For use under an Emergency Use Authorization (EUA) only For use with direct anterior nasal swab specimens For in vitro diagnostic use only on/go™ COVID-19 Antigen Self-Test Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen Healthcare Provider Instructions for Use
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen Intended Use The on/go™ COVID-19 Antigen Self-Test is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection when tested twice over two or three days with at least 24 hours and not more than 48 hours between test
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen defined by the Laboratory In Vitro Diagnostics (LVID) Test Code Mapping for SARS-CoV-2 Tests provided by CDC. The on/go™ COVID-19 Antigen Self-Test is authorized for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older in a nonlaboratory setting.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen barcode is not valid for any reason, the user is presented with a final screen indicating the fail reason by one of the below: Invalid: Barcode Not Found Invalid: Test Expired Invalid: Test Barcode Invalid Invalid: Test Previously Used Reagents and Materials Materials provided All following required components for single-use are packed and sealed in a tray.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen Children aged 13 years old and younger should be tested by a parent or legal guardian. Wear a safety mask or other face-covering when collecting anterior nares swab specimen from a child or another individual. Wash hands thoroughly for at least 20 seconds before and after handling nasal swab samples.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen Chemical Name/CAS Sodium Tetraborate Pentahydrate/12179-04-3 Ethylenediaminetetraacetic acid (EDTA)/13235-36-4 Sodium Chloride (NaCl)/ 7647-14-5 Triton X-100/9002-93-1 N-Lauroylsarcosine sodium salt/137-16-6 Harms (GHS Code) for each Ingredient H319 Causes serious eye irritation. H360 May damage fertility or the unborn child. H302 Harmful if swallowed.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test IFU-RCPM79-E / Rev. A Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen ACCESS BIO, INC.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test IFU-RCPM79-E / Rev. A Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen ACCESS BIO, INC.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen If used for serial testing and the test result is negative, a second test should be obtained two or three days with at least 24 hours and no more than 48 hours between tests. Interpretation of Results The test results will be interpreted by visual reading following the in-app interpretation instructions or provided Quick Reference Instructions.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen test for positive results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection. COVID-19 Not Detected (Negative): One purple-colored line only next to “C” indicates a negative result. Negative results do not rule out SARS-CoV-2 infection.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen 2. The detection of SARS-CoV-2 nucleocapsid antigen is dependent upon proper specimen collection, handling, storage, and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results. 3.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen 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.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Days Since Symptom Onset Asymptomatic 0-1 0-2 0-3 0-4 0-5 0-6 0-7 0-14 Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen PPA (95% CI) 70.0% (7/10) (95% CI: 39.7%-89.2%) 100% (5/5) (95% CI: 56.6%-100%) 100% (11/11) (95% CI: 74.1%-100%) 100% (20/20) (95% CI: 83.9%-100%) 92.0% (23/25) (95% CI: 75.0%-97.8%) 92.6% (25/27) (95% CI: 76.6%-97.9%) 89.7% (26/29) (95% CI: 73.6%-96.4%) 86.7% (26/30) (95% CI: 70.3%-94.7%) 86.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen 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
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen Potential Interfering Substances Concentration Potential Interfering Substances Concentration Acetaminophen Acetyl salicylic acid 10 mg/ml 15 mg/ml 5mg/ml 1:10 dilution Beclomethasone 0.
RCPM-00279, RCPM-00479, RCPM-02079 on/goTM COVID-19 Antigen Self-Test Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen Description of Symbols Symbol Descriptions Symbol Descriptions In vitro diagnostic medical device Catalog number Consult instructions for use Caution Manufacturer Date of manufacture Batch code Temperature limit Do not re-use Do not use if the package is damaged Use by date Contains sufficient for tests Indicates a medical device that is intended to be used a
