2019-nCoV IgM/IgG Antibody Determination Kit

（Immunochromatographic Assay）

Compilation of clinical evaluation results

(As of February 21st, 2020)

Beijing Diagreat Biotechnologies Co.,Ltd

 Summary of new coronavirus validation results

As of February 21st, 2020, 92 positive specimens and 234 negative specimens have
been verified. Among them, the positive detection rate of antibodies was 92.39%.

1 Wuhan Fire God Mountain hospital/Huoshenshan hospital

Validation date: February 20th, 2020.
Validation index: Sensitivity
Validation method: Serum samples from patients was collected and Diagreat's 2019-
nCoV IgM/IgG antibody determination kit were used for detection. The cutoff value is
1. The samples from Wuhan Hospital were confirmed positive samples.
Summary of validation results:
As of February 21st, 2020, 50 positive specimens in total have been validated in Wuhan
Hospital, of which the sensitivity was 94%; among them, the IgG level was significantly
higher than the IgM level of patients in the recovery period.
Clinical Diagreat Test Result(μg/ml)
No. Diagnosis IGM Result
IGM Judgment IGG IGG Result Judgment
20200220001 Positive 2.23 Positive 2.23 Positive
20200220002 Positive 4.46 Positive 0.96 Negative
20200220003 Positive 3.27 Positive 4.1 Positive
20200220004 Positive 3.54 Positive 3.29 Positive
20200220005 Positive 3.57 Positive 1.45 Positive
20200220006 Positive 1.99 Positive 1.42 Positive
20200220007 Positive 1.31 Positive 0.86 Negative
20200220008 Positive 3.65 Positive 0.44 Negative
20200220009 Positive 12.34 Positive 2.3 Positive
20200220010 Positive 2.03 Positive 0.52 Negative
20200220011 Positive 9.99 Positive 2.79 Positive
20200220012 Positive 1.89 Positive 1.88 Positive
20200220013 Positive 4.2 Positive 3.32 Positive
20200220014 Positive 11.5 Positive 4.65 Positive
20200220015 Positive 7.4 Positive 1.78 Positive

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 20200220016 Positive 1.12 Positive 1.28 Positive
20200220017 Positive 1.77 Positive 5.39 Positive
20200220018 Positive 1.58 Positive 0.65 Negative
20200220019 Positive 1.46 Positive 0.45 Negative
20200220020 Positive 13.01 Positive 1.36 Positive
20200220021 Positive 7.68 Positive 0.89 Negative
20200220022 Positive 0.61 Positive 0 Negative
20200220023 Positive 1.86 Positive 0.89 Negative
20200220024 Positive 22.31 Positive 6.81 Positive
20200220025 Positive 5.65 Positive 4.87 Positive
20200220026 Positive 10.42 Positive 2.65 Positive
20200220027 Positive 2.86 Positive 0.41 Negative
20200220028 Positive 2.74 Positive 0.07 Negative
20200220029 Positive 1.52 Positive 0.14 Negative
20200220030 Positive 3.59 Positive 0.16 Negative
20200220031 Positive 8.08 Positive 1.23 Positive
20200220032 Positive 2.23 Positive 0.4 Negative
20200220033 Positive 1.87 Positive 0.33 Negative
20200220034 Positive 26.11 Positive 5.6 Positive
20200220035 Positive 6.94 Positive 0.66 Negative
20200220036 Positive 4.62 Positive 6.41 Positive
20200220037 Positive 21.12 Positive 2.35 Positive
20200220038 Positive 3.3 Positive 1.69 Positive
20200220039 Positive 1.7 Positive 0.56 Negative
20200220040 Positive 3.06 Positive 0.95 Negative
20200220041 Positive 3.1 Positive 0.43 Negative
20200220042 Positive 5.51 Positive 1.6 Positive
20200220043 Positive 5.41 Positive 0.96 Negative
20200220044 Positive 1.78 Positive 0.17 Negative
20200220045 Positive 1.1 Positive 1.41 Positive
20200220046 Positive 2.11 Positive 1.12 Positive
20200220047 Positive 0.72 Positive 0 Negative
20200220048 Positive 0.72 Positive 0.77 Negative
20200220049 Positive 1.87 Positive 1.5 Positive
20200220050 Positive 2.6 Positive 3.36 Positive
2 Shenzhen Hospital of Southern Medical University
Validation date: February 13rd-20th, 2020.
Validation index: Sensitivity and specificity. .
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Validation method: Serum samples of suspected fever cases and recovery patients from
Shenzhen Hospital were collected and Diagreat's 2019-nCoV IgM/IgG antibody
determination kits were used for test. The cutoff value is 1.
Summary of validation results: As of February 21st, 2020, a total of 56 positive
specimens have been verified in Shenzhen Hospital, including 42 suspected positive
cases (including nucleic acid positive and clinical pathological positive), 14 negative
cases, of which the sensitivity was 90.48 %; Among them, the IgG level was obviously
higher than the IgM level in the recovery period.
Clinical Diagnosis Diagreat Test Result(μg/ml)
No.
IGM IGM Result Judgment IGG IGG Result Judgment
1 Positive 1.08 Positive 1.16 Positive
2 Positive 1.17 Positive 1.45 Positive
3 Negative 0.19 Negative 0.16 Negative
4 Positive 1.03 Positive 1.32 Positive
5 Negative 0.27 Negative 0.3 Negative
6 Positive 1.18 Positive 0.62 Negative
7 Positive 1.17 Positive 1.06 Positive
8 Positive 4.12 Positive 47.36 Positive
9 Negative 0.74 Negative 1.02 Positive
10 Positive 1.1 Positive 1.28 Positive
11 Positive 1.58 Positive 1.66 Positive
12 Positive 3.56 Positive 26.31 Positive
13 Negative 0.71 Negative 0.73 Negative
14 Positive 1.26 Positive 0.62 Negative
15 Positive 1.25 Positive 0.91 Negative
16 Positive 1.22 Positive 0.92 Negative
17 Positive 1.71 Positive 1.17 Positive
18 Positive 1.24 Positive 1.65 Positive
19 Positive 0.66 Negative 0.81 Negative
20 Positive 7.61 Positive 13.13 Positive
21 Positive 2.63 Positive 0.7 Negative
22 Positive 0.9 Negative 1.45 Positive
23 Positive 1 Positive 1.53 Positive
24 Positive 1.35 Positive 7.49 Positive
25 Positive 17.62 Positive 33.21 Positive
26 Positive 1.03 Positive 0.62 Negative
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 27 Positive 1.3 Positive 1.15 Positive
28 Positive 1.07 Positive 0.94 Negative
29 Negative 0.85 Negative 0.98 Negative
30 Positive 1.03 Positive 1.13 Positive
31 Positive 0.11 Negative 0.16 Negative
32 Negative 0.1 Negative 0.07 Negative
33 Positive 1.32 Positive 3.52 Positive
34 Negative 0.84 Negative 0.73 Negative
35 Negative 1.11 Positive 0.76 Negative
36 Negative 0.79 Negative 0.83 Negative
37 Negative 0.89 Negative 0.95 Negative
38 Positive 1.03 Positive 0.96 Negative
39 Positive 0.71 Negative 0.75 Negative
40 Negative 0.73 Negative 0.8 Negative
41 Positive 1.07 Positive 1.11 Positive
42 Negative 0.63 Negative 0.67 Negative
43 Positive 1.13 Positive 0.61 Negative
44 Positive 0.95 Negative 0.85 Negative
45 Positive 1.12 Positive 0.99 Negative
46 Positive 1.38 Positive 3.34 Positive
47 Positive 1.02 Positive 1.62 Positive
48 Positive 7.49 Positive 50.03 Positive
49 Positive 8.82 Positive 26.22 Positive
50 Positive 0.58 Negative 1.09 Positive
51 Positive 0.55 Negative 1.79 Positive
52 Positive 12.93 Positive 13.11 Positive
53 Positive 0.7 Negative 2.74 Positive
54 Negative 0.82 Negative 1.06 Positive
55 Positive 0.85 Negative 1.31 Positive
56 Negative 0.9 Negative 1.32 Positive
3. Validation of normal population.
Validation date: February 14th-19th, 2020.
Validation index: Specificity and determination of cutoff value.
Validation method: Normal human specimens were collected and Diagreat's 2019-
nCoV IgM/IgG antibody determination kits, and cutoff value was determined.
Validation result: A total of 220 cases of normal serum were verified, and the cutoff

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value was determined by setting specificity about 90%. Among them, in the verified
normal serum, the IgM specificity was 89.55% and the IgG specificity was 90.45%.
Diagreat Test Result(μg/ml)
Clinical
No.
Diagnosis IGM IGM Result Judgment IGG IGG Result Judgment

1 Negative 0.30 Negative 0.90 Negative

2 Negative 0.89 Negative 0.57 Negative
3 Negative 0.55 Negative 1.17 Positive
4 Negative 0.64 Negative 0.63 Negative
5 Negative 0.96 Negative 0.80 Negative
6 Negative 0.73 Negative 0.83 Negative
7 Negative 0.64 Negative 0.90 Negative
8 Negative 1.32 Positive 0.87 Negative
9 Negative 0.49 Negative 1.03 Positive
10 Negative 0.48 Negative 0.70 Negative
11 Negative 0.60 Negative 1.00 Positive
12 Negative 0.86 Negative 0.87 Negative
13 Negative 0.93 Negative 0.63 Negative
14 Negative 0.49 Negative 0.77 Negative
15 Negative 0.83 Negative 0.40 Negative
16 Negative 0.18 Negative 0.60 Negative
17 Negative 0.16 Negative 1.07 Positive
18 Negative 0.27 Negative 0.50 Negative
19 Negative 0.29 Negative 0.90 Negative
20 Negative 0.56 Negative 0.40 Negative
21 Negative 1.00 Positive 0.77 Negative
22 Negative 0.48 Negative 0.80 Negative
23 Negative 0.57 Negative 0.73 Negative
24 Negative 0.77 Negative 0.53 Negative
25 Negative 0.69 Negative 0.33 Negative
26 Negative 0.24 Negative 0.47 Negative
27 Negative 1.76 Positive 0.50 Negative
28 Negative 0.49 Negative 0.53 Negative
29 Negative 0.64 Negative 0.60 Negative
30 Negative 0.20 Negative 0.33 Negative
31 Negative 0.13 Negative 0.57 Negative
32 Negative 0.33 Negative 0.67 Negative
33 Negative 0.84 Negative 0.67 Negative
34 Negative 0.55 Negative 1.27 Positive
35 Negative 0.09 Negative 0.83 Negative
36 Negative 0.58 Negative 0.73 Negative

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 37 Negative 0.24 Negative 2.43 Positive
38 Negative 0.95 Negative 0.37 Negative
39 Negative 0.51 Negative 0.47 Negative
40 Negative 0.48 Negative 0.57 Negative
41 Negative 0.46 Negative 0.33 Negative
42 Negative 0.69 Negative 0.67 Negative
43 Negative 0.44 Negative 0.60 Negative
44 Negative 0.71 Negative 0.50 Negative
45 Negative 0.44 Negative 0.70 Negative
46 Negative 0.31 Negative 0.53 Negative
47 Negative 0.56 Negative 0.60 Negative
48 Negative 0.34 Negative 0.67 Negative
49 Negative 0.35 Negative 0.77 Negative
50 Negative 0.30 Negative 0.60 Negative
51 Negative 0.63 Negative 0.70 Negative
52 Negative 0.85 Negative 0.70 Negative
53 Negative 0.26 Negative 0.63 Negative
54 Negative 2.79 Positive 0.77 Negative
55 Negative 0.53 Negative 0.27 Negative
56 Negative 0.22 Negative 0.17 Negative
57 Negative 0.27 Negative 0.57 Negative
58 Negative 0.37 Negative 0.23 Negative
59 Negative 0.55 Negative 0.47 Negative
60 Negative 0.43 Negative 0.20 Negative
61 Negative 0.14 Negative 0.47 Negative
62 Negative 0.28 Negative 0.30 Negative
63 Negative 0.37 Negative 0.60 Negative
64 Negative 1.91 Positive 0.37 Negative
65 Negative 0.49 Negative 0.93 Negative
66 Negative 0.21 Negative 0.30 Negative
67 Negative 0.98 Negative 0.37 Negative
68 Negative 0.62 Negative 0.43 Negative
69 Negative 0.24 Negative 0.27 Negative
70 Negative 1.02 Positive 0.53 Negative
71 Negative 0.94 Negative 0.27 Negative
72 Negative 0.80 Negative 0.53 Negative
73 Negative 0.70 Negative 1.06 Positive
74 Negative 0.77 Negative 0.88 Negative
75 Negative 0.67 Negative 0.88 Negative
76 Negative 0.80 Negative 0.82 Negative
77 Negative 0.90 Negative 0.88 Negative
78 Negative 0.90 Negative 0.65 Negative
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 79 Negative 1.00 Positive 0.71 Negative
80 Negative 0.80 Negative 0.71 Negative
81 Negative 0.63 Negative 0.88 Negative
82 Negative 0.50 Negative 0.76 Negative
83 Negative 0.50 Negative 0.59 Negative
84 Negative 0.63 Negative 0.53 Negative
85 Negative 1.30 Positive 0.71 Negative
86 Negative 0.70 Negative 1.00 Positive
87 Negative 0.83 Negative 0.82 Negative
88 Negative 0.87 Negative 0.65 Negative
89 Negative 0.67 Negative 0.53 Negative
90 Negative 0.53 Negative 0.71 Negative
91 Negative 0.60 Negative 0.71 Negative
92 Negative 0.63 Negative 0.53 Negative
93 Negative 0.70 Negative 0.76 Negative
94 Negative 0.80 Negative 0.65 Negative
95 Negative 1.00 Positive 1.00 Positive
96 Negative 0.77 Negative 0.94 Negative
97 Negative 0.53 Negative 1.06 Positive
98 Negative 0.87 Negative 0.65 Negative
99 Negative 0.70 Negative 0.53 Negative
100 Negative 1.00 Positive 0.59 Negative
101 Negative 0.57 Negative 0.59 Negative
102 Negative 0.70 Negative 0.41 Negative
103 Negative 0.60 Negative 0.65 Negative
104 Negative 0.70 Negative 0.65 Negative
105 Negative 0.93 Negative 0.65 Negative
106 Negative 1.10 Positive 0.71 Negative
107 Negative 0.53 Negative 0.71 Negative
108 Negative 0.80 Negative 0.94 Negative
109 Negative 0.90 Negative 0.71 Negative
110 Negative 0.73 Negative 0.59 Negative
111 Negative 0.63 Negative 0.82 Negative
112 Negative 0.57 Negative 0.71 Negative
113 Negative 0.70 Negative 0.47 Negative
114 Negative 0.63 Negative 0.76 Negative
115 Negative 0.57 Negative 0.65 Negative
116 Negative 0.57 Negative 0.71 Negative
117 Negative 0.53 Negative 0.47 Negative
118 Negative 0.53 Negative 0.65 Negative
119 Negative 0.87 Negative 0.65 Negative
120 Negative 5.47 Positive 0.86 Negative
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 121 Negative 0.29 Negative 0.25 Negative
122 Negative 0.42 Negative 0.50 Negative
123 Negative 1.36 Positive 0.50 Negative
124 Negative 0.67 Negative 0.50 Negative
125 Negative 0.36 Negative 0.25 Negative
126 Negative 0.61 Negative 0.50 Negative
127 Negative 0.54 Negative 0.25 Negative
128 Negative 1.11 Positive 1.50 Positive
129 Negative 0.67 Negative 0.25 Negative
130 Negative 0.48 Negative 0.50 Negative
131 Negative 0.54 Negative 0.75 Negative
132 Negative 0.48 Negative 0.50 Negative
133 Negative 0.54 Negative 0.75 Negative
134 Negative 0.48 Negative 0.25 Negative
135 Negative 0.61 Negative 0.25 Negative
136 Negative 0.48 Negative 0.50 Negative
137 Negative 0.98 Negative 0.25 Negative
138 Negative 0.98 Negative 0.50 Negative
139 Negative 0.92 Negative 0.25 Negative
140 Negative 0.29 Negative 0.50 Negative
141 Negative 0.36 Negative 0.25 Negative
142 Negative 1.23 Positive 0.75 Negative
143 Negative 0.79 Negative 0.25 Negative
144 Negative 0.98 Negative 0.25 Negative
145 Negative 0.54 Negative 0.50 Negative
146 Negative 0.54 Negative 0.25 Negative
147 Negative 0.23 Negative 0.25 Negative
148 Negative 0.67 Negative 0.25 Negative
149 Negative 1.30 Positive 0.25 Negative
150 Negative 0.61 Negative 1.25 Positive
151 Negative 0.79 Negative 0.75 Negative
152 Negative 0.54 Negative 0.25 Negative
153 Negative 0.79 Negative 0.50 Negative
154 Negative 0.42 Negative 0.50 Negative
155 Negative 0.23 Negative 2.25 Positive
156 Negative 0.42 Negative 0.25 Negative
157 Negative 0.48 Negative 0.50 Negative
158 Negative 0.98 Negative 0.50 Negative
159 Negative 0.29 Negative 0.50 Negative
160 Negative 1.17 Positive 0.75 Negative
161 Negative 0.36 Negative 0.25 Negative
162 Negative 0.61 Negative 0.25 Negative
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 163 Negative 0.48 Negative 1.50 Positive
164 Negative 0.48 Negative 0.25 Negative
165 Negative 0.42 Negative 0.50 Negative
166 Negative 0.36 Negative 0.50 Negative
167 Negative 0.17 Negative 0.25 Negative
168 Negative 0.54 Negative 0.50 Negative
169 Negative 0.29 Negative 0.25 Negative
170 Negative 0.79 Negative 0.50 Negative
171 Negative 0.48 Negative 0.25 Negative
172 Negative 0.42 Negative 0.25 Negative
173 Negative 1.36 Positive 1.25 Positive
174 Negative 0.48 Negative 0.25 Negative
175 Negative 0.36 Negative 0.00 Negative
176 Negative 5.73 Positive 0.75 Negative
177 Negative 0.48 Negative 0.50 Negative
178 Negative 1.23 Positive 0.50 Negative
179 Negative 0.22 Negative 0.75 Negative
180 Negative 0.74 Negative 0.58 Negative
181 Negative 0.48 Negative 0.85 Negative
182 Negative 0.21 Negative 0.58 Negative
183 Negative 0.94 Negative 0.40 Negative
184 Negative 0.27 Negative 0.15 Negative
185 Negative 0.27 Negative 1.55 Positive
186 Negative 0.36 Negative 0.65 Negative
187 Negative 0.86 Negative 0.43 Negative
188 Negative 0.57 Negative 0.30 Negative
189 Negative 0.38 Negative 1.43 Positive
190 Negative 0.53 Negative 0.38 Negative
191 Negative 0.24 Negative 0.50 Negative
192 Negative 1.16 Positive 0.65 Negative
193 Negative 0.37 Negative 0.53 Negative
194 Negative 0.16 Negative 0.45 Negative
195 Negative 1.10 Positive 0.15 Negative
196 Negative 0.59 Negative 1.00 Positive
197 Negative 0.29 Negative 0.48 Negative
198 Negative 0.26 Negative 0.28 Negative
199 Negative 0.22 Negative 0.68 Negative
200 Negative 0.63 Negative 0.70 Negative
201 Negative 0.81 Negative 0.75 Negative
202 Negative 0.56 Negative 0.85 Negative
203 Negative 0.23 Negative 0.70 Negative
204 Negative 0.73 Negative 2.03 Positive
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 205 Negative 0.58 Negative 0.25 Negative
206 Negative 1.04 Positive 0.95 Negative
207 Negative 0.76 Negative 0.55 Negative
208 Negative 0.26 Negative 0.35 Negative
209 Negative 0.39 Negative 0.48 Negative
210 Negative 0.52 Negative 1.08 Positive
211 Negative 0.36 Negative 0.53 Negative
212 Negative 0.54 Negative 0.70 Negative
213 Negative 0.73 Negative 0.68 Negative
214 Negative 0.42 Negative 0.90 Negative
215 Negative 0.44 Negative 0.78 Negative
216 Negative 0.69 Negative 2.18 Positive
217 Negative 0.71 Negative 0.25 Negative
218 Negative 0.44 Negative 0.55 Negative
219 Negative 0.44 Negative 0.60 Negative
220 Negative 0.46 Negative 0.58 Negative

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 Independent Innovation · Based on · Raw Materials R&D

Beijing Diagreat Biotechnologies Co., Ltd

Http://www.diagreat.com
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Tel: (8610) 69502385
Fax: (8610) 69507615
E-mai: info@diagreat.com
Mob: +86 13524602677

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