User Manual

RCPM-00279, RCPM-00479, RCPM-02079
Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen
on/go
TM
COVID-19 Antigen Self-Test
IFU-RCPM79-E / Rev. A
ACCESS BIO, INC.
Page 12 of 16
20. The performance of this test was established based on the evaluation of a limited number of
clinical specimens collected between March 2021 and May 2021. The clinical performance
has not been established in all circulating variants but is anticipated to be reflective of the
prevalent variants in circulation at the time and location of the clinical evaluation.
Performance at the time of testing may vary depending on the variants circulating, including
newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
Performance Characteristics
Clinical Performance
The clinical performance characteristics of the on/go™ COVID-19 Antigen Self-Test using
anterior nasal swab specimen were evaluated at seven (7) geographically diverse study sites in
the U.S. between March 2021 and May 2021 against an FDA Emergency Use Authorized RT-
PCR molecular assay as a comparator method. Subjects self-sampled and self-tested using the
on/go™ COVID-19 Antigen Self-Test in a simulated home setting utilizing only the labeling
provided with the test. A total of 153 subjects were evaluated in this study. The CareStart™
COVID-19 Antigen Self-Test when conducted by a lay user correctly identified 87% of positive
samples and 98% of negative samples. The overall clinical performance is shown in the following
tables.
on/go™ COVID-19 Antigen Home Test clinical performance against the comparator
method
on/go™ COVID-19 Antigen Home Test
Comparator
Positive
Negative
Total
Positive
26
3
a
29
Negative
4
b
120
124
Total
30
123
153
Positive Percent Agreement (PPA)
87% (26/30) (95% CI: 70%-95%)
Negative Percent Agreement (NPA)
98% (120/123) (95% CI: 93%-99%)
a
COVID-19 was detected in 0/3 False Positive specimens using the Quidel Lyra SARS-CoV-2 Assay
b
COVID-19 was not detected in 2/4 False Negative specimens using the Quidel Lyra SARS-CoV-2 Assay
Patient Demographics
Age Group
on/go™ COVID-19 Antigen Home Test
Female Male
Positivity Rate % (total
positive / total tested)
2-13 Years of Age
6
2
0.0% (0/8)
14-24 Years of Age
16
10
15.4% (4/26)
25-64 Years of Age
69
34
22.3% (23/103)
≥65 Years of Age 9 7 12.5% (2/16)
Total 100 53 13.9% (29/153)
Positive results are broken down by days since onset of symptoms: