LumiQuick COVID-19 Antigen Test Instructions for Use

COVID-19 Antigen Test

FOR THE QUALITATIVE ASSESSMENT OF SARS-COV-2 VIRUS IN THE NASAL SECRETIONS

Note: The kit components featured in the procedural illustrations may differ from those provided in the kit. Refer to the Material Provided section of this document 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.

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 conjugate to colloidal gold as the detection probe. When the test strip is dipped into the sample extracts from the nasopharyngeal swab, if the extracted specimen contains SARS-CoV-2 viral antigens, the antigens will form the antigen-antibody complex with antiSARS-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. Instructions for Use must be read and followed carefully for accurate results.
3. Do not use the kit contents beyond the expiration date printed on the outside of the box.
4. Do not interchange or mix different lots of components of QuickProfile™ COVID-19 Antigen Test.
5. Do not insert the test strip directly into the sampling area (mouth, nasal).
6. Disregard test results beyond specified time (10 minutes).
7. Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used kit contents.
8. Use of protective tools are recommended when handling patient samples.
9. Dispose of containers and used contents in accordance with Federal, State and Local requirements.
10. Do not reuse kit components.
11. The test strip must remain sealed in the protective foil pouch until use.
12. Inadequate or inappropriate specimen collection, storage, and transport may yield inaccurate test results.
13. Seek specific training or guidance if you are not experienced with specimen collection and handling procedures.
14. 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-2viruses 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 strips must be kept in the sealed pouch until use.

MATERIALS PROVIDED

1. Test Strip (20 strips): 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. Instructions for Use (1 copy)

MATERIALS REQUIRED BUT NOT SUPPLIED

1. Specimen collection container
2. Timer
3. Personal Protection 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. Therefore,
to collect a nasopharyngeal swab sample, carefully insert the sterile swab into the nostril that presents the most secretions under visual inspection. Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab several times then remove it from the nasopharynx.

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.

1. Check the expiration date on each component’s package or outer box before use. Do not use any test material beyond the labelled expiration date.

2. Bring the kit components to room temperature before testing.

3. Open the pouch and remove the test strip. Once opened, the test strip must be used immediately.

4. Add 15 full drops (350 – 400 µL) of extraction buffer into the extraction tube.

5. Place the swab with sample into the extraction tube. Roll the swab three to five (3-5) times.

6. Leave the swab in the extraction buffer for 1 minute. Roll the swab head against the side of the extraction tube as you remove it. Dispose of the used swab in accordance with your biohazard waste disposal protocol.

7. Place the test strip into the extraction buffer with the arrows on the test strip pointing down.

8. Do not remove the test strip from the tube until the test is completed. Read result at 10 minutes. Some positive results may appear earlier.

Note: Results after 10 minutes may not be accurate. 

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. Failure to follow the Test Procedure and interpretations of Test Results may adversely affect test performance and/or invalidate the Test Results.
4. Test Results must be evaluated in conjunction with other clinical data available to the physician.
5. 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.
6. Positive test results do not rule out co-infections with other pathogens.
7. 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

Positive result

At 10 minutes, the appearance of any shade of a red color band below the dark purple control band, indicates a positive result for the presence of SARSCoV-2 viral antigen. Report positive test results as ‘Positive for SARS-CoV-2 viral antigen’. A positive
result does not rule out co-infections with other pathogens.

Negative result

At 10 minutes, the appearance of ONLY the dark purple control band indicates SARS-CoV-2 viral antigen were not detected. A negative result indicates that the sample is negative for antigen or the antigen level is below the detection limit. A negative result does not exclude SARS-CoV-2 viral infection and should be confirmed by molecular diagnostic method if COVID-19 disease is suspected.

Invalid result

If at 10 minutes, the dark purple control band does not appear, regardless if a test band appears, the result is considered invalid. If the test is invalid, a new test should be performed with a new patient sample and a new test strip.

PERFORMANCE CHARACTERISTICS

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 confirmed by testing a total of 10 replicates at the target concentration to demonstrate detection at least 95% of the time.

Cross Reactivity

The cross reactivity of the QuickProfile™ COVID-19 Antigen Test was evaluated with a total of 6 bacteria, 13 viruses. Bacteria were evaluated at a concentration over 108 CFU/ml. Viruses were evaluated at a concentration of over 104 TCID50 /ml. None of the microorganisms tested in the following table gave a positive result.

Reproducibility

An evaluation of the QuickProfile™ COVID-19 Antigen Test was conducted at three laboratories using 48 coded samples. Testing was performed by training personnel with educational background
at three different locations. The study panel contained negative, high negative, low positive and moderate positive samples. Each sample level was tested at each site by two operators. The results obtained at each site agreed

99% with what was expected. The data analyses support the hypothesis that QuickProfile™ COVID-19 Antigen Test is easily reproducible by different operators and can be performed with little to no difficulty.

SPECIFICITY

Exogenous (Nasal spray product, common chemicals) and endogenous substances were evaluated and did not interfere with the QuickProfile™ COVID-19 Antigen Test at the levels tested below.

REFERENCES

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.

LumiQuick Diagnostics, Inc.
2946 Scott Blvd.
Santa Clara, CA 95054, USA
Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd, 2595AA,
The Hague, Netherlands
Tel : (408) 855.0061
Fax: (408) 855.0063
Email: info@lumiquick.com
www.lumiquick.com

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