8 - Product Performance - Panbio COVID-19

Abbott Rapid Diagnostics Jena GmbH
6. Product Performance Specification, and Associated

Validation and Verification Studies
For performance qualification of Panbio™ COVID-19 IgG/IgM Rapid Test

Device three different test device lots were tested:
- Panbio™ COVID-19 IgG/IgM Rapid Test Device, Validation Lot

Number: COV0042001, expiry date 03-2021 (lot size 6375 test devices)
Number: COV0042002, expiry date 03-2021 (lot size 6375 test devices)
Panbio™ COVID-19 IgG/IgM Rapid Test Device, Validation Lot Number:

COV0042003, expiry date 03-2021 (lot size 6375 test devices)
All performance studies were performed according to standard EN

13612:2002. Any additional standards used are indicated in the individual
study sub-section.
6.1. Analytical Studies

All analytical studies were performed by laboratory personnel at the study
sites indicated within the following sub-sections.
Specimen Type
6.1.1.1. Performance Equivalency: Serum, Plasma, Venous and
Capillary Whole Blood,
Study Summary Serum/plasma/whole blood consistency study

Report:
Report: See Section 7.8 of report B2020001-04-07
Study Dates: 2020/04/07
Conducted by: QC department of ABON Biopharm (Hangzhou)
Co.,LTD
Testing: Performed at QC Laboratory
Extract from ICO-T402_TF01 Version 01 Confidential

Panbio™ COVID-19 IgG/IgM RTD Page 96 of 163
Study Objective
The purpose of this study was to evaluate the impact of specimen types
(human serum, EDTA plasma, venous and capillary whole blood) on test
results generated with the Panbio™ COVID-19 IgG/IgM Rapid Test Device.
Materials
Product

Number: COV0042003
- Comparator rapid test device (Innovita), Lot Number 20200302
Testing Specimens
For each specimen type 25 negative samples as well as 25 anti-SARS-COV-2
IgG positive samples were tested (Table 6.1-1) according to the product claim.
Table 6.1-1: Tested specimens*

anti-SARS-CoV-2
anti-SARS-CoV-2
Negative IgM Positive
Specimen Type IgG Positive
Samples (Spiked)
(Spiked) Samples
Samples
Serum 25 25 3
EDTA plasma 25 25 3
EDTA venous whole 3
25 25
blood
Fingerstick whole 3
25 5
blood
*For details on specimen see report B2020001-04-07.
Other Materials
- Serum-separating tube (without anticoagulant): Lot Number 1910222
- EDTA vacuum blood collecting tube: Lot Number 1910021
Acceptance Criteria
The use of the different specimen types tested does not impact test results.
This is demonstrated by agreement of results obtained from serum, plasma,

venous and capillary blood samples from each donor. Line intensities of G
and M lines, respectively, had to be within the range defined in Table 6.1-2.
Table 6.1-2: Acceptance criteria regarding Line Intensity
Sample Line Intensity Range
Negative sample G line<G3, M line<G3

anti-SARS-CoV-2 IgG positive
sample
G line≥G3
anti-SARS-CoV-2 IgM positive
sample
M line≥G3
Methodology / Study Design

Blood from 25 healthy donors was collected to generate corresponding
negative plasma (with EDTA), serum, venous (EDTA) blood samples as listed
in the Table 6.1-1. In addition, fingerstick blood from 5 of these 25 healthy
donors was collected. Each of these specimen was confirmed to be negative
using the comparator rapid testing device.
To generate positive samples, an anti-SARS-CoV-2 IgG positive specimen

was diluted 1:8 into each of the negative samples obtained, i.e. into the serum,
plasma, venous and capillary blood sample from each donor. In addition, an
anti-SARS-CoV-2 IgM positive specimen was diluted into these specimen
types (1:5). The spiked serum sample from each donor was then confirmed to
be positive using the reference COVID-19 IgG/IgM rapid test. Each of the
negative specimens and positive specimens was tested in triplicate with the
Panbio™ COVID-19 IgG/IgM Rapid Test Device. Tests were conducted
according to the IFU version 1156183401. Test results were read after 10
minutes for positive specimens and after 15 minutes and 20 minutes for
negative specimen.
Results
As summarized in Table 6.1-3, no discrepancies (i.e. no false negatives or
false positives) were observed comparing test results obtained with the
Panbio™ COVID-19 IgG/IgM Rapid Test Device for any of the specimen types
tested. Measured line intensities are provided in report B2020001-04-07.

Table 6.1-3: Results for tested negative and anti-SARS-CoV-2 IgG and IgM
spiked positive samples
anti-SARS-CoV-2 IgG anti-SARS-CoV-2 IgM
Negative Samples Spiked Positive Spiked Positive
Specimen Samples Samples
Type Negative Positive Positive
Number Agreement Number Agreement Number Agreement
[%] [%] [%]
Serum 25 100 25 100 3 100
EDTA plasma 25 100 25 100 3 100

EDTA venous
25 100 25 100 3 100
whole blood
Fingerstick
25 100 5 100 3 100
whole blood
Conclusions
The acceptance criterion for the use of the specimen types human serum,
EDTA plasma, venous (EDTA) and capillary whole blood without impact on
test results was met. For each sample type full agreement of test results for
negative samples and positive samples could be shown. Measured line
intensities met acceptance criteria.
Therefore, each of the four specimen types is equally suited for use with the
Panbio™ COVID-19 IgG/IgM Rapid Test Device.
6.1.1.2. Specimen Stability
Study Summary Specimen Type – Specimen stability

Report:
Study Dates: 2020/04/03-2020/04/07
Conducted by: QC department of ABON Biopharm (Hangzhou)
Co.,LTD
Testing: Performed at QC Laboratory
Study Objective
The purpose of this study was to evaluate the stability of serum, plasma and
venipuncture whole blood samples stored at 2-8°C before use. Serum and
plasma specimens were stored at 2-8°C for up to 96 hours and whole blood
samples were stored for up to 72 hours before testing. Capillary whole blood

samples are intended for immediate testing and were therefore not included in
stability testing.
Note: Fingerstick whole blood has to be tested immediately after collection

and within 2 minutes as it may hemolyse or coagulate within (after 2 to 16
minutes) (13).
Materials
Product

Number: COV0042003
Testing Specimens
Tested specimens are shown in Table 6.1-4.
Table 6.1-4: Tested specimens

Specimen Type Negative anti-SARS- anti-SARS-CoV-2
CoV-2 IgG IgM Spiked Positive
Spiked Positive
Serum 1 1 1
EDTA-K2 plasma 1 1 1
EDTA-K2 whole blood 1 1 1
Further Materials
- Serum-separating tube (without anticoagulant), Lot Number 1910222

- EDTA vacuum blood collecting tube, Lot Number 1910021
Acceptance criteria
Test results are not impacted by storage of serum and plasma specimens up
to 3 days (72 hours) hours at 2-8°C and three (3) freeze/thaw cycles. Venous
whole blood samples can be stored at 2-8°C for up to 2 days (48 hours) hours
without impact on test results.
Acceptance criteria for line intensity of the G and M line, respectively, were as
follows:
anti-SARS-CoV-2 IgG positive samples : G line≥G3
anti-SARS-CoV-2 IgM positive samples : M line≥G3
Negative samples: G line<G3, M line<G3

A negative EDTA plasma, serum and venipuncture EDTA whole blood sample
were obtained from one donor. The EDTA venipucture whole blood and serum
samples were confirmed to be negative with the reference COVID-19 IgG/IgM
rapid test.
The three anti-SARS-CoV-2 IgG positive samples were prepared by diluting a
known anti-SARS-CoV-2 IgG positive sample 1:8 into the negative serum,
plasma and blood samples. The three anti-SARS-CoV-2 IgM positive samples
were prepared by diluting a known anti-SARS-CoV-2 IgM positive sample 1:5
into the negative serum, plasma and blood samples. The spiked positive
serum samples were confirmed to be positive with the reference COVID-19
IgG/IgM rapid test (T= 0 hour).
Samples were then stored at 2-8°C. Serum and plasma samples were tested
after 72 hours and 96 hours of storage, whole blood samples were tested after
48 and 72 hours of storage (see Table 6.1-5). In addition, the specimen were
tested after three (3) freeze/thaw cycles. Venipuncture whole blood, plasma
and serum specimen were directly tested after equilibration to room
temperature (15 to 30 °C) according to the IFU. Each sample was tested in
triplicate with the Panbio™ COVID-19 IgG/IgM Rapid Test Device according
to the IFU version 1156183401. Test results were read at 10 minutes for
positive specimens and at 15 minutes and 20 minutes for negative specimen.

Table 6.1-5: Test time points

Storage Test Time point
Sample Type Temperature
2-8°C 0 hours 72 hours 96 hours
Serum/plasma
Freeze/Thaw Test the specimen after 3 Freeze/Thaw cycles*
Venipuncture 2-8°C 0 hours 48 hours 72 hours
whole blood
*Note: Step 1: Freeze cycle：Store the sample at -20±10°C for at least 12 hours;
Step 2: Thaw cycle: Thaw the sample at 15-30°C for at least 1 hour and transfer the
sample to 2-8°C for at least the rest time (12 hours minus the time thaw at 15-30°C).
Repeat step 1 and step 2 two times.
Results
As obvious from the line intensities in Tables 6.1-6 and 6.1-7 below, no
discrepancies (i.e. no false negatives or false positives) were observed for any
of the specimens and time points tested.
Table 6.1-6: Stability data of serum and plasma samples

Validation Lot 1(G/M)
Reading After 3
Sample Test 0 hours 72 hours 96 hours
Time Freeze/Thaw
2-8°C 2-8°C 2-8°C
Cycles
Test1 1/1 1/1 1/2 1/2
15min Test2 1/1 1/2 1/2.5 1/2.5
Negative serum Test3 1/1 1/2 1/2 1/2
(G/M line) Test1 1/1 1/1 1/2 1/2
20min Test2 1/2 1/2 1/2.5 1/2.5
Test3 1/1 1/2 1/2 1/2.5
Test1 1/1 1/2 1/2 1/2
15min Test2 1/1 1/2 1/2 1/2
Negative 1/2
Test3 1/1 1/1 1/2
plasma
Test1 1/1 1/2 1/2 2/2.5
(G/M line)
20min Test2 1/1 1/2 1/2 1/2
Test3 1/1 1/1 1/2 1/2
COVID-19 IgG Test1 4.5 4 4.5 3.5
positive serum
10min Test2 4.5 4.5 4 4
sample
(G line) Test3 4.5 4 4 4
COVID-19 IgG Test1 4.5 4.5 4 3.5
positive plasma
10min Test2 4.5 4 4.5 3.5
sample
(G line) Test3 4.5 4 4.5 4
COVID-19 IgM 10min Test1 4.5 3 3 3

Validation Lot 1(G/M)

Reading After 3
Sample Test 0 hours 72 hours 96 hours
Time Freeze/Thaw
2-8°C 2-8°C 2-8°C
Cycles
positive serum Test2 4 3.5 3 3
sample
(M line) Test3 4.5 3.5 3.5 3
COVID-19 IgM Test1 4 3.5 3.5 3
positive plasma
10min Test2 4 3.5 3 3.5
sample
(M line) Test3 4.5 3 3 3
Table 6.1-7: Stability data of whole blood

2-8°C Validation Lot 1 (G/M)
Reading
Sample Test
Time 0 hours 48 hours 72 hours
Test1 1/1 1/1 1/1

15min Test2 1/1 1/1 1/1
Negative venipuncture whole
Test3 1/1 1/1 1/1
blood
(G/M line) Test1 1/1 1/1 1/1
20min Test2 1/1 1/1 1/1
Test3 1/1 1/1 1/2
COVID-19 IgG positive Test1 4.5 5 4
venipuncture whole blood sample 10min Test2 4.5 4.5 3.5
(G line)
Test3 4.5 4.5 4
COVID-19 IgM positive Test1 5 3.5 4
venipuncture whole blood sample 10min Test2 4.5 4 3.5
(M line)
Test3 4.5 4 3.5
Conclusions
All acceptance criteria were met. No impact on test results was observed after
storage of serum and plasma at 2-8ºC for up to 96 hours meeting the
acceptance criterion for storage up to 72 hours (3 days) for these specimen
types and condition.
Three freeze/thaw cycles had no impact on performance.
Venous whole blood samples were stored at 2-8ºC for up to 72 hours without
affecting test results meeting the acceptance criterion for storage up to 48
hours (2 days) for this specimen type and condition.

6.2. Analytical Performance Characteristics

Accuracy of Measurement
6.2.1.1. Trueness of Measurement
Trueness of the Panbio™ COVID-19 IgG/IgM Rapid Test Device has been
assessed as part of diagnostic sensitivity studies.
6.2.1.2. Precision of Measurement

6.2.1.3. Day-to-Day Intra-Lot and Lot-to-Lot Variability
Study Summary Precision- (Intra-Lot and Lot-to-Lot Variability)

Report:
Study Dates: 2020/04/04-2020/04/06
Conducted by: Quality Control Dept, Abon Biopharm (Hangzhou)
Co., Ltd.
Testing: QC laboratory
Study Objective
The purpose of this study was to evaluate the day-to-day intra-lot and lot-to-lot
variability of the Panbio™ COVID-19 IgG/IgM Rapid Test Device by using 3
different lots and 3 different days for generation of results.
Materials
Product
Number: COV0042003 (Lot 1),
Number: COV0042002 (Lot 3)

Testing Specimens
Tested specimens are shown in Table 6.1-8.
Table 6.1-8: Tested specimens and replicates

Intra & Inter assay
Specimen Day-to-Day replicates
replicates
3 per lot and day;
anti-SARS-CoV-2 negative serum 3 per lot
15 min, 20 min
anti-SARS-CoV-2 negative 3 per lot and day;
3 per lot
plasma 15 min, 20 min
3 per lot
venipuncture blood 15 min, 20 min
3 per lot
fingerstick blood 15 min, 20 min
Spiked anti-SARS-CoV-2 IgG low 3 per lot and day;
positive serum/ plasma sample 9 per lot in three days 10 min
L(IgG)
Acceptance Criteria
Test results are not impacted by lot (3), or day (3) used for testing specimens
with the Panbio™ COVID-19 IgG/IgM Rapid Test Device.
The difference between maximum and minimum line intensity within one lot
should be no more than 1 grade for the same sample.
The difference between mean line intensity for one lot and the mean line
intensity of all three lots should be no more than 1 grade.
All line intensity results obtained should be within the range specified in Table
6.1-9.
Table 6.1-9: Acceptance criteria for line intensity
Sample Line Intensity Range
Negative serum G line<G3, M line<G3

Negative plasma G line<G3, M line<G3
Negative venipuncture whole blood G line<G3, M line<G3
Negative fingerstick whole blood G line<G3, M line<G3
anti-SARS-CoV-2 IgG low positive sample G line≥G3
L(IgG)

Anti-SARS-CoV-2 negative samples were obtained from 5 donors. The low

positive plasma/serum sample was prepared by spiking with COVID-19 IgG L.
The performance of 3 validation lots was evaluated by one operator in three
days. Each sample specified in Table 6.1-8 was tested in triplicates.
Measurements were conducted according to the IFU version 1156183401.
Line intensities of positive samples were recorded after 10 minutes and those
of negative samples after 15 minutes and 20 minutes.
Results
Tables 6.1-10 and 6.1-11 show the measured line intensities for the tested
lots and test days per specimen. Summarized test results are provided in
Table 6.1-12. No discrepancies (i.e. no false negatives or false positives) were
observed for any of the specimens tested, comparing results from three
different lots, three replicates per lot, and three different days.

Table 6.1-10: Precision study results day-to-day

Results
Results (G/M line)
(G line)
COVID-19
Negative
Day Lot Negative finger IgG
Negative serum Negative plasma venipuncture
whole blood positive
whole blood
sample L
15mins 20mins 15mins 20mins 15mins 20mins 15mins 20mins 10mins
1/2 1/1 1/2 1/2 1/2.5 1/2 1/1 1/1 3.5
Lot1 1/1 1/1 1/2 1/2 1/2.5 1/2.5 1/1 1/1 3.5
1/1 1/2 1/2.5 1/2.5 1/2.5 1/2.5 1/1 1/1 3
1/2 1/2 1/1 1/2 1/2.5 1/2 1/1 1/1 4.5
Day 1 Lot2 1/2 1/1 1/2 1/1 1/2 1/2 1/1 1/1 4.5
1/1 1/1 1/2 1/2 1/2 1/2 1/1 1/1 3.5
1/1 1/2 1/2 1/1 1/2 1/2 1/1 1/1 3.5
Lot3 1/2 1/2 1/1 1/1 1/2 1/2 1/1 1/1 4
1/2 1/2 1/2 1/2 1/2 1/1 1/1 1/1 3.5
1/1 1/2 1/2.5 1/2.5 1/1 1/2 1/1 1/1 4
Lot1 1/2 1/2 1/2.5 1/2 1/2 1/2 1/1 1/1 3.5
1/2 1/2 1/2.5 1/2 1/2 1/2 1/1 1/1 4
1/2 1/1 1/2 1/1 1/2 1/2 1/1 1/1 4.5
Day 2 Lot2 1/2.5 1/2.5 1/2 1/2 1/1 1/1 1/1 1/1 4.5
1/2 1/2 1/2 1/2 1/2 1/2 1/1 1/1 3.5
1/1 1/1 1/2 1/2 1/2 1/1 1/1 1/1 4.5
Lot3 1/2 1/2 1/1 1/1 1/1 1/2 1/1 1/1 4.5
1/2 1/2 1/2 1/2 1/2.5 1/2 1/1 1/1 4.5
1/1 1/1 1/1 1/1 1/2 1/2 1/1 1/1 3.5
Day 3 Lot1
1/1 1/1 1/2.5 1/2.5 1/1 1/1 1/1 1/1 4

Results
Results (G/M line)
(G line)
COVID-19
Negative
Day Lot Negative finger IgG
Negative serum Negative plasma venipuncture
whole blood positive
whole blood
sample L
15mins 20mins 15mins 20mins 15mins 20mins 15mins 20mins 10mins
1/1 1/1 1/2 1/2 1/1 1/1 1/1 1/1 4
1/1 1/1 1/2 1/1 1/2 1/1 1/1 1/1 3.5
Lot2 1/2.5 1/2.5 1/1 1/1 1/2 1/1 1/1 1/1 4
1/2 1/2 1/2 1/2 1/1 1/1 1/1 1/1 3.5
1/1 1/1 1/2 1/2 1/1 1/1 1/1 1/1 3.5
Lot3 1/2.5 1/2 1/1 1/1 1/2 1/2 1/1 1/1 4
1/2 1/1 1/2 1/2 1/2 1/2 1/1 1/1 3.5

Table 6.1-11: Precision study results inter- and intra-lot

Results(G line) 10mins
Sample No.
Lot1 Lot2 Lot3
1 3.5 4.5 3.5
2 3.5 4.5 4
3 3 3.5 3.5
COVID-19 4 4 4.5 4.5
IgG positive 5 3.5 4.5 4.5
sample (L) 6 4 3.5 4.5
7 3.5 3.5 3.5
8 4 4 4
9 4 3.5 3.5
Max 4 4.5 4.5
Min 3 3.5 3.5
Max-Min 1 1 1
Mean 3.7 4.1 4.1
Total Mean 3.9
Variation between
Mean and Total 0.2 0.2 0.2
Mean
Table 6.1-12: Summarized precision results

Validation Lots
Specimen Amount
Positive Negative
Negative serum/plasma 27 0 27
Negative venipuncture whole blood 27 0 27
Negative fingerstick whole blood 27 0 27
Sum 81 0 81
Correctly identified (%) 100%
Validation Lots
Specimen Amount
Positive Negative
COVID-19 IgG positive sample 27 27 0
Correctly identified (%) 100%
Conclusions
Results of the Panbio™ COVID-19 IgG/IgM Rapid Test Device were
demonstrated to be reproducible and not impacted by using different lots or by
testing on different days. Results for negative, as well as low positive
specimens were correctly identified in every test. No invalid tests were
observed. Differences in line intensities within one lot, in between different lots
and on different days per tested specimen were acceptable. Overall, the
acceptance criteria were fully met.

Analytical Sensitivity
Analytical sensitivity has been determined within the analytical sensitivity /
measuring range / high dose hook effect study which included measurement
of serially diluted anti-SARS-CoV-2 IgG and IgM positive samples (see
Section 6.1.2.5 for results).
Seroconversion Panel Testing

Seroconversion panels are tested as part of the clinical study R-QV-00649
(see respective Section for preliminary results).
Analytical Specificity
6.2.4.1. Cross-Reactivity
Study Summary Analytical specificity-Cross reactivity
Report:
Conducted by: Quality Control Dept, Abon Biopharm (Hangzhou) Co.,
Ltd.
Testing: R&D Laboratory
Study Objective
The purpose of this study was to determine the specificity of the Panbio™
COVID-19 IgG/IgM Rapid Test Device in the presence of rheumatoid factor,
antinuclear antibody, HAMA or anti-Influenza A and B IgG antibodies (i.e.
cross reactivity).
Materials
Reagents
Number: COV0042003

Acceptance Criteria
- There should be no cross-reactivity with the agents tested. There
should be no false positive results.
- Line intensities at 15min/20min: G line<G3, M line<G3.

Commercially available rheumatoid factor, antinuclear antibody, HAMA and
Influenza A and B IgG patient samples (three for each potential cross-reactant)
listed in Table 6.1-13 were obtained and were confirmed to be negative for
anti-SARS-CoV-2 with the reference COVID-19 IgG/IgM rapid test. Each of
the specimen was then measured in triplicate with the Panbio™ COVID-19
IgG/IgM Rapid Test Device according to the IFU version 1156183401. Test
results were read at 15 minutes and 20 minutes.
Table 6.1.-13: Tested specimens

Specimen tested* Number of patient samples
Rheumatoid factor positive specimens 3
Antinuclear antibody (ANA) positive specimens 3
HAMA positive specimens 3
Influenza A and B IgG positive specimens 3
*See test report B2020001-04-07 for details on specimen
Results
12 patient specimens containing potential cross-reactants were tested and
100% specificity was obtained. The results are summarized below in Table
6.1-14.

Table 6.1-14: Results of tested cross-reactants*

Number of Non-reactive Non-reactive
# Specimen Samples after 15 min after 20 min
Tested (IgG/IgM) (IgG/IgM)
Rheumatoid factor positive
1 3 3/3 3/3
specimens
Antinuclear antibody (ANA)
2 3 3/3 3/3
positive specimens
3 HAMA positive specimens 3 3/3 3/3
Influenza A and B IgG positive
4 3 3/3 3/3
specimens
* See test report B2020001-04-07 for details on line intensities
Conclusions
Patient specimens containing rheumatoid factor, antinuclear antibody, HAMA
or anti-Influenza IgG, respectively, did not produce false positive IgG or IgM
results when tested on the Panbio™ COVID-19 IgG/IgM Rapid Test Device.
All acceptance criteria were fulfilled.
6.2.4.2. Interfering Substances

Study Summary Interfering substances
Report:
Study Dates: 2020/04/05-2020/04/09
Conducted by: Quality Control Dept, Abon Biopharm (Hangzhou) Co.,
Ltd.
Testing: QC Laboratory
Study Objective
The purpose of this study was to determine whether potentially interfering
substances found in blood and drugs commonly used in the region of potential
end users have any impact on the sensitivity and specificity performances of
the COVID-19 IgG/IgM Rapid Test Device.
Materials
Reagents
- COVID-19 IgG/IgM Rapid Test Device, Validation Lot Number:
COV0042003

Acceptance Criteria
Potential interfering substances do not change the result of the specimen
tested.
Line intensity results for the G line and M line, respectively, should be in the
following range:
 anti-SARS-CoV-2 IgG positive sample : G line≥G3
 Negative sample: G line<G3, M line<G3

An anti-SARS-CoV-2 IgG low positive sample L(IgG) and anti-SARS-CoV-2
negative specimen were spiked with blood analytes and therapeutic drugs
commonly used in the region of potential end users at the concentrations
shown in Table 6.1-15. In addition, analytes commonly found in blood were
tested at the indicated concentrations. The specimens were tested in triplicate
with the Panbio™ COVID-19 IgG/IgM Rapid Test Device according to the IFU
version 1156183401. Line intensity results were recorded at 10 minutes for
anti-SARS-CoV-2 IgG positive samples and at 15 min and 20 minutes for anti-
SARS-CoV-2 IgG negative samples.
Table 6.1-15: Tested interfering substances

Interference Substance Concentration
Ascorbic acid 0.2mg/mL
Hemoglobin 10 mg/mL
Oxalic acid 0.6 mg/mL
Bilirubin 0.6 mg/mL
Triglyceride 50 mg/mL
Human Serum Albumin 20 mg/mL

Results
Results of the exogenous interfering substance tests are shown in Table 6.1-
16.
Table 6.1-16: Results of interference tests

Anti-SARS-CoV-2 IgG Negative sample
Specimen Content low positive sample
L(IgG), 10 min 15 min 20 min
Ascorbic acid 20 mg/ml 3/3 Positive 3/3 Negative 3/3 Negative
Hemoglobin 10 mg/ml 3/3 Positive 3/3 Negative 3/3 Negative
Oxalic acid 0.6 mg/ml 3/3 Positive 3/3 Negative 3/3 Negative
Bilirubin 0.6 mg/ml 3/3 Positive 3/3 Negative 3/3 Negative
Triglyceride 50 mg/ml 3/3 Positive 3/3 Negative 3/3 Negative
Human Serum
20 mg/ml 3/3 Positive 3/3 Negative 3/3 Negative
Albumin
* See test report B2020001-04-07 for details on line intensities
Conclusion
The exogenous substances tested did not affect the specificity or sensitivity of
the COVID-19 IgG/IgM Rapid Test.
Note: Rheumatoid factor positive specimens, antinuclear antibody (ANA)

positive specimens, HAMA positive specimens, and Influenza A and B IgG
positive specimens have been tested with the COVID-19 IgG/IgM Rapid Test
Device in the cross-reactivity study, see section 6.1.2.3.1.
Traceability of Calibrators and Control Material Values

The Panbio™ COVID-19 IgG/IgM Rapid Test Device includes a qualitative
control that is based on Rabbit-IgG to anti-Rabbit-IgG binding. The control
reaction leads to a red staining at the Control line area which it is visually read
by the user. This control reaction is independent from the analyte reaction.
There is no applicable international standard material to which this kind of
control would need to be traced or calibrated. Therefore, no traceability study
was required in this case.
For diagnostic sensitivity results see Section 6.2.

Measuring Range of the Assay / High Dose Hook Effect

Study Summary Analytical sensitivity/ Measuring range/ High Dose
Report: Hook
Conducted by: QC Dept, Abon Biopharm (Hangzhou) Co., Ltd.
Testing: Guangzhou CDC Laboratory
Study Objective
The purpose of this study was to evaluate the analytical sensitivity and
measuring range of the product, and to determine if there is a high-dose hook
effect for the Panbio™ COVID-19 IgG/IgM Rapid Test Device.
Materials
Reagents
Number: COV0042002 (Lot 3)
Tested Specimens
Three anti-SARS-CoV-2 IgG high positive samples and 3 anti-SARS-CoV-2
IgM high positive samples (see Table 6.1-17) were prepared and serially
diluted until undetectable (see report B2020001-04-07 for further details on
dilution rows).

Table 6.1-17: Tested Specimen

Reference test
No. Sample Lot
result(ELISA)
1 COVID-19 IgG positive 1# NCOV -1008S 3.155 (+)
4 COVID-19 IgM positive 1# NCOV-1022S 3.325 (+)
5 COVID-19 IgM positive 2# NCOV -1007S 2.756 (+)
6 COVID-19 IgM positive 3# NCOV -1006S 2.408 (+)
Acceptance Criteria
- The test results of the validation lots should be consistent with or better
than the result produced by the reference COVID-19 IgG/IgM rapid test.
There is no high-dose hook effect for the tested 6 highly reactive
specimens.
- Criteria for line intensities:
o Negative: G line<G3, M line<G3.
o Positive G line≥G3
o Positive M line≥G3

Three anti-SARS-CoV-2 IgG antibody high positive samples and three anti-
SARS-CoV-2 IgM antibody high positive samples were prepared and then
diluted by a series of ratios (1:5, 1:10, 1:20, 1:140, 1:80…) until undetectable.
The last two dilutions were each tested with the reference COVID-19 IgG/IgM
rapid test.
Each undiluted sample and each diluted sample was tested in triplicate with
each of the three validation lots of the Panbio™ COVID-19 IgG/IgM Rapid
Test Device. Tests were conducted in accordance with the IFU version
1156183401; line intensities were recorded after 10 minutes. The comparator
rapid test device was used to confirm results.

Results
Tables 6.1-18 (A, B, C) and 6.1-19 (A, B, C) present the results obtained for
tested anti-SARS-CoV-2 IgG and anti-SARS-CoV-2 IgM specimens,
respectively.
Six highly-reactive specimens (including 3 anti-SARS-CoV-2 IgG positive and
3 anti-SARS-CoV-2 IgM positive samples) were diluted by a series of dilutions
(ratios: 1:5, 1:10, 1:20, 1:40, 1:800) and tested with 3 validation lots of the
Panbio™ COVID-19 IgG/IgM Rapid Test Device. For each specimen, a series
of dilution was tested and the test result presented from reactive to non-
reactive increased with dilution ratios. The test results indicate that there is no
potential high dose hook effect.
Compared to the reference test, validation lot 1 was more sensitive at the
lower endpoint when testing anti-SARS-CoV-2 IgG positive sample 1#, anti-
SARS-CoV-2 IgM positive sample 2# and 3#. The results also indicate that
validation lot2 and lot3 of COVID-19 IgG/IgM Rapid Test Device have the
same dilution series endpoint as the comparator test when testing most
samples. Only on testing IgG positive sample 2#, the validation lots have the
little lower dilution ratio than comparator test when the test results from
positive to negative. Overall, the test result of validation lots were consistent
with the result generated by the comparator rapid test device (Innovita).

Table 6.1-18 (A): Results for tested anti-SARS-CoV-2 IgG specimen #1

Validation Lot Validation Lot
Dilution Validation Lot 3 Comparator
Sample Test 1 2
ratio Test Result
G G G
Test1 10 10 10
Undiluted Test2 10 10 10 8
Test3 10 10 10
Test1 8.5 8.5 8.5
1：5 Test2 8.5 8 9.5 9
Test3 8.5 8.5 8.5
Test1 7 6 9.5
1：10 Test2 8 6.5 8.5 9.5
Test3 8 6.5 8.5
Test1 5 5 7
1：20 Test2 5 5 6 7
COVID-19 Test3 5 5 6
IgG positive
1# Test1 4 5 7.5
1：40 Test2 4.5 4 5 5.5
Test3 4.5 4 5.5
Test1 4 6 4
1：80 Test2 5 5.5 6 4.5
Test3 4 5 5
Test1 3 2.5 2.5
1：160 Test2 4 3 2.5 2.5
Test3 4 3 2.5
Test1 2.5 2 2
1：320 Test2 2.5 2 2 2
Test3 2 2 2

Table 6.1-18 (B): Results for tested anti-SARS-CoV-2 IgG specimen #2

Sample Test 1 2
ratio Test Result
G G G
Test1 10 10 9.5
Undiluted Test2 10 10 9.5 9.5
Test3 10 10 9.5
Test1 5 5 6.5
1：5 Test2 5.5 6 6 7.5
Test3 5.5 6 6
Test1 3.5 5 4.5
1：10 Test2 3 4 5.5 6
Test3 3 4 5
COVID-19 Test1 4 3 2.5
IgG positive 1：20 Test2 3 2 4 5
2# Test3 3 3 3
Test1 2.5 1 2.5
1：40 Test2 2 3 1 4
Test3 2 2.5 2.5
Test1 3.5 1 2
1：80 Test2 1 1 3 2
Test3 2 2 2
Test1 2 2 2
1：160 Test2 1 2 2 2.5
Test3 1 2 2

Table 6.1-18 (C): Results for tested anti-SARS-CoV-2 IgG specimen #3

Sample Test 1 2
ratio Test Result
G G G
Test1 10 10 10
Test3 10 10 10
Test1 7 7 8
1：5 Test2 7 7 7.5 8
Test3 7 7 7.5
Test1 6.5 6.5 6.5
1：10 Test2 7 6.5 7 6
Test3 7 6.5 6.5
COVID-19 Test1 4 6 6
IgG positive 1：20 Test2 4.5 4 5 5
3# Test3 4.5 5 5
Test1 3 3.5 3.5
1：40 Test2 5 3.5 4 4
Test3 4 3.5 3.5
Test1 2.5 2.5 2.5
1：80 Test2 4.5 2.5 3 2.5
Test3 2.5 2.5 3
Test1 2 2 2
1：160 Test2 2.5 2 2 2
Test3 2.5 2 2

Table 6.1-19 (A): Results for tested anti-SARS-CoV-2 IgM specimen #1

Sample Test 1 2
ratio Test Result
M M M
Test1 9 8 9
Undiluted Test2 8.5 8 8.5 7
Test3 9 9 8.5
Test1 5 5 6
1：5 Test2 7 3 6.5 5
Test3 5 3.5 6
Test1 5 6.5 6
1：10 Test2 6.5 4 5 3.5
COVID-19 Test3 6 4.5 5
IgM positive
1# Test1 3 5 5
1：20 Test2 3 5 5 3.5
Test3 3 4.5 4.5
Test1 2.5 2 2.5
1：40 Test2 2 2 2 2.5
Test3 2 2 2
Test1 2 2 2
1：80 Test2 2 2 2 2
Test3 2 2 2

Table 6.1-19 (B): Results for tested anti-SARS-CoV-2 IgM specimen #2

Sample Test 1 2
ratio Test Result
M M M
Test1 6 5.5 6
Undiluted Test2 6 5.5 6 5
Test3 6 6 6
Test1 3 3 3.5
1：5 Test2 3.5 4 4 3
Test3 3.5 3 4
COVID-19 Test1 3 3.5 2
IgM positive 1：10 Test2 3.5 2.5 2.5 2.5
2# Test3 3 3 2.5
Test1 2 2 2.5
1：20 Test2 2 2 2.5 2
Test3 2 2 2
Test1 2 2 2
1：40 Test2 2 2 2 2
Test3 2 2 2

Table 6.1-19 (C): Results for tested anti-SARS-CoV-2 IgM specimen #3

Sample Test 1 2
ratio Test Result
M M M
Test1 6 5 5
Test3 6 5 5
Test1 3 2 3.5
1：5 Test2 3.5 4 3 3
Test3 3.5 3 3
COVID-19 Test1 3.5 2 2
IgM positive 1：10 Test2 3 2 2 2
3# Test3 3 2 2
Test1 2 2 2
1：20 Test2 2 2 2 2
Test3 2 2 2
Test1 2 1 1
1：40 Test2 2 1 1 1
Test3 2 1 1

Conclusions
The test results indicate that there is no potential high dose hook effect when
testing anti-SARS-CoV-2 IgG and IgM antibody positive specimen.
Overall, the test result of validation lots were consistent with the result
generated by the comparator rapid test device (Innovita).
Validation of Assay Cut-off

A separate assay cut-off validation study has not been conducted. Within the
measuring range / high dose hook effect study serially diluted anti-SARS-
CoV-2 IgG and IgM positive samples were measured.
Robustness Studies
As part of the performance evaluation, the following robustness studies were
conducted. Studies were designed to mitigate identified risks with potential
impact robustness. Multiple skill levels of users were considered as well as
reagent issues.
The robustness studies were designed to assess operator error, usability and
human factors as well as environmental factors. The studies were done to
challenge the product by exposure to different conditions of stress including
temperature and humidity conditions. In addition, studies were conducted to
access the impact of operator error/human factors including incorrect timing of
procedure.
For each study presented, the site and principal investigator were identified,
the date each study was performed, the lot numbers used, and a description
of the study design was given along with testing result and study conclusions
for each specimen included in the study.
The following Table 6.1-20 provides a high level overview on conducted

studies and outcome.

Table 6.1-20: Summary on robustness study results

Study Materials Tested Conditions Results
Sample volume 1 Device Plasma/ serum volumes In summary, the
flexibility Lot : between 5 µL and 80 µL appropriate sample
COV0042003 as well as venous blood volume and buffer volume
(Section 7.7 of sample volumes for the test were as
B2020001-02-07, between 8 µL and follows:
Study Date: 2020/04) 100 µL were each Serum/plasma volume:
tested in combination 5 μL -15 μL
with different buffer
volumes ranging from Whole blood volume:
20µL to 300 µL. Both 8 μL – 25 μL
negative and spiked
positive anti-SARS-CoV- Buffer volume:
2 IgG specimens were 40 μL -120 μL
tested in triplicate.
Based the data above,
sample volume of 10 μL
serum/plasma, 20 μL
whole blood and 2 drops
of buffer (approximately
60 μL) buffer was
recommended.
Temperature 1 Device Negative and spiked All test results generated
flexibility Lot : positive serum/plasma at different operational
COV0042003 samples were tested at temperatures (2-8°C, 15-
(Section 7.10 of 3 different temperatures 30°C, 37°C) meet the
B2020001-02-07, (2-8°C, 15-30°C, and acceptance criteria.
Study Date: 2020/04) 37°C) following a 2-hour Considering the COVID-
equilibration at the 19 IgG/IgM Rapid Test
respective temperature. Device is a product for
Tests were carried out in professional use and will
triplicate for each be mostly used at room
temperature and temperature, the claimed
specimen type. equilibration temperature
(15-30°C) is
recommended (also see
product’s IFU).
Conclusions
Taken together the robustness study results confirmed that the recommended
parameters indicated in the product’s IFU were appropriate.
Validation of Assay Procedure – Reading Time

Study Summary Validation of reading time
Report:
Report See Section 7.9 of report B2020001-04-07
Conducted by: Quality Control Dept. Abon Biopharm (Hangzhou)
Co., Ltd.
Testing: QC Laboratory

Study Objective
The purpose of this study was to evaluate the performance Panbio™ COVID-
19 IgG/IgM Rapid Test Device when results are read after different reading
time intervals.
Materials
Reagents
- COVID-19 IgG/IgM Rapid Test Device, Validation Lot Number:
COV0042003
Testing Specimens
A negative serum/plasma sample was used for testing.
Acceptance Criteria
Line intensities recorded after 10 minutes, 15 minutes and 20 minutes should
be as follows:
- Negative serum/plasma sample: G line<G3, M line<G3
- COVID-19 IgG positive sample L: G line≥G3
The reading time interval for the product should be 10 to 20 min.

A negative serum/plasma sample was tested in triplicate with the Panbio™
COVID-19 IgG/IgM Rapid Test Device according to the IFU (version
1156183401) and results (line intensities) were recorded after 1 minute,
3 minutes, 5 minutes, 8 minutes, 10 minutes, 15 minutes, 20 minutes,
30 minutes, and after 60 minutes.
Results
The study results (line intensities) are listed below in Tables 6.1-21.

Results for the positive sample were invalid after a reading time of 1 minute.
Reading times up to 8 minutes showed lower line intensities increasing
gradually to the 10 minute time point. Results between 10 minutes and 20
minutes showed line intensities of ≥G3. Intensities were lower when reading
after 30 minutes and 60 minutes. The negative specimen provided line
intensities of 1 at all tested time points (meeting the <G3 criterion).
Table 6.1-21: Validation of reading time

Validation Lot1
COVID-19 IgG positive
Reading Time Test Negative Serum/Plasma
sample L
G M G
Test 1 Invalid Invalid

1 min Test 2 Invalid Invalid
Test 3 Invalid Invalid
Test 1 1 1 2
3 min Test 2 1 1 2
Test 3 1 1 3
Test 1 1 1 2.5
5 min Test 2 1 1 3
Test 3 1 1 3.5
Test 1 1 1 2.5
8 min Test 2 1 1 3
Test 3 1 1 3.5
Test 1 1 1 3
10 min Test 2 1 1 3
Test 3 1 1 3.5
Test 1 1 1 3
15 min Test 2 1 1 3
Test 3 1 1 3
Test 1 1 1 3
20 min Test 2 1 1 3
Test 3 1 1 3
Test 1 1 1 2.5
30 min Test 2 1 1 2.5
Test 3 1 1 2.5
60min Test 1 1 1 2

Validation Lot1
COVID-19 IgG positive
Reading Time Test Negative Serum/Plasma
sample L
G M G
Test 2 1 1 2
Test 3 1 1 2
Conclusion
As an outcome, test results met acceptance criterial for reading times 10
minutes, 15 minutes and 20 minutes, validating these reading times.
6.3. Clinical Performance and Clinical Evidence

Diagnostic Sensitivity and Specificity Study (in-house Abon)
Study Summary Diagnostic Sensitivity and Sensitivity

Report:
Protocol: See Section 7.4 of protocol B2020001-02-07
Study Dates: 2020/04/02, 2020/04/03 and 2020/04/07
Conducted by: Quality Control Dept, Abon Biopharm (Hangzhou)
Co., Ltd.
Testing: QC Laboratory in ABON and Guangzhou CDC
Study Objective
The purpose of this study was to evaluate the in-house diagnostic sensitivity
and specificity of COVID-19 IgG/IgM Rapid Test Device.
Materials
Reagents
Number: COV0042003
Tested Specimen
A total of 100 negative specimen (negative serum (25 specimen), negative
plasma (25 specimen); negative venipuncture whole blood (40 specimen) and
negative fingerstick whole blood (10 specimen) were collected from healthy

Abon donors and subjected to confirmatory testing with the comparator rapid
test device. All confirmatory test results were negative. Further details on
these specimens are provided in report B2020001-04-07.
A total 50 anti-SARS-CoV-2 IgG / IgM antibody positive serum/plasma

specimens that were collected from confirmed SARS-CoV-2 infected patients
(China) were tested. These specimen are summarized in Table 6.2-1 below.
Table 6.2-1: Anti-SARS-CoV-2 antibody positive specimen
No. Lot No. Lot
1 NCOV-1001S 26 NCOV-1054S
2 NCOV-1002S 27 NCOV-1055S
3 NCOV-1003S 28 NCOV-1057S
4 NCOV-1004S 29 NCOV-1070S
5 NCOV-1005S 30 NCOV-1071S
6 NCOV-1006S 31 NCOV-1077S
7 NCOV-1007S 32 NCOV-1078S
8 NCOV-1008S 33 NCOV-1083S
9 NCOV-1009S 34 NCOV-1084S
10 NCOV-1010S 35 NCOV-1170S
11 NCOV-1011S 36 NCOV-1262S
12 NCOV-1012S 37 NCOV-1275S
13 NCOV-1013S 38 NCOV-1304S
14 NCOV-1014S 39 NCOV-1350S
15 NCOV-1015S 40 NCOV-1437S
16 NCOV-1016S 41 NCOV-1464S
17 NCOV-1018S 42 NCOV-1465S
18 NCOV-1019S 43 NCOV-1486S
19 NCOV-1020S 44 NCOV-1487S
20 NCOV-1021S 45 NCOV-1518S
21 NCOV-1022S 46 NCOV-1520S
22 NCOV-1023S 47 NCOV-1528S
23 NCOV-1024S 48 NCOV-1529S
24 NCOV-1025S 49 NCOV-1531S
25 NCOV-1042S 50 NCOV-1532S

Acceptance Criteria
Line intensities
- Negative samples: 15min/20min: G line<G3, M line<G3
- Positive samples: 10min: G line≥G3 or/and M line≥G3
The sensitivity and specificity should meet the criteria: Sensitivity ≥80%,
Specificity ≥80%.

Specimen were handled and tested once per lot according to the Instructions
for Use of the rapid test devices. Positive results were read at 10 minutes and
negative results at 15 minutes and 20 minutes after test start.
Results
Study results are summarized in Tables 6.2-2 and 6.2-3. The determined line
intensities are provided in study report B2020001-04-07.
Table 6.2-2: Specificity

Lot1 Comparator Test
Specimen Amount
Positive Negative Positive Negative
Negative
50 0 50 0 50
serum/plasma
Negative venous
40 0 40 0 40
whole blood
Negative fingerstick
10 0 10 0 10
whole blood
Sum 100 0 100 0 100
Specificity 100% 100%
Table 6.2-3: Sensitivity

Lot1 Comparator Test
Specimen Amount
Positive Negative Positive Negative
IgG 49 1 48 2
Positive IgM 18 32 23 27
serum/plasma IgG or
50 0 49 1
IgM
Total Sensitivity 50/50=100% 49/50=98%
IgG 49/50 48/50
IgM 18/50 23/50

Conclusions
The results for Panbio COVID-19 IgG/IgM Rapid Test Device (vs the Innovita
comparator rapid test device) show that COVID-19 IgG/IgM Rapid Test
Device demonstrates a sensitivity of 100% (50/50) with 95% confidence
interval of [94.2%-100%], a specificity of 100% (50/50) with 95% confidence
interval of [94.2%-100%] and percent agreement of 100% (100/100) with 95%
confidence interval of [97.0%-100%].The results for IgG demonstrate a
specificity of 50/50 and a sensitivity of 49/50. The results for IgM demonstrate
a specificity of 50/50 and sensitivity of 18/50.
Diagnostic Sensitivity and Specificity and Seroconversion

Panel Testing (in-house study Jena)
Study Summary Report: Diagnostic Specificity and Sensitivity,
Seroconversion Panel Testing
Protocol: R-QV-00646
Report: R-QV-00649
Study Dates: 2020/04/07 and 2020/04/09;
serum conversion panel testing ongoing
Conducted by: Abbott Rapid Diagnostics Jena GmbH, Germany
Testing: Research and Development Department, S2-
safety level laboratory
Study Objective
The objective of this evaluation was to establish the performance of the
Panbio™ COVID-19 IgG/IgM Rapid Test Device regarding diagnostic
sensitivity and diagnostic specificity, tested in a laboratory environment, and
to provide data to demonstrate the product is safe and effective for its
intended use.
Materials
Reagents
Used test devices including lot numbers are shown in Table 6.2-4 below.

Table 6.2-4: Test device and comparator test information

Catalogue
Description/Name Lot Number Manufacturer/Supplier
Number
Panbio™ COVID-19 IgG/IgM Abbott Rapid
ICO-T402 COV0042003
Rapid Test Device* Diagnostics Jena GmbH
Wondfo® SARS-CoV-2 Guangzhou Wondfo
W195 W19500351
Antibody Test Device Biotech Co Ltd
Test specimens
The following frozen venous EDTA plasma and serum samples were obtained
from commercial sources:
• Negative venous EDTA plasma samples from 50 different donors which
had been collected in June 2013 and thus are most likely negative for
SARS-CoV-2 as first cases of Covid-19 were reported in December
2019 (14) (vendor: BBI Solutions, Crumlin, UK). Positive venous EDTA
plasma samples from 48 different donors tested positive for SARS-
CoV-2 with real-time multiplex PCR, which had been drawn on day five
(36 samples) or day ten (12 samples) after positive PCR test. As
multiplex real-time PCR test either cobas® SARS-CoV-2 Test (Roche,
8 samples) or VIASURE SARS-CoV-2 Real Time PCR Detection Kit
(Certest, 40 samples) had been applied (vendor: SYNLAB Analytics &
Services, Spain).
• Venous serum samples from a seroconversion panel with
approximately 10 panel members and approximately 10 donations per
panel member are tested (vendor: BIOMEX GmbH, Heidelberg).
Further details on the tested specimen are provided in report Q-QV-00649.

Frozen plasma and serum samples were stored at -20°C±10°C and were
thawed at ambient temperature before testing. After thawing, they were stored
in the refrigerator until use (2-8°C). Before application to the test device,
samples were equilibrated to ambient temperature.
Acceptance Criteria
Acceptance criteria were defined as follows:

• Diagnostic sensitivity: ≥95.0% for presence of IgM or IgG

• Diagnostic specificity: ≥95.0% for absence of IgM and IgG

48 venous EDTA plasma patient samples tested positive with real-time
multiplex PCR for SARS-CoV-2, 50 venous EDTA plasma patient samples
presumingly negative for SARS-CoV-2 (drawn before December 2019) and
approximately 100 venous serum patient samples of a seroconversion panel
(from approximately 10 panel members) were tested. For each sample one
test with the Panbio™ COVID-19 IgG/IgM Rapid Test Device was performed
according to the IFU Draft version 2020-03-31. Samples were applied to the
test devices using a volumetric lab pipette. Buffer solution (2 drops) was
applied via the buffer bottle included in the product kit. Results were read after
10 to 20 minutes and interpreted as follows:
− IgG POSITIVE (“T1”): The presence of both the control line I and the
IgG test line (T1) within the reading window indicates a COVID-19 IgG
positive result.
− IgM POSITIVE (“T2”): The presence of both the control line I and the
IgM test line (T2) within the reading window indicates a COVID-19 IgM
positive result.
− IgG and IgM POSITIVE (“T1 and T2”): The presence of the control line
I and the IgM (T1) and IgG (T2) test line within the reading window
indicates both a COVID-19 IgG and a COVID-19 IgM positive result.
− NEGATIVE (“N”): The sole presence of the control line I within the
reading window indicates a COVID-19 negative result.
− INVALID (“I”): No presence of the control line in the reading window
indicates an invalid result.
In case of a discrepant / indeterminate result, the sample was retested with

the Wondfo® SARS-CoV-2 Antibody Test according to this product’s IFUand
the Panbio™ COVID-19 IgG/IgM Rapid Test Device.
This test/study was performed according to the following guidelines and
standards:

• CLSI EP12-A2 (2008): User Protocol for Evaluation of Qualitative Test

Performance
Data analysis:
Diagnostic sensitivity/specificity of the Panbio™ COVID-19 IgG/IgM Rapid
Test Device is reported as the number of true positive/negative samples on
the total number of positive/negative samples tested. A test result was
interpreted as positive if and only if at least one of the analytes (IgG, IgM) was
positive. A test result was interpreted as negative if and only if both analytes
(IgG, IgM) were negative. Both diagnostic sensitivity and diagnostic specificity
are reported together with a 2-sided 95% confidence interval.
Results
Diagnostic Sensitivity and Specificity

In Tables 6.2-5, 6.2-6 and 6.2-7 sensitivity and specificity of the joint test
result, as well as for each analyte separately are provided. These results have
been included in the current version of the product’s Instructions for Use (see
Section 2).
Table 6.2-5: Test Result Table for Joint Result*/** (for the whole data set and in
brackets for samples drawn 5 days / 10 days after positive PCR result)
SARS-CoV-2 status
Positive Negative Total
46
Panbio™ Positive 3 49
(35 / 11)
COVID-19
IgG/IgM 2
Negative 47 49
Rapid Test (1 / 1)
result (Joint
Result) 48
Total 50 98
(36 / 12)
Sensitivity Specificity
Whole data set 95.8% [85.7%; 99.5%]
Samples drawn 5 days
97.2% [85.5%; 99.9%]
after positive PCR 94.0% [83.5%; 98.7%]
91.7% [61.5%; 99.8%]
after positive PCR
*See test report R-QV-00649 for details incl. raw data.
**Percent agreement was determined to be 94.9% (93/98) with 95% confidence

interval of [88.5%-98.3%].

Table 6.2-6: Test Result Table for IgG (for the whole data set and in brackets for
samples drawn 5 days / 10 days after positive PCR result)
SARS-CoV-2 status
46
(35 / 11)
COVID-19
2
IgG/IgM Negative 50 52
(1 / 1)
Rapid Test
result (IgG) 48
Total 50 98
(36 / 12)
Whole data set 95.8% [85.7%; 99.5%]

97.2% [85.5%; 99.9%] 100.0% [92.9%; 100.0%]
after positive PCR
91.7% [61.5%; 99.8%]
after positive PCR
Table 6.2-7: Test Result Table for IgM (for the whole data set and in brackets
for samples drawn 5 days / 10 days after positive PCR result)
SARS-CoV-2 status
27
(22 / 5)
COVID-19
21
IgG/IgM Negative 47 68
(14 / 7)
Rapid Test
result (IgM) 48
Total 50 98
(36 / 12)
Whole data set 56.2% [41.2%; 70.5%]

61.1% [43.5%; 76.9%] 94.0% [83.5%; 98.7%]
after positive PCR
41.7% [15.2%; 72.3%]
after positive PCR
Seroconversion Panels
In Table 6.2-8 first results of the seroconversion panel measurements are
provided. A graphical overview of conducted tests (real-time multiplex PCR
tests and Panbio™ COVID-19 IgG/IgM Rapid Tests) is shown in Figure 6.2-1.
Table 6.2-8: Test Result Table for Seroconversion Panel (N… Negative, P…

Positive)
Panel Ana- Panbio™ COVID-19 IgG/IgM Rapid Test result (majority vote) of Donation
Member lyte 1 2 3 4 5 6 7 8 9 10
IgG N N N tbd* tbd* tbd* tbd* tbd* tbd* tbd*
Donor 1
IgM N N N tbd* tbd* tbd* tbd* tbd* tbd* tbd*
IgG P P P tbd* tbd* tbd* tbd* tbd* tbd* tbd*
Donor 2
IgM P P P tbd* tbd* tbd* tbd* tbd* tbd* tbd*
IgG N N tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd*
Donor 3
IgM N N tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd*
IgG P P tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd*
Donor 4
IgG N P tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd*
Donor 5
Donor 6
IgM P P tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd*
IgG P tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd*
Donor 7
IgM N tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd*
Donor 9
IgG N N N tbd* tbd* tbd* tbd* tbd* tbd* tbd*
Donor 10
IgM N N N tbd* tbd* tbd* tbd* tbd* tbd* tbd*
IgG N tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd*
Donor 11
IgM N tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd* tbd*
* As drawing of seroconversion panel samples is still ongoing, samples will be

delivered gradually. Approximately 79 further samples from seroconversion panels
are planned to be tested depending on availability. Thus, they will be measured as
they become available and results will be included in the next version of the test
report.

Figure 6.2-1: Graphical Overview of PCR and Panbio™ COVID-19 IgG/IgM Rapid
Test Results conducted for each Panel Member. In case a time span was given for
assumed date of infection, the mean date was used for calculation of time differences
between measurement date and assumed date of infection. Panel member 3 and 10
were not tested positive. For panel member 10 no assumed date of infection is given
and thus this panel member is excluded from the figure.
Conclusions
This study was designed to evaluate the diagnostic sensitivity and specificity
of the Panbio™ COVID-19 IgG/IgM Rapid Test. As a result, the diagnostic
sensitivity is determined as 95.8%, diagnostic specificity as 94.0% and
percent agreement as 94.9%. While the acceptance criterion for sensitivity
(≥95.0%) is fulfilled, the acceptance criterion for a target specificity of ≥95.0%
was not achieved in the combined analysis. This is acceptable, since the
specificity requirement of the target product profile is at >90% (see report R-
QV-00649). As one possible explanation, false positives could be caused by
unspecific binding of agents that are similar to IgG and/or IgM (e.g. antibodies
to other coronavirus strains). Furthermore, the competitor test seems to have

similar issues with unspecific binding in some cases. Low diagnostic

sensitivity values for IgM compared to the PCR test could be attributed to the
collection date of the positive cohort or a weak immune response where IgM
levels are lower than the detection level of the test (5, 11).
Results of the Seroconversion Panel Kit are reported in the next version of the
test report.
Diagnostic Sensitivity and Diagnostic Specificity (external

study)
This study is planned to be conducted in April 2020. Results will be added to

this dossier as soon as they become available. In the following, information on
the planned study design is provided.
Study Summary Evaluation of the Diagnostic Sensitivity and

Report: Diagnostic Specificity of the COVID-19 IgG/IgM
Rapid Test Device (Fingerstick Whole Blood/
Venous Whole Blood/Serum/Plasma) using
serum/plasma samples
Protocol: CPSP COVID-19 IgG/IgM Rapid Test Device
20200401
Report: Pending
Study Dates: Planned: 2020/04
Conducted by: Abon Biopharm (Hangzhou) Co., Ltd. (study
sponsor)
Testing: State Key Laboratory of Organ Failure Research,
Guangzhou, Guangdong Province, China
Investigator: Dr. Hou Jinlin
Study Objective
Purpose of this study was to establish the sensitivity and specificity of the
Panbio™ COVID-19 IgG/IgM Rapid Test Device using left-over clinical
specimens, and to provide data to demonstrate the product is safe and
effective for its intended use.
Materials
Reagents


Number to be defined
Acceptance Criteria
The assay’s clinical performance is considered acceptable if the following
requirements are met:
- (Overall) Diagnostic sensitivity: >85.0%.
Sensitivity is being calculated as overall sensitivity, IgM or IgG
presence or IgG and IgM presence would determine a sample to be
positive.
- Diagnostic specificity: > 90.0%

This prospective study on left-over samples was an observational study
aiming to establish the diagnostic sensitivity and diagnostic specificity of the
COVID-19 IgG/IgM Rapid Test Device (Fingerstick Whole Blood/Venous
Whole Blood/Serum/Plasma), tested in a laboratory environment.
In total, at least 100 frozen serum/plasma samples will be tested with the
Panbio™ COVID-19 IgG/IgM Rapid Test Device according to the IFU version
1156183401. Samples included:
• At least 50 serum/plasma samples found positive according to the
following rules:
− Positive PCR result
− Positive by clinical presentation
− Window of 5-20 days after onset of the disease or first positive
PCR result
− Samples need to be positive by serology test
• At least 50 negative serum/plasma samples that were obtained in 2018
or early 2019 and are thus unrelated to the COVID-19 pandemic with
no need for PCR confirmation.
The results of the COVID-19 IgG/IgM Rapid Test Device are read between 10
and 20 minutes after sample addition and interpreted according to following
rules:

IgG POSITIVE: * The presence of both Control line and IgG test line within the
reading window indicates an IgG positive result.
IgM POSITIVE: * The presence of both Control line and IgM test line within
the reading window indicates an IgM positive result.
IgG and IgM POSITIVE: * The presence of Control line and IgM and IgG test
line within the reading window indicates both IgG and IgM positive result.
*NOTE: The intensity of the color in the IgG and IgM test line regions may
vary depending on the concentration of COVID-19 antibodies present in the
specimen. Therefore, any visible line at G area or M area was considered
positive.
NEGATIVE:
The sole presence of the Control line within the reading window indicates a
negative result.
INVALID:
No presence of the Control line in the reading window indicates an invalid
result.
Data analysis:
Diagnostic sensitivity of the COVID-19 IgG/IgM Rapid Test Device is reported
as the number of positive samples for the PCOVID-19 IgG/IgM Rapid Test
Device per the total number of ‘true’ positive samples tested.
Diagnostic specificity of the PaOVID-19 IgG/IgM Rapid Test Device is
reported as the number of negative samples for the PanVID-19 IgG/IgM Rapid
Test Device per the total number of negative samples tested.
Both diagnostic sensitivity and diagnostic specificity are reported together with
a 2-sided 95% confidence interval.


8 - Product Performance - Panbio COVID-19

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8 - Product Performance - Panbio COVID-19

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Abbott Rapid Diagnostics Jena GmbH

6. Product Performance Specification, and Associated

For performance qualification of Panbio™ COVID-19 IgG/IgM Rapid Test

- Panbio™ COVID-19 IgG/IgM Rapid Test Device, Validation Lot

Panbio™ COVID-19 IgG/IgM Rapid Test Device, Validation Lot Number:

All performance studies were performed according to standard EN

6.1. Analytical Studies

Study Summary Serum/plasma/whole blood consistency study

Extract from ICO-T402_TF01 Version 01 Confidential

- Panbio™ COVID-19 IgG/IgM Rapid Test Device, Validation Lot

- Comparator rapid test device (Innovita), Lot Number 20200302

Table 6.1-1: Tested specimens*

Extract from ICO-T402_TF01 Version 01 Confidential

Table 6.1-2: Acceptance criteria regarding Line Intensity

Sample Line Intensity Range

Negative sample G line<G3, M line<G3

Methodology / Study Design

To generate positive samples, an anti-SARS-CoV-2 IgG positive specimen

Extract from ICO-T402_TF01 Version 01 Confidential

EDTA plasma 25 100 25 100 3 100

6.1.1.2. Specimen Stability

Study Summary Specimen Type – Specimen stability

Extract from ICO-T402_TF01 Version 01 Confidential

Note: Fingerstick whole blood has to be tested immediately after collection

- Panbio™ COVID-19 IgG/IgM Rapid Test Device, Validation Lot

- Comparator rapid test device (Innovita), Lot Number 20200302

Tested specimens are shown in Table 6.1-4.

Table 6.1-4: Tested specimens

- Serum-separating tube (without anticoagulant), Lot Number 1910222

anti-SARS-CoV-2 IgG positive samples : G line≥G3

anti-SARS-CoV-2 IgM positive samples : M line≥G3

Negative samples: G line<G3, M line<G3

Methodology / Study Design

Extract from ICO-T402_TF01 Version 01 Confidential

Table 6.1-5: Test time points

Table 6.1-6: Stability data of serum and plasma samples

Extract from ICO-T402_TF01 Version 01 Confidential

Validation Lot 1(G/M)

Table 6.1-7: Stability data of whole blood

Test1 1/1 1/1 1/1

Extract from ICO-T402_TF01 Version 01 Confidential

6.2. Analytical Performance Characteristics

6.2.1.2. Precision of Measurement

Study Summary Precision- (Intra-Lot and Lot-to-Lot Variability)

Extract from ICO-T402_TF01 Version 01 Confidential

Tested specimens are shown in Table 6.1-8.

Table 6.1-8: Tested specimens and replicates

Table 6.1-9: Acceptance criteria for line intensity

Sample Line Intensity Range

Negative serum G line<G3, M line<G3

Extract from ICO-T402_TF01 Version 01 Confidential

Methodology / Study Design

Anti-SARS-CoV-2 negative samples were obtained from 5 donors. The low

Extract from ICO-T402_TF01 Version 01 Confidential

Table 6.1-10: Precision study results day-to-day

Extract from ICO-T402_TF01 Version 01 Confidential

Extract from ICO-T402_TF01 Version 01 Confidential

Table 6.1-11: Precision study results inter- and intra-lot

Table 6.1-12: Summarized precision results

Extract from ICO-T402_TF01 Version 01 Confidential

Seroconversion Panel Testing

- Comparator rapid test device (Innovita), Lot Number 20200302

Extract from ICO-T402_TF01 Version 01 Confidential