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

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download