Innovita (Tangshan) Biological Technology Co., Ltd.

Address: No. 699 Juxin Street, High-tech Industrial

Development Zone,Qian'an,064400,Hebei,
China.
Phone: 86-10-83681277
Fax: 86-10-83682966
Website: www.innovita.com.cn

Stability Test Report

Project Name (Code): 2019-nCoV Ab Test (Colloidal Gold)

Item Name (Code): Stability Test Report

Project leader: Li Lanying

Participants: Zheng Chunlei, Chen Tingyou, Zhang Chunli,

Xia Ruijuan

INNOVITA (Tangshan) Biological Technology Co., Ltd.

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Innovita (Tangshan) Biological Technology Co., Ltd.
Address: No. 699 Juxin Street, High-tech Industrial
Development Zone,Qian'an,064400,Hebei,
China.
Phone: 86-10-83681277
Fax: 86-10-83682966
Website: www.innovita.com.cn

The Stability Test for Innovita 2019-nCoV Ab Test (Colloidal Gold) was performed in compliance to EN ISO 13612.

1. Claimed Shelf Life

Real time stability and accelerated stability were performed to validate the product shelf life of 6 months.

Real Time Stability Test

The following three batches of Innovita 2019-nCoV Ab Tests are used.

LOT No.: 20200201
LOT No.: 20200202
LOT No.: 20200203

Specimen: Positive Whole Blood/Serum/Plasma sample, Negative Whole Blood/Serum/Plasma sample

Test Method:
• 5 test kits from each batch were stored at 4°C, 10°C, 25°C, 30°C.
• The test kits were tested on regular intervals of not more than 1 month.
• The qualitative procedure was followed as per the Instructions for Use.

Acceptance Criteria:
Minimum detection limit L of nCoV IgM is positive.

Real-time test results under 4°C:

Storage Positive Whole Blood/Serum/Plasma sample Negative
Batch No. Month
Temperature (°C) With nCoV IgM concentration ＝ L (+) Sample (-)
4 20200201 0 + -
4 20200202 0 + -
4 20200203 0 + -

Real-time test results under 10°C:

Storage Positive Whole Blood/Serum/Plasma sample Negative
Batch No. Month
Temperature (°C) With nCoV IgM concentration ＝ L (+) Sample (-)
10 20200201 0 + -
10 20200202 0 + -
10 20200203 0 + -

Real-time test results under 25°C:

Storage Batch No. Month Positive Whole Blood/Serum/Plasma sample Negative

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Innovita (Tangshan) Biological Technology Co., Ltd.
Address: No. 699 Juxin Street, High-tech Industrial
Development Zone,Qian'an,064400,Hebei,
China.
Phone: 86-10-83681277
Fax: 86-10-83682966
Website: www.innovita.com.cn

Temperature (°C) With nCoV IgM concentration ＝ L (+) Sample (-)

25 20200201 0 + -
25 20200202 0 + -
25 20200203 0 + -

Real-time test results under 30°C:

Storage Positive Whole Blood/Serum/Plasma sample Negative
Batch No. Month
Temperature (°C) With nCoV IgM concentration ＝ L (+) Sample (-)
30 20200201 0 + -
30 20200202 0 + -
30 20200203 0 + -

Acceptance Criteria:
Minimum detection limit L of nCoV IgG is positive.

Real-time test results under 4°C:

Storage Positive Whole Blood/Serum/Plasma sample Negative
Batch No. Month
Temperature (°C) With nCoV IgG concentration ＝ L (+) Sample (-)
4 20200201 0 + -
4 20200202 0 + -
4 20200203 0 + -

Real-time test results under 10°C:

Storage Positive Whole Blood/Serum/Plasma sample Negative
Batch No. Month
Temperature (°C) With nCoV IgG concentration ＝ L (+) Sample (-)
10 20200201 0 + -
10 20200202 0 + -
10 20200203 0 + -

Real-time test results under 25°C:

Storage Positive Whole Blood/Serum/Plasma sample Negative
Batch No. Month
Temperature (°C) With nCoV IgG concentration ＝ L (+) Sample (-)
25 20200201 0 + -
25 20200202 0 + -
25 20200203 0 + -

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Innovita (Tangshan) Biological Technology Co., Ltd.
Address: No. 699 Juxin Street, High-tech Industrial
Development Zone,Qian'an,064400,Hebei,
China.
Phone: 86-10-83681277
Fax: 86-10-83682966
Website: www.innovita.com.cn

Real-time test results under 30°C:

Storage Positive Whole Blood/Serum/Plasma sample Negative
Batch No. Month
Temperature (°C) With nCoV IgG concentration ＝ L (+) Sample (-)
30 20200201 0 + -
30 20200202 0 + -
30 20200203 0 + -

Accelerated Stability Test

The following three batches of Innovita 2019-nCoV Ab Tests are used.

LOT No.: 20200201

LOT No.: 20200202
LOT No.: 20200203

Specimen: Positive Whole Blood/Serum/Plasma sample, Negative Whole Blood/Serum/Plasma sample

Test Method:
• 5 test kits from each batch were stored at 37°C.
• The test kits were tested on regular intervals of 7 days.
• The qualitative procedure was followed as per the Instructions for Use.

Acceptance Criteria:
Minimum detection limit L of nCoV IgM is positive.

Accelerated test results:

Storage Positive Whole Blood/Serum/Plasma sample Negative
Batch No. Days
Temperature (°C) with nCoV IgM concentration ＝L(+) Sample (-)
37 20200201 7 + -
37 20200202 7 + -
37 20200203 7 + -

Acceptance Criteria:
Minimum detection limit L of nCoV IgG is positive.
Accelerated test results:
Storage Positive Whole Blood/Serum/Plasma sample Negative
Batch No. Days
Temperature (°C) with nCoV IgG concentration ＝L (+) Sample (-)
37 20200201 7 + -
37 20200202 7 + -
37 20200203 7 + -
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Innovita (Tangshan) Biological Technology Co., Ltd.
Address: No. 699 Juxin Street, High-tech Industrial
Development Zone,Qian'an,064400,Hebei,
China.
Phone: 86-10-83681277
Fax: 86-10-83682966
Website: www.innovita.com.cn

• Three consecutive batches were stored at 25°C for real time study and 37°C for accelerated studies.
• The test kits were tested on regular intervals of not more than 1 month for real-time test and 7 days for
accelerated test.

Conclusion: The above test results support 6 months’ shelf life for Innovita 2019-nCoV Ab Test (Colloidal Gold)if
stored at 4°C to 30°C.

2. Stability Test After Opening The Foil Pouch

The following three batches of Innovita 2019-nCoV Ab Test (Colloidal Gold)are used.

LOT No.: 20200201

LOT No.: 20200202
LOT No.: 20200203

Specimen: Positive Whole Blood/Serum/Plasma sample, Negative Whole Blood/Serum/Plasma sample

Test Method:
• 5 test kits from each batch were stored at 25°C.
• Open the foil pouch and place the reagent for 60 minutes at normal temperature and humidity (about 60%
relative humidity). Then test the performances after 90 minutes.
• The qualitative procedure was followed as per the Instructions for Use.

Acceptance Criteria:

Minimum detection limit L of nCoV IgM is positive.

Test results:
Time after Positive Whole Blood/Serum/Plasma sample Negative
Batch No.
pouch opening with nCoV IgM concentration ＝L(+) Sample (-)
60 minutes + -
20200201
90 minutes + -
60 minutes + -
20200202
90 minutes + -
60 minutes + -
20200203
90 minutes + -

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Innovita (Tangshan) Biological Technology Co., Ltd.
Address: No. 699 Juxin Street, High-tech Industrial
Development Zone,Qian'an,064400,Hebei,
China.
Phone: 86-10-83681277
Fax: 86-10-83682966
Website: www.innovita.com.cn

Minimum detection limit L of nCoV IgG is positive.

Test results:
Time after Positive Whole Blood/Serum/Plasma sample Negative
Batch No.
pouch opening with nCoV IgG concentration ＝L (+) Sample (-)
60 minutes + -
20200201
90 minutes + -
60 minutes + -
20200202
90 minutes + -
60 minutes + -
20200203
90 minutes + -

Based on these results, the product met the acceptance criteria within 60 min and 90 min after opening the foil
pouch at normal temperature and humidity. But the flow performance is decreased when the reagents are exposed
for 90 minutes after opening the pouch if observed by naked eye. A number of studies indicate that the humidity has
a great effect on the colloidal gold reagents. The performance of test kit will gradually decrease due to absorption of
moisture in exposed environment. This test indicates that there is no significant effect within 90 minutes. But to
ensure the stability of the products, it is better to use immediately after opening the pouch but do not exceed 60
minutes.

3. Transportation Stability Test:

Set the simulated transportation conditions to 45 ± 5 ℃ and relative humidity ≥90%; -65 ± 5 ℃ and relative
humidity ≥90%.
When the three batches of trial production were stored under simulated transportation conditions for 7 days, the
test was conducted once using the enterprise reference control. The results show that the kit has good high
temperature stability and the kit has good low temperature stability.
The three batches of trial production were packed in the largest packing box of our company's colloidal gold product
packaging and transportation. The goods were dropped from a height of 3 meters, and after repeated 5 times, the
test was performed once with the enterprise reference control. The results showed that the stability of the
mechanical force outside the kit was good. Meet performance requirements.

All kits remained closed and sealed with no signs of deterioration or damage.

All positive controls created a test line and control line - PASS.

All negative controls created a control line only - PASS.