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 13 of 16
Days Since
Symptom Onset
PPA (95% CI) NPA (95% CI)
Asymptomatic
70.0% (7/10) (95% CI: 39.7%-89.2%)
97.6% (123/126) (95% CI: 93.2%-99.2%)
0-1
100% (5/5) (95% CI: 56.6%-100%)
96.8% (30/31) (95% CI: 83.8%-99.4%)
0-2
100% (11/11) (95% CI: 74.1%-100%)
94.8% (55/58) (95% CI: 85.9%-98.2%)
0-3
100% (20/20) (95% CI: 83.9%-100%)
96.3% (78/81) (95% CI: 89.7%-98.7%)
0-4
92.0% (23/25) (95% CI: 75.0%-97.8%)
97.1% (100/103) (95% CI: 91.8%-99.0%)
0-5
92.6% (25/27) (95% CI: 76.6%-97.9%)
97.3% (108/111) (95% CI: 92.4%-99.1%)
0-6
89.7% (26/29) (95% CI: 73.6%-96.4%)
97.3% (109/112) (95% CI: 92.4%-99.1%)
0-7
86.7% (26/30) (95% CI: 70.3%-94.7%)
97.5% (116/119) (95% CI: 92.9%-99.1%)
0-14
86.7% (26/30) (95% CI: 70.3%-94.7%)
97.6% (120/123) (95% CI: 93.1%-99.2%)
Invalid Test Rate: The overall invalid result rate within a total of 172 subjects that performed
testing in a clinical study was 2.9% (5/172).
Analytical Sensitivity: Limit of Detection (LoD)
The LoD for direct nasal swab was established using gamma-irradiated SARS-CoV-2 isolate
USA-WA1/2020 (NR-52287). The strain was spiked into the pooled human nasal swab matrix
obtained from multiple healthy volunteers eluted in PBS and confirmed as SARS-CoV-2 negative
by RT-PCR to prepare positive samples. The estimated LoD found from the initial two-fold serial
dilution test was confirmed by testing 20 replicates. The confirmed LoD for direct swab was 2.8
x 10
3
TCID
50
/ml.
Analytical Specificity: Cross Reactivity (Exclusivity) and Microbial Interference
The potential cross-reactivity (exclusivity) of a panel of common organisms was evaluated with
SARS-CoV-2 negative samples using the on/go™ COVID-19 Antigen Home Test. Potential
microbial interference was evaluated with samples containing gamma-irradiated SARS-CoV-2
isolate USA-WA1/2020 at approximately 3x LoD. A total of 10 bacteria were tested at a target
concentration of approximately 10
7
cfu/ml with the exception of Mycoplasma pneumoniae, which
was tested at a final concentration of 1.5 x 10
3
cfu/ml. The 18 viruses were tested at
concentrations between 10
5.2
and 10
7.9
TCID
50
/ml. All negative samples gave negative results
at the concentrations of the potentially cross-reactive common organisms tested showing no
cross-reactivity with on/go™ COVID-19 Antigen Self-Test assay. All samples with SARS-CoV-2
strain tested positive showing no microbial interference at the concentrations of the potentially
interfering common organisms tested.
Potential Cross-Reactant
Adenovirus 1
MERS-Coronavirus, Irradiated Lysate
Bodetella pertussis
Adenovirus 7
Parainfluenza virus type 1
Candida albicans
Enterovirus 71, Tainan/4643/1998
Parainfluenza virus type 2
Chlamydophila pneumoniae
Human coronavirus (OC43)
Parainfluenza virus type 3
Haemophilus influenzae
Human coronavirus (229E) Parainfluenza virus type 4 Legionella pneumophila