COVID-19 Test Kit

Quidel QuickVue At-Home OTC COVID-19 Test Kit
Quidel QuickVue At-Home OTC COVID-19 Test Kit is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from
individuals with or without symptoms or other epidemiological reasons to suspect COVID-19. This test is authorized for nonprescription home use with
self-collected direct anterior nasal swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals
aged 2 years or older.

COVID-19 Test Kit Features
 The test is intended to be used twice over two to three days, with at least 24 hours and no more than 36 hours between tests
 Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to
determine infection status
 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
 The test is intended to be read at 10 minutes; If the test is read before this or is read more than 5 minutes after the indicated read time, results may be
inaccurate and the test should be repeated
 Includes:
– Individually wrapped sterile foam swabs
– Individually packaged
– (2) Single-Use test strips
– Pre-Filled tubes
– Tube holder
– Instruction sheet
– Fact sheet for individuals
Specification
Particulars Product Specifications
Reading Type Visual Read

Sample Type Direct Anterior Nasal (NS) Swab Sample
Test Format Test Strip Format
Test Method Lateral Flow Immunoassay
Test Type Antigen Test