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The CareSuperb™ COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider. Performance characteristics for SARS-CoV-2 were established from October 2023 to April 2024 when SARS-CoV-2 Omicron variant was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

The CareSuperb™ COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein in anterior nasal samples. To begin the test, a self-collected anterior nasal swab sample (in individuals between the age of 2 to 14 a swab collected by a parent or quardian), or a heathcare-provider collected anterior nasal swab sample is inserted into the sample port and the extraction reagent in the dropper vial is added to the extraction to occur exposing the viral nucleocapsid antigens The SARS-CoV-2 antigens present in the sample bind with anti-SARS-CoV-2 antibodies dispensed in the conjuqate wick filter. These antigen-antibody complexes migrate to the the plastic cassette and travel across the membrane through capillary action. The complexes are captured at the tegion, causing a colored line to appear on the membrane. If the sample contains SARS-CoV-2 antigen, a visible line at the test line ("T") and a procedural control line at the control line ("C") will appear in the result window indicating a positive result. If SARS-CoV 2 viral nucleocapsid antigens are not present, or are present at very low levels, only the procedural control line will appear.

The CareStart™ Flu A&B Plus is an in vitro rapid immunochromatographic assay for the qualitative detection of influenza virus type A and B nucleoprotein antigens directly from nasopharyngeal swab specimens of symptomatic patients. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and B viral infections. This test is intended to distinguish between influenza type A and/or B virus in a single test. This test is not intended to detect influenza type C viral antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the basis for treatment or other patient management decisions. Performance characteristics for influenza A and B were established during the 2018-2019 influenza season when influenza A/H3N2, A/H1N1pdm09, and B/Victoria were the predominant influenza viruses in circulation. When other influenza viruses are emerging, performance characteristics may vary. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to the state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to received and culture specimens.

The CareStart™ Flu A&B Plus test is an immunochromatographic assay for detection of extracted influenza type A and B virus nucleoprotein antigens in nasopharyngeal specimens. Nasopharyngeal swabs require a sample preparation step in which the sample is eluted and washed off into the extraction buffer solution. Extracted swab sample is added to the sample well of the test device to initiate the test. When the swab sample migrates in the test strip, influenza A or B viral antigens bind to anti-influenza antibodies conjugated to indicator particles in the test strip forming an immune complex. The immune complex is then captured by each test line and control line on the membrane as it migrates through the strip. Test results are interpreted at 10 minutes. The presence of two colored lines, a purplecolored line in the control region "C" and a red-colored line in the influenza A test region "A", indicates influenza A positive. The presence of two colored lines, a purplecolored line in the control region "C" and a blue-colored line in the influenza B test region "B", indicates influenza B positive. The presence of three colored lines, a purple-colored line in the control region "C", a red-colored line in the influenza A test region "A", and a blue-colored line in the influenza B test region "B indicates, influenza A and B dual positive result. The absence of a line on both influenza A and B test regions with a purple-colored line in the control region "C" indicates negative. No appearance of purple-colored line in the control region "C" indicates invalid test.