On/Go COVID-19 Antigen Rapid At Home Test - OTC

On/Go COVID-19 Antigen Rapid At Home Test – OTC

Principle of Test
The kit is a rapid self-test for detecting SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swabs samples. These swabs require preparation, which involves eschewing into the extraction buffer solution. The sample is incorporated into the test device’s sample well to begin the test. When the sample migrates across the strip, the viral antigens bind with antibodies in the conjugate solution to form an immune complex. The user needs to conduct the test according to in-app self-paced guidelines. The tests can be interpreted within ten minutes after loading the sample as per the instructions. The presence of doubled-colored lines within the control line and test line region ‘C’ and ‘T’ regions indicates COVID-19. On the other hand, the presence of a single-colored line within ‘C,’ the control region, mirrors an invalid test. Results can only be read after fifteen minutes.

Description

Intrivo On/Go COVID-19 Antigen Test At Home

On/Go is an artificial intelligence-powered solution for COVID-19 management. It is an FDA-approved and easy-to-use antigen test with COVID-19 management and diagnostic system. On/Go COVID-19 Antigen integrates cutting-edge technology with the latest science to deliver diagnostics with a system for information management for an end-to-end solution.

Intended Use for COVID-19 Antigen Test

The On/GoTM COVID-19 Test at Home is categorized as a COVID-19 rapid test. It detects SARS-Cov-2 antigens from people with COVID-19 symptoms qualitatively, or those health providers suspect to have COVID-19 infection after testing twice over 48 or 72 hours with at least a day between the two tests. The FDA has authorized the test for non-prescription self-use with direct anterior nasal swabs samples from persons aged fourteen years above or children aged two years and above.

Test Results

The results are used to identify the nucleocapsid protein antigen of SAR-CoV-2. Usually, the antigen is detectable in the samples from anterior nasal swabs in the acute phase of COVID-19 infection. Positive results mirror the existence of viral antigens, although it is necessary to make a clinical correlation with diagnostic information and medical history to establish infection status. When positive, the results may exclude bacterial infection, and the detected agent may certainly not cause the disease.

Persons that test positive with the self-test kit should seek follow-up care while self-isolating and extra testing may be necessary. Health providers should consider negative tests as presumptive, and have to confirm them through a molecular assay. Negative results do not exclude SARS-CoV-2 infection, and it should not solely be the basis for patient management or treatment decisions. Doctors should consider negative results in the context of the person’s history, exposures, and presence of symptoms and clinical signs consistent with COVID-19.

Additional confirmatory testing using a molecular test concerning negative results may be necessary for serial testing programs. For positive results, additional confirmatory testing using molecular tests may be necessary if the chances of exposure are low. Those that test negative and experience symptoms related to COVID-19, such as shortness of breath and fever, could still be infected with SARS-CoV-2, and follow-up care would be necessary.