Clinical Evaluation Report of SARS-CoV-2 IgM&IgG Rapid Test

1. Purpose

The purpose of this report is to provide information regarding the analytical performance
of the “Edan SARS-CoV-2 IgM&IgG Rapid Test”, compared to the already well-
established PCR system, present on Chinese market.

2. Introduction

2.1 Description of SARS-CoV-2 IgM&IgG Rapid Test

Edan SARS-CoV-2 IgM&IgG Rapid Test is a product for in-vitro analysis of whole blood,
serum and plasma, designed to deliver qualitative results for a panel of tests. The
resulting complex overflows a nitrocellulose membrane where the specific antigens
against IgM or IgG antibodies are immobilized on the test zone and forms the pink to
purple line at the “T” position of the window. The unreacted colloidal gold-labeled
antigens react with the antibodies on the control zone and forms the pink to purple line at
the “C” position of the window. The intensity and speed at which the color develops
depends on the concentration of 2019-nCoV IgM&IgG antibodies in the specimen. The
user can get the qualitative result by observing the T-Integral. If there is an obvious color
line in T-Integral, means positive result, otherwise, means negative result.

Product Lot # Manufacturer

Dongguan Bosh
SARS-CoV-2 IgM&IgG
20200210 Biotechnologies,
Rapid Test
Ltd.

2.2 Intended Use

The Edan SARS-CoV-2 IgM&IgG Rapid Test is a lateral flow immunoassay for the
qualitative detection of 2019-nCoV IgM/IgG antibodies in serum, plasma or whole blood
specimens. It is intended to be used as a screening test and aid in the diagnosis of
SARS-CoV-2 viral infections. Any reactive specimen with the Edan SARS-CoV-2
IgM&IgG Rapid Test must be confirmed with alternative testing method(s).

3. Clinical Methods

3.1 Performance evaluation of an IVD medical device

Comparative method of Edan SARS-CoV-2 IgM&IgG Rapid Test is done according to the
established and standardized guideline NCCLS Evaluation Protocol. The study was
performed by testing 140 samples collected from West China Hospital, Sichuan
University.

3.2 Analytical Performance

A total of 140 samples should be selected for inclusion in the trial. Each sample should
be tested in duplicate on the Edan and reference PCR system.
Specimen should be selected to obtain as wide a concentration distribution for the
intended tests as possible. Whenever possible. Using the NCCLS Evaluation Protocol as
a guideline, the following table provides the suggested distribution of sample
concentrations:

Positive Sample % of Samples

Edan SARS-CoV-2
99 ≥50%
IgM&IgG Rapid Test

Sample will be used throughout the study period. The positive and negative coincidence
rate will be analysis as following.

Reference Method
Total
+ -
+ a b a+b
Test Method
- c d c+d
Total a+c b+d a+b+c+d

Positive coincidence rate =a/(a+c)*100%

Negative coincidence rate =d/(b+d)*100%
Total coincidence rate =(a+d)/(a+b+c+d)*100%

3.3 Experiment data

Edan SARS-CoV-2 IgM&IgG Reference

No. Rapid Test Method Confirmed Date
IgM IgG PCR
1 + + + 2020/02/12
2 + - + 2020/02/12
3 + - + 2020/02/12
4 + + + 2020/02/12
5 + + + 2020/02/12
6 + + + 2020/02/12
7 - - - 2020/02/12
8 - - - 2020/02/12
9 + + + 2020/02/12
10 + + + 2020/02/13
11 + + + 2020/02/13
12 + + + 2020/02/13
13 - - - 2020/02/13
14 - + + 2020/02/13
15 + - + 2020/02/13
16 - + + 2020/02/13
17 + - + 2020/02/13
18 - - - 2020/02/13
19 - - - 2020/02/13
20 + - + 2020/02/13
21 + - + 2020/02/13
22 - - - 2020/02/14
23 + - + 2020/02/14
24 - - + 2020/02/14
25 + + + 2020/02/14
26 + + + 2020/02/14
27 - - - 2020/02/14
28 - + + 2020/02/14
29 - + + 2020/02/14
30 + - + 2020/02/14
31 + + + 2020/02/14
32 + + + 2020/02/14
33 + + + 2020/02/14
34 + + + 2020/02/14
35 + + + 2020/02/14
36 + + + 2020/02/14
37 + + + 2020/02/14
38 - - - 2020/02/14
39 + - + 2020/02/14
40 - - + 2020/02/15
41 - + + 2020/02/15
42 + + + 2020/02/15
43 + + + 2020/02/15
44 - + + 2020/02/15
45 - + + 2020/02/15
46 + + + 2020/02/15
47 + + + 2020/02/15
48 + + + 2020/02/15
49 - - - 2020/02/15
50 + + + 2020/02/15
51 + + + 2020/02/15
52 + - + 2020/02/15
53 + - + 2020/02/15
54 + + + 2020/02/16
55 + + + 2020/02/16
56 - + + 2020/02/16
57 + - + 2020/02/16
58 - + + 2020/02/16
59 + + + 2020/02/16
60 + + + 2020/02/16
61 + + + 2020/02/16
62 - + + 2020/02/16
63 + - + 2020/02/16
64 - - - 2020/02/16
65 - - - 2020/02/16
66 - + + 2020/02/16
67 + + + 2020/02/16
68 - - - 2020/02/16
69 - - - 2020/02/16
70 - - + 2020/02/16
71 + + + 2020/02/16
72 + + + 2020/02/16
73 + + + 2020/02/16
74 + + + 2020/02/16
75 + + + 2020/02/16
76 - + + 2020/02/16
77 + - + 2020/02/16
78 + - + 2020/02/16
79 - - - 2020/02/16
80 - - - 2020/02/16
81 - - - 2020/02/16
82 - - - 2020/02/16
83 - - - 2020/02/16
84 + + + 2020/02/17
85 + + + 2020/02/17
86 + + + 2020/02/17
87 - + + 2020/02/17
88 + - + 2020/02/17
89 + + + 2020/02/17
90 + + + 2020/02/17
91 - - - 2020/02/17
92 - - - 2020/02/17
93 - - - 2020/02/17
94 + + + 2020/02/17
95 + + + 2020/02/17
96 + + + 2020/02/17
97 - + + 2020/02/17
98 - + + 2020/02/17
99 - + + 2020/02/17
100 + + + 2020/02/17
101 + + + 2020/02/17
102 + + + 2020/02/17
103 + - + 2020/02/17
104 + - + 2020/02/17
105 + - + 2020/02/17
106 - + + 2020/02/17
107 - + + 2020/02/17
108 + + + 2020/02/18
109 + + + 2020/02/18
110 + + + 2020/02/18
111 - - - 2020/02/18
112 - - - 2020/02/18
113 - + + 2020/02/18
114 + + + 2020/02/18
115 + + + 2020/02/18
116 - - - 2020/02/18
117 - - - 2020/02/18
118 - - - 2020/02/18
119 - + + 2020/02/18
120 + + + 2020/02/18
121 + + + 2020/02/18
122 - - - 2020/02/18
123 - + + 2020/02/18
124 + + + 2020/02/18
125 + + + 2020/02/18
126 - - - 2020/02/18
127 - - - 2020/02/18
128 - - - 2020/02/18
129 - - - 2020/02/18
130 - + - 2020/02/18
131 - - - 2020/02/18
132 - - - 2020/02/18
133 - - - 2020/02/18
134 - - - 2020/02/18
135 - - - 2020/02/18
136 - - - 2020/02/18
137 - - - 2020/02/18
138 - - - 2020/02/18
139 + - - 2020/02/18
140 - - - 2020/02/18
3.4 Clinical Performance

The conclusion is as below. A very good coincidence rate was found between the two
methods. Positive coincidence rate is 96.9%, Negative coincidence rate is 95.2%, and
Total coincidence rate is 96.4%.

Reference Method
Total
+ -
+ 95 2 97
Test Method
- 3 40 43
Total 98 42 140
Positive coincidence rate =96.9%
Negative coincidence rate =95.2%
Total coincidence rate =96.4%

4. Conclusion

Method comparison shows good agreement between Edan and comparative method.
Positive coincidence rate is 96.9%, Negative coincidence rate is 95.2%, and Total
coincidence rate is 96.4%.
The submitted information in this premarket notification is complete and supports a
substantial equivalence decision.