COVID 19 Antigen Test Kit (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.