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 14 of 16
Potential Cross-Reactant
Human coronavirus (NL63) Respiratory syncytial virus Type B Mycoplasma pneumoniae
Human metapneumovirus (hMPV)
Rhinovirus
Staphylococcus aureus
Influenza A/Michigan/45/2015 SARS-Coronavirus Staphylococcus epidermidis
Influenza B/Wisconsin/01/2010
Pooled human nasal wash
Streptococcus pneumoniae
Streptococcus pyogenes, Group A
To estimate the likelihood of cross-reactivity with SARS-CoV-2 of organisms that were not
available for wet testing, in silico analysis using the Basic Local Alignment Search Tool (BLAST)
managed by the National Center for Biotechnology Information (NCBI) was used to assess the
degree of protein sequence homology.
https://blast.ncbi.nlm.nih.gov/Blast.cgi?PAGE=Proteins&PROGRAM=blastp&BLAST_PRO
GRAMS=blastp&PAGE_TYPE=BlastSearch&BLAST_SPEC=blast2seq&DATABASE=n/a&
QUERY=&SUBJECTS=
• The homology between SARS-CoV-2 nucleocapsid protein and human coronavirus HKU1
nucleocapsid protein is relatively low, at 36.7% across 86.4% of sequences, but cross-
reactivity cannot be ruled out.
• The homology between SARS-CoV-2 nucleocapsid protein and Mycobacterium
tuberculosis total protein (3,991 proteins) is relatively low, homology-based cross-reactivity
cannot be ruled out.
• The homology between SARS-CoV-2 nucleocapsid protein and Pneumocystis jirovecii total
protein (3,745 proteins) is relatively low, homology-based cross-reactivity cannot be ruled
out.
• The homology between SARS-CoV-2 nucleocapsid protein and human coronavirus 229E
nucleocapsid protein is relatively low, at 28.8% across 72.1% of sequences, but cross-
reactivity cannot be ruled out. However, a result of the cross-reactivity wet study showed
that CareStart™ COVID-19 Antigen Self-Test had no cross-reactivity against human
coronavirus 229E.
• No homologous protein was detected as a result of in silico assay with all the proteins (686
proteins) of Mycoplasma pneumoniae and the nucleocapsid protein (NP) of SARS-CoV-2,
however cross-reactivity cannot be ruled out.
Endogenous Interfering Substances Effect
To assess substances with the potential to interfere with the performance of the on/go™ COVID-
19 Antigen Home Test, positive and negative samples were tested with the addition of potentially
interfering substances. The SARS-CoV-2 target concentration in the positive samples was
approximately 2x LoD. All samples tested produced expected results, demonstrating that the
on/go™ COVID-19 Antigen Self-Test performance was not affected by any of the 35 potentially
interfering substances listed in the table below at the concentrations tested.