1. Introduction 1.1. Overview This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). 1.2. Intended Use/Purpose COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings. 1.3. Scope This risk analysis addresses the safety risks that may affect the patient or the operator as associated with the operation of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma), which references the standard of ISO 14971:2012.

1. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 1 of 16
Risk Analysis Report
COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
Zhejiang Orient Gene Biotech Co., Ltd

2. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 2 of 16
1. Introduction
1.1. Overview
This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma).
1.2. Intended Use/Purpose
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic
assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in
human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive
specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed
with alternative testing method(s) and clinical findings.
1.3. Scope
This risk analysis addresses the safety risks that may affect the patient or the operator as associated with the
operation of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma).
This document provides a safety risk analysis for COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma), which references the standard of ISO 14971:2012.
Safety Risk Analysis Table
Definition of Severity
Severity
Ranking
Severity Ranking
(descriptive)
Description
1 Negligible Temporary discomfort or no injury to user /
operator
2 Marginal Injury (usually requiring medical intervention) to
user / operator
3 Critical Severe injury or impairment to user / operator
4 Catastrophic Life-threatening or death to user / operator
Definition of Probability of Occurrence
Ranking Likelihood Description Probability (in
fractions)
Probability (in
percentage)
1 Incredible Almost impossible to occur N/A N/A
2 Improbable Unlikely to occur N < 1/10,000 N < 0.01%
3 Remote Unlikely but possible to
occur
1/10,000 < N
<1/1,000
0.01% < N < 0.1%
4 Occasional Likely to occur sometime 1/1,000 < N <
1/100
0.1% < N < 1%
5 Probable Likely to occur several
times
1/1,00 < N < 1/10 1% < N < 10%
6 Frequent Likely to occur frequently 1/1,0 < N 10% < N
Risk Assessment Tables
Probability
Frequent
Probable
Occasional

3. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 3 of 16
Remote
Improbable
Incredible
Negligible Marginal Critical Catastrophic
Risk Assessment Level
Risk Assessment Level
Level Safety Risk Description
Red Unacceptable Risk in this region in not tolerated. Resolution Required –
re-design, do not release.
Blue ALAP
As Low as possible
Risks are reduced to As Low As Possible.
The risk is acceptable after reduction of risk as low as possible
when compare to the benefit resulting from its
acceptance,without there being any room for economic
consideration
Green Acceptable Risk is considered to be negligible compared to the risk of other
hazards.

4. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 4 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
False
Results
Users
requires
medical
attention
Critical
raw
material
Critical Occasional Unacceptable Design &
Development
Control
(QSP-1000)
require
product
testing,
verification &
validation;
incoming QC
inspection
must be done
(QSP-2100)
Critical Incredible Acceptable Yes [ ]
_______
No [√]
_______
A0148-1
Inadequate
stability of
the raw
material
Critical Occasional Unacceptable Qualification
of alternate
suppliers if
possible
(QSP-1200),
appropriate
QC inspection
criteria
Critical Incredible Acceptable Yes [ ]
_______
No [√]
_______
A0148-2

5. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 5 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
(QSP-2100).
Stability
testing should
be done.
The quality
of the
antigen
does not
produce
the
expected
performan
c
Critical Occasional Unacceptable Design control
require
verification
and validation
(QSP-1000).
Incoming QC
inspection
documents
(QSP-2100)
Critical Improbable ALAP Yes [ ]
_______
No [√]
_______
A0148-3
False
Results
Users
requires
medical
attention
The
sample
pad does
not
conform to
specificatio
ns
Critical Occasional Unacceptable Manufacture
Process
Control
Procedure
(QSP-1400),
Incoming QC
inspection
Critical Improbable ALAP Yes [ ]
_______
No [√]
_______
A0148-4

6. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 6 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
documents
(QSP-2100),
and
Manufacture
SOPs
The raw
material
Storage
conditions
not correct
Critical Occasional Unacceptable The shelf life
of the raw
material
should be
defined in
COA from
vender and
validated by
R&D during
the product
development;
Manufacturing
SOPs
Critical Incredible Acceptable Yes [ ]
_______
No [√]
_______
A0148-5
Operator
not
following
Critical Occasional Unacceptable C line
solution, T
line solution,
Critical Improbable ALAP Yes [ ]
_______
No [√]
A0148-6

7. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 7 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
manufactur
ing
procedures
Label pad
manufacturing
SOPs & QC
inspection
documents;
training
procedures
(QSP-2600)
_______
False
Results
Users
requires
medical
attention
Bad
adhesive
ability of
the
component
(deviation
from
specificatio
ns)
Critical Occasional Unacceptable IQC-0020
(White
Polystyren
e Backing
Splits
Inspection
Specification
Critical Incredible Acceptable Yes [ ]
_______
No [√]
_______
A0148-7
The
desiccant is
missing
Critical Occasional Unacceptable QSR-2107
(Desiccant
Inspection
Specificati
Critical Incredible Acceptable Yes [ ]
_______
No [√]
_______
A0148-8

8. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 8 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
on)
Incorrect
QC
Samples
used,
inappropria
te QC
procedure
Critical Occasional Unacceptable Manufacturing
& QC
inspection
documents;
training
procedures
(QSP-2600)
Critical Incredible Acceptable Yes [ ]
_______
No [√]
_______
A0148-9
False
Results
Users
requires
medical
attention
Storage
conditions
are not
correct
(2°C to
30°C)
Critical Occasional Unacceptable Package insert
and labeling
provides the
proper storage
conditions.
Critical Incredible Acceptable Yes [ ]
_______
No [√]
_______
A0148-10
The
labeling is
altered or
lost
Critical Remote ALAP Manufacturing
SOPs & QC
inspection
documents
Critical Incredible Acceptable Yes [ ]
_______
No [√]
_______
A0148-11
Incorrect
test is
assembled
Critical Remote ALAP Manufacturing
SOPs & QC
inspection
Critical Incredible Acceptable Yes [ ]
_______
No [√]
A0148-12

9. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 9 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
documents _______
False
Results
Users
requires
medical
attention
The
nature/char
acteristic
of the
sample
gives
interferenc
e
Critical Occasional Unacceptable Validation
studies
(QSP-
1000)
Critical Incredible Acceptable Yes [ ]
_______
No [√]
_______
A0148-13
Cross
reaction
with other
interferenc
e
substances
Critical Occasional Unacceptable Interferences
substances
were tested
during
development
and field trials
Critical Improbable ALAP Yes [ ]
_______
No [√]
_______
A0148-14
Interferenc
es due to
the
different
types of
samples
Critical Probable Unacceptable The different
samples to use
are tested
during
development
and field
Critical Improbable ALAP Yes [ ]
_______
No [√]
_______
A0148-15

10. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 10 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
trials. The
package insert
indicates
which samples
to use.
False
Results
Users
requires
medical
attention
Finger
contact
leads to
contaminat
ion of the
test
Critical Probable Unacceptable The package
insert warns
the user not to
touch the
membrane
Critical Improbable ALAP Yes [ ]
_______
No [√]
_______
A0148-16
Incorrect
Reading
Users
requires
medical
attention
Cassette
was
removed
before
measureme
Marginal Occasional ALAP The package
insert warns
the user not to
remove the
strip before
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-17

11. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 11 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
nt
complete
measurement
complete
Test was
used or
dirty
Marginal Occasional ALAP Information in
the package
insert
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-18
Insufficient
or
superabund
ant sample
applied
Marginal Occasional ALAP Information in
the package
insert
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-19
Users
requires
medical
attention
Ambient
temperatur
e too high
or too low
Marginal Occasional ALAP The storage
conditions of
the sample are
established
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-20

12. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 12 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
during
development
and
validation.
The package
insert
mentions the
condition of
sample
storage
Instruction
s for use
regarding
Read
Result
Time not
followed.
Marginal Occasional ALAP The read
result times
are established
during
development
and validated
during the
validation
studies. The
package insert
describes the
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-21

13. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 13 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
correct
reading time.
Confusion
between
Control
line and
test line
band
results
Marginal Occasional ALAP Information
presented in
the package
insert
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-22
Users/
Bystander
contamina
tion
Health
Risk
The user is
in contact
with the
sample
during or
after
sample
application
Marginal Remote ALAP The package
insert warns
the user that
the sample is
potentially
infectious.
Insure proper
handing.
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-23

14. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 14 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
Biological
and/or
chemical
contaminat
ion
Marginal frequent Unacceptable The package
insert warns
the user about
any
potentially
hazardous
material and
Insure proper
handing.
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-24
The
bystander
is
contaminat
ed with the
biological
material
(raw
material of
animal
origin)
Marginal Remote ALAP The package
insert informs
the user about
the biological
material
present in the
test. The raw
material is
controlled to
insure the
absence of
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-25

15. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 15 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
contained
in the test
during the
removal of
unused or
expired
material.
infectious
agents.
Environm
ental
Hazard
Health
Risk
Removal
of test that
contains
(BSA,
antibodies)
Marginal Remote ALAP The package
insert warns
the user about
the removal
conditions,
The raw
material is
controlled to
insure the
absence of
infectious Ab.
The antibody
and BSA are
in very low
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-26

16. COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
File No：TF- COVID-19
Version: 1.0 Page:
Page 16 of 16
Risk Assessment before Mitigation Risk Assessment after Mitigation
Hazard Adverse Cause Risk Definition Risk
Evaluation
Risk Risk Definition Risk
Evaluation
Any New
Hazard be
Generated
Item
Hazard Adverse Cause Severity Probability
of
Occurrence
Risk
Evaluation
Risk Severity Probability
of
Occurrence
Risk
Evaluation
Any New
Hazard
Item
concentrations
and under a
dry form on
the membrane,
label pad.
Non
recycling
plastic
(Adhesive
backing)
Marginal frequent Unacceptable Adhesive
backing
should be
recyclable
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-27
Non
recycled
packaging
Marginal frequent Unacceptable Packaging
recyclable
Marginal Improbable Acceptable Yes [ ]
_______
No [√]
_______
A0148-28
Conclusion: The Risk Control Measure Effectiveness and Verification Methods Effectiveness has been reviewed and all hazards / risks are either acceptable or ALAP
Prepared by Reviewed by
Date 2020-02-11 Date 2020-02-12