Roche SD Biosensor Covid-19 At Home Test
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Roche’s COVID-19 At-Home Test.
Click here for the FDA Approval of Roche Covid-19 At-Home Test.
Click here for the User Manual of Roche (SD Biosensor) At-Home-Test.
Click here for the Clinical Evaluation Report of Roche (SDBio) Covid-19 At-Home-Test.
The COVID-19 At-Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 6 days of symptom onset.
This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 6 days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
The COVID-19 At-Home Test does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the COVID-19 At-Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Roche’s COVID-19 At-Home Test.
Click here for the FDA Approval of Roche Covid-19 At-Home Test.
Click here for the User Manual of Roche (SD Biosensor) At-Home-Test.
Click here for the Clinical Evaluation Report of Roche (SDBio) Covid-19 At-Home-Test.
The COVID-19 At-Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 6 days of symptom onset.
This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 6 days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
The COVID-19 At-Home Test does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the COVID-19 At-Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Roche’s COVID-19 At-Home Test.
Click here for the FDA Approval of Roche Covid-19 At-Home Test.
Click here for the User Manual of Roche (SD Biosensor) At-Home-Test.
Click here for the Clinical Evaluation Report of Roche (SDBio) Covid-19 At-Home-Test.
The COVID-19 At-Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 6 days of symptom onset.
This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 6 days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
The COVID-19 At-Home Test does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the COVID-19 At-Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.