News and information

search：

Two level classification：

COVID 19 Antigen Test Kit (Clinical Investigation Report)--For export only

COVID 19 Antigen Test Kit 
(Colloidal gold method)
Clinical Investigation Report
I. Test Protocol
1. Purpose
The main purpose of this research is to study the correlation between COVID 19 antigen test kit (colloidal gold method) and the clinical reference standards (clinical diagnostic standard of pneumonia caused by novel coronavirus infection and determination of disease course) to verify the clinical performance of the product.
2. Verification Item
COVID 19 antigen test kit (colloidal gold method) developed by: Neo-nostics (Suzhou) Biological Engineering Co., Ltd.
Test location: Wuhan Institute of Virology, CAS.
3. Procedure
3.1 Calculation of coincidence rate
The test was carried out in accordance with the instructions for use, the results were recorded and the four-fold table was drawn (as below):
Table 1-1: Comparison of kit test results with clinical reference standard results
Nasal / Nasopharyngeal / Oropharyngeal specimen samples PCR Test Results Total
Positive Negative
COVID 19 antigen test kit (colloidal gold method) N protein results Positive A B A+B
Negative C D C+D
Total A+C B+D A+B+C+D
Diagnostic sensitivity: A/(A+C)×100%;
95% CI：A/(A+C)±1.96×[(A*C)/ (A+C)] 1/2/ (A+C)
Diagnostic specificity: D/(B+D)×100%;
95% CI：D/(B+D)±1.96×[(B*D)/ (B+D)] 1/2/ (B+D)
Total coincidence rate=(A+D)/(A+B+C+D)×100%.
95% CI：(A+D)/(A+B+C+D)±1.96×[(A+D)*(A+B+C+D)/(A+B+C+D)] 1/2/ (A+B+C+D)
3.2 Test method
1. Previous preparation of reagents: it took about 30 minutes for all reagents and samples to equilibrate to room temperature.
2. Determination procedure: loosen the cover of the diluent bottle and take 400ul (about 13 drops of bubble free diluent) into a plastic test tube.Collecting the Nasopharyngeal/Oropharyngeal or throat secretion put into the diluent of the plastic test tube,squeeze the sample fully with your fingers for one minute.After the swab is taken out as far as possible,add 3 drops (about 90ul) into the sample hole(s) of the test kit.Count for 15 minutes and observe the results. Please note that the result is invalid after 30 minutes.
II.  Clinical Test Results and Analysis 
This product was verified in the Wuhan Institute of Virology, CAS.
1 Nasal
A total of 246 samples were collected (RT-PCR tested), including 123 COVID-19 patients  (male: 61, female: 62) and 123 healthy people (RT-PCR tested) (male: 62, female: 61).
 
The samples were tested, and the specific test results are analyzed as follows:
Table 2-1 Comparison of kit test results with clinical reference standard results
Nasal
specimen samples		 PCR Test Results Total
Positive Negative
COVID 19 antigen test kit (colloidal gold method) N protein results Positive 118 1 119
Negative 5 122 128
Total 123 123 246
Diagnostic sensitivity:
A/(A+C)×100%= 118/(118+5)×100%=95.94%;
95% CI：
A/(A+C)±1.96×[(A*C)/ (A+C)] 1/2/ (A+C)
=118/(118+5)±1.96×[(118*5)/ (118+5)] 1/2/ (118+5)
= [92.44%，99.42%];
Diagnostic specificity:
D/(B+D)×100%=122/(1+122)×100%=99.19%
95% CI：
D/(B+D)±1.96×[(B*D)/ (B+D)] 1/2/ (B+D)=122/(1+122)±1.96×[(1*122)/ (1+122)] 1/2/ (1+122)= [97.60%，100.77%];
Total coincidence rate:
(A+D)/(A+B+C+D)×100%
=(118+122)/(118+1+5+122)×100%=97.56%;
95% CI：
(A+D)/(A+B+C+D)±1.96×[(A+D)*(A+B+C+D)/(A+B+C+D)] 1/2/ (A+B+C+D)
=(118+122)/(118+1+5+122)±1.96×[(118+122)*(118+1+5+122)/(118+1+5+122)] 1/2/ (118+1+5+122)
= [85.22%，109.90%];
Male confirmed cases: among the 123 people, including 62 healthy people, 59 were tested with positive antigen (+) and 61 healthy people with negative (-). It was consistent with the clinical diagnosis results and the antigen production during disease progression. The positive coincidence rate was 96.72% and the negative coincidence rate was 98.39%. 2 patients had negative antigen test results (-). 1 healthy peoples had positive antigen test results (+).The reason was that the patients were in the early stages of the disease and the virus content in the body is low, which may be lower than the lowest LOD of this product. In very few cases, individual differences lead to false positives.
Female confirmed cases: among the 123 people, including 61 healthy people, 59 were tested with positive antigen (+) and 61 healthy people with negative (-).The positive coincidence rate was 95.16%; and the negative coincidence rate was 100.00%; 3 patients had negative antigen test results (-).The reason was that the patients were in the early stages of the disease and the virus content in the body is low, which may be lower than the lowest LOD of this product.
2 Nasopharyngeal/Oropharyngeal
 A total of 245 samples were collected (RT-PCR tested), including 122 COVID-19 patients  (male: 61, female: 61) and 123 healthy people (RT-PCR tested) (male: 62, female: 61).
The samples were tested, and the specific test results are analyzed as follows:
Table 2-2 Comparison of kit test results with clinical reference standard results
Nasopharyngeal/Oropharyngeal specimen samples PCR Test Results Total
Positive Negative
COVID 19 antigen test kit (colloidal gold method) N protein results Positive 120 1 121
Negative 2 122 124
Total 122 123 245
Diagnostic sensitivity:
A/(A+C)×100%= 120/(120+2)×100%=98.36%;
95% CI：
A/(A+C)±1.96×[(A*C)/ (A+C)] 1/2/ (A+C)
=120/(120+2)±1.96×[(120*2)/ (120+2)] 1/2/ (120+2)
= [96.11%，100.61%];
Diagnostic specificity:
122/(1+122)×100%=122/(1+122)×100%=99.19%
95% CI：
D/(B+D)±1.96×[(B*D)/ (B+D)] 1/2/ (B+D)=122/(1+122)±1.96×[(1*122)/ (1+122)] 1/2/ (1+122)= [97.60%，100.77%];
Total coincidence rate:
(A+D)/(A+B+C+D)×100%
=(120+122)/(120+1+2+122)×100%=98.78%;
95% CI：
(A+D)/(A+B+C+D)±1.96×[(A+D)*(A+B+C+D)/(A+B+C+D)] 1/2/ (A+B+C+D)
=(120+122)/(120+1+2+122)±1.96×[(120+122)*(120+1+2+122)/(120+1+2+122)] 1/2/
(120+1+2+122)= [86.33%，111.22%];
 
Male confirmed cases:among the 123 people, including 62 healthy people, 60 were tested with positive antigen (+) and 61healthy people with negative (-). It was consistent with the clinical diagnosis results and the antigen production during disease progression. The positive coincidence rate was 98.36% and the negative coincidence rate was 98.39%. 1 patient had negative antigen test results (-). 1 healthy peoples had positive antigen test results (+).The reason was that the patients were in the early stages of the disease and the virus content in the body is low, which may be lower than the lowest LOD of this product. In very few cases, individual differences lead to false positives.
Female confirmed cases:among the 122 people, including 61 healthy people, 60 were tested with positive antigen (+) and 61 healthy people with negative (-).The positive coincidence rate was 98.36%;, and the negative coincidence rate was 100.00%; 1 patients had negative antigen test results (-).The reason was that the patients were in the early stages of the disease and the virus content in the body is low, which may be lower than the lowest LOD of this product.
 
3. Conclusion
The above results show that the diagnostic of test results of COVID 19 antigen test kit (colloidal gold method) produced by Neo-nostics (Suzhou) Biological Engineering Co., Ltd. 
Nasal specimen samples:
Sensitivity is 95.94%, the specificity is 99.19%, and the total coincidence rate is 97.56%;
Nasopharyngeal/Oropharyngeal specimen samples:
Sensitivity is 98.36%, the specificity is 99.19%, and the total coincidence rate is 98.78%;
which is consistent with the clinical diagnosis results and has strong clinical application value. See the next page for the table attached. 
 
3.1 Nasal specimen samples  
Serial No. Name Sex Collection time Determination time Result (Neo-nostics) Nasal PCR  Test result Remarks
1 A1 Female 2.1 2.25 + + 　
2 B1 Female 2.9 2.25 + + 　
3 C1 Female 2.18 2.25 - + 　
4 D1 Male 2.16 2.25 + + 　
5 E1 Female 2.16 2.25 + + 　
6 F1 Female 2.15 2.25 + + 　
7 G1 Male 2.22 2.25 + + 　
8 H1 Male 2.15 2.25 - + 　
9 I1 Male 2.22 2.25 + + 　
10 J1 Male 2.25 2.25 + + 　
11 K1 Female 2.1 2.25 + + 　
12 L1 Female 2.19 2.25 + + 　
13 M1 Female 2.17 2.25 + + 　
14 N1 Male 2.25 2.25 + + 　
15 O1 Male 2.25 2.25 + + 　
16 P1 Female 2.23 2.25 + + 　
17 Q1 Female 2.2 2.25 + + 　
18 R1 Male 2.16 2.25 + + 　
19 S1 Male 2.18 2.25 + + 　
20 T1 Female 2.2 2.25 + + 　
21 U1 Female 2.22 2.25 + + 　
22 V1 Male 2.24 2.25 + + 　
23 W1 Female 2.2 2.25 + + 　
24 X1 Female 2.2 2.25 + + 　
25 Y1 Female 2.16 2.25 + + 　
26 Z1 Male 2.18 2.25 + + 　
27 A2 Female 2.23 2.25 + + 　
28 B2 Male 2.24 2.25 + + 　
29 C2 Female 2.17 2.25 + + 　
30 D2 Female 2.17 2.25 + + 　
31 E2 Male 2.22 2.25 + + 　
32 F2 Female 2.17 2.25 - + 　
33 G2 Male 2.23 2.25 + + 　
34 H2 Female 2.17 2.25 + + 　
35 I2 Male 2.20 2.25 + + 　
36 J2 Male 2.23 2.25 + + 　
37 K2 Female 2.17 2.25 + + 　
38 L2 Female 2.17 2.25 + + 　
39 M2 Male 2.19 2.25 + + 　
40 N2 Female 2.19 2.25 + + 　
41 O2 Male 2.25 2.25 + + 　
42 P2 Male 2.21 2.25 + + 　
43 Q2 Female 2.17 2.25 + + 　
44 R2 Male 2.24 2.25 + + 　
45 S2 Male 2.22 2.25 + + 　
46 T2 Female 2.23 2.25 + + 　
47 U2 Female 2.17 2.25 + + 　
48 V2 Female 2.17 2.25 + + 　
49 W2 Male 2.17 2.25 + + 　
50 X2 Male 2.15 2.25 + + 　
51 Y2 Male 2.25 2.25 + + 　
52 Z2 Female 2.20 2.25 + + 　
53 A3 Female 2.17 2.25 + + 　
54 B3 Male 2.17 2.25 + + 　
55 C3 Female 2.17 2.25 + + 　
56 D3 Female 2.16 2.25 + + 　
57 E3 Male 2.23 2.25 + + 　
58 F3 Male 2.17 2.25 + + 　
59 G3 Male 2.17 2.25 + + 　
60 H3 Female 2.15 2.25 + + 　
61 I3 Female 2.15 2.25 + + 　
62 J3 Male 2.21 2.25 + + 　
63 K3 Female 2.17 2.25 + + 　
64 L3 Female 2.17 2.25 + + 　
65 M3 Female 2.17 2.25 + + 　
66 N3 Male 2.15 2.25 + + 　
67 O3 Male 2.17 2.25 + + 　
68 P3 Female 2.18 2.25 + + 　
69 Q3 Male 2.19 2.25 + + 　
70 R3 Male 2.21 2.25 + + 　
71 S3 Female 2.18 2.25 + + 　
72 T3 Female 2.17 2.25 + + 　
73 U3 Male 2.17 2.25 + + 　
74 V3 Female 2.2 2.25 + + 　
75 W3 Female 2.17 2.25 + + 　
76 X3 Female 2.17 2.25 + + 　
77 Y3 Male 2.14 2.25 + + 　
78 Z3 Male 2.15 2.25 + + 　
79 A4 Female 2.17 2.25 + + 　
80 B4 Male 2.18 2.25 + + 　
81 C4 Male 2.16 2.25 + + 　
82 D4 Male 2.18 2.25 + + 　
83 E4 Male 2.19 2.25 + + 　
84 F4 Female 2.20 2.25 + + 　
85 G4 Female 2.20 2.25 + + 　
86 H4 Male 2.22 2.25 + + 　
87 I4 Female 2.17 2.25 + + 　
88 J4 Female 2.13 2.25 + + 　
89 K4 Female 2.16 2.25 + +  
90 L4 Male 2.15 2.25 + + 　
91 M4 Female 2.17 2.25 + + 　
92 N4 Female 2.21 2.25 + + 　
93 O4 Male 2.20 2.25 + + 　
94 P4 Female 2.17 2.25 + + 　
95 Q4 Male 2.17 2.25 + + 　
96 R4 Female 2.17 2.25 + + 　
97 T4 Male 2.21 2.25 + + 　
98 U4 Female 2.17 2.25 + + 　
99 V4 Male 2.17 2.25 + + 　
100 W4 Male 2.24 2.25 + + 　
101 X4 Female 2.17 2.25 - + 　
102 Y4 Male 2.24 2.25 + + 　
103 Z4 Male 2.24 2.25 + + 　
104 A5 Male 2.24 2.25 + + 　
105 B5 Female 2.24 2.25 + + 　
106 C5 Male 2.24 2.25 + + 　
107 D5 Male 2.24 2.25 + + 　
108 E5 Male 2.24 2.25 + + 　
109 F5 Female 2.24 2.25 + + 　
110 G5 Female 2.24 2.25 + + 　
111 H5 Female 2.24 2.25 - + 　
112 I5 Female 2.24 2.25 + + 　
113 J5 Male 2.24 2.25 + + 　
114 K5 Male 2.24 2.25 + + 　
115 L5 Male 2.24 2.25 + + 　
116 M5 Female 2.24 2.25 + + 　
117 N5 Male 2.24 2.25 + + 　
118 O5 Female 2.24 2.25 + + 　
119 P5 Male 2.24 2.25 + + 　
120 Q5 Male 2.24 2.25 + + 　
121 R5 Male 2.24 2.25 + + 　
122 S5 Male 2.24 2.25 + + 　
123 T5 Female 2.21 2.26 + + 　
124 Healthy person A6 Female 2.21 2.26 - - Negative control
125 Healthy person B6 Female 2.21 2.26 - - Negative control
126 Healthy person C6 Female 2.21 2.26 - - Negative control
127 Healthy person D6 Male 2.21 2.26 - - Negative control
128 Healthy person E6 Male 2.21 2.26 - - Negative control
129 Healthy person F6 Male 2.21 2.26 - - Negative control
130 Healthy person G6 Female 2.21 2.26 - - Negative control
131 Healthy person H6 Female 2.21 2.26 - - Negative control
132 Healthy person I6 Female 2.22 2.26 - - Negative control
133 Healthy person J6 Female 2.23 2.26 - - Negative control
134 Healthy person K6 Female 2.23 2.26 - - Negative control
135 Healthy person L6 Male 2.23 2.26 - - Negative control
136 Healthy person M6 Male 2.23 2.26 - - Negative control
137 Healthy person N6 Male 2.23 2.26 - - Negative control
138 Healthy person O6 Female 2.23 2.26 - - Negative control
139 Healthy person P6 Female 2.23 2.26 - - Negative control
140 Healthy person Q6 Male 2.23 2.26 - - Negative control
141 Healthy person R6 Male 2.23 2.26 - - Negative control
142 Healthy person S6 Male 2.23 2.26 - - Negative control
143 Healthy person T6 Female 2.23 2.26 - - Negative control
144 Healthy person U6 Female 2.23 2.26 - - Negative control
145 Healthy person V6 Female 2.23 2.26 - - Negative control
146 Healthy person W6 Female 2.23 2.26 - - Negative control
147 Healthy person X6 Female 2.23 2.26 - - Negative control
148 Healthy person Y6 Male 2.23 2.26 - - Negative control
149 Healthy person Z6 Male 2.24 2.26 - - Negative control
150 Healthy person A7 Male 2.24 2.26 - - Negative control
151 Healthy person B7 Female 2.24 2.26 - - Negative control
152 Healthy person C7 Male 2.24 2.26 - - Negative control
153 Healthy person D7 Male 2.24 2.26 - - Negative control
154 Healthy person E7 Male 2.24 2.26 - - Negative control
155 Healthy person F7 Female 2.24 2.26 - - Negative control
156 Healthy person G7 Female 2.24 2.26 - - Negative control
157 Healthy person H7 Female 2.24 2.26 - - Negative control
158 Healthy person I7 Female 2.24 2.26 - - Negative control
159 Healthy person J7 Male 2.24 2.26 - - Negative control
160 Healthy person K7 Male 2.24 2.26 - - Negative control
161 Healthy person L7 Male 2.24 2.26 - - Negative control
162 Healthy person M7 Female 2.24 2.26 - - Negative control
163 Healthy person N7 Male 2.21 2.26 - - Negative control
164 Healthy person O7 Male 2.21 2.26 - - Negative control
165 Healthy person P7 Female 2.21 2.26 - - Negative control
166 Healthy person Q7 Female 2.21 2.26 - - Negative control
167 Healthy person R7 Female 2.21 2.26 - - Negative control
168 Healthy person S7 Male 2.21 2.26 - - Negative control
169 Healthy person T7 Male 2.21 2.26 - - Negative control
170 Healthy person U7 Male 2.21 2.26 - - Negative control
171 Healthy person V7 Male 2.21 2.26 - - Negative control
172 Healthy person W7 Female 2.21 2.26 - - Negative control
173 Healthy person X7 Female 2.22 2.26 - - Negative control
174 Healthy person Y7 Female 2.22 2.26 - - Negative control
175 Healthy person Z7 Male 2.22 2.26 - - Negative control
176 Healthy person A8 Male 2.22 2.26 - - Negative control
177 Healthy person B8 Male 2.22 2.26 - - Negative control
178 Healthy person C8 Male 2.22 2.26 - - Negative control
179 Healthy person D8 Male 2.22 2.26 - - Negative control
180 Healthy person E8 Male 2.22 2.26 - - Negative control
181 Healthy person F8 Male 2.22 2.26 + - Negative control
182 Healthy person G8 Female 2.22 2.26 - - Negative control
183 Healthy person H8 Female 2.23 2.26 - - Negative control
184 Healthy person I8 Female 2.23 2.26 - - Negative control
185 Healthy person J8 Male 2.23 2.26 - - Negative control
186 Healthy person K8 Female 2.23 2.26 - - Negative control
187 Healthy person L8 Female 2.23 2.26 - - Negative control
188 Healthy person M8 Female 2.23 2.26 - - Negative control
189 Healthy person N8 Male 2.23 2.26 - - Negative control
190 Healthy person O8 Male 2.23 2.26 - - Negative control
191 Healthy person P8 Female 2.23 2.26 - - Negative control
192 Healthy person Q8 Female 2.23 2.26 - - Negative control
193 Healthy person R8 Female 2.23 2.26 - - Negative control
194 Healthy person S8 Male 2.23 2.26 - - Negative control
195 Healthy person T8 Male 2.23 2.26 - - Negative control
196 Healthy person U8 Male 2.23 2.26 - - Negative control
197 Healthy person V8 Male 2.23 2.26 - - Negative control
198 Healthy person W8 Male 2.23 2.26 - - Negative control
199 Healthy person X8 Female 2.23 2.26 - - Negative control
200 Healthy person Y8 Female 2.23 2.26 - - Negative control
201 Healthy person Z8 Female 2.23 2.26 - - Negative control
202 Healthy person A9 Male 2.24 2.26 - - Negative control
203 Healthy person B9 Male 2.24 2.26 - - Negative control
204 Healthy person C9 Male 2.24 2.26 - - Negative control
205 Healthy person D9 Male 2.24 2.26 - - Negative control
206 Healthy person E9 Male 2.24 2.26 - - Negative control
207 Healthy person F9 Female 2.24 2.26 - - Negative control
208 Healthy person G9 Female 2.24 2.26 - - Negative control
209 Healthy person H9 Female 2.24 2.26 - - Negative control
210 Healthy person I9 Male 2.24 2.26 - - Negative control
211 Healthy person J9 Female 2.24 2.26 - - Negative control
212 Healthy person K9 Female 2.24 2.26 - - Negative control
213 Healthy person L9 Female 2.24 2.26 - - Negative control
214 Healthy person M9 Male 2.24 2.26 - - Negative control
215 Healthy person N9 Male 2.24 2.26 - - Negative control
216 Healthy person O9 Male 2.24 2.26 - - Negative control
217 Healthy person P9 Female 2.24 2.26 - - Negative control
218 Healthy person Q9 Female 2.24 2.26 - - Negative control
219 Healthy person R9 Female 2.24 2.26 - - Negative control
220 Healthy person S9 Male 2.24 2.26 - - Negative control
221 Healthy person T9 Female 2.24 2.26 - - Negative control
222 Healthy person U9 Female 2.24 2.26 - - Negative control
223 Healthy person V9 Female 2.24 2.26 - - Negative control
224 Healthy person W9 Male 2.24 2.26 - - Negative control
225 Healthy person X9 Female 2.24 2.26 - - Negative control
226 Healthy person Y9 Female 2.24 2.26 - - Negative control
227 Healthy person Z9 Male 2.24 2.26 - - Negative control
228 Healthy person A10 Male 2.24 2.26 - - Negative control
229 Healthy person B10 Male 2.24 2.26 - - Negative control
230 Healthy person C10 Female 2.24 2.26 - - Negative control
231 Healthy person D10 Female 2.24 2.26 - - Negative control
232 Healthy person E10 Female 2.24 2.26 - - Negative control
233 Healthy person F10 Female 2.24 2.26 - - Negative control
234 Healthy person G10 Male 2.24 2.26 - - Negative control
235 Healthy person H10 Male 2.24 2.26 - - Negative control
236 Healthy person I10 Male 2.24 2.26 - - Negative control
237 Healthy person J10 Female 2.24 2.26 - - Negative control
238 Healthy person K10 Male 2.24 2.26 - - Negative control
239 Healthy person L10 Male 2.24 2.26 - - Negative control
240 Healthy person M10 Male 2.24 2.26 - - Negative control
241 Healthy person N10 Female 2.24 2.26 - - Negative control
242 Healthy person O10 Female 2.24 2.26 - - Negative control
243 Healthy person P10 Female 2.24 2.26 - - Negative control
244 Healthy person Q10 Male 2.24 2.26 - - Negative control
245 Healthy person R10 Male 2.24 2.26 - - Negative control
246 Healthy person S10 Male 2.24 2.26 - - Negative control
 
3.2 Nasopharyngeal/Oropharyngeal specimen samples
Serial No. Name Sex Collection time Determination time Result (Neo-nostics)
Nasopharyngeal / Oropharyngeal		 PCR  Test result Remarks
1 A11 Male 2.1 2.25 + + 　
2 B11 Female 2.9 2.25 + + 　
3 C11 Female 2.18 2.25 + + 　
4 D11 Male 2.16 2.25 + + 　
5 E11 Female 2.16 2.25 + + 　
6 F11 Female 2.15 2.25 + + 　
7 G11 Male 2.22 2.25 + + 　
8 H11 Female 2.15 2.25 + + 　
9 I11 Male 2.22 2.25 + + 　
10 J11 Male 2.25 2.25 + + 　
11 K11 Female 2.1 2.25 + + 　
12 L11 Female 2.19 2.25 + + 　
13 M11 Female 2.17 2.25 + + 　
14 N11 Male 2.25 2.25 + + 　
15 O11 Male 2.25 2.25 + + 　
16 P11 Female 2.23 2.25 + + 　
17 Q11 Female 2.2 2.25 + + 　
18 R11 Male 2.16 2.25 + + 　
19 S11 Male 2.18 2.25 + + 　
20 T11 Female 2.2 2.25 + + 　
21 U11 Female 2.22 2.25 + + 　
22 V11 Male 2.24 2.25 + + 　
23 W11 Female 2.2 2.25 + + 　
24 X11 Female 2.2 2.25 + + 　
25 Y11 Female 2.16 2.25 + + 　
26 Z11 Male 2.18 2.25 + + 　
27 A12 Female 2.23 2.25 + + 　
28 B12 Male 2.24 2.25 + + 　
29 C12 Female 2.17 2.25 - + 　
30 D12 Female 2.17 2.25 + + 　
31 E12 Male 2.22 2.25 + + 　
32 F12 Female 2.17 2.25 + + 　
33 G12 Male 2.23 2.25 + + 　
34 H12 Female 2.17 2.25 + + 　
35 I12 Male 2.20 2.25 + + 　
36 J12 Male 2.23 2.25 + + 　
37 K12 Female 2.17 2.25 + + 　
38 L12 Female 2.17 2.25 + + 　
39 M12 Male 2.19 2.25 + + 　
40 N12 Male 2.19 2.25 + + 　
41 O12 Male 2.25 2.25 + + 　
42 P12 Male 2.21 2.25 + + 　
43 Q12 Female 2.17 2.25 + + 　
44 R12 Male 2.24 2.25 + + 　
45 S12 Male 2.22 2.25 + + 　
46 T12 Female 2.23 2.25 + + 　
47 U12 Female 2.17 2.25 + + 　
48 V12 Female 2.17 2.25 + + 　
49 W12 Female 2.17 2.25 + + 　
50 X12 Male 2.15 2.25 + + 　
51 Y12 Male 2.25 2.25 + + 　
52 Z12 Male 2.20 2.25 + + 　
53 A13 Female 2.17 2.25 + + 　
54 B13 Female 2.17 2.25 + + 　
55 C13 Female 2.17 2.25 + + 　
56 D13 Male 2.16 2.25 + + 　
57 E13 Female 2.23 2.25 + + 　
58 F13 Female 2.17 2.25 + + 　
59 G13 Female 2.17 2.25 + + 　
60 H13 Female 2.15 2.25 + + 　
61 I13 Female 2.15 2.25 + + 　
62 J13 Male 2.21 2.25 + + 　
63 K13 Female 2.17 2.25 + + 　
64 L13 Male 2.17 2.25 + + 　
65 M13 Female 2.17 2.25 + + 　
66 N13 Male 2.15 2.25 + + 　
67 O13 Male 2.17 2.25 + + 　
68 P13 Female 2.18 2.25 + + 　
69 Q13 Male 2.19 2.25 + + 　
70 R13 Male 2.21 2.25 + + 　
71 S13 Female 2.18 2.25 + + 　
72 T13 Female 2.17 2.25 + + 　
73 U13 Male 2.17 2.25 + + 　
74 V13 Female 2.2 2.25 + + 　
75 W13 Female 2.17 2.25 + + 　
76 X13 Female 2.17 2.25 + + 　
77 Y13 Male 2.14 2.25 - + 　
78 Z13 Male 2.15 2.25 + + 　
79 A14 Female 2.17 2.25 + + 　
80 B14 Male 2.18 2.25 + + 　
81 C14 Male 2.16 2.25 + + 　
82 D14 Male 2.18 2.25 + + 　
83 E14 Male 2.19 2.25 + + 　
84 F14 Female 2.20 2.25 + + 　
85 G14 Male 2.20 2.25 + + 　
86 H14 Male 2.22 2.25 + + 　
87 I14 Male 2.17 2.25 + + 　
88 J14 Female 2.13 2.25 + + 　
89 K14 Female 2.16 2.25 + +  
90 L14 Male 2.15 2.25 + + 　
91 M14 Female 2.17 2.25 + + 　
92 N14 Female 2.21 2.25 + + 　
93 O14 Male 2.20 2.25 + + 　
94 P14 Female 2.17 2.25 + + 　
95 Q14 Female 2.17 2.25 + + 　
96 R14 Female 2.17 2.25 + + 　
97 S14 Male 2.21 2.25 + + 　
98 T14 Female 2.17 2.25 + + 　
99 U14 Male 2.17 2.25 + + 　
100 V14 Male 2.24 2.25 + + 　
101 W14 Female 2.17 2.25 + + 　
102 X14 Male 2.24 2.25 + + 　
103 Y14 Female 2.24 2.25 + + 　
104 Z14 Male 2.24 2.25 + + 　
105 A15 Female 2.24 2.25 + + 　
106 B15 Male 2.24 2.25 + + 　
107 C15 Male 2.24 2.25 + + 　
108 D15 Female 2.24 2.25 + + 　
109 E15 Male 2.24 2.25 + + 　
110 F15 Female 2.24 2.25 + + 　
111 G15 Male 2.24 2.25 + + 　
112 H15 Male 2.24 2.25 + + 　
113 I15 Male 2.24 2.25 + + 　
114 J15 Male 2.24 2.25 + + 　
115 K15 Female 2.24 2.25 + + 　
116 L15 Male 2.24 2.25 + + 　
117 M15 Male 2.24 2.25 + + 　
118 N15 Female 2.24 2.25 + + 　
119 O15 Male 2.24 2.25 + + 　
120 P15 Male 2.24 2.25 + + 　
121 Q15 Female 2.24 2.25 + + 　
122 R15 Male 2.24 2.25 + + 　
123 Healthy person A16 Male 2.21 2.26 - - Negative control
124 Healthy person B16 Female 2.21 2.26 - - Negative control
125 Healthy person C16 Male 2.21 2.26 - - Negative control
126 Healthy person D16 Female 2.21 2.26 - - Negative control
127 Healthy person E16 Female 2.21 2.26 - - Negative control
128 Healthy person F16 Male 2.21 2.26 - - Negative control
129 Healthy person G16 Female 2.21 2.26 - - Negative control
130 Healthy person H16 Female 2.21 2.26 - - Negative control
131 Healthy person I16 Male 2.21 2.26 - - Negative control
132 Healthy person J16 Female 2.22 2.26 - - Negative control
133 Healthy person K16 Male 2.23 2.26 - - Negative control
134 Healthy person L16 Female 2.23 2.26 - - Negative control
135 Healthy person M16 Male 2.23 2.26 - - Negative control
136 Healthy person N16 Male 2.23 2.26 - - Negative control
137 Healthy person O16 Male 2.23 2.26 - - Negative control
138 Healthy person P16 Female 2.23 2.26 - - Negative control
139 Healthy person Q16 Female 2.23 2.26 - - Negative control
140 Healthy person R16 Female 2.23 2.26 - - Negative control
141 Healthy person S16 Male 2.23 2.26 - - Negative control
142 Healthy person T16 Female 2.23 2.26 - - Negative control
143 Healthy person U16 Male 2.23 2.26 - - Negative control
144 Healthy person V16 Male 2.23 2.26 - - Negative control
145 Healthy person W16 Female 2.23 2.26 - - Negative control
146 Healthy person X16 Female 2.23 2.26 - - Negative control
147 Healthy person Y16 Male 2.23 2.26 - - Negative control
148 Healthy person Z16 Female 2.23 2.26 - - Negative control
149 Healthy person A17 Male 2.24 2.26 - - Negative control
150 Healthy person B17 Female 2.24 2.26 - - Negative control
151 Healthy person C17 Male 2.24 2.26 - - Negative control
152 Healthy person D17 Female 2.24 2.26 - - Negative control
153 Healthy person E17 Female 2.24 2.26 - - Negative control
154 Healthy person F17 Female 2.24 2.26 - - Negative control
155 Healthy person G17 Male 2.24 2.26 - - Negative control
156 Healthy person H17 Female 2.24 2.26 - - Negative control
157 Healthy person I17 Female 2.24 2.26 - - Negative control
158 Healthy person J17 Female 2.24 2.26 - - Negative control
159 Healthy person K17 Male 2.24 2.26 - - Negative control
160 Healthy person L17 Female 2.24 2.26 - - Negative control
161 Healthy person M17 Female 2.24 2.26 - - Negative control
162 Healthy person N17 Male 2.24 2.26 - - Negative control
163 Healthy person O17 Male 2.21 2.26 - - Negative control
164 Healthy person P17 Male 2.21 2.26 - - Negative control
165 Healthy person Q17 Female 2.21 2.26 - - Negative control
166 Healthy person R17 Male 2.21 2.26 + - Negative control
167 Healthy person S17 Female 2.21 2.26 - - Negative control
168 Healthy person T17 Male 2.21 2.26 - - Negative control
169 Healthy person U17 Female 2.21 2.26 - - Negative control
170 Healthy person V17 Male 2.21 2.26 - - Negative control
171 Healthy person W17 Male 2.21 2.26 - - Negative control
172 Healthy person X17 Female 2.21 2.26 - - Negative control
173 Healthy person Y17 Male 2.22 2.26 - - Negative control
174 Healthy person Z17 Male 2.22 2.26 - - Negative control
175 Healthy person A18 Male 2.22 2.26 - - Negative control
176 Healthy person B18 Female 2.22 2.26 - - Negative control
177 Healthy person C18 Male 2.22 2.26 - - Negative control
178 Healthy person D18 Female 2.22 2.26 - - Negative control
179 Healthy person E18 Female 2.22 2.26 - - Negative control
180 Healthy person F18 Male 2.22 2.26 - - Negative control
181 Healthy person G18 Male 2.22 2.26 - - Negative control
182 Healthy person H18 Male 2.22 2.26 - - Negative control
183 Healthy person I18 Female 2.23 2.26 - - Negative control
184 Healthy person J18 Female 2.23 2.26 - - Negative control
185 Healthy person K18 Female 2.23 2.26 - - Negative control
186 Healthy person L18 Male 2.23 2.26 - - Negative control
187 Healthy person M18 Male 2.23 2.26 - - Negative control
188 Healthy person N18 Male 2.23 2.26 - - Negative control
189 Healthy person O18 Female 2.23 2.26 - - Negative control
190 Healthy person P18 Female 2.23 2.26 - - Negative control
191 Healthy person Q18 Female 2.23 2.26 - - Negative control
192 Healthy person R18 Male 2.23 2.26 - - Negative control
193 Healthy person S18 Female 2.23 2.26 - - Negative control
194 Healthy person T18 Female 2.23 2.26 - - Negative control
195 Healthy person U18 Female 2.23 2.26 - - Negative control
196 Healthy person V18 Male 2.23 2.26 - - Negative control
197 Healthy person W18 Male 2.23 2.26 - - Negative control
198 Healthy person X18 Male 2.23 2.26 - - Negative control
199 Healthy person Y18 Female 2.23 2.26 - - Negative control
200 Healthy person Z18 Male 2.23 2.26 - - Negative control
201 Healthy person A19 Male 2.23 2.26 - - Negative control
202 Healthy person B19 Female 2.24 2.26 - - Negative control
203 Healthy person C19 Male 2.24 2.26 - - Negative control
204 Healthy person D19 Female 2.24 2.26 - - Negative control
205 Healthy person E19 Male 2.24 2.26 - - Negative control
206 Healthy person F19 Male 2.24 2.26 - - Negative control
207 Healthy person G19 Male 2.24 2.26 - - Negative control
208 Healthy person H19 Female 2.24 2.26 - - Negative control
209 Healthy person I19 Male 2.24 2.26 - - Negative control
210 Healthy person J19 Male 2.24 2.26 - - Negative control
211 Healthy person K19 Male 2.24 2.26 - - Negative control
212 Healthy person L19 Female 2.24 2.26 - - Negative control
213 Healthy person M19 MaleFe 2.24 2.26 - - Negative control
214 Healthy person N19 Female 2.24 2.26 - - Negative control
215 Healthy person O19 Male 2.24 2.26 - - Negative control
216 Healthy person P19 male 2.24 2.26 - - Negative control
217 Healthy person Q19 Male 2.24 2.26 - - Negative control
218 Healthy person R19 Male 2.24 2.26 - - Negative control
219 Healthy person S19 Female 2.24 2.26 - - Negative control
220 Healthy person T19 MaleFe 2.24 2.26 - - Negative control
221 Healthy person U19 Female 2.24 2.26 - - Negative control
222 Healthy person V19 Male 2.24 2.26 - - Negative control
223 Healthy person W19 Male 2.24 2.26 - - Negative control
224 Healthy person X19 Male 2.24 2.26 - - Negative control
225 Healthy person Y19 Female 2.24 2.26 - - Negative control
226 Healthy person Z19 Male 2.24 2.26 - - Negative control
227 Healthy person A20 Male 2.24 2.26 - - Negative control
228 Healthy person B20 Female 2.24 2.26 - - Negative control
229 Healthy person C20 Female 2.24 2.26 - - Negative control
230 Healthy person D20 Male 2.24 2.26 - - Negative control
231 Healthy person E20 Female 2.24 2.26 - - Negative control
232 Healthy person F20 Female 2.24 2.26 - - Negative control
233 Healthy person G20 Male 2.24 2.26 - - Negative control
234 Healthy person H20 Female 2.24 2.26 - - Negative control
235 Healthy person I20 Male 2.24 2.26 - - Negative control
236 Healthy person J20 Female 2.24 2.26 - - Negative control
237 Healthy person K20 Male 2.24 2.26 - - Negative control
238 Healthy person L20 Female 2.24 2.26 - - Negative control
239 Healthy person M20 Female 2.24 2.26 - - Negative control
240 Healthy person N20 Male 2.24 2.26 - - Negative control
241 Healthy person O20 Female 2.24 2.26 - - Negative control
242 Healthy person P20 Male 2.24 2.26 - - Negative control
243 Healthy person Q20 Male 2.24 2.26 - - Negative control
244 Healthy person R20 Female 2.24 2.26 - - Negative control
245 Healthy person R21 Female 2.24 2.26 - - Negative control
 
Ⅲ. Cross Reaction and Interference
cross reaction and interference with the potential cross reacting microorganisms listed below.
Substance Strain Concentration Result (Neo-nostics)
Human coronavirus MERS 5ug/ml -
OC43 1:20 -
229E 1:20 -
HKU1 1:20 -
Influenza B virus
 		 Yamagata 1:20 -
victoria 1:20 -
Influenza A virus H5N1 1:40 -
H7N9 1:40 -
H3N2 1:40 -
HIN1  5ug/ml -
B-V 5ug/ml /  5ug/ml -
Measles / 1:40 -
Rotavirus / 1:40 -
CMV / 1:40 -
Chlamydia TWAR strain
TW-183		 1:40 -
RSV / 50ug/ml -
Mumps virus / 50ug/ml -
Adeno-virus Type 1 10ug/ml -
Type 2 10ug/ml -
Type 3 10ug/ml -
Type 4 10ug/ml -
Type 5 10ug/ml -
Type 7 10ug/ml -
Type 55 10ug/ml -
Parainfluenza Type 1 5ug/ml -
Type 2 5ug/ml -
Type 3 5ug/ml -
Type 4A 5ug/ml -
VZ / 30ug/ml -
 
Conclusion: There was no cross reaction and interference with the potential cross reacting microorganisms listed.
 

 Return list