ARISTA COVID-19 Antigen Rapid Test_Clinical Study_Venezuela 11/27/2021 18:42:28

Nr. Topic Details Expectation Time Frame

Stage 1: 304 positive patients samples (symptomatic &

asymptomatic) - for self-use Immediate
Target 25
For assays intended to be used in asymptomatic population, subjects every kick off
at least 50% of the positive subjects should include samples started on
week
from asymptomatic individuals with at least 50% of them 1st July 2021
1 Target subjects having CT>30

Stage 2: 1,000 negative patients samples (symptomatic &

asymptomatic) - for self use To be advised To be
A proportion (let's say 10%) of symptomatic PCR negative advised
patients with no exposure of SARS-Cov-2

ARISTATM COVID-19 Test on Anterior Nares (AN), saliva and sputum (3 sample
2
Antigen Rapid Testing types)

3 RT-PCR testing Nasopharyngeal (NP)

Sampling handling For self-use: Subjects need to perform sampling by

themselves for Anterior Nares, Saliva and Sputum

Who do the sampling The subjects do Anterior Nares, Saliva and Sputum
sampling themselves (Self-collected) for antigen test
Suject population
4 (Subjects age group Subject population
requirement)
5 Study Reference Clinical Study 300 (AAGCS09)
Subject data input
6 form VE_subjects-data-304 positives. Fill in the results of the subjects

Inclusion & exclusion

7 criteria Inclusion_Exclusion_criteria

Send the picture

8 Subject Records (1) Take picture of each ARISTA TM antigen test of antigen test to
Yolly every Friday

9 Device Accountability (1) Please fill the details of device accountability log
Log

1 / 87
 Test Specimen Types
Nr Study Ref Recruitment Country No. of No. of No. of RT-PCR Time Frame Remark
Centre Participants Positives Negatives (NP) NP AN SP SA
1 AAGCS08 IVSS Venezuela 12 12 0 ● ● ● ● Jun-21
2 AAGCS09 IVSS Venezuela 304 Recruiting ● ● ● ●

IVSS: IVSS Centro Hospital Cardón – Servicio de Diagnóstico Preco Covid-19 Dr Juvenal Bracho, June 2021
 Positive specimens Negative specimens
Age group of Nr. of Nr. of
randomized % of Nr. of Nr. of
subjects symptomatic asymptomatic symptomatic asymptomatic
recruited subjects positive positive negative subject negative subject
specimens specimens

●<14 (~20%) 20% 30 30 20 180

●14-24 (~10-15%) 10% 15 15 10 90
●24-64 (~30-35%) 35% 54 54 35 315
●≥65 (~35%) 35% 53 53 35 315
Total 100% 152 152 100 900

304 1000
Inclusion Criteria
A. Positive cases_Symptomatic and asymptomatic
• The subjects will be screened, consented, blindly and sequentially
enrolled to secure at least up to a total of 304 subjects with positive
result according to the percentage range of the requested age
breakdown group. At least 50% (152 subjects) of the positive samples
from asymptomatic individuals in which 50% (76 subjects) with CT
value greater than 30.
1
Provision of verbal informed consent form or signed written
Informed Consent.
2 Subject is suspected case of COVID-19 by clinical criteria:
(a) . a person with clear respiratory tract infection symptoms:
acute onset of fever AND cough within the last 7 days.
(b) Acute onset of ANY THREE OR MORE of the following signs or
symptoms: Fever, cough, general weakness/fatigue 1, headache,
myalgia, sore throat, coryza, dyspnoea,
anorexia/nausea/vomiting1, diarrhoea, altered mental status
within the last 7 days. (1 Signs separated with slash (/) are to be
counted as one sign.)
(c) A person with recent onset of anosmia (loss of smell) or
ageusia (loss of taste) in the absence of any other identified
cause.
(d) With no other aetiology that fully explains the clinical
presentation, with or without a history of close contact with a
confirmed or probable COVID-19 case in the last 14 days prior to
onset of symptoms.
3 Ability to read and understand English
3
Subject is an appropriate candidate for anterior nares,
nasopharyngeal, saliva and sputum collection.
4
Subject is willing to provide anterior nares, nasopharyngeal,
saliva and sputum swab.
B. Negative cases_Symptomatic and asymptomatic
·The subjects will be screened, consented, blindly and
sequentially enrolled to secure at least up to 1,000 subjects with
negative results including a proportion of symptomatic PCR
negative subjects with no exposure to SAR-CoV-2 according to the
percentage range of the requested age breakdown group:
1 Provision of verbal informed consent form.
2 Subject is suspected case of COVID-19 by clinical criteria:
(a) A person with clear respiratory tract infection symptoms:
acute onset of fever AND cough within the last 7 days.
(b) Acute onset of ANY THREE OR MORE of the following signs or
symptoms: Fever, cough, general weakness/fatigue1, headache,
myalgia, sore throat, coryza, dyspnoea,
anorexia/nausea/vomiting1, diarrhoea, altered mental status
within the last 7 days. (1 Signs separated with slash (/) are to be
counted as one sign.)
(c ) A person with recent onset of anosmia (loss of smell) or
ageusia (loss of taste) in the absence of any other identified
cause.
(d) With no other aetiology that fully explains the clinical
presentation, with or without a history of close contact with a
confirmed or probable COVID-19 case in the last 14 days prior to
onset of symptoms.
3 Ability to read and understand English
3
Subject is an appropriate candidate for anterior nares,
nasopharyngeal, saliva and sputum sample.
4
Subject is willing to provide anterior nares, nasopharyngeal, saliva
and sputum sample.
 5
Subject is an asymptomatic individual not meeting epidemiologic 5
Subject is an asymptomatic individual not meeting epidemiologic
criteria. criteria.

Exclusion Criteria
(A) Positive and Negative__Symptomatic and asymptomatic

First onset of Covid-19-like symptoms occurring more than 7

days from study visit. COVID-19 related symptoms (Fever,
1 Cough, Fatigue, Anosmia, Decreased Appetite, Shortness of
Breath, Myalgia) or post-defervescence and/or convalescence,
will be excluded from participation in this study.

2 Unable or unwilling to provide signed Informed Consent.

3 Less than 2 years old.
4
Subjects who have received any dose of the SARS-CoV-2 vaccine
or participation in a COVID-19 vaccine study.
5 Invalid or missing PCR test results.

6
Unable to demonstrate understanding of study and instructions
in English.

7
Experienced severe adverse reactions on prior nose and/or
throat swabs.

Use of a non-high-sensitive SARS-CoV-2 test as the qualifying

SARS-CoV-2 RT-PCR test (e.g., RT-PCR tests that do not approved
8
by one of the following countries or areas: United States, Japan,
Canada, United Kingdom, Belgium, Germany, Switzerland,
France, Australia, or Sweden. Or, the tests do not approve by
Sponsor for use in the study).
 Comparator RT-PCR Nasopharyngeal (NP)
PCR NP sample
Nr. Sample* ID sample PCR Tested RT-PCR Source of received & NP_Antigen NP_Antigen
received date (DD- CT value results sample antigen test Test result Test result
date MM-YY) date (+ve/-ve)
(DD-MM-YY) (DD-MM-YY)

1 5176450 10-Jun-21 16-Jun-21 29.9 +ve NP

2 3527021 10-Jun-21 16-Jun-21 32 +ve NP
3 10404115 10-Jun-21 16-Jun-21 34.31 +ve NP
4 11451211 10-Jun-21 16-Jun-21 28.22 +ve NP
5 10088697 10-Jun-21 16-Jun-21 34.44 +ve NP
6 9585377 10-Jun-21 10-Jun-21 34.67 +ve NP
7 31037269 16-Jun-21 19-Jun-21 34.9 +ve NP
8 11802070 16-Jun-21 19-Jun-21 25 +ve NP
9 10966112 16-Jun-21 19-Jun-21 32.21 +ve NP
10 26496391 16-Jun-21 19-Jun-21 27.57 +ve NP
11 28731142 16-Jun-21 19-Jun-21 33.02 +ve NP
12 13516571 16-Jun-21 19-Jun-21 29.81 +ve NP
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
 Anterior Nares (AN) Saliva Sputum
AN sample
Saliva sample Sputum Sample
received & AN_
AN_Antige received & Saliva_Anti received & Sputum_Anti Age Gender
antigen test Antigen Test n Test
gen Test
result** antigen test date gen Test antigen test Date result
date (DD-MM-YY) result (DD-MM-YY)
(DD-MM-YY)

16-Jun-21 +ve 16-Jun-21 +ve 16-Jun-21 +ve 64 M

16-Jun-21 +ve 16-Jun-21 +ve 16-Jun-21 +ve 74 M
16-Jun-21 +ve 16-Jun-21 +ve 16-Jun-21 +ve 50 F
16-Jun-21 +ve 16-Jun-21 +ve 16-Jun-21 +ve 50 M
17-Jun-21 +ve 17-Jun-21 +ve 17-Jun-21 +ve 52 F
17-Jun-21 +ve 17-Jun-21 -ve 17-Jun-21 +ve 56 F
21-Jun-21 -ve 21-Jun-21 +ve 21-Jun-21 -ve 18 M
21-Jun-21 +ve 21-Jun-21 +ve 21-Jun-21 +ve 47 F
21-Jun-21 +ve 21-Jun-21 +ve 21-Jun-21 +ve 49 M
21-Jun-21 +ve 21-Jun-21 +ve 21-Jun-21 +ve 23 M
25-Jun-21 +ve 25-Jun-21 +ve 25-Jun-21 +ve 18 M
25-Jun-21 +ve 25-Jun-21 +ve 25-Jun-21 +ve 44 F
 Symptoms / Symptom Days after Storage
Symptoms 1 Symptoms 2 Symptoms 3 Start Date symptom temperature Clinical Study
Asymptomatic (DD-MM-YY) onset before testing

Asymptomatic June 2021 Vene

Asymptomatic June 2021 Vene
Asymptomatic June 2021 Vene
Asymptomatic June 2021 Vene
Asymptomatic June 2021 Vene
Asymptomatic June 2021 Vene
Asymptomatic June 2021 Vene
Asymptomatic June 2021 Vene
Asymptomatic June 2021 Vene
Asymptomatic June 2021 Vene
Asymptomatic June 2021 Vene
Asymptomatic June 2021 Vene
Study Ref.

AAGCS08
AAGCS08
AAGCS08
AAGCS08
AAGCS08
AAGCS08
AAGCS08
AAGCS08
AAGCS08
AAGCS08
AAGCS08
AAGCS08
AAGCS09
 Comparator RT-PCR Nasopharyngeal (NP) Anterior Nares (AN)

NP sample AN sample
Nr. Sample ID PCR sample PCR Tested CT RT-PCR Source of received & NP_Antigen received &
received date date (DD- value results sample antigen test Test result antigen test
(DD-MM-YY) MM-YY) date (+ve/-ve) date
(DD-MM-YY) (DD-MM-YY)

1 19648616 22-Jul-21 26-Jul-21 40.38 -ve NP 26-Jul-21

2 10614526 22-Jul-21 26-Jul-21 44.45 -ve NP 26-Jul-21
3 910508 22-Jul-21 26-Jul-21 19.91 +ve NP 26-Jul-21
4 3679288 22-Jul-21 26-Jul-21 20.11 +ve NP 26-Jul-21
5 3393343 22-Jul-21 26-Jul-21 24.12 +ve NP 26-Jul-21
6 10378831 22-Jul-21 26-Jul-21 34.85 +ve NP 26-Jul-21
7 4178651 22-Jul-21 26-Jul-21 36.0 -ve NP 26-Jul-21
8 5294685 22-Jul-21 26-Jul-21 34.05 +ve NP 26-Jul-21
9 4788399 22-Jul-21 26-Jul-21 18.75 +ve NP 26-Jul-21
10 1421842 22-Jul-21 26-Jul-21 48.88 -ve NP 26-Jul-21
11 7567244 22-Jul-21 26-Jul-21 30.44 +ve NP 29-Jul-21
12 23673977 22-Jul-21 26-Jul-21 33.95 +ve NP 29-Jul-21
13 7568900 22-Jul-21 26-Jul-21 50.02 -ve NP 29-Jul-21
14 28695521 22-Jul-21 26-Jul-21 49.25 -ve NP 29-Jul-21
15 11477885 22-Jul-21 26-Jul-21 49.11 -ve NP 29-Jul-21
16 1412085 22-Jul-21 26-Jul-21 48.75 -ve NP 29-Jul-21
17 19441451 05-Aug-21 24-Aug-21 13.12 +ve NP 05-Aug-21
18 16197511 05-Aug-21 24-Aug-21 28.9 +ve NP 05-Aug-21
19 17665089 05-Aug-21 24-Aug-21 31.22 +ve NP 05-Aug-21
20 25402155 05-Aug-21 24-Aug-21 52.88 -ve NP 05-Aug-21
21 3682472 5-Sep-21 9-Sep-21 30.04 +ve NP 9-Sep-21 +ve 9-Sep-21
22 18057756 5-Sep-21 9-Sep-21 11.13 +ve NP 9-Sep-21 +ve 9-Sep-21
23 11766524 5-Sep-21 9-Sep-21 10 +ve NP 9-Sep-21 +ve 9-Sep-21
24 2757618 5-Sep-21 9-Sep-21 34.45 +ve NP 9-Sep-21 -ve 9-Sep-21
25 31582669 5-Sep-21 9-Sep-21 15.31 +ve NP 9-Sep-21 +ve 9-Sep-21
26 24389686 5-Sep-21 9-Sep-21 23.33 +ve NP 9-Sep-21 +ve 9-Sep-21
27 11764560 5-Sep-21 9-Sep-21 29.84 +ve NP 10-Sep-21 +ve 10-Sep-21
28 9810957 5-Sep-21 9-Sep-21 30.4 -ve NP 10-Sep-21 -ve 10-Sep-21
29 18769507 5-Sep-21 9-Sep-21 29.71 +ve NP 10-Sep-21 +ve 10-Sep-21
30 7567717 5-Sep-21 9-Sep-21 27.8 +ve NP 10-Sep-21 +ve 10-Sep-21
31 27590618 5-Sep-21 9-Sep-21 24.4 +ve NP 10-Sep-21 +ve 10-Sep-21
32 28369385 5-Sep-21 9-Sep-21 19.88 +ve NP 11-Sep-21 +ve 11-Sep-21
33 9808871 5-Sep-21 9-Sep-21 17.65 +ve NP 11-Sep-21 +ve 11-Sep-21
34 9589747 5-Sep-21 9-Sep-21 54 -ve NP 11-Sep-21 -ve 11-Sep-21
35 10413891 5-Sep-21 9-Sep-21 36.77 -ve NP 11-Sep-21 -ve 11-Sep-21
36 2860007 5-Sep-21 9-Sep-21 49 -ve NP 11-Sep-21 -ve 11-Sep-21
37 4151718 5-Sep-21 9-Sep-21 60.17 -ve NP 11-Sep-21 -ve 11-Sep-21
38 12446490 9-Sep-21 13-Sep-21 12.09 +ve NP 14-Sep-21 +ve 14-Sep-21
39 1406707 9-Sep-21 13-Sep-21 49.21 -ve NP 14-Sep-21 -ve 14-Sep-21
40 15385502 9-Sep-21 13-Sep-21 10.2 +ve NP 14-Sep-21 +ve 14-Sep-21
41 25986273 19-Sep-21 25-Sep-21 30.32 +ve NP 19-Sep-21 +ve 19-Sep-21
42 18689632 19-Sep-21 25-Sep-21 9.84 +ve NP 19-Sep-21 +ve 19-Sep-21
43 20171050 19-Sep-21 25-Sep-21 29.85 +ve NP 19-Sep-21 +ve 19-Sep-21
44 22606509 19-Sep-21 23-Sep-21 23.43 +ve NP 23-Sep-21 +ve 23-Sep-21
45 3680747 19-Sep-21 23-Sep-21 28.15 +ve NP 23-Sep-21 +ve 23-Sep-21
46 5318386 19-Sep-21 23-Sep-21 33.4 +ve NP 23-Sep-21 +ve 23-Sep-21
47 13106590 19-Sep-21 24-Sep-21 26.41 +ve NP 24-Sep-21 +ve 24-Sep-21
48 14478972 19-Sep-21 23-Sep-21 22.8 +ve NP 23-Sep-21 +ve 23-Sep-21
49 23675311 19-Sep-21 24-Sep-21 13.49 +ve NP 24-Sep-21 +ve 24-Sep-21
50 24325587 20-Sep-21 24-Sep-21 24.44 +ve NP 24-Sep-21 +ve 24-Sep-21
51 24351240 20-Sep-21 24-Sep-21 37.01 -ve NP 24-Sep-21 +ve 24-Sep-21
52 21447915 20-Sep-21 25-Sep-21 12 +ve NP 25-Sep-21 +ve 25-Sep-21
53 19899725 20-Sep-21 25-Sep-21 32.19 +ve NP 25-Sep-21 +ve 25-Sep-21
54 15385502 20-Sep-21 25-Sep-21 80.09 -ve NP 25-Sep-21 -ve 25-Sep-21
55 3678286 20-Sep-21 24-Sep-21 34.28 +ve NP 24-Sep-21 -ve 24-Sep-21
56 7571373 20-Sep-21 24-Sep-21 45.44 -ve NP 24-Sep-21 -ve 24-Sep-21
57 7527619 20-Sep-21 24-Sep-21 10.49 +ve NP 24-Sep-21 +ve 24-Sep-21
58 4180283 20-Sep-21 25-Sep-21 9.48 +ve NP 25-Sep-21 +ve 25-Sep-21
59 6659146 20-Sep-21 25-Sep-21 27.23 +ve NP 25-Sep-21 +ve 25-Sep-21
60 8599649 20-Sep-21 25-Sep-21 31 +ve NP 25-Sep-21 +ve 25-Sep-21
61 10967513 20-Sep-21 25-Sep-21 19.32 +ve NP 25-Sep-21 +ve 25-Sep-21
62 5752502 27-Sep-21 1-Oct-21 31.09 +ve NP 1-Oct-21 +ve 1-Oct-21
63 7561870 27-Sep-21 1-Oct-21 32.03 +ve NP 1-Oct-21 +ve 1-Oct-21
64 9501630 27-Sep-21 1-Oct-21 29.99 +ve NP 1-Oct-21 +ve 1-Oct-21
65 9586915 27-Sep-21 1-Oct-21 31.45 +ve NP 1-Oct-21 +ve 1-Oct-21
66 12802367 27-Sep-21 2-Oct-21 19.77 +ve NP 2-Oct-21 +ve 2-Oct-21
67 17842290 27-Sep-21 2-Oct-21 31.22 +ve NP 2-Oct-21 +ve 2-Oct-21
68 19945256 27-Sep-21 2-Oct-21 19.8 +ve NP 2-Oct-21 +ve 2-Oct-21
69 20550540 28-Sep-21 3-Oct-21 34.23 +ve NP 3-Oct-21 +ve 3-Oct-21
70 20552325 28-Sep-21 3-Oct-21 33.33 +ve NP 3-Oct-21 +ve 3-Oct-21
71 28363015 28-Sep-21 3-Oct-21 31.14 +ve NP 3-Oct-21 +ve 3-Oct-21
72 4208447 28-Sep-21 3-Oct-21 9.02 +ve NP 3-Oct-21 +ve 3-Oct-21
73 14022130 28-Sep-21 3-Oct-21 84.02 -ve NP 3-Oct-21 -ve 3-Oct-21
74 12205491 28-Sep-21 3-Oct-21 34.05 +ve NP 3-Oct-21 -ve 3-Oct-21
75 2858354 2-Oct-21 6-Oct-21 30 +ve NP 6-Oct-21 +ve 6-Oct-21
76 10970137 2-Oct-21 6-Oct-21 31.25 +ve NP 6-Oct-21 +ve 6-Oct-21
77 9550139 2-Oct-21 6-Oct-21 33.33 +ve NP 6-Oct-21 +ve 6-Oct-21
78 27140972 2-Oct-21 6-Oct-21 34.09 +ve NP 6-Oct-21 +ve 6-Oct-21
79 28723148 2-Oct-21 6-Oct-21 29.9 +ve NP 6-Oct-21 +ve 6-Oct-21
80 15981075 3-Oct-21 7-Oct-21 30.44 +ve NP 7-Oct-21 +ve 7-Oct-21
81 2834161 3-Oct-21 7-Oct-21 25.43 +ve NP 7-Oct-21 +ve 7-Oct-21
82 17135625 3-Oct-21 7-Oct-21 32.22 +ve NP 7-Oct-21 +ve 7-Oct-21
83 9954885 3-Oct-21 8-Oct-21 30.02 +ve NP 8-Oct-21 +ve 8-Oct-21
84 28026130 3-Oct-21 8-Oct-21 30.09 +ve NP 8-Oct-21 +ve 8-Oct-21
85 26656185 3-Oct-21 8-Oct-21 31.05 +ve NP 8-Oct-21 +ve 8-Oct-21
86 4179700 3-Oct-21 8-Oct-21 32.08 +ve NP 8-Oct-21 +ve 8-Oct-21
87 17499282 9-Oct-21 12-Oct-21 33.19 +ve NP 12-Oct-21 +ve 12-Oct-21
88 20795163 9-Oct-21 12-Oct-21 29.95 +ve NP 12-Oct-21 +ve 12-Oct-21
89 4790463 9-Oct-21 12-Oct-21 12.47 +ve NP 12-Oct-21 +ve 12-Oct-21
90 15016154 9-Oct-21 13-Oct-21 13.68 +ve NP 13-Oct-21 +ve 13-Oct-21
91 3702033 10-Oct-21 14-Oct-21 32.89 +ve NP 14-Oct-21 +ve 14-Oct-21
92 32854929 10-Oct-21 14-Oct-21 34.76 +ve NP 14-Oct-21 +ve 14-Oct-21
93 10611868 10-Oct-21 14-Oct-21 34.09 +ve NP 14-Oct-21 +ve 14-Oct-21
94 24305396 10-Oct-21 14-Oct-21 33.96 +ve NP 14-Oct-21 +ve 14-Oct-21
95 10970507 10-Oct-21 14-Oct-21 31.14 +ve NP 14-Oct-21 +ve 14-Oct-21
96 7196518 10-Oct-21 14-Oct-21 32.23 +ve NP 14-Oct-21 +ve 14-Oct-21
97 17518703 13-Oct-21 17-Oct-21 34.49 +ve NP 17-Oct-21 +ve 17-Oct-21
98 14654586 13-Oct-21 17-Oct-21 29.9 +ve NP 17-Oct-21 +ve 17-Oct-21
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
Anterior Nares (AN) Saliva (SA) Sputum (SP)

Saliva_Anti Sputum Sample Sputum_Anti

AN_Antigen Saliva sample Symptoms /
received & gen Test received & gen Test Age Gender Asymptomatic
Test
result result
(+ve/-ve) antigen test date antigen test Date
(+ve/-ve)
(DD-MM-YY) (+ve/-ve) (DD-MM-YY)

-ve 26-Jul-21 -ve 26-Jul-21 -ve 35 F Asymptomatic

-ve 26-Jul-21 -ve 26-Jul-21 -ve 51 F Asymptomatic
+ve 26-Jul-21 +ve 26-Jul-21 +ve 87 M Symptomatic
+ve 26-Jul-21 +ve 26-Jul-21 +ve 75 F Symptomatic
+ve 26-Jul-21 +ve 26-Jul-21 +ve 71 M Symptomatic
+ve 26-Jul-21 -ve 26-Jul-21 -ve 50 F Symptomatic
-ve 26-Jul-21 -ve 26-Jul-21 -ve 68 F Symptomatic
+ve 26-Jul-21 -ve 26-Jul-21 +ve 61 F Symptomatic
+ve 26-Jul-21 +ve 26-Jul-21 +ve 65 M Symptomatic
-ve 26-Jul-21 -ve 26-Jul-21 -ve 85 F Asymptomatic
+ve 29-Jul-21 +ve 29-Jul-21 +ve 59 F Symptomatic
+ve 29-Jul-21 +ve 29-Jul-21 -ve 28 M Symptomatic
-ve 29-Jul-21 -ve 29-Jul-21 -ve 56 F Asymptomatic
-ve 29-Jul-21 -ve 29-Jul-21 -ve 18 M Asymptomatic
-ve 29-Jul-21 -ve 29-Jul-21 -ve 48 M Asymptomatic
-ve 29-Jul-21 -ve 29-Jul-21 -ve 92 F Asymptomatic
+ve 5-Aug-21 +ve 5-Aug-21 +ve 31 M Asymptomatic
+ve 5-Aug-21 +ve 5-Aug-21 +ve 37 F Asymptomatic
+ve 5-Aug-21 +ve 5-Aug-21 +ve 35 F Asymptomatic
-ve 5-Aug-21 -ve 5-Aug-21 -ve 25 F Asymptomatic
-ve 9-Sep-21 +ve 9-Sep-21 +ve 66 F Asymptomatic
+ve 9-Sep-21 +ve 9-Sep-21 +ve 35 M Asymptomatic
+ve 9-Sep-21 +ve 9-Sep-21 +ve 47 F Symptomatic
-ve 9-Sep-21 -ve 9-Sep-21 -ve 71 F Asymptomatic
+ve 9-Sep-21 +ve 9-Sep-21 +ve 16 F Symptomatic
+ve 9-Sep-21 +ve 9-Sep-21 +ve 26 F Asymptomatic
+ve 10-Sep-21 +ve 10-Sep-21 +ve 48 F Asymptomatic
-ve 10-Sep-21 -ve 10-Sep-21 -ve 50 M Asymptomatic
+ve 10-Sep-21 +ve 10-Sep-21 +ve 31 F Asymptomatic
+ve 10-Sep-21 +ve 10-Sep-21 +ve 59 M Asymptomatic
+ve 10-Sep-21 +ve 10-Sep-21 +ve 21 F Asymptomatic
+ve 11-Sep-21 +ve 11-Sep-21 +ve 19 F Symptomatic
+ve 11-Sep-21 +ve 11-Sep-21 +ve 49 M Symptomatic
-ve 11-Sep-21 -ve 11-Sep-21 -ve 54 F Asymptomatic
-ve 11-Sep-21 -ve 11-Sep-21 -ve 52 F Asymptomatic
-ve 11-Sep-21 -ve 11-Sep-21 -ve 79 F Asymptomatic
-ve 11-Sep-21 -ve 11-Sep-21 -ve 70 F Asymptomatic
+ve 14-Sep-21 +ve 14-Sep-21 +ve 48 M Symptomatic
-ve 14-Sep-21 -ve 14-Sep-21 -ve 85 F Asymptomatic
+ve 14-Sep-21 +ve 14-Sep-21 +ve 38 F Symptomatic
+ve 19-Sep-21 +ve 19-Sep-21 +ve 27 M Asymptomatic
+ve 19-Sep-21 +ve 19-Sep-21 +ve 32 F Symptomatic
+ve 19-Sep-21 +ve 19-Sep-21 +ve 30 M Asymptomatic
+ve 23-Sep-21 +ve 23-Sep-21 +ve 29 M Symptomatic
+ve 23-Sep-21 +ve 23-Sep-21 +ve 67 F Symptomatic
+ve 23-Sep-21 +ve 23-Sep-21 +ve 62 F Symptomatic
+ve 24-Sep-21 +ve 24-Sep-21 +ve 45 F Symptomatic
+ve 23-Sep-21 +ve 23-Sep-21 +ve 43 M Symptomatic
+ve 24-Sep-21 +ve 24-Sep-21 +ve 28 F Symptomatic
+ve 24-Sep-21 +ve 24-Sep-21 +ve 26 F Symptomatic
+ve 24-Sep-21 +ve 24-Sep-21 +ve 28 F Asymptomatic
+ve 25-Sep-21 +ve 25-Sep-21 +ve 31 F Symptomatic
+ve 25-Sep-21 +ve 25-Sep-21 +ve 30 M Symptomatic
-ve 25-Sep-21 -ve 25-Sep-21 -ve 38 F Asymptomatic
-ve 24-Sep-21 -ve 24-Sep-21 -ve 68 M Symptomatic
-ve 24-Sep-21 -ve 24-Sep-21 -ve 62 M Asymptomatic
+ve 24-Sep-21 +ve 24-Sep-21 +ve 63 M Symptomatic
+ve 25-Sep-21 +ve 25-Sep-21 +ve 68 M Symptomatic
+ve 25-Sep-21 +ve 25-Sep-21 +ve 59 F Asymptomatic
+ve 25-Sep-21 +ve 25-Sep-21 +ve 57 F Asymptomatic
+ve 25-Sep-21 +ve 25-Sep-21 +ve 49 F Symptomatic
+ve 1-Oct-21 +ve 1-Oct-21 +ve 62 F Symptomatic
+ve 1-Oct-21 +ve 1-Oct-21 +ve 61 F Asymptomatic
+ve 1-Oct-21 +ve 1-Oct-21 +ve 64 F Asymptomatic
+ve 1-Oct-21 +ve 1-Oct-21 +ve 54 F Symptomatic
+ve 2-Oct-21 +ve 2-Oct-21 +ve 46 F Symptomatic
+ve 2-Oct-21 +ve 2-Oct-21 +ve 34 M Symptomatic
+ve 2-Oct-21 +ve 2-Oct-21 +ve 31 F Asymptomatic
+ve 3-Oct-21 +ve 3-Oct-21 +ve 31 F Symptomatic
+ve 3-Oct-21 +ve 3-Oct-21 +ve 29 F Symptomatic
+ve 3-Oct-21 +ve 3-Oct-21 +ve 20 F Asymptomatic
+ve 3-Oct-21 +ve 44472 +ve 65 F Symptomatic
-ve 3-Oct-21 -ve 10/3/2021 -ve 49 F Asymptomatic
-ve 3-Oct-21 -ve 10/3/2021 -ve 49 F Asymptomatic
+ve 6-Oct-21 +ve 6-Oct-21 +ve 79 F Asymptomatic
+ve 6-Oct-21 +ve 6-Oct-21 +ve 52 F Asymptomatic
+ve 6-Oct-21 +ve 6-Oct-21 +ve 55 F Asymptomatic
+ve 6-Oct-21 +ve 6-Oct-21 +ve 21 F Asymptomatic
+ve 6-Oct-21 +ve 6-Oct-21 +ve 19 F Symptomatic
+ve 7-Oct-21 +ve 7-Oct-21 +ve 38 F Symptomatic
+ve 7-Oct-21 +ve 7-Oct-21 +ve 77 M Asymptomatic
+ve 7-Oct-21 +ve 7-Oct-21 +ve 37 M Asymptomatic
+ve 8-Oct-21 +ve 8-Oct-21 +ve 52 F Symptomatic
+ve 8-Oct-21 +ve 8-Oct-21 +ve 22 F Symptomatic
+ve 8-Oct-21 +ve 8-Oct-21 +ve 23 M Symptomatic
+ve 8-Oct-21 +ve 8-Oct-21 +ve 65 M Asymptomatic
+ve 12-Oct-21 +ve 12-Oct-21 +ve 38 M Asymptomatic
+ve 12-Oct-21 +ve 12-Oct-21 +ve 29 F Symptomatic
+ve 12-Oct-21 +ve 12-Oct-21 +ve 66 F Symptomatic
+ve 13-Oct-21 +ve 13-Oct-21 +ve 41 M Symptomatic
+ve 14-Oct-21 +ve 14-Oct-21 +ve 72 M Symptomatic
+ve 14-Oct-21 +ve 14-Oct-21 +ve 15 F Symptomatic
+ve 14-Oct-21 +ve 14-Oct-21 +ve 52 F Asymptomatic
+ve 14-Oct-21 +ve 14-Oct-21 +ve 25 F Asymptomatic
+ve 14-Oct-21 +ve 14-Oct-21 +ve 48 F Symptomatic
+ve 14-Oct-21 +ve 14-Oct-21 +ve 64 M Symptomatic
+ve 17-Oct-21 +ve 17-Oct-21 +ve 62 M Symptomatic
+ve 17-Oct-21 +ve 17-Oct-21 +ve 35 M Symptomatic
 Storage
Symptoms 1 Days after
Symptom Start Date temperature
(if cannot find symptoms, please Symptoms 2 Symptoms 3 symptom
(DD-MM-YY) before
put in the remark column) onset
testing

19 °C
19 °C
Dyspnoea (difficult in breathing) 19-Jul-21 7 19 °C
Fatigue 21-Jul-21 5 19 °C
Dyspnoea (difficult in breathing) 20-Jul-21 6 19 °C
Coughing 21-Jul-21 5 19 °C
Coughing 12-Jul-21 19 °C
Coughing 21-Jul-21 5 19 °C
Dyspnoea (difficult in breathing) 22-Jul-21 4 19 °C
19 °C
Coughing 22-Jul-21 7 19 °C
Coryza 21-Jul-21 7 19 °C
19 °C
19 °C
19 °C
19 °C
19 °C
19 °C
19 °C
19 °C
19 °C
19 °C
Coughing Fatigue Dyspnoea (dif 4-Sep-21 5 19 °C
19 °C
Anosmia (loss of smell) Fever Fatigue 4-Sep-21 5 19 °C
19 °C
19 °C
19 °C
19 °C
19 °C
19 °C
Anosmia (loss of smell) Ageusia (lossCoughing 4-Sep-21 7 19 °C
Anosmia (loss of smell) Coryza Coughing 4-Sep-21 7 19 °C
19 °C
19 °C
19 °C
19 °C
Anosmia (loss of smell) Ageusia (lossChest imagin 9-Sep-21 5 19 °C
19 °C
Dyspnoea (difficult in breathing) Coughing Fatigue 9-Sep-21 5 19 °C
19 °C
Anosmia (loss of smell) Coughing Fatigue 15-Sep-21 4 19 °C
19 °C
Fever Anosmia (lossAgeusia (loss 18-Sep-21 5 19 °C
Fever Headache Coryza 17-Sep-21 6 19 °C
Fever Headache Coughing 18-Sep-21 5 19 °C
Fever Headache Dyspnoea (dif 17-Sep-21 7 19 °C
Fever Anosmia (lossAgeusia (loss 18-Sep-21 5 19 °C
Fever Headache Coryza 17-Sep-21 7 19 °C
Anosmia (loss of smell) Ageusia (lossDiarrhoea 18-Sep-21 6 19 °C
19 °C
Anosmia (loss of smell) Coughing Chest imagin 18-Sep-21 7 19 °C
Anosmia (loss of smell) Fever Diarrhoea 18-Sep-21 7 19 °C
19 °C
Coryza Headache Fever 19-Sep-21 5 19 °C
19 °C
Diarrhoea Decreased app
Nausea/vomit 18-Sep-21 6 19 °C
Anosmia (loss of smell) 19-Sep-21 6 19 °C
19 °C
19 °C
Diarrhoea Fever Fatigue 19-Sep-21 6 19 °C
Dyspnoea (difficult in breathing) Fever Headache 4 19 °C
19 °C
19 °C
Fever Coryza Headache 27-Sep-21 4 19 °C
Fever Headache Dyspnoea (dif 26-Sep-21 6 19 °C
Ageusia (loss of taste) Headache Dyspnoea (dif 27-Sep-21 5 19 °C
19 °C
Fever Headache Coughing 28-Sep-21 6 19 °C
Anosmia (loss of smell) Headache Coryza 28-Sep-21 6 19 °C
19 °C
Dyspnoea (difficult in breathing) Chest imaginCoughing 26-Sep-21 7 19 °C
19 °C
19 °C
19 °C
19 °C
19 °C
19 °C
Coryza Anosmia (lossDyspnoea (dif 1-Oct-21 5 19 °C
Fever Headache Coryza 2-Oct-21 5 19 °C
19 °C
19 °C
Fever Headache Coryza 2-Oct-21 6 19 °C
Fever Coryza Sore throat 2-Oct-21 6 19 °C
Fever Decreased app
Sore throat 2-Oct-21 6 19 °C
19 °C
19 °C
Fever Ageusia (lossAnosmia (loss 7-Oct-21 5 19 °C
Fever Coryza Anosmia (loss 6-Oct-21 6 19 °C
Shortness of breath Fatigue Myalgia 6-Oct-21 6 19 °C
Fever Anosmia (lossAgeusia (loss 7-Oct-21 7 19 °C
Coryza Coughing Shortness of 7-Oct-21 7 19 °C
19 °C
19 °C
Ageusia (loss of taste) Anosmia (lossFatigue 9-Oct-21 5 19 °C
Coughing 7-Oct-21 7 19 °C
Fever Headache Sore throat 10-Oct-21 7 19 °C
Anosmia (loss of smell) Ageusia (lossSore throat 13-Oct-21 4 19 °C
 Clinical Study Study Ref. Remark

July 2021 Venezuela AAGCS09 No symptoms found

July 2021 Venezuela AAGCS09 No symptoms found
July 2021 Venezuela AAGCS09
July 2021 Venezuela AAGCS09
July 2021 Venezuela AAGCS09
July 2021 Venezuela AAGCS09
July 2021 Venezuela AAGCS09
July 2021 Venezuela AAGCS09
July 2021 Venezuela AAGCS09
July 2021 Venezuela AAGCS09 No symptoms found
July 2021 Venezuela AAGCS09
July 2021 Venezuela AAGCS09
July 2021 Venezuela AAGCS09 No symptoms found
July 2021 Venezuela AAGCS09 No symptoms found
July 2021 Venezuela AAGCS09 No symptoms found
July 2021 Venezuela AAGCS09 No symptoms found
August 2021 VenezueAAGCS09 No symptoms found
August 2021 VenezueAAGCS09 No symptoms found
August 2021 VenezueAAGCS09 No symptoms found
August 2021 VenezueAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09 No symptoms found
September 2021 VeneAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09 No symptoms found
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
October 2021 VenezuAAGCS09
 Device Accountability Log (ARISTATM COVID-19 Antigen Rapid Test Kit)

Device Receipt Device Use Device Return/Repair/Destruction

Device
Date Date Used Disposition Date of final Confirmed
Nr. Batch # or Device Type Lot #, Serial #, or Received by (DD-MM- Subject Dispensed by Device Reaso by (staff Comments
Received Ref Model Number(s) (staff initials) Study ID (staff initials) (RET=Returned; n
(DD-MM-YY) YY) DES-Destroyed; Disposition initials)
REP=Repaired)

1 1-Jul-21 ARISTA-AG-SBEN-001 405-07009-2104014 Nataniel 15-Jul-21 5176450 Nataniel

2
3
4
5

10

11

12

13

14

15

16

17

18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
example
WHO COVID-19 : Case Definitions
Type of
Type of Sample Positive (+ve)
Sample Symptoms Index
Index /Negative (-ve)
Index

AN AN_Anterior Nares Asymptomatic +ve

OP OP_Oropharyngeal Symptomatic -ve
NP NP_Nasopharyngeal
SA SA_Saliva
SP SP_Sputum
 NO. of days post-
Female (F)/
onset of patient COVID-19 Symptoms Index
Male (M)
symptoms Index

F 0 Ageusia (loss of taste)

M 1 Anosmia (loss of smell)
2 Chest imaging
3 Coryza
4 Coughing
5 Decreased appetite
6 Diarrhoea
7 Dyspnoea (difficult in breathing)
Fatigue
Fever
Headache
Myalgia
Nausea/vomiting
Shortness of breath
Sore throat
 Device Device
Return/Repair/ Return/Repair/
Destruction Key Destruction Key

RET RET=Returned
DES DES-Destroyed
REP REP=Repaired