Document No. (Version)：MD71-5-S18 (V1.

0)

For internal use only Secret

Confidentiality
Confidential Top secret

Document Category Design History File

Project Code MD71-S MYO(CLIA)

Stability Study
Prepared by/Date Li Xueqing / 2021.05.18

Reviewed by/Date Xiao Liangpin / 2021.05.18

Approved by/Date Xiao Liangpin / 2021.05.18

Document Revision Record

Version EPTD No. Revision Description Prepared by

V1.0 Initial version. Xiao Liangpin

Medcaptain Confidential. All Rights Reserved. Page 1 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

Contents

1 Foreword ................................................................................................................................... 3
1.1 Purpose.............................................................................................................................................. 3
1.2 Scope ................................................................................................................................................. 3
2 Evaluation of Reagent Stability ....................................................................................................... 3
2.1 Real-time Stability Evaluation ............................................................................................................ 3
2.1.1 Results from Evaluation of Real-time Stability ....................................................................... 3
2.1.2 Summary of Real-time Stability Evaluation ............................................................................ 7
2.2 Transportation Stability Evaluation ................................................................................................... 7
2.2.1 Results from Transportation Stability Evaluation ................................................................... 7
2.2.2 Summary about Transportation Stability Evaluation .............................................................. 8
2.3 Bottle opening stability of Calibrators C0 .......................................................................................... 8
2.3.1 Results from Stability Evaluation of Bottle opening for Calibrators C0 .................................. 9
2.3.2 Summary about Stability Evaluation of Bottle opening for Calibrators C0 ............................. 9
2.4 Stability of Reconstituted Calibrators C1 ........................................................................................... 9
2.4.1 Results from Stability Evaluation of Reconstituted Calibrators ............................................ 10
2.4.2 Summary about Stability Evaluation of Reconstituted Calibrator ........................................ 11
3 Evaluation of Sample Stability ....................................................................................................... 12
3.1 Test Method .................................................................................................................................... 12
3.1.1 Evaluation of serum and plasma Sample Stability .......................................................... 12
3.1.2 Evaluation of whole blood Sample Stability..................................................................... 12
3.2 Test Results ...................................................................................................................................... 13
3.3 Summary of Sample Stability Study ................................................................................................ 25
4 Summary of Stability Study ........................................................................................................... 25

Medcaptain Confidential. All Rights Reserved. Page 2 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

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 and EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro

diagnostic reagents, stability of MYO (CLIA) has been studied, including real-time long-term stability, transportation stability, stability of reconstituted

calibrators, vial opening stability of calibrators and sample stability.

1.2 Scope

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

Immunoassay Analyzer.

2 Evaluation of Reagent Stability

2.1 Real-time Stability Evaluation

Place three batches (20180401, 20180501, and 20180502) of MYO (CLIA) at 2~8 ℃ for long term storage. Test the kit at the start (time 0), 3rd

month, 6th month, 9th month, 12th month, 13th month,14th month, and 15th month (after expiration of claimed shelf life) respectively, perform the tests

according to the protocol in sections 3.1~3.11, and evaluate the real-time stability of MYO (CLIA) stored in the actual storage conditions.

2.1.1 Results from Evaluation of Real-time Stability

Table 1 Results from real-time stability evaluation

Matched instrument: Immu F6 Batch No. of MYO (CLIA): 20180401

Acceptance Start 3rd 6th 9th 12th 13th 14th 15th 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 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

R2 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

R3 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Fill

volume R4 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

C0 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

Reconst.
Pass 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

Medcaptain Confidential. All Rights Reserved. Page 3 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

Number of test

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

than LoB ≤3

I 100.0 101.5% 96.5% 97.7% 95.7% 106.6% 106.1% 96.1% 104.7%

Pass
II ±10.0 % 98.6% 103.6% 100.3% 96.1% 100.0% 93.7% 97.7% 99.5%
Accuracy-
I 1.4% -3.6% -1.3% -0.2% 3.3% 6.2% -0.8% 2.6%
recovry test ±10.0 % Pass
II -1.4% 3.6% 1.3% 0.2% -3.3% -6.2% 0.8% -2.6%

I/ II ≤10.0 % 0.1% 0.0% 1.0% 4.1% 3.3% 0.1% 3.1% 2.1% Pass

-7.0% 5.2% 4.3% 9.0% 8.2% 5.8% 8.0% 2.1%

I ±10.0 % 6.6% 7.4% 7.1% 4.6% 4.8% -3.3% 0.7% -6.9% Pass
Accuracy-
-2.4% 3.9% -3.7% 5.8% -0.7% -3.8% 9.1% -3.3%
enterprise
0.6% 3.8% -4.5% 6.4% 6.9% 3.2% 7.1% -5.3%
reference test
II ±10.0 % -4.9% -1.5% 0.3% -3.8% 2.8% -4.0% 0.4% -0.6% Pass

-0.6% 1.9% 0.3% 3.0% 6.4% 7.2% 8.4% 7.1%

Linearity r≥0.990 0.9998 0.9994 1.0000 0.9999 0.9999 1.0000 0.9998 0.9995 Pass

I CV≤8% 6.7% 4.9% 5.1% 4.1% 4.3% 3.6% 4.0% 4.6%

Repeatability Pass
II CV≤8% 5.2% 4.3% 5.5% 3.7% 3.7% 6.3% 2.6% 4.4%

Batch-to- I CV≤10% 5.0% 4.7% 4.4% 4.4% 4.4% 5.2% 5.2% 5.0%
batch Pass
II CV≤10% 4.4% 4.8% 4.2% 5.0% 4.8% 4.7% 4.7% 4.3%
variation

Accuracy of

Value C1 ±10% 2.9% 0.9% -1.7% -2.9% 4.4% -2.6% 4.2% -2.0% Pass

Assignment

Within-vial C0 SD≤5 0.2 0.0 0.4 0.0 0.0 0.0 0.0 0.2
Pass
homogeneity C1 CV≤8% 3.6% 3.8% 4.2% 4.0% 3.2% 3.7% 4.6% 3.7%

Between-vial C0 SD≤5 0.1 0.0 0.0 0.2 0.0 0.1 0.0 0.0
Pass
homogeneity C1 CV≤8% 2.0% 2.7% 3.7% 3.2% 4.0% 2.6% 1.2% 2.3%

Matched instrument: Immu F6 Batch No. of MYO (CLIA): 20180501

Acceptance Start 3rd 6th 9th 12th 13th 14th 15th 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 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

R2 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Fill
R3 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
volume
R4 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

C0 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

Medcaptain Confidential. All Rights Reserved. Page 4 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

Reconst.
Pass 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

Number of test

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

than LoB ≤3

I 100.0 93.7% 100.1% 97.9% 102.3% 96.5% 98.7% 106.0% 106.4%

Pass
II ±10.0 % 101.2% 102.6% 98.2% 98.5% 96.4% 96.1% 99.4% 100.2%
Accuracy-
I -3.7% -1.3% -0.2% 1.9% 0.0% 1.3% 3.3% 3.1%
recovry test ±10.0 % Pass
II 3.7% 1.3% 0.2% -1.9% 0.0% -1.3% -3.3% -3.1%

I/ II ≤10.0 % 2.5% 1.4% 1.9% 0.4% 3.6% 2.6% 2.7% 3.3% Pass

4.1% -2.5% -8.1% -6.9% -6.0% 3.0% 0.6% -6.3%

I ±10.0 % -3.2% 1.8% 4.6% -3.2% -3.2% 3.4% 7.0% -3.4% Pass
Accuracy-
-0.8% -5.5% 0.6% 7.4% -4.1% 0.6% -4.2% -5.3%
enterprise
0.9% -0.7% -7.0% 2.0% 3.8% -2.2% 8.6% 2.2%
reference test
II ±10.0 % 2.0% -4.8% -5.6% 1.1% -3.6% -3.5% 7.0% 1.0% Pass

-4.2% 5.2% 2.0% 0.6% 4.2% -5.0% -5.6% 0.5%

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

I CV≤8% 7.5% 4.6% 4.2% 3.2% 5.7% 4.8% 5.4% 4.6%

Repeatability Pass
II CV≤8% 3.4% 4.2% 3.0% 4.9% 6.4% 4.7% 4.3% 5.4%

Batch-to- I CV≤10% 5.0% 4.7% 4.4% 4.4% 4.4% 5.2% 5.2% 5.0%
batch Pass
II CV≤10% 4.4% 4.8% 4.2% 5.0% 4.8% 4.7% 4.7% 4.3%
variation

Accuracy of

Value C1 ±10% -0.3% 1.7% -1.7% -2.2% -3.6% 2.2% 5.4% 3.4% Pass

Assignment

Within-vial C0 SD≤5 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.3
Pass
homogeneity C1 CV≤8% 4.7% 4.8% 4.2% 4.2% 3.5% 3.9% 4.4% 4.6%

Between-vial C0 SD≤5 0.0 0.0 0.1 0.1 0.0 0.0 0.0 0.1
Pass
homogeneity C1 CV≤8% 1.3% 3.5% 2.2% 1.5% 2.5% 3.7% 3.1% 0.0%

Matched instrument: Immu F6 Batch No. of MYO (CLIA): 20180502

Acceptance Start 3rd 6th 9th 12th 13th 14th 15th 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 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

Medcaptain Confidential. All Rights Reserved. Page 5 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

R2 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

R3 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

Fill R4 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
volume
C0 Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

Reconst.
Pass 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

Number of test

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

than LoB ≤3

I 100.0 98.3% 96.0% 96.0% 104.0% 94.6% 106.1% 97.6% 97.9%

Pass
II ±10.0 % 97.9% 97.2% 99.7% 96.6% 101.5% 104.9% 97.2% 98.1%
Accuracy-
I 0.2% -0.6% -1.8% 3.7% -3.4% 0.6% 0.2% -0.1%
recovry test ±10.0 % Pass
II -0.2% 0.6% 1.8% -3.7% 3.4% -0.6% -0.2% 0.1%

I/ II ≤10.0 % 1.9% 3.4% 2.1% 0.3% 2.0% 5.5% 2.6% 2.0% Pass

4.1% 7.0% 5.3% 6.6% -3.3% -2.7% 3.4% -0.4%

I ±10.0 % 7.5% -2.5% -8.2% 5.3% -5.7% 7.5% 2.3% -4.1% Pass
Accuracy-
-3.9% -1.1% 0.4% -4.6% 6.0% 4.7% 4.1% 2.1%
enterprise
-2.4% -0.3% -6.0% -2.9% 2.3% 4.0% -1.1% -5.3%
reference test
II ±10.0 % -0.8% -1.8% 1.0% 1.3% -0.1% 6.5% -3.6% 6.1% Pass

7.2% -0.5% 4.3% 0.6% -5.4% -2.6% -0.2% 7.7%

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

I CV≤8% 6.8% 4.7% 4.6% 3.7% 4.7% 3.4% 3.6% 3.8%

Repeatability Pass
II CV≤8% 5.0% 4.4% 3.8% 4.7% 4.5% 4.6% 4.6% 4.2%

Batch-to- I CV≤10% 5.0% 4.7% 4.4% 4.4% 4.4% 5.2% 5.2% 5.0%
batch Pass
II CV≤10% 4.4% 4.8% 4.2% 5.0% 4.8% 4.7% 4.7% 4.3%
variation

Accuracy of

Value C1 ±10% 1.4% -0.8% 0.7% -3.1% -0.6% 0.8% -3.2% 1.5% Pass

Assignment

Within-vial C0 SD≤5 0.3 0.1 0.0 0.0 0.0 0.0 0.1 0.4
Pass
homogeneity C1 CV≤8% 3.7% 3.7% 3.9% 4.5% 4.3% 3.8% 2.6% 3.8%

Between-vial C0 SD≤5 0.0 0.0 0.2 0.0 0.0 0.0 0.0 0.0
Pass
homogeneity C1 CV≤8% 1.8% 3.3% 3.3% 2.5% 1.2% 3.1% 4.0% 1.4%

Medcaptain Confidential. All Rights Reserved. Page 6 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

2.1.2 Summary of Real-time Stability Evaluation

Three batches of MYO (CLIA) have been manufactured in the reagent plant, and stored at 2~8 ℃ from the start (Time 0) to the 15th month (after

claimed shelf life). Real-time stability 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.

2.2 Transportation Stability Evaluation

MYO (CLIA) (batch No. 20180401) were shipped to Shanghai, Lanzhou, and Harbin through cold chain transportation respectively. Keep

temperature at 2~8 ℃ during the whole transportation process. After MYO (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 July 1, 2019 (expiration date is June

27, 2019).

Table 2 Transportation stability study

Transportation
Packing Size Batch No. Expiration Date Test Date
Destination

60×1 Tests/Pkg
Shanghai 20180401 2019.06.27 2019.07.02
(calibrator included)

60×1 Tests/Pkg
Lanzhou 20180401 2019.06.27 2019.07.03
(calibrator included)

60×1 Tests/Pkg
Harbin 20180401 2019.06.27 2019.07.04
(calibrator included)

2.2.1 Results from Transportation Stability Evaluation

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

Packing size: 60×1 Tests/Pkg Matched instrument:

(calibrator included) 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

R3 ≥ 100μL Pass Pass Pass Pass

Fill volume Pass

R4 ≥ 100μL Pass Pass Pass

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

Medcaptain Confidential. All Rights Reserved. Page 7 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

Number of test results

LoD 0 0 0 Pass
smaller than LoB≤3

I 94.8% 95.6% 102.5%

100.0 ±10.0 % Pass
II 96.3% 97.3% 99.1%
Accuracy-
I -3.0% -0.9% 1.7%
recovery test ±10.0 % Pass
II 3.0% 0.9% -1.7%

I/ II ≤10.0 % 6.7% 3.5% 0.8% Pass

7.1% -0.5% 7.1%

I ±10.0 % -2.3% 1.1% 5.0% Pass

Accuracy-
-5.8% 7.9% -5.2%
enterprise

reference test 1.6% -1.3% 5.5%

Pass
II ±10.0 % -1.4% 6.3% -0.6%

4.9% 2.7% -5.7%

Linearity r≥0.990 0.999 0.9997 1.0000 Pass

I CV≤8% 5.7% 4.3% 6.1%

Repeatability Pass
II CV≤8% 4.8% 3.6% 4.7%

Batch-to-batch I CV≤10.0 % 5.2% 4.6% 4.8%

Pass
variation II CV≤10.0 % 4.4% 4.8% 4.8%

Accuracy of
C1 ±10% -2.5% 2.8% 0.0% Pass
value assignment

Within-vial C0 SD≤5 0.0 0.4 0.2

Pass
homogeneity C1 CV≤8 % 4.6% 5.5% 4.1%

Between-vial C0 SD≤5 0.0 0.2 0.0

Pass
homogeneity C1 CV≤5 % 2.7% 3.5% 3.3%

2.2.2 Summary about Transportation Stability Evaluation

For transportation stability evaluation, MYO (CLIA) (Batch 20180401) 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 MYO (CLIA) can be maintained, and the kit can still meet quality requirement after transportation during its 14-month shelf life.

2.3 Bottle opening stability of Calibrators C0

Bottle opening of calibrator C0, and stored at different temperatures. Bottle opening stability of Calibrators is evaluated. The specific study

method is as follows, Lot 20180401 batch MYO kit was used to evaluate the stability of calibrator C0:

Room temperature (10~30 ℃): Take out 6 vials calibrators C0 from batche 20180401 of MYO (CLIA). Open the vial cap at room temperature (10-

Medcaptain Confidential. All Rights Reserved. Page 8 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

30 ℃), and then close the vial cap, two vials were placed in the constant temperature and other two vials were placed in humidity box with the temperature

set at 10 ℃ and 30 ℃ respectively. They were taken out at 0 h, 12 h, 24 h and 36 h respectively and tested with MYO kit. The test was repeated 3 times

each time. After each sampling, the vial cap was tightened immediately and put back to its original position for further storage.

2~8 ℃ storage: Take out 2 vials calibrators C0 from batche 20180401 of MYO (CLIA). Open the vial cap at room temperature (10-30 ℃), and

then close the vial cap and stored at 2~8 ℃. They were taken out on day 0, day 30, day 60 and day 70 respectively and tested with MYO kit. The test

was repeated 3 times each time. After each sampling, the vial cap was tightened immediately and put back to 2~8 ℃ immediately for further storage.

Acceptance Criteria: Repeat the test for 3 times, and the result of each test is less than 5 ng/mL (LOD).

2.3.1 Results from Stability Evaluation of Bottle opening for Calibrators C0

Table 4 Results from stability evaluation of Bottle opening for Calibrators C0

Room temperature (10~30 ℃) 2~8 ℃ storage

10℃ 30℃
Time 23.2～25.8 ℃(ng/mL) Time (ng/mL)
(ng/mL) (ng/mL)

0.0 0.2 0.0 0.2

0h 1.4 0.2 1.4 Day 0 0.6

0.6 0.9 0.7 1.9

0.0 0.0 0.3 0.8

12 h 0.3 0.6 0.4 Day 30 1.0

1.9 1.6 0.7 1.9

0.4 0.0 1.7 0.4

24 h 0.9 1.1 0.5 Day 60 0.9

1.8 1.1 1.7 1.3

0.9 1.8 0.1 0.6

36 h 1.2 1.5 1.4 Day 70 0.0

0.0 0.0 0.9 0.5

2.3.2 Summary about Stability Evaluation of Bottle opening for Calibrators C0

The test results are as follows:

 MYO calibrator C0 is tested within 36h after it is opened and stored at room temperature (10~30 ℃), and all test results meet the acceptance

criteria, indicating that MYO calibrator C0 can be stored at room temperature for one day after vial opening.

 MYO calibrator C0 is tested within 70 days after it is opened and stored at 2~8 ℃, and all test results meet the acceptance criteria,

indicating that MYO calibrator C0 can be stored at 2~8 ℃ for 60 days after vial opening.

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

calibrators stored at room temperature (10~30 ℃) for no longer than 24h. The calibrators can be stored at 2~8 ℃ fono longer than 60 days.

2.4 Stability of Reconstituted Calibrators C1

Dry powder of calibrator C1 is reconstituted, and stored at different temperatures. Stability of reconstituted calibrators is evaluated. The specific

study method is as follows:

Medcaptain Confidential. All Rights Reserved. Page 9 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

Room temperature (10~30 ℃): Take out 6 vials of calibration sample C1 from 20180401, 20180501 and 20180502 kits, add the corresponding

batch of reconstitution solvent, re-dissolve for 10 minutes until reconstitution is completed, then put 2 vials in the constant temperature and the other 2

vials in humidity box with the temperature set at 10 ℃and 30 ℃ respectively. Take out the calibrator at 0 h, 6 h, 12 h, 24 h and 28 h to test the accuracy

of assignment. After each sampling, tighten the vial cap immediately and put it back to its original position for further storage.

2~8 ℃ storage: Take out calibrators from three batches (20180401, 20180501, and 20180502) of MYO (CLIA), open the vial cap at room

temperature (10-30 ℃), add the corresponding batch of reconstitution solvent, re-dissolve for 10 minutes until reconstitution is completed. After testing

the accuracy of calibrator assignment (day 0), put the vial cap back to 2-8 ℃ for storage, and take them out on the 1st, 3rd, 5th and 7th day respectively

to test the accuracy of calibrator assignment, After each sampling, tighten the vial cap immediately and put it back to 2~8 ℃ immediately for further

storage.

-20 ℃ storage: Take 3 vials of calibrators from MYO kits of 20180401, 20180501 and 20180502 respectively, open the vial cap at room temperature

(10-30 ℃), add the corresponding batch of reconstitution solvent, re-dissolve for 10 minutes until reconstitution is completed. After testing the accuracy

of calibrator assignment (day 0), put the vial cap back to -20 ℃ for storage. And take them out on the 30th, 60th and 70th day respectively to test the

accuracy of calibrator assignment

Freeze-thaw Cycles: Take 3 vials of calibrators from MYO kits of 20180401, 20180501 and 20180502 respectively, open the vial cap at room

temperature (10-30 ℃), add the corresponding batch of reconstitution solvent, re-dissolve for 10 minutes until reconstitution is completed. 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, test the

accuracy of calibrator assignment from each vial which has experienced 0, 1, and 2 freeze-thaw cycles.

Acceptance Criteria: Use the working calibrators with values assigned using a higher-level measurement procedure to calibrate the

chemiluminescence immunoassay system. After that, use the MYO (CLIA) of the same batch to test calibrator C1, The deviation between the test value

and the assigned value of calibrator C1 does not exceed ±10.0%.

2.4.1 Results from Stability Evaluation of Reconstituted Calibrators

Table 5 Results from stability evaluation of reconstituted calibrators

Room Temperature (10～30℃)

22.8～ 2～8℃ -20℃ Freeze-thaw Cycles

10℃ 30℃
25.2℃
Batch Storage
Relative Relative Relative Relative Relative
Time Storage Storage Number of Relative
Deviation Deviation Deviation Deviation Deviation
Time Time Cycles Deviation (B)
(B) (B) (B) (B) (B)

20180401 0h 0.41% 3.5% 1.46% 0 day -4.4% 0 day 1.4% 0 4.4%

Medcaptain Confidential. All Rights Reserved. Page 10 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

6h 0.71% 0.4% 0.93% 1 day 2.9% 30 days -4.0% 1 -0.3%

12 h 0.86% 3.8% 1.20% 3 days -3.4% 60 days -1.0% 2 -1.4%

24h 0.88% 0.2% 1.62% 5 days -0.2% 70 days 3.6% / /

28 h 0.92% -3.7% 0.77% 7 days 0.6% / / / /

0h -0.10% -3.4% 0.68% 0 day -0.3% 0 day -1.3% 0 0.6%

6h 0.45% 0.8% 1.00% 1 day 1.1% 30 days 0.5% 1 2.5%

20180501 12 h 0.51% -1.1% 1.05% 3 days 1.0% 60 days -1.2% 2 0.8%

24h -0.81% 0.6% 0.99% 5 days 2.2% 70 days -4.0% / /

28 h -0.01% -0.1% 1.35% 7 days 1.2% / / / /

0h 2.17% -2.5% 1.76% 0 day -2.5% 0 days -2.0% 0 -0.8%

6h 0.86% -1.9% 1.92% 1 day 3.4% 30 days 0.9% 1 -1.7%

20180502 12 h 1.07% -4.4% 2.21% 3 days 0.4% 60 days 0.5% 2 -3.1%

24h 1.27% -2.3% 1.73% 5 days 1.2% 70 days -2.0% / /

28 h 2.83% 2.2% 1.81% 7 days -2.2% / / / /

2.4.2 Summary about Stability Evaluation of Reconstituted Calibrator

The test results are as follows:

 MYO calibrator is tested within 28h after it is reconstituted and stored at room temperature (10~30 ℃), and all test results meet the

acceptance criteria, In order to ensure the accuracy of calibration, it is recommended that MYO calibrator be used as soon as possible after

reconstituted; It can be stored at room temperature for 1 day;.

 MYO calibrator is tested within 6 days after it is reconstituted and stored at 2~8 ℃, and all test results meet the acceptance criteria, In

order to ensure the accuracy of calibration, it is recommended that MYO calibrator be used as soon as possible after reconstituted; It can

be stored at 2~8 ℃ for 5 days after reconstitution.

 MYO calibrator is tested within 70 days after it is reconstituted and stored at -20 ℃, and all test results meet the acceptance criteria, it is

recommended that MYO calibrator be used as soon as possible after reconstituted; It can be stored at -20℃ for 60 days after reconstitution.

 MYO 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 MYO 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.

Medcaptain Confidential. All Rights Reserved. Page 11 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

3 Evaluation of Sample Stability

Samples are stored at room temperature (10~30 ℃), 2~8 ℃, and -20 ℃ respectively, verifying the stability of different sample types (Serum,

plasma and whole blood with different anticoagulants) at different temperatures. The impact of freeze-thaw cycles on test results has also been evaluated.

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, EDTA-K3, 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, 6th hour, and 8th 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, EDTA-K3, 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 8th hour, 12th hour, 24th hour, and 28th hour and measure MYO 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, EDTA-K3, 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 10th day, 20th day, 30th day, and 40th day and test them after they are thawed and reach room

temperature, measure MYO 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, EDTA-K3, sodium heparin, and lithium

heparin). Each sample is equally divided into 5 aliquots. Place one of the 5 aliquots at 2~8 ℃ as the control sample (for no more than 24 hours). Place

the other four 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 three aliquots back to the -20 ℃ freezer. Repeat this freeze/thaw procedure until the fourth

sample has been thawed. Test all five 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 1-4 freeze-thaw cycles does not exceed 10%.

3.1.2 Evaluation of whole blood Sample Stability

Take 10 fresh samples (whole blood with EDTA-K2, EDTA-K3, sodium heparin, 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.

Medcaptain Confidential. All Rights Reserved. Page 12 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

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

3.2 Test Results

Table 6 Results of sample stability evaluation

1. Serum samples at stored at 10 ℃

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

1 3.8% -5.1% 5.3% -4.0%

2 3.8% 0.8% 0.7% 4.7%

3 -4.1% 4.7% -0.1% -0.2%

4 -3.3% 5.6% -1.2% -3.4%

5 1.7% -5.2% 0.2% 0.9%

6 3.7% 3.9% -2.0% 0.9%

7 -2.3% 7.0% 2.5% -2.5%

8 4.7% -4.7% -0.2% 2.5%

9 -2.9% -0.7% 5.8% -1.3%

10 2.6% -7.5% 3.6% -3.9%

2. Serum samples stored at room room temperature (22~26℃℃)

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

1 -1.7% -5.4% -5.6% 0.5%

2 4.6% -1.3% -6.9% -1.1%

3 2.4% 2.8% 8.0% 9.0%

4 2.6% 2.7% 7.3% 9.6%

5 -0.7% -7.8% 8.4% 9.3%

6 -0.3% 1.3% 0.3% 2.4%

7 0.3% 7.4% -3.9% 5.4%

8 -0.4% -5.4% -0.5% -2.4%

9 4.1% -2.4% 1.7% 8.8%

10 2.3% 1.3% -0.2% 2.2%

3. Serum samples stored at 30℃

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

1 1.1% -8.0% 5.6% 5.2%

2 0.6% 2.7% 3.1% 7.7%

3 2.6% -5.6% -1.9% 8.6%

4 -2.5% 3.0% 3.7% -5.8%

5 -0.8% -3.9% 3.4% 3.4%

6 1.5% -6.0% -1.6% 5.0%

7 -3.9% -4.6% -1.2% -2.9%

8 -3.0% 1.3% 5.7% -3.3%

9 -4.3% -4.0% -6.9% 9.0%

10 1.3% 0.2% -3.5% -3.3%

4. Serum samples stored at 2～8℃

Sample Relative deviation(8 h) Relative deviation(12 h) Relative deviation(24 h) Relative deviation(28 h)

1 4.2% -5.0% 7.8% 6.7%

Medcaptain Confidential. All Rights Reserved. Page 13 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

2 0.9% -0.1% 1.6% 1.2%

3 4.1% 6.8% 4.6% 0.4%

4 5.0% 7.2% -7.0% -2.9%

5 4.2% -3.7% -0.3% 0.1%

6 -4.8% 0.8% 2.1% -2.3%

7 2.9% -0.5% -6.8% -0.6%

8 3.9% -6.0% 0.4% -5.8%

9 0.2% 5.2% 2.6% 8.4%

10 4.1% 0.2% 6.7% 7.7%

5. Serum samples stored at -20℃

Relative deviation(10 Relative deviation(20 Relative deviation(30

Sample Relative deviation(40 days)
days) days) days)

1 -1.7% -0.9% -1.9% 3.6%

2 4.2% 5.9% -3.7% -4.9%

3 -2.9% -4.9% 1.0% 9.9%

4 3.4% 3.1% 3.4% 1.4%

5 1.9% 5.3% -7.7% 9.0%

6 -4.6% 6.5% 5.8% -0.3%

7 -3.9% 3.2% 7.5% 1.4%

8 -4.5% 4.9% -6.4% 5.2%

9 -2.8% -3.8% 4.1% 1.9%

10 -4.8% -7.9% 0.1% -6.0%

6. Serum samples undergoing Freeze/thaw cycles

Relative deviation(three Relative deviation(four

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

1 0.3% 4.4% 5.4% 15.1%

2 3.4% -4.1% 10.8% 11.3%

3 2.5% 7.9% 11.8% 5.2%

4 0.1% 7.2% 9.2% 3.9%

5 -0.2% 2.7% 8.1% 6.3%

6 4.7% -0.8% 11.8% 3.1%

7 -2.2% 1.0% 4.7% 5.6%

8 -0.1% -3.8% 11.8% 18.0%

9 -1.1% 1.6% 12.1% 7.9%

10 4.6% -4.4% -2.8% 10.8%

7. EDTA-K2 plasma stored at 10℃

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

1 1.2% -4.5% -1.8% 0.2%

2 4.6% -7.4% 3.8% -0.1%

3 -4.5% -6.1% -5.5% 8.2%

4 1.0% -1.6% 0.8% -3.4%

5 1.8% 7.0% -6.4% 0.1%

6 -0.1% -2.9% 2.7% 0.7%

Medcaptain Confidential. All Rights Reserved. Page 14 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

7 4.4% -5.4% -3.0% 8.5%

8 2.1% 0.3% 3.8% 2.5%

9 -2.6% 1.3% -2.6% 7.6%

10 -1.7% 2.1% 0.6% -4.8%

8. EDTA-K2 plasma stored at room temperature (22~26℃)

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

1 1.2% -4.5% -1.8% 0.2%

2 4.6% -7.4% 3.8% -0.1%

3 -4.5% -6.1% -5.5% 8.2%

4 1.0% -1.6% 0.8% -3.4%

5 1.8% 7.0% -6.4% 0.1%

6 -0.1% -2.9% 2.7% 0.7%

7 4.4% -5.4% -3.0% 8.5%

8 2.1% 0.3% 3.8% 2.5%

9 -2.6% 1.3% -2.6% 7.6%

10 -1.7% 2.1% 0.6% -4.8%

9. EDTA-K2 plasma stored at 30℃

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

1 1.2% -4.5% -1.8% 0.2%

2 4.6% -7.4% 3.8% -0.1%

3 -4.5% -6.1% -5.5% 8.2%

4 1.0% -1.6% 0.8% -3.4%

5 1.8% 7.0% -6.4% 0.1%

6 -0.1% -2.9% 2.7% 0.7%

7 4.4% -5.4% -3.0% 8.5%

8 2.1% 0.3% 3.8% 2.5%

9 -2.6% 1.3% -2.6% 7.6%

10 -1.7% 2.1% 0.6% -4.8%

10. EDTA-K2 plasma stored at 2～8℃

Sample Relative deviation(8 h) Relative deviation(12 h) Relative deviation(24 h) Relative deviation(28 h)

4.1% 4.1% -0.3% -2.8%

1 1.8% 7.2% 3.3% 4.1%

3 -2.6% 1.4% -5.2% 2.7%

4 -1.1% 5.3% 1.7% -0.2%

5 -4.3% 7.0% -0.6% 2.5%

6 0.5% -5.8% -0.7% 3.4%

7 3.5% -2.6% -4.6% 8.3%

8 -0.2% 7.9% 4.4% 7.7%

9 -0.6% 4.0% -3.5% 1.5%

10 -1.0% 2.3% 4.8% 4.9%

11. EDTA-K2 plasma stored at -20℃

Relative deviation(10 Relative deviation(20 Relative deviation(30

Sample Relative deviation(40 days)
days) days) days)

Medcaptain Confidential. All Rights Reserved. Page 15 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

1 2.3% -6.5% -2.2% 6.5%

2 2.0% 1.4% -3.3% 7.1%

3 -3.0% 0.0% -1.9% 6.7%

4 2.0% 5.9% 1.0% -4.8%

5 0.0% 1.9% -0.4% -5.0%

6 -2.7% 0.9% 1.3% -3.7%

7 4.4% 6.0% 7.3% -3.4%

8 -0.6% -3.7% 5.4% 9.3%

9 -2.3% -4.5% 7.3% 5.3%

10 -3.4% -2.5% 0.5% -1.2%

12. EDTA-K2 plasma undergoing Freeze/thaw cycles

Relative deviation(three Relative deviation(four

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

1 3.6% -5.1% 7.2% 10.2%

2 4.4% 4.8% 4.6% 7.2%

3 2.2% -1.2% 9.7% 8.6%

4 -1.6% 3.0% 10.1% 17.4%

5 0.5% 5.7% 7.7% 10.6%

6 4.7% -0.8% 3.7% 6.6%

7 3.9% 2.6% 7.8% 10.0%

8 3.8% 5.2% 2.9% 15.9%

9 2.2% 7.5% 13.0% 3.6%

10 -3.2% -6.4% 12.4% 3.2%

13. EDTA-K3 plasma stored at 10℃

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

1 2.3% 7.0% -0.9% 5.1%

2 -0.4% -4.9% -4.2% -0.9%

3 -1.5% -3.9% 6.6% -0.7%

4 -3.0% 2.9% 1.6% -2.7%

5 4.7% 7.3% -6.7% 6.3%

6 -0.7% 1.0% 1.8% 2.0%

7 -4.5% 6.2% 3.7% 0.7%

8 -2.6% 4.6% -5.5% -3.1%

9 -3.8% 5.6% 5.2% -5.1%

10 2.3% 5.5% 1.8% 1.8%

14. EDTA-K3 plasma stored at room temperature (22~26℃)

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

1 4.4% 4.1% -6.7% -0.1%

2 2.6% 3.2% 0.2% 7.0%

3 -2.1% -3.6% 3.6% -3.6%

4 4.0% -0.2% -6.5% 5.1%

5 0.6% -0.2% 3.8% -0.9%

6 2.8% -2.5% -6.1% -4.8%

Medcaptain Confidential. All Rights Reserved. Page 16 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

7 -0.8% 0.1% 5.5% -1.5%

8 -5.0% -2.3% 8.7% 5.1%

9 1.2% -2.3% -6.5% 1.8%

10 0.9% -3.4% -2.4% 0.3%

15. EDTA-K3 plasma stored at 30℃

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

1 -3.7% -4.8% 6.4% 4.7%

2 -3.6% 1.6% -5.6% 6.2%

3 -2.6% 5.4% -0.4% -5.0%

4 1.1% 5.3% 1.4% -3.9%

5 3.4% -0.8% -3.5% 10.0%

6 0.6% -5.8% -3.2% 2.6%

7 2.9% -2.2% 6.9% -6.0%

8 1.5% 6.6% -1.7% 9.0%

9 -1.9% 1.2% 4.0% 8.3%

10 5.0% -5.6% 8.4% 5.2%

16. EDTA-K3 plasma stored at 2～8℃

Sample Relative deviation(8 h) Relative deviation(12 h) Relative deviation(24 h) Relative deviation(28 h)

1 -2.3% 6.3% -5.0% 2.7%

2 -4.7% 0.0% 6.9% 4.2%

3 0.4% 7.6% -6.6% 6.6%

4 -3.4% 4.1% -0.6% -2.3%

5 4.3% 6.7% -4.5% -0.5%

6 4.1% -0.8% 0.0% 0.8%

7 -2.9% 1.3% 4.8% 1.3%

8 2.7% 0.6% 1.6% -4.8%

9 -3.9% -1.4% -2.7% 6.6%

10 3.5% -1.6% -2.3% -2.7%

17. EDTA-K3 plasma stored at -20℃

Relative deviation(10 Relative deviation(20 Relative deviation(30

Sample Relative deviation(40 days)
days) days) days)

1 -2.1% 7.3% 1.7% 1.4%

2 2.7% -3.4% 3.1% -5.0%

3 4.8% 4.8% 0.2% -5.7%

4 0.4% -1.8% -3.8% 0.7%

5 -2.5% 6.4% -1.5% 0.8%

6 -2.9% -1.2% 5.7% 9.2%

7 -3.7% -2.4% -5.6% 9.0%

8 2.7% -1.4% -5.7% -1.4%

9 -4.2% -5.7% 2.5% 1.7%

10 2.6% -6.1% 1.0% 2.7%

18. EDTA-K3 plasma undergoing freeze/thaw cycles

Medcaptain Confidential. All Rights Reserved. Page 17 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

Relative deviation(three Relative deviation(four

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

1 0.0% -2.2% 4.7% 6.6%

2 -3.9% -2.5% -1.2% 17.3%

3 0.2% 3.0% 7.4% 12.6%

4 2.1% 6.2% -1.2% 11.7%

5 -2.3% -1.7% 5.6% 13.0%

6 -4.0% 0.9% 7.6% 13.0%

7 -1.1% -3.4% 11.5% 9.9%

8 -2.5% -4.9% 2.4% 7.1%

9 -4.9% 2.8% -2.5% 17.7%

10 2.1% 5.3% 4.9% 11.5%

19. Lithium heparin plasma stored at 10℃

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

1 2.4% -7.9% 8.2% 0.3%

2 4.9% -3.8% 3.1% 2.9%

3 3.4% 7.0% 6.8% 1.3%

4 2.0% 7.6% -2.2% -2.9%

5 -0.2% -3.0% -4.6% 9.2%

6 -2.4% -4.1% 7.4% -3.9%

7 -2.7% -4.1% 0.6% -0.8%

8 1.0% -1.5% 2.2% 5.0%

9 -4.4% -4.8% 6.1% -4.2%

10 -0.8% -6.6% -5.9% 6.8%

20. Lithium heparin plasma stored at room temperature (22~26℃)

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

1 2.3% -2.5% -5.5% -3.4%

2 0.7% -1.8% -2.3% -1.0%

3 0.6% -3.2% -0.1% 3.6%

4 -3.7% -5.3% -3.2% 6.9%

5 4.1% 0.7% 8.7% 5.3%

6 2.7% 3.6% 6.0% 2.1%

7 4.5% 3.6% 0.9% 8.3%

8 -3.9% -7.4% -5.7% -3.1%

9 -3.7% 5.9% 6.5% 6.2%

10 2.9% -6.9% -5.0% -4.9%

21. Lithium heparin plasma stored at 30℃

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

1 -3.3% 5.0% 2.4% -5.2%

2 -0.9% -2.4% -1.1% 1.9%

3 -1.6% 4.7% 2.9% 3.9%

4 0.7% -4.6% 0.6% 5.2%

5 -1.0% 3.4% 5.1% -5.2%

Medcaptain Confidential. All Rights Reserved. Page 18 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

6 -2.8% 7.2% 7.2% 8.4%

7 -1.4% 0.5% -4.9% 2.2%

8 -2.4% -1.5% -1.1% -0.2%

9 -3.7% 2.9% 0.8% 4.6%

10 3.9% -3.1% -0.7% -2.8%

22. Lithium heparin plasma stored at 2～8℃

Sample Relative deviation(8 h) Relative deviation(12 h) Relative deviation(24 h) Relative deviation(28 h)

1 4.2% 4.1% 7.4% -4.6%

2 3.4% -1.0% -0.1% -3.4%

3 -4.2% -3.7% -7.2% -3.5%

4 -4.1% -6.4% 5.8% 0.0%

5 4.7% -5.1% 6.9% -2.8%

6 0.5% -2.5% -2.9% 0.5%

7 -4.3% -4.6% -1.1% -0.1%

8 1.1% -1.6% 7.6% -0.4%

9 -1.6% -1.8% 4.0% 5.9%

10 2.7% -2.3% 4.7% -2.9%

23. Lithium heparin plasma stored at -20℃

Relative deviation(10 Relative deviation(20 Relative deviation(30

Sample Relative deviation(40 days)
days) days) days)

1 3.0% 0.9% 6.8% 0.3%

2 3.8% -1.2% 4.4% -4.0%

3 1.6% 1.1% -2.6% 3.0%

4 5.0% -7.6% 3.8% 7.8%

5 -4.2% -3.8% 1.1% -4.7%

6 2.2% 0.6% -6.5% -4.6%

7 -4.7% 6.2% 6.2% 6.2%

8 -2.6% -4.3% -0.5% 2.7%

9 2.9% -4.4% -5.3% 4.0%

10 -3.9% 5.6% -4.6% -0.4%

24. Lithium heparin plasma undergoing Freeze/thaw cycles

Relative deviation(three Relative deviation(four

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

1 1.6% 7.4% 6.7% 3.1%

2 3.3% -1.8% -0.1% 15.6%

3 -1.5% 7.1% -0.8% 13.2%

4 -2.4% 7.2% -1.3% 10.3%

5 3.2% -0.7% -2.2% 12.0%

6 -5.0% 7.2% 4.3% 12.8%

7 -2.6% -0.3% 9.2% 14.7%

8 2.2% -0.2% -1.6% 6.4%

9 -3.6% -1.2% 5.4% 10.7%

10 4.2% 3.8% -2.1% 16.4%

Medcaptain Confidential. All Rights Reserved. Page 19 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

25. Sodium heparin plasma stored at 10℃

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

1 1.5% 7.8% -3.0% -4.4%

2 1.8% -3.3% -6.5% 0.1%

3 2.2% -7.9% -5.3% 5.5%

4 -2.2% 2.0% 4.2% -0.3%

5 -4.6% 1.5% -3.7% 8.2%

6 -0.9% -1.2% 3.9% 5.9%

7 4.1% 4.3% 6.2% -3.3%

8 3.0% -1.9% -1.2% -1.7%

9 -0.6% 2.8% -1.1% -1.7%

10 -0.6% 4.2% 2.2% 3.4%

26. Sodium heparin plasma stored at room temperature (22~26℃)

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

1 3.2% 1.5% -5.2% -1.7%

2 1.1% 4.1% -4.0% 1.9%

3 1.6% 5.8% -2.4% -2.5%

4 -4.0% -5.3% 3.3% 9.8%

5 0.9% -3.4% 5.1% 0.5%

6 3.7% 1.3% -0.7% 4.6%

7 -4.2% -1.7% 6.1% -3.9%

8 -0.3% -3.1% -2.0% -1.5%

9 2.8% 1.8% 7.9% 4.8%

10 2.7% 4.0% 8.9% -0.2%

27. Sodium heparin plasma stored at 30℃

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

1 -1.5% -1.9% -5.1% -5.0%

2 3.2% -0.3% -1.1% 6.2%

3 -2.0% 0.0% 0.0% -5.9%

4 -4.7% -6.2% 3.8% 3.9%

5 -2.4% 7.2% 8.3% -5.6%

6 -1.7% -7.9% -2.4% 1.1%

7 1.0% 3.2% -4.2% 5.0%

8 0.6% -1.4% 3.5% -5.9%

9 3.0% -6.8% -4.9% 8.9%

10 4.6% 0.5% 2.1% -1.9%

28. Sodium heparin plasma stored at 2～8℃

Sample Relative deviation(8 h) Relative deviation(12 h) Relative deviation(24 h) Relative deviation(28 h)

1 -3.5% -4.2% 2.1% -3.1%

2 -2.1% -7.5% 3.3% 7.2%

3 4.1% -6.5% -4.4% -5.7%

4 2.0% 7.5% 6.8% -3.4%

5 3.3% -4.5% -4.3% -2.5%

Medcaptain Confidential. All Rights Reserved. Page 20 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

6 -0.8% 2.5% 2.6% 7.2%

7 3.6% 1.2% 3.1% 2.4%

8 2.9% -2.2% 2.7% -2.9%

9 0.9% -1.2% 4.9% 2.5%

10 2.6% 7.2% -6.7% -0.8%

29. Sodium heparin plasma stored at -20℃

Relative deviation(10 Relative deviation(20 Relative deviation(30

Sample Relative deviation(40 days)
days) days) days)

1 1.9% -0.2% 6.2% -6.0%

2 4.6% -3.6% -5.8% 3.4%

3 4.0% 3.2% 7.1% -5.4%

4 4.3% -1.6% -6.6% -4.4%

5 -0.7% -6.6% -0.5% -1.3%

6 2.0% 2.1% 4.5% -4.9%

7 2.5% 7.7% -6.8% 4.2%

8 0.9% 5.7% 1.7% 3.7%

9 -3.1% 7.6% 5.1% 6.5%

10 -4.2% -0.5% -3.1% 5.2%

30. Sodium heparin plasma undergoing Freeze/thaw cycles

Relative deviation(three Relative deviation(four

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

1 -2.4% -7.3% 4.3% 15.9%

2 -1.0% 2.7% 10.8% 16.1%

3 4.7% 7.3% -0.3% 7.9%

4 1.0% 4.5% 8.2% 12.5%

5 -3.0% 4.3% 11.5% 10.1%

6 -3.8% 3.5% -0.8% 17.5%

7 3.3% -1.4% 3.9% 4.4%

8 -3.1% 6.1% 4.7% 9.3%

9 4.9% 1.2% 4.2% 15.4%

10 3.4% -4.5% -1.4% 16.4%

31. EDTA-K2 whole blood stored at 10℃

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

1 -3.2% 5.8% 8.4% 2.3%

2 3.9% -7.4% 1.9% 4.4%

3 -2.7% 6.1% 1.3% -0.6%

4 -4.3% -6.4% -3.6% 1.2%

5 -0.8% 4.0% -1.5% 3.2%

6 0.1% 5.6% -4.5% -3.6%

7 -4.0% -6.3% -1.7% 5.0%

8 3.3% -1.5% -4.8% 3.9%

9 -0.3% -3.5% -3.9% -2.1%

10 -1.2% 6.1% -1.8% 3.5%

Medcaptain Confidential. All Rights Reserved. Page 21 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

32. EDTA-K2 whole blood stored at room temperature (22~26℃)

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

1 2.2% 0.1% -3.8% 2.7%

2 -0.9% 0.5% 3.2% 16.7%

3 1.3% 1.9% -1.5% 6.7%

4 -4.3% 0.4% 8.2% 7.8%

5 0.0% -6.1% 7.8% 10.0%

6 -0.8% -2.1% 8.2% 11.0%

7 1.2% -4.3% 6.1% 7.5%

8 -1.5% 5.6% 1.4% 14.6%

9 -2.1% -6.5% 9.7% 7.7%

10 -2.2% -5.4% -6.0% 3.2%

33. EDTA-K2 whole blood stored at 30℃

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

1 1.2% -1.7% 8.7% -1.2%

2 -2.3% 3.3% 1.9% 3.1%

3 -0.1% -6.0% 5.6% -4.5%

4 5.0% 0.3% 1.8% 7.7%

5 -1.5% 1.3% 1.0% 9.1%

6 2.2% 3.9% 8.8% 8.0%

7 3.5% 0.0% -2.5% -5.0%

8 0.1% 5.4% 5.6% 6.5%

9 -2.3% -1.9% -3.8% 6.6%

10 0.5% -6.6% -5.0% 0.9%

34. EDTA-K3 whole blood stored at 10℃

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

1 -4.9% 5.7% 1.8% 6.1%

2 -0.3% -2.4% 0.6% 3.3%

3 4.4% 2.5% -3.0% 10.9%

4 4.9% 4.0% 5.0% 4.8%

5 -4.0% 6.6% 8.1% 10.1%

6 3.8% 0.6% -4.3% 12.1%

7 1.2% 7.6% 5.3% 2.9%

8 -2.5% -4.7% 2.4% 11.8%

9 2.2% 1.4% 1.8% -1.5%

10 1.8% -0.3% 4.5% 9.3%

35. EDTA-K3 whole blood stored at room temperature (22~26℃)

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

1 2.4% 7.8% -0.8% 15.6%

2 1.8% 4.6% 9.6% 2.3%

3 -4.3% 6.5% 7.4% 9.2%

4 0.9% 0.7% 4.0% 14.1%

5 4.8% 5.3% -2.5% 2.8%

Medcaptain Confidential. All Rights Reserved. Page 22 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

6 -0.5% -3.3% 7.2% 9.9%

7 -4.7% -4.3% 7.6% 10.2%

8 4.4% 5.3% -5.4% 13.2%

9 0.7% -2.8% -0.2% 6.8%

10 3.5% -7.8% 8.4% 12.3%

36. EDTA-K3 whole blood stored at 30℃

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

1 4.8% -6.6% -1.0% 2.8%

2 -4.8% -6.7% 1.4% -2.4%

3 -1.6% 3.5% 8.8% 12.9%

4 4.2% -5.1% 6.1% -2.5%

5 -1.8% 4.4% 1.0% -0.6%

6 -0.1% -1.5% -5.5% -2.4%

7 0.7% 7.3% -1.9% 12.3%

8 -2.4% 7.1% -6.2% 11.9%

9 1.8% -0.2% -6.2% -0.3%

10 1.6% 2.8% 8.7% 4.3%

37. Lithium heparin whole blood stored at 10℃

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

1 1.1% 1.7% -6.8% 2.5%

2 -3.7% 4.3% -5.2% 8.8%

3 0.9% 7.3% 4.5% -2.4%

4 4.3% 0.9% -3.5% 5.2%

5 1.5% 3.4% 4.3% 5.1%

6 -2.2% 2.3% -3.3% -1.3%

7 0.5% 2.8% 3.7% -1.4%

8 -1.7% -1.7% -4.3% 1.1%

9 -0.4% 3.4% -3.3% -1.6%

10 -4.3% -2.8% 0.9% 7.5%

38. Lithium heparin whole blood stored at room temperature (22~26℃)

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

1 0.4% 5.3% -2.1% 2.1%

2 -1.8% -6.4% -5.7% 3.2%

3 2.4% -0.5% 2.5% 4.9%

4 1.6% -3.1% -2.5% 2.5%

5 -4.3% -6.5% 3.9% 5.4%

6 -1.7% -7.9% 4.4% 5.7%

7 -1.7% -7.0% -5.5% 12.0%

8 3.8% -2.9% 3.0% 16.8%

9 2.5% 2.0% 8.9% 12.5%

10 -1.7% -4.4% 0.2% 16.8%

39. Lithium heparin whole blood stored at 30℃

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

Medcaptain Confidential. All Rights Reserved. Page 23 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

1 -0.4% 7.1% 6.2% 11.6%

2 4.9% -4.5% 7.7% 0.0%

3 -4.2% -6.3% 2.2% 11.6%

4 -1.0% -3.7% -2.6% 6.0%

5 1.8% 5.2% -5.4% 11.2%

6 -0.4% 1.5% -3.2% 1.2%

7 4.0% 0.8% 8.0% 2.7%

8 -0.7% -1.6% 6.2% -0.9%

9 3.0% 3.6% -4.9% 6.0%

10 2.0% -5.5% 4.4% 12.3%

40. Sodium heparin whole blood stored at 10℃

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

1 3.8% 3.7% 1.6% -3.6%

2 5.0% 4.0% -5.8% 9.0%

3 -2.8% 0.0% -0.1% -0.8%

4 0.6% 0.8% 5.0% 4.8%

5 4.8% 5.3% 4.7% 7.2%

6 0.1% 3.0% -4.9% 5.2%

7 2.5% -7.2% 2.9% -3.4%

8 -4.4% -7.2% 4.0% 2.2%

9 1.8% 6.4% 8.8% 4.5%

10 -1.6% -1.1% 3.4% 1.1%

41. Sodium heparin whole blood stored at room temperature (22~26℃)

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

1 -0.3% 2.9% 8.4% 0.9%

2 -4.4% -3.8% 3.5% 3.7%

3 2.8% 7.7% 3.0% -1.6%

4 -2.1% 5.3% 3.8% -5.7%

5 -0.6% -6.6% 3.6% -0.7%

6 -4.1% -0.3% -2.6% -3.8%

7 3.0% 5.4% 3.8% -3.7%

8 2.7% -0.8% 1.8% 5.4%

9 -3.9% -3.8% 3.0% -5.0%

10 -4.0% 7.8% 2.9% -3.3%

42. Sodium heparin whole blood stored at 30℃

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

1 4.6% 0.7% 7.9% 2.5%

2 -4.5% -3.1% 1.2% 3.3%

3 1.8% 3.8% 8.5% 4.7%

4 -4.7% -6.6% 6.9% 12.7%

5 4.7% -2.9% 4.5% 11.8%

6 0.4% -0.8% 5.5% 1.6%

7 1.4% 2.6% 1.9% 1.4%

Medcaptain Confidential. All Rights Reserved. Page 24 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

8 0.3% 5.7% -3.6% 3.0%

9 -1.6% -0.8% -4.1% 3.2%

10 1.9% -4.6% 1.2% 5.3%

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 ℃) within 6 hours, the relative deviation of measurement results

does not exceed 10.0%. After they are stored for 8 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 4 hours.

 Serum, EDTA and heparin plasma samples were colleted and stored at room temperature (10~30 ℃) within 8 hours, the relative deviation of

measurement results does not exceed 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 6 hours.

 Serum, EDTA and heparin plasma samples were colleted and stored in a 2~8 ℃ refrigerator for 24 hours, the relative deviation of measurement

results does not exceed 10.0%. After they are stored for 48 hours, 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 24 hours after sample collection and processing.

 Serum, EDTA and heparin plasma samples were colleted and stored in a -20℃ refrigerator for 30 days, the relative deviation of measurement

results does not exceed 10.0%. After they are stored for 40 days, 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 30 days 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 three times, 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

 Real-time stability study:

The real-time stability of MYO (CLIA) has been studied, and the results show that the shelf life of MYO (CLIA) stored at 2~8 ℃ is at least 14

months.

 Transportation stability study:

The transportation stability of MYO (CLIA) has been studied, and the results show that performance of MYO (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 calibration sample C0 during vial opening

Medcaptain Confidential. All Rights Reserved. Page 25 of 26

 Document No. (Version)：MD71-5-S18 (V1.0)

The stability test of MYO calibrator C0, which is a reusable component in MYO kit (CLIA), was carried out. The results showed that : to prevent

the calibrator from contamination during lab operation, or to prevent incorrect test results for other causes,, it is recommended that MYO calibrator C0

should be capped immediately after use, and it can be stored at room temperature (10-30℃) for no more than 24 hours, and seal at 2-8℃ for no more

than 60 days

 Stability study of reconstituted Calibrators of C1

The stability test of reconstituted MYO calibrators C1, which is a reusable component in MYO kit (CLIA), was carried out. 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 MYO calibrator must not exceed once.

 Sample stability study:

A stability study is performed for several commonly used sample types with MYO (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 6 hours at room temperature (10~30 ℃),

not exceed 24 hours at 2~8 ℃, and not exceed 30 days at -20 ℃. MYO samples cannot undergo freeze/thaw cycles repeatedly. The freeze/thaw cycle

of MYO sample must not exceed once.

Medcaptain Confidential. All Rights Reserved. Page 26 of 26