：MD71-5-Q19 (V1.

0)
Document No.（Version）

For internal use only Secret

Confidentiality
Confidential Top secret

Document Category Design History File

Project Code MD71-Q NT-proBNP(CLIA)

Stability Study
Prepared by/Date Li Xueqing/2021.05.08

Reviewed by/Date Xiao Liangpin/2021.05.10

Approved by/Date Xiao Liangpin/2021.05.10

Document Revision Record

Version EPTD No. Revision Description Prepared by

V1.0 / Initial version. Li Xueqing/2021.05.08

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Contents

1 Foreword ................................................................................................................................... 3
1.1 Purpose.............................................................................................................................................. 3
1.2 Scope ................................................................................................................................................. 3
2 Evaluation of Reagent Stability ....................................................................................................... 3
2.1 Shelf-life Stabiity Evaluation .............................................................................................................. 3
2.1.1 Results from Evaluation of Shelf-life Stabiity.......................................................................... 3
2.1.2 Summary of Shelf-life Stabiity Evaluation .............................................................................. 6
2.2 Transport stability Evaluation ............................................................................................................ 6
2.2.1 Results from Transport stability Evaluation ............................................................................ 7
2.2.2 Summary about Transport stability Evaluation ...................................................................... 8
2.3 Stability of Reconstituted Calibrators ................................................................................................ 8
2.3.1 Results from Stability Evaluation of Reconstituted Calibrators .............................................. 9
2.3.2 Summary about Stability Evaluation of Reconstituted Calibrator ........................................ 10
3 Evaluation of Sample Stability ....................................................................................................... 11
3.1 Test Method .................................................................................................................................... 11
3.1.1 Evaluation of serum and plasma Sample Stability .......................................................... 11
3.1.2 Evaluation of whole blood Sample Stability..................................................................... 11
3.2 Test Results ...................................................................................................................................... 12
3.3 Summary of Sample Stability Study ................................................................................................ 20
4 Summary of Stability Study ........................................................................................................... 21

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1 Foreword

1.1 Purpose

Stability evaluation provides important evidence for verifying the effectiveness and quality of reagent to meet customer needs on the market place.

Based on the stipulation in relevant Chinese regulations, EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro

diagnostic reagents and YY/T1579-2018 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents, stability of NT-

proBNP (CLIA) has been studied, including Shelf-life long-term stability, transportation stability, stability of reconstituted calibrators, and sample

stability.

1.2 Scope

This document is applicable to stability evaluation of NT-proBNP (CLIA) that matches Immu F6 or Immu F6S Automated Chemiluminescence

Immunoassay Analyzer.

2 Evaluation of Reagent Stability

2.1 Shelf-life Stabiity Evaluation

Place three batches (20180201, 20180301, and 20180401) of NT-proBNP (CLIA) at 2~8 ℃ for long term storage. Accordingly, test the three

batch kit at the start (time 0), 3rd month, 6th month, 9th month, 12th month, 14th month, 16th month, and after 16th month (after expiration of claimed

shelf life) respectively. All the test on three batches was performed according to the protocol in sections 3.1~3.11, and evaluate the Shelf-life Stabiity of

NT-proBNP (CLIA) stored in the actual storage conditions.

2.1.1 Results from Evaluation of Shelf-life Stabiity

Table 1 Results from Shelf-life Stabiity evaluation

Matched instrument: Immu F6 Batch No. of NT-proBNP (CLIA): 20180201

Acceptance Start 3rd 6th 9th 12th 14th 16th After 16th Pass
Test Item
Criteria (Time 0) month month month month month month month /Fail

Appearance 3.1.1 Pass Pass Pass Pass Pass Pass Pass Pass Pass

R1 50±5 μL Pass Pass Pass Pass Pass Pass Pass Pass Pass

R2 ≥ 50 μL Pass Pass Pass Pass Pass Pass Pass Pass Pass

R4 ≥ 100 μL Pass Pass Pass Pass Pass Pass Pass Pass Pass
Fill volume
C0 ≥1.0 mL Pass Pass Pass Pass Pass Pass Pass Pass Pass

Reconst.
±10.0 % Pass Pass Pass Pass Pass Pass Pass Pass Pass
solvent

Number of test

LoB results greater 0 0 0 0 0 0 0 0 Pass

than LoB ≤3

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Number of test

LoD results smaller 0 0 0 0 0 0 0 0 Pass

than LoB ≤3

I recovery
100.0%±10.0% 99.0% 103.5% 99.7% 99.3% 97.6% 100.3% 95.6% 101.4%
rate
Pass
D-value of
±10.0 % -0.9% 2.2% 3.3% -0.3% -2.9% -2.7% -4.9% -2.0%
sample I

II recovery
Accuracy 100.0%±10.0% 100.8% 99.0% 93.1% 99.9% 103.3% 105.8% 105.4% 105.3% Pass
rate

D-value of
±10.0 % 0.9% -2.2% -3.3% 0.3% 2.9% 2.7% 4.9% 2.0% Pass
sample II

Proportional
≥10.0 % 0.1% 1.3% 3.6% 0.4% 0.5% 3.0% 0.5% 3.3% Pass
system error

r≥0.99
Linearity r≥0.990 0.9990 0.9994 1.0000 0.9997 1.0000 1.0000 1.0000 Pass
0
I CV≤8% 3.1% 2.6% 2.9% 3.6% 3.1% 3.7% 3.6% 3.1%
Pass
Repeatability II CV≤8% 4.6% 3.4% 3.3% 2.6% 3.6% 2.4% 5.6% 3.3%

III CV≤8% 2.7% 2.3% 2.7% 2.5% 2.6% 4.1% 3.1% 3.6% Pass

I CV≤10% 3.3% 3.0% 3.3% 3.4% 3.5% 3.1% / /

Batch-to-
Pass
batch II CV≤10% 4.1% 3.5% 3.5% 3.2% 3.5% 3.1% / /

variation
III CV≤10% 3.6% 2.5% 3.1% 3.4% 2.4% 3.9% / / Pass

Accuracy of

Value C1 ±10% 0.5% 1.5% 0.4% 1.8% 1.4% -0.7% 1.5% -0.6% Pass

Assignment

Within-vial C0 SD≤5 0.32 0.00 0.30 0.85 0.22 0.68 0.40 0.73
Pass
homogeneity C1 CV≤8% 1.9% 3.6% 3.2% 4.0% 2.2% 3.9% 4.8% 2.3%

Between-vial C0 SD≤5 0.00 0.38 0.47 0.00 0.56 0.00 0.10 0.00
Pass
homogeneity C1 CV≤5% 2.8% 0.0% 0.0% 2.8% 3.0% 1.3% 0.0% 0.4%

Matched instrument: Immu F6 Batch No. of NT-proBNP (CLIA): 20180301

Acceptance Start 3rd 6th 9th 12th 14th 15th 16th Pass
Test Item
Criteria (Time 0) month month month month month month month /Fail

Appearance 3.1.1 Pass Pass Pass Pass Pass Pass Pass Pass Pass

R1 50±5 μL Pass Pass Pass Pass Pass Pass Pass Pass Pass

R2 ≥ 50 μL Pass Pass Pass Pass Pass Pass Pass Pass Pass

R4 ≥ 100 μL Pass Pass Pass Pass Pass Pass Pass Pass Pass
Fill volume
C0 ≥1.0 mL Pass Pass Pass Pass Pass Pass Pass Pass Pass

Reconst.
±10.0 % Pass Pass Pass Pass Pass Pass Pass Pass Pass
solvent

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Number of test

LoB results greater 0 0 0 0 0 0 0 0 Pass

than LoB ≤3

Number of test

LoD results smaller 0 0 0 0 0 0 0 0 Pass

than LoB ≤3

I recovery
100.0%±10.0% 100.3% 100.5% 101.1% 99.3% 98.8% 98.4% 97.4% 97.6%
rate
Pass
D-value of
±10.0 % 1.9% -0.6% 2.2% -0.3% -1.7% -0.5% -2.4% -1.3%
sample I

II recovery
Accuracy 100.0%±10.0% 96.4% 101.7% 96.7% 99.9% 102.2% 99.4% 102.2% 100.2% Pass
rate

D-value of
±10.0 % -1.9% 0.6% -2.2% 0.3% 1.7% 0.5% 2.4% 1.3% Pass
sample II

Proportional
≤10.0 % 1.6% 1.1% 1.1% 0.4% 0.5% 1.1% 0.2% 1.1% Pass
system error

Linearity r≥0.990 r≥0.990 0.9995 0.9999 0.9999 1.0000 1.0000 1.0000 1.0000 Pass

I CV≤8% 3.6% 3.4% 3.9% 4.0% 4.4% 2.9% 2.0% 3.9%

Pass
Repeatability II CV≤8% 3.7% 3.4% 3.0% 2.6% 3.5% 3.9% 4.4% 4.3%

III CV≤8% 4.8% 2.7% 2.4% 4.6% 2.3% 3.7% 3.9% 0.3% Pass

Accuracy of

Value C1 ±10% -0.5% -1.5% 0.7% -1.1% -2.4% 0.1% -1.7% 2.6% Pass

Assignment

Within-vial C0 SD≤5 0.00 0.00 0.39 0.71 0.20 0.53 0.69 0.69
Pass
homogeneity C1 CV≤8 % 2.7% 3.3% 3.4% 2.5% 2.6% 3.9% 2.3% 5.3%

Between-vial C0 SD≤5 0.42 0.53 0.64 0.00 0.47 0.50 0.16 0.16
Pass
homogeneity C1 CV≤5 % 2.3% 0.0% 3.7% 3.3% 2.6% 0.0% 0.0% 0.9%

Matched instrument: Immu F6 Batch No. of NT-proBNP (CLIA): 20180401

Acceptance Start 3rd 6th 9th 12th 14th 15th 16th Pass
Test Item
Criteria (Time 0) month month month month month month month /Fail

Appearance 3.1.1 Pass Pass Pass Pass Pass Pass Pass Pass Pass

R1 50±5 μL Pass Pass Pass Pass Pass Pass Pass Pass Pass

R2 ≥ 50 μL Pass Pass Pass Pass Pass Pass Pass Pass Pass

R4 ≥ 100 μL Pass Pass Pass Pass Pass Pass Pass Pass Pass
Fill volume
C0 ≥1.0 mL Pass Pass Pass Pass Pass Pass Pass Pass Pass

Reconst.
±10.0 % Pass Pass Pass Pass Pass Pass Pass Pass Pass
solvent

Number of test

LoB results greater 0 0 0 0 0 0 0 0 Pass

than LoB ≤3

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Number of test

LoD results smaller 0 0 0 0 0 0 0 0 Pass

than LoB ≤3

I recovery
100.0%±10.0% 102.8% 100.5% 100.8% 98.5% 97.3% 97.2% 101.0% 96.1%
rate
Pass
D-value of
±10.0 % 2.7% -1.7% -0.2% -1.5% -2.0% -2.7% -1.2% -3.0%
sample I

II recovery
Accuracy 100.0%±10.0% 97.4% 103.8% 101.3% 101.5% 101.3% 102.7% 103.5% 102.1% Pass
rate

D-value of
±10.0 % -2.7% 1.7% 0.2% 1.5% 2.0% 2.7% 1.2% 3.0% Pass
sample II

Proportional
≤10.0 % 0.1% 2.1% 1.0% 0.0% 0.7% 0.0% 2.3% 0.9% Pass
system error

Linearity r≥0.990 0.9998 0.9999 1.0000 0.9991 0.9998 1.0000 0.9999 0.9999 Pass

I CV≤8% 3.3% 3.3% 2.8% 2.6% 3.1% 2.9% 1.8% 3.9%

Pass
Repeatability II CV≤8% 2.8% 2.6% 4.1% 3.8% 3.6% 3.1% 3.0% 3.6%

III CV≤8% 2.4% 2.5% 4.0% 2.6% 2.6% 3.7% 3.3% 0.4% Pass

Accuracy of

Value C1 ±10% -3.4% -2.7% -1.3% -3.3% -3.1% -2.8% -3.5% 3.5% Pass

Assignment

Within-vial C0 SD≤5 0.58 0.49 0.47 0.63 0.28 0.76 0.50 0.50
Pass
homogeneity C1 CV≤8 % 3.5% 2.0% 1.9% 3.9% 3.2% 1.8% 2.0% 4.8%

Between-vial C0 SD≤5 0.00 0.00 0.38 0.00 0.39 0.00 0.00 0.00
Pass
homogeneity C1 CV≤5 % 0.0% 3.1% 3.4% 0.0% 2.8% 2.7% 1.5% 5.0%

2.1.2 Summary of Shelf-life Stabiity Evaluation

The 20180201 batche of NT-proBNP (CLIA) have been manufactured in the reagent plant, and stored at 2~8 ℃ from the start (Time 0) to beyond

16th month (after claimed shelf life). Shelf-life Stabiity study has evaluated various performance parameters, such as appearance, fill volume, LoB, LoD,

accuracy, linearity range, repeatability, batch-to-batch variation, accuracy of value assignment of calibrators, within-vial homogeneity, and between-vial

homogeneity of calibrators, all meet the acceptance criteria. The 20180301 and 20180401 batches of NT-proBNP which also stored at 2~8 ℃ from the

start (Time 0) to beyond 15th month. For these two batches, the same test protocal was taken and all the result meet the acceptance criteria.

2.2 Transport stability Evaluation

NT-proBNP (CLIA) (batch No. 20180201) were shipped to Shanghai, Lanzhou, and Harbin through cold chain transportation respectively. Keep

temperature at 2~8 ℃ during the whole transportation process. After NT-proBNP (CLIA) reached the destination, it was transported back again, and

then stored at 2~8 ℃ until it got to the shelf life. Then, perform the tests according to the stability evaluation protocol on June 18, 2019 (expiration date

is June 6, 2019). The test was conducted with the same procedure as stability study (using 20180301 and 20180401 batches for batch-to-batch variation

test).

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Table 2 Transport stability study

Transportation
Packing Size Batch No. Expiration Date Test Date
Destination

60×1 Tests/Pkg
Shanghai 20180201 2019.06.06 2019.06.18
(calibrator included)

60×1 Tests/Pkg
Lanzhou 20180201 2019.06.06 2019.06.19
(calibrator included)

60×1 Tests/Pkg
Harbin 20180201 2019.06.06 2019.06.20
(calibrator included)

2.2.1 Results from Transport stability Evaluation

Table 3 Results of Transport stability evaluation (packing size: 60×1 Tests/Pkg (calibrator included)

Matched instrument:
Batch No. of NT-proBNP (CLIA): 20180201
Immu F6

Transportation Destination
Test Item Acceptance Criteria Pass/Fail
Shanghai Lanzhou Harbin

Appearance 3.1.1 Pass Pass Pass Pass

R1 50±5μL Pass Pass Pass Pass

R2 ≥ 50μL Pass Pass Pass Pass

R4 ≥ 100μL Pass Pass Pass Pass

Fill volume
C0 ≥1.0 mL Pass Pass Pass Pass

Reconstitution
±10.0 % Pass Pass Pass Pass
solvent

Number of test results

LoB 0 0 0 Pass
greater than LoB≤3

Number of test results

LoD 1 0 0 Pass
smaller than LoB≤3

I recovery rate 99.5% 96.6% 97.2%

100.0%±10.0%
D-value of Pass
±10.0 % 0.9% -3.8% -2.2%
sample I

II recovery rate 100.0%±10.0% 97.6% 100.8% 101.7% Pass

Accuracy
D-value of
±10.0 % -0.9% 3.8% 2.2% Pass
sample II

Proportional
≥10.0 % 1.5% 1.1% 0.5% Pass
system error

Linearity r≥0.990 1.0000 0.9997 0.9996 Pass

I CV≤8% 3.9% 3.6% 3.0%

Pass
Repeatability II CV≤8% 2.9% 3.5% 4.5%

III CV≤8% 4.5% 4.8% 3.6% Pass

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Matched instrument:
Batch No. of NT-proBNP (CLIA): 20180201
Immu F6

Transportation Destination
Test Item Acceptance Criteria Pass/Fail
Shanghai Lanzhou Harbin

I CV≤10% 3.4% 4.3% 3.3%

Batch-to-batch Pass
II CV≤10% 4.2% 4.4% 4.7%
variation
III CV≤10% 4.9% 4.7% 4.8% Pass

Accuracy of
C1 ±10% -1.3% 0.4% 0.3% Pass
value assignment

Within-vial C0 SD≤5 0.09 0.09 0.08

Pass
homogeneity C1 CV≤8 % 2.7% 4.6% 3.2%

Between-vial C0 SD≤5 0.56 0.53 0.45

Pass
homogeneity C1 CV≤5 % 3.2% 0.0% 1.9%

2.2.2 Summary about Transport stability Evaluation

For Transport stability evaluation, NT-proBNP (CLIA) (Batch 20180201) has been sent to Shanghai, Lanzhou, and Harbin respectively, and then

returned back via cold chain transportation. Afterwards, the kit was stored at 2~8 ℃, and tested before its expiration date. The test results show that

various performance parameters such as appearance, fill volume, LoB, LoD, accuracy, linearity range, repeatability, accuracy of value assignment of

calibrators, within-vial and between-vial homogeneity of calibrators all meet the acceptance criteria. This indicates that the stability and effectiveness

of NT-proBNP (CLIA) can be maintained, and the kit can still meet quality requirement after transportation during its 16-month shelf life.

2.3 Stability of Reconstituted Calibrators

Dry powder of calibrator is reconstituted, and stored at different temperatures. Stability of reconstituted calibrators is evaluated. The specific

study method is as follows:

Room temperature (10~30 ℃): Take out calibrators from three batches (20180201, 20180301, and 20180401) of NT-proBNP (CLIA). After equilibrated

to room temperature, each batch of calibrator is dissolved with reconstitution solvent, wait for about 10 min until reconstitution is completed, measure

NT-proBNP of each calibrator and record the value (start, Time 0). Cap each reconstituted calibrator and keep it at room temperature. Sample each

calibrator stored at room temperature and measure NT-proBNP value at the 6th hour, 12th hour, 24th hour, and 36th hour respectively. Remember to re-

cap the calibrator every time aliquot is sampled and tested from the vial, and store it at room temperature all the time.

2~8 ℃ storage: Take out calibrators from three batches (20180201, 20180301, and 20180401) of NT-proBNP (CLIA). After equilibrated to room

temperature, each batch of calibrator is dissolved with reconstitution solvent, wait for about 10 min until reconstitution is completed, measure NT-

proBNP of each calibrator and record the value (start, Time 0). Cap each reconstituted calibrator and keep it at 2~8 ℃. Sample each calibrator stored at

2~8 ℃ and measure NT-proBNP value at the 1st day, 3rd day, 5th day, and 7th day respectively. Remember to re-cap the calibrator every time aliquot is

sampled and tested from the vial, and store it back at 2~8 ℃ immediately.

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-20 ℃ storage: Take out calibrators from three batches (20180201, 20180301, and 20180401) of NT-proBNP (CLIA). After equilibrated to room

temperature, each batch of calibrator is dissolved with reconstitution solvent, wait for about 10 min until reconstitution is completed, measure NT-

proBNP of each calibrator and record the value (start, Time 0). Cap each reconstituted calibrator and keep it at -20 ℃. Sample each calibrator stored at

-20 ℃ after thaw and equilibrium to room temperature, and measure NT-proBNP value at he 30th day, 60th day, and 80th day respectively. Remember

to re-cap the calibrator every time aliquot is sampled and tested from the vial, and store it back at -20 ℃ immediately.

Freeze-thaw Cycles: Take out calibrators from three batches (20180201, 20180301, and 20180401) of NT-proBNP (CLIA). After equilibrated to room

temperature, each batch of calibrator is dissolved with reconstitution solvent, wait for about 10min until reconstitution is completed, measure NT-proBNP

of each calibrator and record the value (start, Time 0). Divide each vial of calibrator into 3 small vials, store the first vial at 2~8 ℃, and store another

two vials in a -20 ℃ freezer. After frozen, take out both vials and place them at 2~8 ℃ for thawing. Afterwards, store one vial at 2~8 ℃ which has been

frozen and thawed once. Place another vial back to the -20 ℃ freezer, wait until it is totally frozen. Take out the vial for thawing, use this vial as the

calibrator which has been frozen and thawed twice. Then, measure NT-proBNP of the calibrator from each vial which has experienced 0, 1, and 2 freeze-

thaw cycles. Record the test results.

2.3.1 Results from Stability Evaluation of Reconstituted Calibrators

Table 4 Results from stability evaluation of reconstituted calibrators

The stability of reconstituted calibrators

Acceptance Conclusion
Room Temperature 2~8 ℃ -20℃ Freeze-thaw Cycles
Criteria
Batch No.
Storage Relative Storage Relative Storage Relative Number of Relative Use the /
working
Time Deviation (B) Time Deviation (B) Time Deviation (B) Cycles Deviation (B)
calibrators with

0h 0.1% 0 day -0.9% 0 day -2.8% 0 1.4% values assigned Pass

using a higher-
6h -2.1% 1 days -1.4% 30 days -0.8% 1 -2.3% Pass
level

20180201 12 h 0.7% 3 days -1.6% 60 days -0.3% 2 -9.5% measurement Pass

procedure to
24h 0.4% 5 days 0.0% 80 days 1.6% / / Pass
calibrate the

/ chemiluminesce
36 h -0.5% 7 days 0.6% / / / Pass
nce
0h 0.4% 0 day -3.7% 0 day 1.0% 0 -1.1% immunoassay Pass

system. After
6h -1.4% 1 days -0.8% 30 days -3.6% 1 -3.5% Pass
that, use kit of
20180301 12 h -0.2% 3 days -2.4% 60 days 0.8% 2 -13.4% the same batch to Pass

test each
24h 0.9% 5 days -0.3% 80 days -3.4% / / Pass
calibrator. The
36 h -1.1% 7 days -4.5% / / / / deviation Pass

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between the test

0h -2.3% 0 day -2.8% 0 day -3.4% 0 -2.7% Pass
value and the
6h -4.5% 1 days -3.6% 30 days -0.6% 1 -6.9% assigned value of Pass

each calibrator
20180401 12 h -2.5% 3 days -3.5% 60 days -4.7% 2 -8.0% Pass
does not exceed
24h -5.3% 5 days -2.6% 80 days -3.7% / / ±10.0%. Pass

36 h -6.6% 7 days -2.7% / / / / Pass

2.3.2 Summary about Stability Evaluation of Reconstituted Calibrator

The test results are as follows:

 NT-proBNP calibrator is tested within 1 day (24h) after it is reconstituted and stored at room temperature (10~30 ℃), and all test results

meet the acceptance criteria, indicating that NT-proBNP calibrator can be stored at room temperature for one day after reconstitution.

 NT-proBNP calibrator is tested within 5 days after it is reconstituted and stored at 2~8 ℃, and all test results meet the acceptance criteria,

indicating that NT-proBNP calibrator can be stored at 2~8 ℃ for 5 days after reconstitution.

 NT-proBNP calibrator is tested within 60 days after it is reconstituted and stored at -20 ℃, and all test results meet the acceptance criteria,

indicating that NT-proBNP calibrator can be stored at -20 ℃ for 60 days after reconstitution.

 NT-proBNP calibrator that is reconstituted, stored at -20 ℃, frozen and thawed twice can still meet the acceptance criteria.

To prevent contamination of calibrators during use, or prevent incorrect test results caused by other cause, it is suggested that opened and

reconstituted NT-proBNP calibrators stored at room temperature (10~30 ℃) for no longer than one day. The calibrators can be stored at 2~8 ℃ for a

short-term (no longer than 5 days). For a relative long-term storage (no longer than 60 days), the calibrator must be stored at -20 ℃. However, the

calibrator is only allowed to be frozen and thawed for no more than once.

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3 Evaluation of Sample Stability

Using 20180201 batch for the following sample stability evaluation. Samples are stored at room temperature (10~30 ℃), 2~8 ℃, and -20 ℃

respectively, verifying the stability of different sample types (Serum and plasma with different anticoagulants such as EDTA-K2, sodium heparin, and

lithium heparin) at different temperatures. The impact of freeze-thaw cycles on test results has also been evaluated. Meanwhile, the stability of whole

blood with different anticoagulants such as EDTA-K2, sodium heparin, and lithium heparin under room temperature (10~30 ℃) was also evaluated with

same protocol.

3.1 Test Method

3.1.1 Evaluation of serum and plasma Sample Stability

(1) Stability at room temperature (10~30 ℃): Take 10 fresh samples (serum, plasma samples containing anticoagulant EDTA-K2, sodium heparin, and

lithium heparin). Each sample is equally divided into 5 aliquots. One aliquot is used for immediate test to obtain the initial result of the sample. Place

the other 4 aliquots at room temperature (10~30 ℃), test one of them at the 2nd hour, 4th hour, 8th hour, and 12th hour respectively, and compare

measurement results with the initial value.

(2) Stability at 2~8 ℃: Take 10 fresh samples (serum, plasma samples containing anticoagulant EDTA-K2, sodium heparin, and lithium heparin). Each

sample is equally divided into 5 aliquots. One aliquot is used for immediate test to obtain the initial result of the sample. Place the other 4 aliquots in a

2~8 ℃ refrigerator. Sample one of them at the 2nd day, 4th day, 6th day, and 8th day and measure NT-proBNP value after the sample aliquot reaches

room temperature, and compare measurement results with the initial value.

(3) Stability at -20 ℃: Take 10 fresh samples (serum, plasma samples containing anticoagulant EDTA-K2, sodium heparin, and lithium heparin). Each

sample is equally divided into 5 aliquots. One aliquot is used for immediate test to obtain the initial result of the sample. Place the other 4 aliquots in -

20 ℃ freezer. Sample one of them at the 15th day, 30th day, 45th day, and 60th day and test them after they are thawed and reach room temperature,

measure NT-proBNP value after the sample aliquot reaches room temperature, and compare measurement results with the initial value.

(4) Freeze-thaw Cycles: Take 10 fresh samples (serum, plasma samples containing anticoagulant EDTA-K2, sodium heparin, and lithium heparin). Each

sample is equally divided into 4 aliquots. Place one of the 4 aliquots at 2~8 ℃ as the control sample (for no more than 24 hours). Place the other three

aliquots in a -20 ℃ freezer. After totally frozen (stored in the freezer for more than 2 hours), take all three aliquots out and thaw them. Afterwards, leave

one aliquot at 2~8 ℃, and place another two aliquots back to the -20 ℃ freezer. Repeat this freeze/thaw procedure until the third sample has been

thawed. Test all four aliquots at the same time, and compare measurement results with the control aliquot, which has not experienced any freeze/thaw

cycle.

Acceptance criteria: The relative deviation between measurement result at each time point and the initial value does not exceed 10%, and the

relative deviation between measurement result of the control aliquot and the aliquots experiencing 1-3 freeze-thaw cycles does not exceed 10%.

3.1.2 Evaluation of whole blood Sample Stability

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Take 10 fresh samples (whole blood with EDTA-K2 or lithium heparin). Each sample is equally divided into 5 aliquots. One aliquot is used for immediate

test to obtain the initial result of the sample. Place the other 4 aliquots at room temperature (10~30 ℃), test one of them at the 2nd hour, 4th hour, 6th

hour, and 8th hour respectively, and compare measurement results with the initial value.

Note: whole blood samples should be mixed before testing.

3.2 Test Results

Table 5 Results of sample stability evaluation

1. Serum samples at room temperature (10~30 ℃)

Sample Relative deviation (2h) Relative deviation (4h) Relative deviation (8h) Relative deviation (12h)

1 1.1% -4.5% -2.5% 3.6%

2 3.4% 3.8% 2.5% 1.6%

3 -4.0% -4.0% 0.9% -1.7%

4 0.7% 5.0% -2.7% 2.9%

5 -3.2% 0.4% -3.5% 1.6%

6 -3.8% 0.3% -3.5% -14.1%

7 0.9% -0.3% 1.1% -3.3%

8 2.6% 2.9% 0.6% -3.3%

9 -4.0% -0.6% -6.1% -25.7%

10 -3.5% -2.8% -4.9% -14.6%

2. Serum samples stored at 2~8 ℃

Sample Relative deviation (2 days) Relative deviation (4 days) Relative deviation (6 days) Relative deviation (8 days)

1 -1.1% -3.0% -5.8% -30.9%

2 -3.4% 3.1% -5.6% -26.3%

3 -0.7% 2.5% -1.2% 3.9%

4 -2.8% 2.4% 1.9% 4.8%

5 -4.2% 2.7% 4.9% -8.1%

6 -3.5% 0.5% 4.5% -13.0%

7 -0.6% -3.4% -2.6% 2.1%

8 -2.3% 0.7% 3.9% 1.1%

9 4.7% 1.9% 1.8% -18.6%

10 -3.7% 0.9% 3.4% -2.0%

3. Serum samples stored at -20 ℃

Sample Relative deviation (2 months) Relative deviation (4 months) Relative deviation (6 months) Relative deviation (8 months)

1 4.7% 4.0% 4.2% 1.6%

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2 1.8% 1.7% 4.3% -13.0%

3 2.7% 2.1% 1.9% 4.1%

4 -4.6% 1.2% -5.0% -10.7%

5 -1.6% -0.3% -1.3% 2.1%

6 -3.5% -4.9% -4.9% -13.3%

7 -2.6% -2.2% -4.1% 0.0%

8 -2.6% 1.9% 1.4% -4.9%

9 -2.3% 4.0% 0.6% -8.3%

10 0.5% -4.1% -3.2% 2.8%

4. Serum samples undergoing Freeze/thaw cycles

Sample Relative deviation (once) Relative deviation (twice) Relative deviation (three times) Relative deviation (four times)

1 1.7% -7.7% -14.0% -20.3%

2 -4.6% -5.2% -12.1% -17.7%

3 -2.8% -12.1% -12.3% -18.4%

4 4.2% -9.5% -4.0% -10.8%

5 -4.2% -0.3% -2.8% -8.8%

6 4.7% -9.3% -16.5% -19.3%

7 -4.0% 2.9% -7.7% -20.7%

8 -3.3% -7.5% -12.7% -11.6%

9 -0.5% 5.0% -5.0% -12.0%

10 -1.5% -2.5% 0.5% -7.6%

5. EDTA-K2 plasma stored at room temperature (10~30 ℃)

Sample Relative deviation (2h) Relative deviation (4h) Relative deviation (8h) Relative deviation (12h)

1 2.9% 4.3% 2.6% 2.5%

2 -2.4% 2.4% 3.0% 3.7%

3 3.4% -1.4% -4.6% 3.0%

4 3.1% -3.9% 2.1% -7.7%

5 -0.2% 1.8% 3.4% 3.5%

6 2.6% -0.7% -3.0% -2.5%

7 2.7% -2.4% -6.9% -12.1%

8 -1.1% -2.8% -3.5% 2.3%

9 -4.6% 0.6% 0.1% -12.7%

10 0.2% -1.9% 3.3% 3.3%

6. EDTA-K2 plasma stored at 2~8 ℃

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Sample Relative deviation (2 days) Relative deviation (4 days) Relative deviation (6 days) Relative deviation (8 days)

1 4.4% 4.0% -0.5% -3.0%

2 1.3% -3.6% -0.8% -3.2%

3 3.6% -0.7% -1.4% -11.6%

4 0.5% 2.9% 0.8% -5.8%

5 -0.6% 2.7% -0.8% -3.1%

6 4.8% -0.2% 1.1% -0.2%

7 1.0% -3.3% -0.7% -1.3%

8 -0.8% -1.1% -5.2% -12.6%

9 2.1% -2.7% -3.9% 2.0%

10 -4.2% -0.8% -5.7% -25.7%

7. EDTA-K2 plasma stored at-20 ℃

Sample Relative deviation (2 months) Relative deviation (4 months) Relative deviation (6 months) Relative deviation (8 months)

1 0.4% -1.8% -3.1% -10.5%

2 -4.9% -0.6% -4.3% -1.1%

3 4.8% -2.6% -0.9% -3.8%

4 -3.4% -3.1% 3.1% -3.3%

5 -4.9% -2.5% -4.0% -10.6%

6 -0.5% -1.1% 1.5% -4.2%

7 1.9% -2.2% 2.2% 1.7%

8 0.0% 4.9% -2.8% 2.8%

9 2.2% 3.3% 3.4% -0.4%

10 3.2% 1.4% -3.4% 0.4%

8. EDTA-K2 plasma undergoing freeze/thaw cycles

Sample Relative deviation (once) Relative deviation (twice) Relative deviation (twice) Relative deviation (three times)

1 -4.6% -0.1% -12.8% -14.7%

2 3.1% -11.3% -3.9% -5.8%

3 3.2% -13.3% -10.0% -14.6%

4 -2.7% -11.1% -15.5% -15.9%

5 3.7% -12.6% -18.5% -27.2%

6 -2.0% -1.4% -8.3% -10.9%

7 3.8% -8.7% -1.0% -10.6%

8 -2.4% -0.6% -0.1% -2.5%

9 -2.5% -14.4% -2.4% -2.4%

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10 -0.6% -12.0% -1.7% -13.1%

9. EDTA-K3 plasma stored at room temperature (10~30 ℃)

Sample Relative deviation (2h) Relative deviation (4h) Relative deviation (8h) Relative deviation (12h)

1 -4.4% -6.9% -7.4% -11.3%

2 -1.4% -0.6% -4.2% -1.8%

3 -3.4% -4.6% -1.8% -3.7%

4 -2.2% 0.0% -4.6% -12.2%

5 -1.7% -1.8% -3.9% -0.8%

6 -3.1% -0.9% -0.1% -0.4%

7 -1.6% -1.3% -4.0% -4.4%

8 -1.1% -3.3% -3.1% -2.8%

9 -3.4% -4.0% -4.0% -0.8%

10 -0.7% -1.9% -0.1% -4.9%

10. EDTA-K3 plasma stored at 2~8 ℃

Sample Relative deviation (2 days) Relative deviation (4 days) Relative deviation (6 days) Relative deviation (8 days)

1 -4.6% -4.2% -1.9% -4.2%

2 -4.2% -2.7% -4.6% -1.8%

3 -1.8% -4.2% -2.8% -8.9%

4 -2.7% -2.5% -0.8% -3.2%

5 -1.9% -2.2% -3.7% -2.1%

6 -4.5% -1.4% -3.2% -2.5%

7 -3.3% -5.0% -4.6% -4.1%

8 -2.8% -6.5% -4.1% -13.5%

9 -2.0% -3.0% -4.2% -1.5%

10 -0.7% -3.8% -3.8% -4.1%

11. EDTA-K3 plasma stored at-20 ℃

Sample Relative deviation (2 months) Relative deviation (4 months) Relative deviation (6 months) Relative deviation (8 months)

1 -1.5% -1.5% -3.0% -2.1%

2 -2.7% -1.0% -4.7% -2.6%

3 -0.4% -0.2% -1.5% -4.0%

4 -3.3% -4.8% -6.5% -12.4%

5 -4.4% -1.9% -4.1% -1.2%

6 -2.9% -6.7% -5.1% -11.3%

7 -3.2% -0.5% -3.4% -3.1%

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8 -2.0% -1.4% -4.6% -1.9%

9 -3.0% -4.9% -9.2% -14.5%

10 -4.7% -3.7% -1.2% -6.5%

12. EDTA-K3 plasma undergoing freeze/thaw cycles

Sample Relative deviation (once) Relative deviation (twice) Relative deviation (three times) Relative deviation (four times)

1 -0.7% -17.9% -25.5% -24.0%

2 -4.9% -3.9% -12.6% -13.6%

3 -4.0% -1.0% -0.8% -8.9%

4 -1.7% -7.3% -14.7% -18.5%

5 -2.3% -3.1% -2.1% -8.4%

6 -4.7% -3.8% -2.5% -3.3%

7 -0.3% -1.3% -3.5% -9.4%

8 -3.9% -14.4% -16.8% -21.1%

9 -1.9% -1.4% -1.0% -1.4%

10 -1.5% -2.4% -2.9% -9.3%

13. Lithium heparin plasma stored at room temperature (10~30 ℃)

Sample Relative deviation (2h) Relative deviation (4h) Relative deviation (8h) Relative deviation (12h)

1 3.7% 2.4% -1.1% 3.6%

2 -5.0% 3.3% -4.6% 1.7%

3 -2.3% -4.9% 2.1% -7.2%

4 -2.3% -1.2% 4.0% -6.5%

5 -4.0% -3.2% -2.4% 4.7%

6 2.4% -0.4% -4.6% 0.3%

7 -0.1% -4.8% -3.1% -11.3%

8 -0.6% 4.0% 0.9% 0.4%

9 2.6% -4.5% 3.1% -0.5%

10 -2.7% 0.8% 0.4% -22.7%

14. Lithium heparin plasma stored at 2~8 ℃

Sample Relative deviation (2 days) Relative deviation (4 days) Relative deviation (6 days) Relative deviation (8 days)

1 -4.0% 3.5% 0.4% -11.2%

2 -1.6% -3.6% 2.9% -3.6%

3 -3.9% -1.6% -2.0% 2.9%

4 -0.4% -4.0% 4.4% -4.9%

5 5.0% 2.4% -4.7% 3.3%

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6 2.5% 0.6% -1.3% 3.4%

7 2.3% -2.8% -7.0% -11.8%

8 4.1% 0.2% 3.3% -3.2%

9 -0.2% 4.2% -4.0% 2.5%

10 4.2% 1.0% 1.8% -9.3%

15. Lithium heparin plasma stored at -20 ℃

Sample Relative deviation (2 months) Relative deviation (4 months) Relative deviation (6 months) Relative deviation (8 months)

1 0.3% 4.0% -1.7% -3.6%

2 2.0% -1.8% -0.9% -8.9%

3 3.2% -1.4% -4.6% 2.4%

4 -4.5% -4.6% -6.9% -14.4%

5 -3.0% -3.6% 2.0% 2.2%

6 1.6% 1.8% -5.4% -12.9%

7 3.6% 2.8% -0.1% 4.3%

8 -0.5% 2.5% 2.0% -0.3%

9 3.8% 2.8% -0.9% -4.4%

10 -2.8% -3.3% -3.8% 3.2%

16. Lithium heparin plasma undergoing Freeze/thaw cycles

Sample Relative deviation (once) Relative deviation (twice) Relative deviation (three times) Relative deviation (four times)

1 -3.2% -6.5% -10.2% -15.6%

2 -3.3% 3.8% -0.4% -6.2%

3 -4.9% -9.7% -13.3% -18.5%

4 -4.5% 3.4% -0.8% -6.8%

5 1.8% 2.8% -1.3% -7.2%

6 -2.7% 2.7% -1.4% -7.3%

7 0.4% -11.5% -15.1% -20.2%

8 -1.8% -4.9% -8.8% -14.2%

9 0.1% -0.6% -4.5% -10.2%

10 4.1% 2.4% -1.7% -7.6%

17. Sodium heparin plasma stored at room temperature (10~30 ℃)

Sample Relative deviation (2h) Relative deviation (4h) Relative deviation (8h) Relative deviation (12h)

1 -2.4% -2.0% -1.2% -2.1%

2 -4.2% -1.7% -3.2% -2.2%

3 -4.0% -2.9% -3.2% -2.4%

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4 -2.9% -4.9% -2.8% -1.8%

5 -2.3% -4.9% -2.7% -3.6%

6 -1.3% -3.5% -0.5% -3.1%

7 -1.5% -3.7% -0.6% -0.8%

8 -3.8% -2.9% -6.8% -12.6%

9 -2.6% -4.7% -3.6% -1.4%

10 -4.2% -2.2% -4.4% -2.4%

18. Sodium heparin plasma stored at 2~8 ℃

Sample Relative deviation (2 days) Relative deviation (4 days) Relative deviation (6 days) Relative deviation (8 days)

1 -0.2% -4.4% -6.9% -10.7%

2 -3.2% -0.7% -1.0% -2.4%

3 0.0% -0.6% -4.1% -1.4%

4 -1.6% -3.5% -6.4% -2.9%

5 -0.1% -0.7% -1.9% -4.1%

6 -4.2% -3.4% 2.7% 0.0%

7 -2.3% -0.8% -1.4% 0.2%

8 -3.8% 1.9% 7.2% -5.3%

9 -2.1% -1.2% -3.0% -0.4%

10 -2.0% -3.2% -0.4% -2.3%

19. Sodium heparin plasma stored at -20 ℃

Sample Relative deviation (2 months) Relative deviation (4 months) Relative deviation (6 months) Relative deviation (8 months)

1 -4.1% -8.2% -5.2% -16.5%

2 -3.1% -1.4% -4.8% -3.7%

3 -3.5% -6.6% -1.5% 1.6%

4 -4.6% -1.4% -3.2% -1.7%

5 -1.2% -3.6% -0.3% -1.8%

6 0.0% -1.0% -1.3% -4.3%

7 -2.2% -5.0% -5.2% -11.1%

8 -3.6% -2.8% -1.6% -4.2%

9 -4.2% -4.1% -0.4% -8.9%

10 -4.2% -3.5% -4.8% -6.9%

20. Sodium heparin plasma undergoing Freeze/thaw cycles

Sample Relative deviation (once) Relative deviation (twice) Relative deviation (three times) Relative deviation (four times)

1 -1.9% -6.9% -11.8% -8.1%

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2 -1.3% -14.3% -19.3% -21.0%

3 -4.0% -4.0% -33.7% -44.4%

4 -1.4% -43.9% -3.6% -5.4%

5 -2.8% 2.1% -32.3% -34.5%

6 -4.6% -4.1% -0.7% -23.0%

7 -0.5% -3.1% -3.2% -5.2%

8 -0.4% -1.4% -13.0% -18.8%

9 -3.4% -4.9% -12.8% -26.1%

10 -1.5% -3.4% -3.7% -0.4%

21. EDTA-K2 whole blood stored at room temperature (10~30 ℃)

Sample Relative deviation (2h) Relative deviation (4h) Relative deviation (6h) Relative deviation (8h)

1 2.5% -3.0% -5.3% -11.0%

2 -4.4% -2.5% -0.2% 2.0%

3 2.4% 0.1% 0.1% -2.6%

4 -1.0% 2.0% -4.8% -5.5%

5 -1.5% 2.7% 0.7% -3.3%

6 2.0% -2.0% 4.0% 1.7%

7 2.2% -2.4% -3.2% -3.1%

8 4.2% -1.5% -4.7% -10.7%

9 0.1% -6.1% -18.9% -14.2%

10 2.7% -4.0% -2.3% -3.8%

22. EDTA-K3 whole blood stored at room temperature (10~30 ℃)

Sample Relative deviation (2h) Relative deviation (4h) Relative deviation (6h) Relative deviation (8h)

1 -2.9% -3.9% -4.5% -1.4%

2 -3.8% -2.6% -0.8% -2.7%

3 -1.0% -1.5% -4.1% -2.8%

4 -2.3% -0.5% -2.8% -2.2%

5 -4.3% -1.4% -4.9% -1.2%

6 -3.7% -3.3% -10.0% -13.1%

7 -3.6% -5.5% -2.3% -3.9%

8 -2.9% -2.8% -0.3% -12.3%

9 -3.7% -3.8% -0.6% -2.5%

10 -4.4% -3.1% -2.0% -4.8%

23. Lithium heparin whole blood stored at room temperature (10~30 ℃)

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Sample Relative deviation (2h) Relative deviation (4h) Relative deviation (6h) Relative deviation (8h)

1 -0.3% -2.1% -10.0% -13.6%

2 -2.9% -1.2% -3.4% -10.5%

3 3.9% -1.5% 3.6% -1.6%

4 -0.2% -2.6% 1.1% -3.9%

5 1.7% -2.3% 1.0% -4.0%

6 -2.7% 1.0% -1.0% -6.0%

7 -4.8% -0.5% 8.8% 3.3%

8 -2.2% -3.5% -11.5% -10.2%

9 0.2% -2.1% -1.0% -6.0%

10 -4.0% -3.0% -4.9% -9.7%

24. sodium heparin whole blood stored at room temperature (10~30 ℃)

Sample Relative deviation (2h) Relative deviation (4h) Relative deviation (6h) Relative deviation (8h)

1 -2.6% -3.1% -3.6% -3.0%

2 -3.2% -0.1% -3.2% -8.7%

3 -2.1% -3.9% -3.4% -9.8%

4 -3.0% -3.0% -12.2% -16.0%

5 -3.0% -4.4% -3.7% -0.7%

6 -3.5% -4.5% -3.9% -6.9%

7 -2.5% -4.6% -4.9% -4.2%

8 -2.0% -3.3% -0.7% -7.9%

9 -1.3% -2.6% -0.1% -4.7%

10 -2.6% -6.5% -11.0% -10.3%

3.3 Summary of Sample Stability Study

The results from sample stability study are as follows:

 Whole blood samples were collected and stored at room temperature (10~30 ℃) for 2 hours and 4 hours, the relative deviation of measurement

results does not exceed 10.0%. After they are stored for 4 hours (6 hours and 8hours), the relative deviation of some test results exceeds 10.0%.

To ensure the accuracy of measurement result, it is recommended to test the samples as soon as possible after sample collection and processing,

and the storage time at room temperature should not be longer than 4 hours.

 Serum, EDTA and heparin plasma samples were colleted and stored at room temperature (10~30 ℃) for 2 hours, 4 hours and 8 hours, the

relative deviation of measurement results does not exceed 10.0%. After they are stored for 12 hours, the relative deviation of some test results

exceeds 10.0%. To ensure the accuracy of measurement result, it is recommended to test the samples as soon as possible after sample collection

and processing, and the storage time at room temperature should not be longer than 8 hours.

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 Serum, EDTA and heparin plasma samples were colleted and stored in a 2~8 ℃ refrigerator for 6 days, the relative deviation of

measurement results does not exceed 10.0%. After they are stored for 8 day, the relative deviation of some test results exceeds 10.0%. To ensure

the accuracy of measurement result, it is recommended to store the samples at 2~8 ℃ for no longer than 6 days after sample collection and

processing.

 Serum, EDTA and heparin plasma samples were colleted and stored in a -20℃ refrigerator for 6 months, the relative deviation of

measurement results does not exceed 10.0%. After they are stored for 8 months, the relative deviation of some test results exceeds 10.0%. To

ensure the accuracy of measurement result, it is recommended to store the samples at -20 ℃ for no longer than 6 months after sample collection

and processing.

 Serum, EDTA and heparin plasma samples were colleted, and are frozen and thawed once, the relative deviation of the test results does not

exceed 10.0%. After frozen and thawed twice, the relative deviation of the test results exceeds 10.0%. Therefore, plasma or serum sample should

not be frozen and thawed repeatedly. Only one freeze-thaw cycle is recommended.

4 Summary of Stability Study

 Shelf-life Stabiity study:

The Shelf-life Stabiity of NT-proBNP (CLIA) has been studied, and the results show that the shelf life of NT-proBNP (CLIA) stored at 2~8 ℃ is

at least 16 months.

 Transport stability study:

The Transport stability of NT-proBNP (CLIA) has been studied, and the results show that performance of NT-proBNP (CLIA) is not impacted by

transportation thourgh 2~8 ℃ cold chain, as long as the kit is stored back at 2~8 ℃ after returned back.

 Stability study of reconstituted Calibrators

Reconstituted NT-proBNP calibrators cannot be used up in a single run, so stability of reconstituted calibrators has been studied. The results show

that: To prevent the calibrator from contamination during lab operation, or to prevent incorrect test results for other causes, it is recommended that

reconstitured calibrator should be capped immediately after use, and it can be stored at room temperature for no longer than 1 day. For short-term storage

(no longer than 5 days), the calibrator should be stored at 2~8 ℃. For long-term storage (longer than 5 days but not longer than 60 days), the calibrator

should be stored at -20 ℃. Freeze/thaw cycle of NT-proBNP calibrator must not exceed once.

 Sample stability study:

A stability study is performed for several commonly used sample types with NT-proBNP (CLIA). The results show that: To ensure the reliability

of test results, the collected sample should be capped for storage and tested as soon as possible. Whole blood must be analyzed within 4 hours after

sample collection at room temperature (10~30 ℃). The storage time of serum and plasma samples must not exceed 8 hours at room temperature

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(10~30 ℃), not exceed 6 days at 2~8 ℃, and not exceed 6 months at -20 ℃. NT-proBNP samples cannot undergo freeze/thaw cycles repeatedly. The

freeze/thaw cycle of NT-proBNP sample must not exceed once.

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