Test directory: SARS Antigen

Ordering Code7752
Test NameSARS Antigen
AliasCOVID Antigen
Preferred SpecimenNasal Swab
Use the nasal swab supplied in the kit
Preferred ContainerOriginal package/container
Other Specimen/ContainerDirect nasal swab should be tested as soon as possible after collection.
Optimum Volume1 Swab
Transport RequirementsOahu: Refrigerated
Specimen StabilityAmbient: 5 Days
Refrigerated: 5 Days
Rejection CriteriaPreservatives used, Frozen, Swab in gel transport media
Avail. StatYES
MethodologyLateral flow immunoassay

Reference range(s)

The reference ranges listed below are valid on this date of November 21, 2024.
ComponentAgeMale NormMale Critical LowMale Critical HighFemale NormFemale Critical HighFemale Critical LowUnitsAdd'l info
SARS (COVID) AntigenALLNEGATIVENEGATIVE

This product...
This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA). The performance characteristics have been verified by DLS. This product is authorized for use at the Point of
Care (POC) i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
Individuals without symptoms or not suspected to have active
COVID-19 should be tested twice over 2 or 3 days with at least 24 hours and no more than 48 hours between tests
^
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, do not rule out SARS-CoV-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 the presence of clinical signs and symptoms consistent with
COVID-19, and confirmed with a molecular assay, if necessary, for patient management. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such in an individual with as a close contact with
COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection
^
Quidel QuickVue SARS Antigen Test - Fact Sheet for Patients - https://www.fda.gov/media/144667/download
Note1

Note1:


This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA). The performance characteristics have been verified by DLS. This product is authorized for use at the Point of
Care (POC) i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
Individuals without symptoms or not suspected to have active
COVID-19 should be tested twice over 2 or 3 days with at least 24 hours and no more than 48 hours between tests
^
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, do not rule out SARS-CoV-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 the presence of clinical signs and symptoms consistent with
COVID-19, and confirmed with a molecular assay, if necessary, for patient management. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such in an individual with as a close contact with
COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection
^
Quidel QuickVue SARS Antigen Test - Fact Sheet for Patients - https://www.fda.gov/media/144667/download
.