Please note that test kits can only be ordered by medical professionals or businesses and are required to be administered by a healthcare professional, a company nurse or by occupational health staff. We offer services to administer tests if required. Business orders require a Valid VAT number.

All instructions and data are for the aforementioned.

Test kits can be sold to the public if ordered with our GP visiting test service. Click here for details.

INTENDED USE

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.

SUMMARY

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
death.
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.

PRINCIPLE

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.

PRECAUTIONS

Read the package insert carefully prior to testing the kit and follow the instructions to obtain accurate results.

1. For in vitro diagnostic use.
2. Do not use the kit contents beyond the expiration date printed on the outside of the box.
3. Do not interchange or mix different lots of components of QuickProfile™ COVID-19 Antigen
   Test.
4. Do not insert the test device directly into the sampling area (mouth, nostrils).
5. Disregard test results beyond the specified time (20 minutes).
6. Use appropriate precautions in the collection, handling, storage, and disposal of patient samples
   and used kit contents.
7. Use of protective tools are recommended when handling patient samples.
8. Dispose of containers and used contents in accordance with Federal, State and Local
   requirements.
9. Do not reuse kit components.
10. The test device must remain sealed in the protective foil pouch until use.
11. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate
    test results.
12. Seek specific training or guidance if you are not experienced with specimen collection and
    handling procedures.
13. 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

1. Store the test device at 4-30oC in the original pouch. Do Not Freeze.
2. Kit contents are stable until the expiration date printed on the outer box based on the proper
   storage conditions.
3. The test device must be kept in the sealed pouch until use.

MATERIALS PROVIDED

1. 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.
2. Extraction Buffer (2 bottles): Solution contains salt and detergent
3. Sample extraction tube (20 tubes)
4. Nasopharyngeal Swab (20 pieces)
5. Sample transfer pipet (20 pieces): one each enclosed with test device in the foil pouch.
6. Instructions for Use (1 copy)

MATERIALS REQUIRED BUT NOT SUPPLIED

1. Specimen collection container
2. Timer
3. Personal Protective Equipment

SAMPLE COLLECTION

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

2. Nasopharyngeal Swabbing

QUALITY CONTROL

1. The control band is an internal reagent and procedural control. It will appear if the test has been performed correctly and the reagents are reactive.
2. Good laboratory practice recommends the daily use of control materials to validate the reliability of the device. Control materials, which are not provided with this test kit, may be commercially available.

PROCEDURE

All specimens and assay procedures must be handled at room temperature.

LIMITATIONS

1. The contents of this kit are to be used for the qualitative detection of SARS-CoV-2 viral antigen from the nasopharyngeal swab.
2. A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
3. 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.
4. Failure to follow the Test Procedure and interpretations of Test Results may adversely affect test performance and/or invalidate the Test Results.
5. Test Results must be evaluated in conjunction with other clinical data available to the physician.
6. Negative test results do not rule out other potential non-SARS-CoV-2 viral infections. Negative results should be confirmed by molecular diagnosis if COVID-19 disease is suspected.
7. Positive test results do not rule out co-infections with other pathogens.
8. Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that have undergone minor amino acid changes in the target epitope region.

Interpretation of results

CLINICAL EVALUATION

The clinical evaluation was conducted in different countries. The nasopharyngeal swab samples were confirmed by RT-PCR. One hundred and twenty-seven (127) positive samples and eighty-six (86) negative samples were tested. The results are summarized below.

ANALYTICAL SENSITIVITY

The limit of detection (LoD) for the QuickProfile™ COVID-19 Antigen Test was established in an analytical sensitivity study performed with one virus strain and three recombinant nucleocapsid proteins. The LoD was determined as the analytical concentration corresponding to 95% positive rate. A total of 10 replicates at the target concentration of each analyte listed in the table showed 100% positive results.

CROSS REACTIVITY

The cross reactivity of the QuickProfile™ COVID-19 Antigen Test was evaluated with a total of 6 bacteria and 17 viruses. None of the microorganisms tested in the following table gave a positive result at the defined concentration. The specificity of non-cross reactivity is 100%.

INTERFERENCE

Exogenous (Nasal spray product, common chemicals) and endogenous substances listed in the table below were evaluated by spiking into extraction buffer with or without 1 x LOD SARS-CoV-2 virus and tested by six replicates. The results showed 100% positive on samples spiked with 1 x LOD and 100% negative without virus. These substances did not interfere with the QuickProfile™ COVID-19 Antigen Test at the levels tested below.

REFERENCE

1. Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, et al. (15 February 2020). “Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study”. The Lancet. 395 (10223): 507–513.
2. Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, et al. (February 2020). “Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods”. Acta Pharmaceutica Sinica B. doi:10.1016.
3. “How to Protect Yourself & Others”. Centers for Disease Control and Prevention (CDC). 8 April 2020. Archived from the original on 26 February 2020. Retrieved 9 April 2020.
4. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. U.S. Department of Health and Human Services, CDC, NIH, Washington, DC (2007).
5. Henretig F.M. MD, King C. MD, Textbook of Pediatric Procedures, Chapter 123 – Obtaining Biologic Specimens Williams and Williams (April 1997).
6. The Clinical Virology Laboratory, Department of Laboratory Medicine at Yale: http://info.med.yale.edu/labmed/virology/booklet.html.
7. “Interim Guidance for Rapid Antigen Testing for SARS-CoV-2 Using Antigen Tests” (CDC), updated September 4, 2020, https://www.cdc.gov/coronavirus/2019-nCoV/resources/antigen-test-guidance.html.