QuickProfile™ COVID-19 Antigen Test is a rapid in vitro immunochromatographic assay for the qualitative detection of SARS-CoV-2 virus antigen present in human nasopharynx. The test is intended for professional and laboratory use as an aid in the rapid diagnosis of SARS-CoV-2 virus infections. According to CDC’s guidance, COVID-19 antigen test has the best sensitivity from day 1 to day 5 after the onset of symptoms. Antigen levels in specimens collected beyond 5-7 days of the onset of symptoms may drop below the limit of detection of the test.
SARS-CoV-2 is single-stranded RNA virus with envelope, the virion is approximately 50–200
nanometers in diameter. It has four structural proteins, known as the spike (S), envelope (E),
membrane (M), and nucleocapsid (N) proteins; the N protein holds the RNA genome, and the S, E,
and M proteins together create the viral envelope. The incubation period for COVID-19 typically
ranges from 2 to 14 days. Those infected with the virus may be asymptomatic or develop common
respiratory symptoms, including fever, cough and fatigue (other symptoms may include muscle pain,
diarrhea, sore throat, loss of taste and smell, and abdominal pain). Severe patients may progress to
acute respiratory distress syndrome (ARDS), septic shock, diffuse alveolar damage (DAD) and even
QuickProfile™ COVID-19 Antigen Test provides a quick and easy to use test to help in the diagnosis
of SARS-CoV-2 infection to humans.
QuickProfile™ COVID-19 Antigen Test is a rapid immunochromatographic assay that utilizes specific monoclonal antibodies to detect Nucleocapsid protein of SARS-CoV-2 virus in nasopharyngeal swab specimens. Anti-SARS-CoV-2 antibodies are coated on nitrocellulose membrane as the capture zone and conjugated to colloidal gold as the detection probe. When sample extracts from the nasopharyngeal swab are applied to the test device’s sample port, if the extracted specimen contains SARS-CoV-2 viral antigens, the antigens will form the antigen-antibody complex with anti-SARS-CoV-2-colloidal gold conjugate. The complex will continue to move on the membrane and can be captured by anti-SARS-CoV-2 antibodies coated on the test zone to form a colored band indicating a positive result. Absence of the color band on the test zone indicates a negative result. A built-in control band will always appear when the test is performed properly regardless of the presence or absence of SARS-CoV-2 antigen in the specimen.
Read the package insert carefully prior to testing the kit and follow the instructions to obtain accurate results.
- For in vitro diagnostic use.
- Do not use the kit contents beyond the expiration date printed on the outside of the box.
- Do not interchange or mix different lots of components of QuickProfile™ COVID-19 Antigen
- Do not insert the test device directly into the sampling area (mouth, nostrils).
- Disregard test results beyond the specified time (20 minutes).
- Use appropriate precautions in the collection, handling, storage, and disposal of patient samples
and used kit contents.
- Use of protective tools are recommended when handling patient samples.
- Dispose of containers and used contents in accordance with Federal, State and Local
- Do not reuse kit components.
- The test device must remain sealed in the protective foil pouch until use.
- Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate
- Seek specific training or guidance if you are not experienced with specimen collection and
- If infection with a novel SARS-CoV-2 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 SARS-CoV-2
viruses and sent to state or local health departments for testing. Viral culture should not be
attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
STORAGE AND STABILITY
- Store the test device at 4-30oC in the original pouch. Do Not Freeze.
- Kit contents are stable until the expiration date printed on the outer box based on the proper
- The test device must be kept in the sealed pouch until use.
- Test card (20 devices):
Each test houses a strip incorporated with a pair of anti-SARS-CoV-2 specific mouse
monoclonal antibodies and packed in individual foil pouch.
- Extraction Buffer (2 bottles): Solution contains salt and detergent
- Sample extraction tube (20 tubes)
- Nasopharyngeal Swab (20 pieces)
- Sample transfer pipet (20 pieces): one each enclosed with test device in the foil pouch.
- Instructions for Use (1 copy)
MATERIALS REQUIRED BUT NOT SUPPLIED
- Specimen collection container
- Personal Protective Equipment
Proper specimen collection, storage, and transport are critical to the performance of this test. Specimens should be tested as soon as possible after collection. The training in specimen collection is highly recommended because of the importance of specimen quality. For optimal test performance, use the swabs supplied in the kit. It is important to obtain as much secretion as possible. Secretion specimens can be collected by either of the following two swabbing locations.
1. Anterior Nasal Swabbing