For in vitro diagnostic use. Others LumiraDx SARS-CoV-2 Ag Ultra IVD LumiraDx SARS-CoV-2 Ag Ultra PID00000898 10 418 184 001 10418184001 LumiraDx SARS-CoV-2 Ag Ultra (48T) ML01 LumiraDx SARS-CoV-2 Ag Ultra (48T) ML01 05060537713700 Reagents, kits L016000401048 48 tests Not Available undefined The LumiraDx SARS-CoV-2 Ag Ultra test is an automated rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform, for near-patient testing, intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 directly from anterior nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19. The LumiraDx SARS-CoV-2 Ag Ultra 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 swab samples 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. Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out SARSCoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19. The LumiraDx SARS-CoV-2 Ag Ultra test is intended for use by healthcare professionals trained in point of care settings, and proficient in performing tests using the LumiraDx Instrument. en The LumiraDx SARS-CoV-2 Ag Ultra test is a single use fluorescence immunoassay device designed to detect the presence of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab samples, without transport media. The test procedure involves collecting an anterior nasal swab sample (using a recommended swab or a swab supplied with specific product codes) which is eluted into a vial containing Extraction Buffer. A single drop of the sample in Extraction Buffer is added to the Test Strip using the vial dropper cap provided. The LumiraDx Instrument is programmed to perform the test protocol using the dried reagents contained within the strip. The test result is determined from the amount of fluorescence the Instrument detects within the measurement zone of the Test Strip. The concentration of the analyte in the sample is proportional to the fluorescence detected. The results are displayed on the Instrument touchscreen within 5 minutes from the addition of the sample. en

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