迈克生物股份有 限公 司 Maccu 「

a Biotechnology Co., Ltd

地 址 ：成 都 市 离 新 区 百 川 路 16 号 Add: 16#, Baichuan Road, Hi-tech Zone, 611731 Chengdu,
电话 ：028 87826777 I 传真 ：028 87825783 s
PEO PLE ’ REPUBLIC OF CHINA
邮 编 ：们 才731 丁el: +86 28 87826777 Fa ×：＋86 28 87825783
E-mail: maccura@)maccura.com www.maccura.com

Certificate of Analysis
Inspection NO.: ZJB-20-03-09-01
Kit Name:Severe Acute Resoiratorv Svndrome Coronavirus 2(SARS-QoV-2) laM/laG Antibodv Assav Kit bv Colloidal Gold
Method Kit lot#: 0320032 Specification: 20 servinas/ box Unit: Box
Sampling quantity:3 boxes
Instrument: / Inspection quantity: 53 7. 000000 Qualified quantity:537 .000000
Unqualified quantity:0.000000
Production date: 2020-03-06 Expiration date: 2021-03-06 Inspection date: 2020-03-09
Test standard (acc. SOP): Enterorise aualitv insoection SOP of Severe Acute Resoiratorv Svndrome Coronavirus
2(SARS-CoV-2) laM/laG Antibodv Assav Kit bv Colloidal Gold Method
Comment: I

C0n u
内
M
Category Inspection item Target value / range Result ．
0
创 H
n

， The appearance should be neat and The appearance is neat and

Physical 仰pea rance o E
T

integrated. Texts and figures integrated. Texts and PASS

characteristics padta ge
should be clear. figures are clear.

Physical Film strip width should not be less I Film strip widths: 4.0mm,
Flim strip width PASS
characteristics than 2.5mm I 4.0mm, and 4.0mm

The liquid migration speed:

Physical The liquid migration speed should
Liquid migration speed 33mm I min, 33mm / min, PASS
characteristics not be less than 10mm I min.
33mm I min.

Use 3 SARS-CoV-2-lgG companies I Use 3 SARS-CoV-2-lgG

to detect the lowest detection limit I companies to detect the
reference products: L 1 should be I lowest detection limit
positive, L2 can be positive or reference products: L 1, L2
Minimum detection Minimum detection negative, L3 should be are positive, L3 is negative.
PASS
limit limit negative.Use 3 SARS-CoV-2-lgM I Use 3 SARS-CoV-2-lgM
enterprise to detect the lowest enterprise to detect the
detection m reference lowest detection limit
products:L 1 should be positive, L2 reference products: L 1, L2
can be positive or negative, L3 are positive, L3 is negative.
should be negative.
Tested with 5 SARS-CoV-2-lgM I I Tested with 5
lgG enterprise positive reference I SARS-CoV-2-lgM I lgG
Positive reference Positive reference products, P1, P2, P3 lgG I enterprise positive
PASS
compliance rate compliance rate antibodies were positive, and P4, I reference products, P1, P2,
P5 lgM antibodies were positive. I P3 lgG antibodies were
The positive coincidence rate I positive, and P4, P5 lgM

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迈克生物股份有限公司 Maccu 「 a Biotechnology Co., Ltd
地址 ：成都市高新区百川路 16 号 Add: 16#, Baichuan Road, Hi-tech Zone, 61173 才 Chengdu,
电话 ：028 87826777 I 传真 ：028 87825783 PEOPLE'S REPUBLIC OF CHINA
邮编 ：611731 Tel: +86 28 87826777 Fa ×：＋86 28 87825783
E-mail: maccura@maccura.com www.maccura.com

should be no less than 5/5. antibodies were positive.

The positive coincidence
rate was 5/5.
Positive reference Positive reference
Tested with 20
compliance rate compliance rate Tested with 20 SARS-CoV-2-lgM /
SARS-CoV-2-lgM / lgG
lgG enterprise negative reference
enterprise negative
materials. 丁he compliance rate of
reference materials. The
lgG antibody negative reference
lgG antibody negative
materials should not be less than PASS
reference compliance rate
20/20, and the compliance rate of
was 20/20, and the lgM
lgM antibody negative reference
antibody negative
materials should not be less than
reference compliance rate
18/20.
was 20/20.

One sample of
One sample of SARS-CoV-2-lgM / SARS-CoV-2-lgM / lgG
lgG enterprise reproducible enterprise reproducible
Repeatability Repeatability reference was tested in parallel for reference was tested in
PASS
10 times. The lgM antibody I lgG parallel for 10 times. The
antibody should be positive and lgM antibody / lgG antibody
consistent in color. should be positive and
consistent in color.

Maccura
Department of

Operator:
-i;{,
Reviewer: 队 d
）
Approver:

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