ OSHA-Ca (Occupational Safety & Health Administration):
▪ Product related hazard information:
Observe the general safety regulations when handling chemicals.
The product is not subject to identification regulations according to directives
on hazardous materials.
(Contd. on page 8)
(Contd. of page 7)
▪ Hazard symbols:
Harmful
▪ Risk phrases:
R11 Highly flammable.
R20/21/22 Harmful by inhalation, in contact with skin and if swallowed
R32 Contact with acids liberates very toxic gas.
R36 Irritating to eyes.
R67 Vapours may cause drowsiness and dizziness
▪ Safety phrases:
S3 Keep in a cool place
S7 Keep container tightly closed
S13 Keep away from food, drink and animal feeding stuffs.
S15 Keep away from heat
S21 When using do not smoke
S24/25 Avoid contact with skin and eyes.
S26 In case of contact with eyes, rinse immediately with plenty of
water and seek medical advice.
S36/37/39 Wear suitable protective clothing, gloves and eye/face protection.
S46 If swallowed, seek medical advice immediately and show this
container or label.
▪ National regulations:
▪ Technical Instructions on Air Quality Control (TA Luft):
▪ Water hazard class:
Water hazard class 2 (Self-assessment): hazardous for water.
16 Other information
This information is based on our present knowledge. However, this shall not
constitute a guarantee for any specific product features and shall not establish a
legally valid contractual relationship.
Trade name: COVID-19-Cartridge
1 Identification of substance
▪ Product details
▪ Trade name: COVID-19-Cartridge
▪ Manufacturer/Supplier:
Bldg C, Fl 1-2 and Bldg A, Fl 5, 399 Qiuyi Rd,
Changhe Street, Binjiang Dist, Hangzhou, China 310052
Tel.: 86-571-8893 9358
Email: sales@bioustar.com
▪ Information department:
Technical Support
Fl 8, 3766 Nanhuan Rd, Binjiang Dist,
Tel.: 86-400-8707 025
Email: service@bioustar.com
▪ Emergency information:
Chemtrec: 4001-204937 (China, 24hours)
Chemtrec: +1 703-527-3887 (International, 24hours)
2 Composition/Data on components
▪ Chemical characterization
▪ Description:
Mixture of the substances listed below with nonhazardous additions.
▪ Dangerous components:
8002-74-2 Paraffin wax 5-15%
63148-62-9 Silicone oil 10-40%
3 Hazards identification
▪ Hazard description: Irritant to the eyes and skin

▪ Information pertaining to particular dangers for man and environment:
Irritant by inhalation, in contact with skin and if swallowed.
(Contd. on page 2)
(Contd. of page 1)
▪ Classification system:
The classification was made according to the latest editions of international
substances lists, and expanded upon from company and literature data.
▪ NFPA ratings (scale 0 - 4)
Health = 1
Fire = 1
Reactivity = 1
▪ WHMIS-ratings (scale 0 - 4)
Health = 1
Fire = 1
Reactivity = 1
4 First aid measures
▪ General information:
Immediately remove any clothing soiled by the product.
▪ After inhalation:
Supply fresh air; consult doctor in case of complaints.
▪ After skin contact:
Immediately wash with water and soap and rinse thoroughly.
▪ After eye contact:
Rinse opened eye for several minutes under running water. Then call a doctor
immediately.
▪ After swallowing:
Call a doctor immediately.
5 Fire fighting measures
▪ Suitable extinguishing agents:

CO2, extinguishing powder or water spray.
Fight larger fires with water spray or alcohol resistant foam.
▪ Protective equipment:
Do not inhale explosion gases or combustion gases.
6 Accidental release measures
▪ Person-related safety precautions:

Ensure adequate ventilation
▪ Measures for environmental protection:
Do not allow to enter sewers/ surface or ground water.
▪ Measures for cleaning/collecting:
Absorb with liquid-binding material (sand, diatomite, acid binders, universal
binders, sawdust).
▪ Additional information:
See Toxicological information (item 11).
7 Handling and storage
▪ Handling:
▪ Information for safe handling:
Keep receptacles tightly sealed.
Ensure good ventilation/exhaustion at the workplace.
▪ Information about protection against explosions and fires:
No special measures required.
▪ Storage:
▪ Requirements to be met by storerooms and receptacles:
No special requirements.
▪ Information about storage in one common storage facility:
Do not store together with acids.
▪ Further information about storage conditions:
Store in cool, dry conditions in well sealed receptacles.
8 Exposure controls and personal protection
▪ Additional information about design of technical systems:

No further data; see Handling and storage (item 7).
▪ Components with limit values that require monitoring at the workplace:
The product does not contain any relevant quantities of materials with critical
values that have to be monitored at the workplace.
(Contd. on page 4)
(Contd. of page 3)
▪ General protective and hygienic measures:
Keep away from foodstuffs, beverages and feed.
Wash hands before breaks and at the end of work.
Avoid contact with the eyes and skin.
▪ Protection of hands: Protective gloves
▪ Material of gloves:
The selection of the suitable gloves does not only depend on the material, but
also on further marks of quality and varies from manufacturer to manufacturer.
▪ Penetration time of glove material:
The exact break trough time has to be found out by the manufacturer of the
protective gloves and has to be observed.
▪ Eye protection: Goggles recommended during refilling.
9 Physical and chemical properties
▪ General Information
Form: Fluid.
Color: Colorless.
Odor: Characteristic.
▪ Change in condition
Melting point/Melting range: Undetermined.
Boiling point/Boiling range: Undetermined.
▪ Flash point: Not applicable.
▪ Auto igniting: Product is not selfigniting.
▪ Danger of explosion: Product does not present an explosion
hazard.
▪ Density: Undetermined.
▪ Solubility in / Miscibility
with Water: Undetermined.
▪ pH-value: Undetermined.
10 Stability and reactivity
▪ Thermal decomposition / conditions to be avoided:

No decomposition if used according to specifications.
(Contd. on page 5)
(Contd. of page 4)
▪ Dangerous reactions: Reacts with acids, alkalis and oxidizing agents.
▪ Dangerous products of decomposition: Danger of toxic pyrolysis products.
11 Toxicological information
▪ Acute toxicity:
▪ Primary irritant effect:
▪ On the skin: Irritant to skin and mucous membranes.
▪ On the eye: Irritant to the eye.
▪ Sensitization: No sensitizing effects known.
▪ Additional toxicological information:
The product shows the following dangers according to internally approved
calculation methods for preparations:
Irritant
12 Ecological information
▪ General notes:
Water hazard class 1 (Self-assessment): slightly hazardous for water.
Do not allow product to reach ground water, water course or sewage system.
13 Disposal considerations
▪ Product:
▪ Recommendation:
Must not be disposed of together with household garbage. Do not allow
product to reach sewage system.
▪ Unclean packages:
▪ Recommendation: Disposal must be made according to official regulations.
▪ Recommended cleansing agent: Water, if necessary with cleansing agents.
14 Transport information
▪ DOT regulations:
▪ Hazard class: 3
▪ Identification number: UN1993
▪ Packing group: II
▪ Proper shipping name (technical name): FLAMMABLE LIQUID, N.O.S.
▪ Label 3
▪ Land transport ADR/RID (cross-border):

▪ ADR/RID class: 3
▪ UN-Number: 1993
▪ Packaging group: II
▪ Description of goods: 1993 FLAMMABLE LIQUID,
N.O.S.
▪ Maritime transport IMDG:

▪ IMDG Class: 3
▪ UN Number: 1993
▪ Label 3
▪ Marine pollutant: No
▪ Proper shipping name: FLAMMABLE LIQUID, N.O.S.
▪ Air transport ICAO-TI and IATA-DGR:

▪ ICAO/IATA Class: 3
▪ UN/ID Number: 1993
▪ Label 3
▪ Proper shipping name: FLAMMABLE LIQUID, N.O.S.
15 Regulations
▪ Sara(Superfund Amendments and Reauthorization Act)

▪ Section 313 (Specific toxic chemical listings):
▪ TSCA (Toxic Substances Control Act):

▪ Proposition 65
▪ Chemicals known to cause cancer:
▪ Chemicals known to cause reproductive toxicity for females:
▪ Chemicals known to cause reproductive toxicity for males:
▪ Chemicals known to cause developmental toxicity:
▪ Cancerogenity categories
▪ EPA (Environmental Protection Agency):
▪ IARC (International Agency for Research on Cancer):
▪ NTP (National Toxicology Program):
▪ TLV (Threshold Limit Value established by ACGIH):
▪ MAK (German Maximum Workplace Concentration):
▪ NIOSH-Ca (National Institute for Occupational Safety and Health):
▪ OSHA-Ca (Occupational Safety & Health Administration):
▪ Product related hazard information:
Observe the general safety regulations when handling chemicals.
The product is not subject to identification regulations according to directives
on hazardous materials.
(Contd. on page 8)
(Contd. of page 7)
▪ Hazard symbols:
Irritant
▪ Risk phrases:
R10 Flammable.
R36/37/38 Irritating to eyes, respiratory system and skin.
▪ Safety phrases:
S13 Keep away from food, drink and animal feeding stuffs.
S26 In case of contact with eyes, rinse immediately with plenty of
water and seek medical advice.
S36/37/39 Wear suitable protective clothing, gloves and eye/face protection.
S46 If swallowed, seek medical advice immediately and show this
container or label.
▪ National regulations:
▪ Technical Instructions on Air Quality Control (TA Luft):
▪ Water hazard class:
Water hazard class 1 (Self-assessment): slightly hazardous for water.
16 Other information
This information is based on our present knowledge. However, this shall not
constitute a guarantee for any specific product features and shall not establish a
legally valid contractual relationship.
Instructions for Use
Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay) Product Instruction
Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real

Time Fluorescence Assay)
ǏProduct Nameǐ
Diagnostic Kit for Novel-Coronavirus(2019-nCoV) RNA (Isothermal Amplification-Real Time
Fluorescence Assay)
ǏSpecificationsǐ
20 tests/Box, Product Code: U20223
ǏExpected Usageǐ
This kit is used for the qualitative detection of pneumonia suspected cases of Novel-
Coronavirus(2019-nCoV) infection, patients with suspected clustering cases, other cases that need
to identify the novel coronavirus or oropharyngeal swab and sputum samples from patients who
need to be diagnosed with Novel-Coronavirus(2019-nCoV) ORF1ab gene, N gene.
The definitions of "suspected cases" and "suspected clustered cases" and other groups are
implemented with reference to documents such as the "Pneumonitis Diagnosis and Treatment
Program for Novel Coronavirus Infection" and "Monitoring Scheme for Pneumonia Cases with
Novel Coronavirus Infection."
This product is only used in the pneumonia outbreak of the novel coronavirus (2019-nCoV) since
December 2019. The auxiliary diagnosis of related cases and the emergency reserve for in vitro
diagnosis of this epidemic cannot be used in the clinic as conventional in vitro diagnostic reagents.
And the relevant requirements of the "Pneumonitis Diagnosis and Treatment Program for Novel
Coronavirus Infection" and "Pneumonitis Prevention and Control Scheme for Novel Coronavirus
Infection" should be complied with.
Carrying out the detection of novel coronavirus (2019-nCoV) RNA should meet the requirements
of "Technical Guide for Laboratory Testing of Pneumonia of Novel Coronavirus Infection" and
take good biological protection measures. The results of the kit are for clinical reference only and
should not be used as the sole standard for clinical diagnosis. It is recommended to conduct a
comprehensive analysis of the condition in combination with the clinical manifestations of the
patient and other laboratory tests.
ǏMain Componentsǐ
The kit is composed by the components in Table 1:
Table 1 Main Components

1
S/N Name of Components Specification Quantity Main components
Tris, MgSO4, 2019-nCoV specific primers and probe,

human GAPDH specific primers and probes,
1 2019-nCoV -Cartridge 20
1 test/cartridge deoxyribonucleoside triphosphate (dNTP), DNA
cartridges
polymerase
2019-nCoV -RNA
2 1 mL/test/tube 20 tubes Guanidine salt, Magnet beads
Extraction Solution
3 2019-nCoV -Positive Control 1.2 mL/tube 1 tube containing ORF1ab and N gene target fragments
2019-nCoV -Negative
4 1.2 mL/tube 1 tube containing human GAPDH target fragment
Control
Notes:
1. The components in different batches of kits cannot be used interchangeably.
2. Sample preservation solution: Youkang Hengye Biotechnology (Beijing) Co., Ltd/ Registration
Certificate No˖ӜỠ⌘߶ 20182400236
Ǐ Test Principleǐ
The 2019-nCoV- cartridge in this kit is equipped with multiple hydrophobic separation layers to
isolate the lysate, cleaning solution and reaction solution in the cartridge. Controlled by an external
instrument, the extract is chemically cracked at high temperatures to test the sample and release the
nucleic acid. Through the magnetic permeability of the external instrument, the nucleic acid of the
specimen used for detection passes through different liquid layers, and finally the nucleic acid is
eluded in the cartridge leg and the expansion reaction
occurs, so as to realize the "one tube" full-automatic
nucleic acid analysis, that is, the cleavage binding,
cleaning, elution and amplification reaction are
completed in a closed test tube.
This kit used Crossing Priming Amplification
(CPA1) to detect ORF1ab and N gene sequences specific
to the novel coronavirus (2019-nCoV). Through specific
amplification primers, specific fluorescent probes and
DNA polymerases with high activity of reverse
transcriptase and chain displacement characteristic, the reaction system can complete the specific
amplification process of novel coronavirus fragments at a single time at a constant temperature, and
the fluorescence signal is detected by adaptive instruments and real-time fluorescence curve is
2
automatically generated.
The 2019-nCoV- cartridge is include an internal standard (IC),which consists of a CPA system
that specifically detects human GAPDH mRNA to monitor the effectiveness of sampling, extraction,
purification, and amplification reactions. 2019-nCoV- cartridge is pre-loaded with nucleic acid
purification reagents, nucleic acid elution reagents and CPA reaction reagents. Before starting the
instrument, the user only needs to add 2019-nCoV-RNA extract and the sample to be tested, and the
RNA in the sample can be purified automatically under the control of the adaptive instrument. After
the purified RNA and CPA reaction reagent are mixed and heated by the adaptive instrument, the
constant temperature expansion will be carried out, and the fluorescence probe will specifically bind
to the target to produce fluorescence signal. The instrument can collect the fluorescence signal in
real time and analyze the change of the fluorescence signal to determine the test result automatically.
ǏStorage conditions and Expiration dateǐ

Store at 2ć-8ć, expiration date is 6months. Please refer to the label for production date and
expiration date
ǏSample Requirementsǐ
1. Applicable for: Oropharyngeal swabs and sputum.
2. Sample collection refers to "Technical Guidelines for Laboratory Testing of Pneumonia Due to
Novel Coronavirus Infection (Current Edition)":
a) Oropharyngeal swab ˖Gently wipe the bilateral pharyngeal tonsils and the posterior pharyngeal
wall simultaneously with two plastic rod swabs of polypropylene fiber head, immerse the swab head in a
tube containing 3ml of sampling solution, discard the tail, and tighten the tube cap tightly.
b) Sputum: After the patient is asked to have a deep cough, collect the coughed sputum in a screw
mouth plastic tube containing 3ml of sampling solution, and screw the tube cap tightly.
3. Sample Pre-treatment
3.1 Add an equal volume of proteinase K buffer (0.4mg / mL) to the sputum sample, shake for 15s
3.2 Place Oropharyngeal swab or sputum sample in a 56 ° C water bath for 30 minutes to inactivate.
After inactivation
3.3 The supernatant of the oropharyngeal swab specimen was directly added to the test tube as the test
sample; the sputum sample was centrifuged at 13,000 rpm for 3 minutes, and the supernatant was
taken as the test sample and added to the test tube.
4. Storage˖
According to the "Technical Guide for Laboratory Testing of Pneumonia of Novel Coronavirus
Infection (Current Edition)", throat swabs or sputum samples should be submitted for inspection
tested as soon as possible. Specimens that can be tested within 24 hours can be stored at 4 ° C;
3
The tested specimens should be stored at -70 ° C or below (if there is no -70 ° C storage conditions,
they should be temporarily stored in a -20 ° C refrigerator). A special library or counter should be
set up to keep specimens separately. Avoid repeated freeze-thaw cycles during specimen transport.
5. Transportation:
Specimens should be sent to the laboratory as soon as possible after collection. If the specimens
need to be transported over long distances, it is recommended to use dry ice for preservation.
Ǐ Applicable Instrument ǐ Nucleic acid amplification and detection analyzer produced by Ustar
Biotechnologies (Model UC0102)
Nucleic acid amplification and detection analyzer embedded software version: v1.
ǏInspection Methodǐ:Refer to the manual
1. Sample Inspection
1.1 Sample addition
1.1.1 Thoroughly mix the 2019-nCoV-RNA extracting solution, and then transfer it to the 2019-nCoV-RNA-
cartridge.
1.1.2 Add 500μL (oropharyngeal swab test sample) or 200μL (sputum supernatant test sample) to 2019-
nCoV-RNA-cartridge, cover the lid tightly, shake well (paraffin may float, continue to the next step) and
wait to be tested.
1.2 Running Test
Important Reminder: This section lists the basic steps for running the test. While check the instructions for
the applicable instrument for details.
1.2.1 Input test tube information: System will automatically input the test tube information and
the amplification detection program CoV10 when scanning the QR code of the prepared test tube
(located above the lid of the test tube) according to Inspection Method 1.2. If it cannot be input
automatically, then entered manually by clicking the Scan QR Code of the Detection Tube on the
applicable instrument.
1.2.2 Input sample information: System will automatically input the sample information when
scanning the bar code of test tube according to step 1.2.1 on the applicable instrument. If it cannot
be input automatically, then entered manually by clicking the Scan the QR Code of the Detection
Tube of the applicable instrument.
1.2.3 Start Testing: Put the test tube in the sample chamber of the applicable instrument, cover the
sample chamber, and click the Start button on the touch screen of the applicable instrument. The
instrument will start the test procedure and the countdown will be displayed on the screen. The
4
total test duration was 79 minutes, including: sample processing for 39 minutes (CoVtq), and
amplification at 58 ° C for 40 minutes (CoVfr).
1.3 Test Result
After testing, the results will be displayed and saved automatically. For details, please refer to
Interpretation of the Test Results.
2. Quality Control
2.1 Thoroughly mix the 2019-nCoV-RNA extracting solution, and then transfer it to the 2019-
nCoV-RNA-cartridge.
2.2 Add 500μL 2019-nCoV- positive control or 2019-nCoV -negative control to 2019-nCoV-RNA-
cartridge, cover the lid tightly, shake well (paraffin may float, continue to the next step) and wait to be
tested.
2.3 Other operations are the same as steps Inspection Method 1.2-1.3
ǏCut-off Value for Positive Resultsǐ
As soon as the test program is complete, the analyzer will report test results automatically.
The analyzer calculates Tt values for the amplification curves of gene ORF1ab, N, and both ICs,
respectively, and reports positive or negative results by the following criteria:
l If the Tt value of gene ORF1ab is N/A, test result for gene ORF1ab will be ‘Negative’. If the Tt
value of gene ORF1ab is ื40, test result for gene ORF1ab will be ‘Positive’.
l If the Tt value of gene N is N/A, test result for gene N will be ‘Negative’. If the Tt value of gene
N is ื40, test result for gene N will be ‘Positive’.
l If the Tt value of an IC is N/A, test result for the corresponding IC will be ‘Negative’. If the Tt
value of an IC is ื40, test result for the corresponding IC will be ‘Positive’.
ǏInterpretation of the Test Resultsǐ
Table 2 Test Results and Interpretation
Test Result Interpretation
Gene ORF1ab and/or N is ‘Positive’, which means 2019-nCoV RNA

Positive is detected in the sample.
Remark: Test result for either IC is not required.
5
Both gene ORF1ab and N are reported as ‘Negative’, and ICr and/or
Negative
ICl is ‘Positive’, which means no 2019-nCoV RNA is detected in the
sample.
Gene ORF1ab , N, ICr, and ICl are all ‘Negative’, which means the
Invalid
test fails in detecting 2019-nCoV RNA or human GAPDH mRNA.
No Results Insufficient data for analysis.
1. Conditions That Require a Retest
If any of the following situations occur, please retest with a new COVID-19-Automatic test tube.
l Invalid results. Invalid results may be caused by improper sample collection/processing

procedures, inhibition of test reagent, or expired products.
l No results. The test is aborted .before the due time.
l Abnormal results of external quality control (COVID-19-positive control and 2019-ncov-negative

control). For example, if the COVID-19-negative control reports a positive result, there may be
contamination in the experiment area.
2ˊQuality Control
This product contains Internal Quality Control and External Quality Control.
2.1 Internal Quality Control
Internal Quality Control is intended to monitor failures in sample collection, sample

processing, amplification reagents, and malfunctions of analyzers.
If a 2019-nCoV Positive result is reported, the test results of ICs are not required. However,
at least one IC must be positive, if a 2019-nCoV Negative result is reported. The analyzer
reports Invalid results if amplification fails in all fluorescence channels.
2.2 External Quality Control
The COVID-19-positive control in the kit is an artificially constructed nucleic acid fragment containing the
target gene of novel corona virus. It is used to monitor the failure of the amplification reagents, and the
malfunctions of analyzers. The COVID-19-negative control is distilled water to monitor potential
contamination in the amplification reagents and in the experiment area.
The test result of COVID-19-positive control should be Positive (Ttื40 for ORF1ab or N ), while the test
6
result of COVID-19-negative control should be Negative(Tt=N/A for ORF1ab and N, and Tt≤40 for at
least one IC).
ǏThe Limitation of the Test Method ǐ
1. Test results from this product are only for reference clinical physicians. For patients’ clinical
diagnosis and treatment, it should be considered in combination with their symptoms, signs,
medical history, other laboratory tests, and therapeutic effects.
2. False negative results may come from improper sample collection, transportation, and
processing procedures, or samples with low viral load.
3. Other unverified interfering substances or amplification inhibitors may cause false negative
results.
ǏProduct Performance Indexǐ
1. Consistency rate on Positive Reference Panels: Test results on all samples in the National
Positive Reference Panel should be 2019-nCoV Positive.
Test results on all samples in the Enterprise Positive Reference Panel should be 2019-nCoV
Positive.
2. Consistency rate on Negative Reference Panels: Test results on all samples in the National
Positive Reference Panel should be 2019-nCoV Negative.
Test results on all samples in the Enterprise Negative Reference Panel should be 2019-nCoV
Negative.
3. Consistency rate on Reproducibility Reference Panels: Test results on all samples in the
National Reproducibility Reference Panel should be 2019-nCoV Negative.
Test results on all weakly positive samples in the Enterprise Reference Panel should be 2019-
nCoV Negative.
Test results on all moderately positive samples in the Enterprise Reference Panel should be 2019-
nCoV Negative.
4. Limit of Detection (LOD): The LOD of this product is 1×103 copies/mL.

Using the National Sensitivity Reference Panel, test results are positive on S1-S3 samples, which
meet the criteria of related requirements.
5. Reproducibility: Three different lots of products were tested on moderately positive samples,
weakly positive samples, and negative samples, by two operators in twenty days. The inter- and
intra-lot reproducibility, inter- and intra-day reproducibility, as well as inter- and intra-operator
7
reproducibility should be 100% for all test rest results.
6. Interfering substances: The following substances have no effects on test results of this product.
6.1 Endogenous interfering substances: human blood(1% v/v), human mucoprotein (1% v/v),
human genomic DNA (300 mg)
6.2 Nasal spray or nose drops: Phenylephrine , hydroxymethozolin, sodium chloride (with
preservative) (1% v/v)
6.3 Exogenous interfering substances: Beclomethasone, dexamethasone, fluorinone,

triamcinolone acetonide, budesonide, mometasone, fluticasone; histamine hydrochloride;
interferon α, zanamivir, ribavirin, oseltamivir, palamivir, arbidol, lopinavir, ritonavir;
mopirosin, levofloxacin, azithromycin, cephalosporin, minocycline, tobramycin.
7. Cross-reactivity: Inactivated cultures or nucleic acid extracts from following respiratory
pathogens have no effect on the performance of the kit, including: human coronavirus (HKU1,
OC43, NL63 and 229E), SARS coronavirus, MERS coronavirus ; Influenza virus (H1N1, H3N2,
H5N1, H7N9), influenza B virus BY, influenza B virus BV, respiratory syncytial virus A,B,
parainfluenza virus 1, 2, 3, rhinovirus, adenovirus, Enterovirus , Human Interstitial Pneumovirus
(Human Metapneumovirus), Epstein Barr Virus, Measles Virus, Human Cytomegalovirus,
Rotavirus, Norovirus, Mumps Virus, Varicella-Zoster Virus; Mycoplasma Pneumoniae,
Pneumonia Chlamydia; Legionella, Pertussis, Haemophilus influenzae, Staphylococcus aureus,
Streptococcus pneumoniae, Streptococcus pyogenes, Klebsiella pneumoniae, Mycobacterium
tuberculosis; Aspergillus fumigatus, Candida albicans, Candida parapsilosis, Cryptococcus
neoformans.
8. Clinical evaluation: clinical trials of 592 samples were completed in five clinical institutions,
compared with comparison kit that have been approved for marketing: positive compliance rate of
98.0%, negative compliance rate of 95.4%, and a total compliance rate of 96.3%.
ǏAttentionsǐ
1. This product contains no human-derived materials.
2. Please read instructions carefully before use.
3. Before using the product, you need to test 2019-nCoV-positive control and 2019-nCoV-negative
control. For the operation method, please refer to [Inspection Method-Quality Control].
4. This kit is disposable
5. All samples and other materials should be disposed in accordance with [Medical Waste
8
Management Regulations] 2
6. The work table and required items need to be disinfected regularly with 1% sodium hypochlorite,
75% alcohol or ultraviolet lamp.
7. The 2019-nCoV-RNA extract contains insoluble particles. Please mix well before pipetting.
8. Please ensure that the QR code of the 2019-nCoV-cartridge (located above the cover of cartridge)
is clean, clear and should not be written or painted, so as not to affect the function of QR code.
9. 2019-nCoV-cartridge shall be amplified immediately once opening.
10. Do not open the lid of the sample chamber when running test.
11. The instrument will save test results automatically, please check in the View interface.
12. Do not squeeze the middle and lower part of the 2019-nCoV-cartridge when operating.
13. Please operate strictly in accordance with the instructions, the 2019-nCoV-cartridge is not
allowed to insert first.
14.Operators should use the product in a laboratory with biosafety protection and need to wear
protective equipment.
15.All items and samples to be tested in the laboratory shall be considered to be contagious, and
all operations in the laboratory shall conform to the [General Guidelines for Biosafety of
Microbiology Laboratory] 3.
16. Various factors may cause performance changes during the storage, transportation, and
use of reagents. For example, improper storage, transportation, sample collection, sample
processing and testing procedures are not standardized. Please strictly follow the
instructions. Due to the characteristics of the sample collection such as oropharyngeal swabs
sample and virus infection, there may be false negative results caused by insufficient sample
volumeˈother factors should be comprehensively judged in conjunction with other clinical
diagnosis and treatment information and retested if necessary.
ǏExplanation of logoǐ
None
ǏReferencesǐ
1. Xu G, Hu L, Zhong H, etc. Cross priming amplification: mechanism and

optimization for isothermal DNA amplification. Sci. Rep. 2012;2:246.
2. Regulations on the management of medical waste: promulgated by the state

council of the People's Republic of China on June 16, 2003.
9
3. General Guidelines for Biosafety in Pathogenic Microbiology Laboratories:
Issued by the National Health and Family Planning Commission of the People's
Republic of China on July 24, 2017
ǏManufacturer informationǐ
Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Registered address: Fl 8, 3766 Nanhuan Rd, Binjiang Dist, Hangzhou, Zhejiang Province, China
310053
Telephone: +86571 88939388
Fax: +86571 88939378
Company website: http://www.bioustar.com/en/
Sale Service: Ustar Biotechnologies (Hangzhou) Ltd.
Technical support: 86-4008707025
Address of manufacturing:Bldg C, Fl 1-2 and Bldg A, Fl 5, 399 Qiuyi Rd, Changhe Street,
Binjiang Dist, Hangzhou, China 310052
Production license number: Zhejiang Food and Drug Supervisory Production/Production No.
20120044
ǏMedical Device Registration Certificate Number/Product Technical Requirement
NumberǐഭỠ⌘߶ 20203400241
ǏDate of approval and amendment of the manualǐMarch 16, 2020
10
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Ustar Biotechnologies (Hangzhou) Ltd.

Ustar Biotechnologies was established in 2005, dedicated to the research,

We were also recognized by international organizations: We participate in the Bill &

We have developed 2 nucleic acid diagnostic systems for the detection of

1. Traditional real-time RT-PCR. We developed the RT-PCR reagents that can be

2. An integrated, automated system, The EasyNAT2.0 platform, consists of an

Products 2 were developed according to WHO’s “ASSURED” guidance:

Ustar Biotechnologies (Hangzhou) Ltd.

Tel: 86-571-88939358; 86-4008707025

The following components are included:

Trade name: COVID-19-RNA Extraction Solution

▪ Hazard description: Harmful

Trade name: COVID-19-RNA Extraction Solution

4 First aid measures

5 Fire fighting measures

▪ Suitable extinguishing agents:

Trade name: COVID-19-RNA Extraction Solution

6 Accidental release measures

▪ Person-related safety precautions:

7 Handling and storage

8 Exposure controls and personal protection

▪ Additional information about design of technical systems:

Trade name: COVID-19-RNA Extraction Solution

9 Physical and chemical properties

10 Stability and reactivity

▪ Thermal decomposition / conditions to be avoided:

Trade name: COVID-19-RNA Extraction Solution

Trade name: COVID-19-RNA Extraction Solution

▪ Land transport ADR/RID (cross-border):

▪ Maritime transport IMDG:

▪ Air transport ICAO-TI and IATA-DGR:

Trade name: COVID-19-RNA Extraction Solution

▪ Sara(Superfund Amendments and Reauthorization Act)

▪ TSCA (Toxic Substances Control Act):

Trade name: COVID-19-RNA Extraction Solution

Trade name: COVID-19-Cartridge

▪ Hazard description: Irritant to the eyes and skin

Trade name: COVID-19-Cartridge

4 First aid measures

5 Fire fighting measures

▪ Suitable extinguishing agents:

Trade name: COVID-19-Cartridge

6 Accidental release measures

▪ Person-related safety precautions:

7 Handling and storage

8 Exposure controls and personal protection

▪ Additional information about design of technical systems:

Trade name: COVID-19-Cartridge

9 Physical and chemical properties

10 Stability and reactivity

▪ Thermal decomposition / conditions to be avoided:

Trade name: COVID-19-Cartridge

Trade name: COVID-19-Cartridge

▪ Land transport ADR/RID (cross-border):

▪ Maritime transport IMDG:

▪ Air transport ICAO-TI and IATA-DGR:

Trade name: COVID-19-Cartridge

▪ Sara(Superfund Amendments and Reauthorization Act)

▪ TSCA (Toxic Substances Control Act):

Trade name: COVID-19-Cartridge

Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real

20 tests/Box, Product Code: U20223

The kit is composed by the components in Table 1: