Clinical Study for Rapid ResponseTM COVID-19 Antigen Rapid Test ... - BIOZOL
570 Hood Road, Unit 23,
Markham, ON
T: 905-944-9565
F: 905-944-0406
Clinical Study
Rapid Response? COVID-19 Antigen Rapid Test Cassette
(Oral Fluid)
COV-2C25B
Clinical Study for Rapid ResponseTM COVID-19 Antigen Rapid
Test Cassette (Oral Fluid)
The Rapid ResponseTM COVID-19 Antigen Rapid Test Cassette has been evaluated with
saliva specimens. The study was completed at multiple clinical sites in the United States. A
highly sensitive US FDA EUA approved PCR test was used as the comparator method for
this evaluation.
Reagent:
Rapid ResponseTM COVID-19 Antigen Rapid Test Cassette
Product code: COV-2C25B
Lot numbers: COVG2007001-T, Exp:2022-07
COVG2007002-T, Exp:2022-07
COVG2007003-T, Exp:2022-07
PCR:
Thermo Fisher TaqPath COVID-19 Combo kit
Method:
Study 1: Each individual was sampled with a Nasopharyngeal swab and a Saliva specimen. The
NP swab was sent for the PCR test. The saliva sample collection and testing procedure was
followed from the Product Insert of COV-2C25B. Specimens were considered positive when the
result of PCR was positive.
Clinical Study summary of Rapid ResponseTM COVID-19 Antigen Test Cassette for Study 1:
COVG2007001-T, Exp:2022-07
COVG2007002-T, Exp:2022-07
COVG2007003-T, Exp:2022-07
Method
Antigen Rapid Test Cassette (Saliva)
Total Results
Results
Positive
Negative
PCR (NP swab)
Positive
Negative
38
0
2
324
40
324
Total
Results
38
326
364
Relative Sensitivity: 95.0% (95%CI*:83.1%-99.1%)*
Relative Specificity: 100% (95%CI*:98.53%-100.0%)*
Relative accuracy: 99.5% (95%CI*:97.8%-99.9%)*
Study 2: The study was extended to evaluate the performance on frozen specimen. The
Nasopharyngeal swab was collected for the PCR and saliva specimen from each individual was
collected to be stored at -20oC. The saliva specimens of the PCR positive individuals was tested
1
570 Hood Road, Unit 23,
Markham, ON
T: 905-944-9565
F: 905-944-0406
Clinical Study
Rapid Response? COVID-19 Antigen Rapid Test Cassette
(Oral Fluid)
COV-2C25B
with the Rapid ResponseTM COVID-19 Antigen Rapid Test Cassette after bringing it to room
temperature.
Clinical Study summary of Rapid ResponseTM COVID-19 Antigen Test Cassette for Study 2:
COVG2007001-T, Exp:2022-07
Method
PCR (NP swab)
Total
Results
Positive
Negative
Results
Antigen Rapid Test Cassette (Frozen
Positive
88
0
88
Saliva)
Negative
11
0
11
Total Results
99
0
99
Relative Sensitivity: 88.9% (95%CI*:80.6%-94.1%)*
Combined Clinical Results of Study 1 and Study 2:
Method
Antigen Rapid Test Cassette (Saliva)
Results
Positive
Negative
Total Results
PCR (NP swab)
Positive
Negative
126
0
13
324
139
324
Total
Results
126
337
463
Relative Sensitivity: 90.6% (95%CI*:84.5%-94.9%)*
Relative Specificity: 100% (95%CI*:98.53%-100.0%)*
Relative accuracy: 99.5% (95%CI*:97.8%-99.9%)*
Clinical Data from Study 1:
1
2
3
4
5
6
7
8
9
10
11
12
Specimen
PCR Comparator
Rapid Response?
COVID-19 Antigen
Rapid Test
Cassette(Oral Fluid)
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Positive
Negative
Negative
Gender
Age
Male
Male
Female
Female
Female
Male
Female
Male
Female
Male
Male
Male
45
57
69
64
42
52
50
56
64
42
35
65
2
570 Hood Road, Unit 23,
Markham, ON
T: 905-944-9565
F: 905-944-0406
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
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Positive
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Clinical Study
Rapid Response? COVID-19 Antigen Rapid Test Cassette
(Oral Fluid)
COV-2C25B
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Positive
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Male
Male
Male
Male
Male
Female
Female
Female
Male
Male
Male
Female
Female
Male
Female
Male
Female
Male
Female
Male
Female
Male
Male
Male
Female
Male
Female
Female
Male
Male
Male
Female
Female
Male
Male
Male
Male
Female
Female
Female
Female
Female
Male
Female
Male
Female
67
50
36
43
61
56
55
37
63
49
56
20
61
54
56
38
50
52
39
71
72
58
71
68
34
54
72
45
63
65
64
68
51
61
40
49
64
59
49
41
36
63
67
71
38
67
3
570 Hood Road, Unit 23,
Markham, ON
T: 905-944-9565
F: 905-944-0406
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
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Clinical Study
Rapid Response? COVID-19 Antigen Rapid Test Cassette
(Oral Fluid)
COV-2C25B
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Female
Female
Male
Female
Female
Female
Male
Female
Female
Male
Male
Male
Female
Female
Male
Male
Female
Male
Male
Male
Male
Male
Female
Male
Male
Female
Female
Male
Male
Female
Female
Male
Male
Male
Male
Female
Male
Male
Male
Male
Female
Male
Female
Female
Male
Female
69
50
64
37
69
56
43
71
49
37
45
44
56
43
42
64
59
56
70
57
39
44
35
68
50
27
63
37
68
59
65
72
53
45
45
49
54
46
35
45
66
40
68
42
53
35
4
570 Hood Road, Unit 23,
Markham, ON
T: 905-944-9565
F: 905-944-0406
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
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Oral fluid
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Clinical Study
Rapid Response? COVID-19 Antigen Rapid Test Cassette
(Oral Fluid)
COV-2C25B
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Positive
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Negative
Female
Female
Male
Female
Female
Male
Female
Female
Female
Female
Female
Female
Female
Male
Male
Female
Male
Female
Male
Female
Male
Male
Male
Female
Male
Male
Female
Female
Male
Male
Male
Female
Female
Male
Male
Male
Female
Male
Male
Female
Male
Female
Female
Female
Male
Female
67
70
51
72
58
62
53
38
41
46
66
47
67
68
43
50
38
37
38
66
35
42
54
22
70
57
37
36
54
56
56
71
52
69
41
36
70
69
49
68
35
69
41
49
37
61
5
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