Quick Reference Instructions

QuickFinder™ COVID-19/Flu Antigen Self Test

For Over The Counter Use. For in vitro diagnostic use. For use with anterior nasal swab specimens.

Product Information

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Carefully read the instructions below before performing the test. Failure to follow the instructions may result in inaccurate test results. Refer to the full Instructions for Use (IFU) for complete information.

An anterior nasal swab sample can be self-collected by an individual age 14 years and older. Children aged 2-13 years should be tested by an adult. Do not use for testing children younger than 2 years of age.

Warnings, Precautions, and Safety Information

  • Do not use the test if you have had symptoms for more than 4 days or no symptoms at all.
  • Do not use the test if the test kit components or packaging is damaged or opened.
  • When collecting a sample, only use the swab provided in the kit.
  • Test components are for single-use. Do not re-use.
  • Testing should be performed in an area with good lighting.
  • Once opened, the test cassette should be used immediately.
  • When the tests are stored at hot or humid conditions, faint lines may appear on the unused test strip prior to the addition of the sample. Do not read or interpret test results until after the sample has been added to the test cassette and the test has been allowed to run for 15 minutes.
  • Faint blue lines can occur near the ‘A’ position of the test strip with some Flu B samples at high viral loads. Only test lines that appear at both the correct position and in the correct color should be read and interpreted.
  • Do not use any nasal sprays, gels or creams at least 30 minutes before you collect a nasal sample.
  • Do not use this test if you have been vaccinated with the FluMist/Flu-Mist quadrivalent live intranasal influenza virus vaccine within the last two weeks.
  • Please ensure that hands are dry after washing prior to performing the test.
  • Remove any piercings from nose before starting the test.
  • Keep testing kit and kit components away from children and pets before and after use.
  • Avoid contact with your skin, eyes, nose, or mouth. Do not ingest any kit components. The reagent solution contains harmful chemicals (see table in the next column). If the solution contacts your skin, eyes, nose, or mouth, flush with large amounts of water. If irritation persists, seek medical advice: https://www.poisonhelp.org or 1-800-222-1222.
    Hazard Category (Mixture) GHS Hazard Statement for Mixture Labeling of Harm(s) Hazardous Ingredients (%)
    3 Mild skin irritation Causes mild skin irritation (H316) -Triton X-100 / 1%
    -Proclin 300 / 0.05%
    2 Serious eye irritation Causes serious eye irritation (H319) -Triton X-100 / 1%
    -Proclin 300 / 0.05%
  • For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19

Materials Provided

Sterile Swab

A swab in a narrow paper and plastic pouch with peel tabs by the thinner, stick end of the swab. The swab head on the opposite end is soft and rounded

Test Cassette

A flat, narrow, rectangular, plastic test cassette. From top to bottom, it features: a label “COVID-19 slash Flu,” a long oval indentation, a label “O-H-C,” a smaller oval indentation, and a label “droplet icon X 4”

Extraction Buffer Tube w/ solution

A narrow cylindrical tube with a wider top end and peelable foil seal, and a small amount of fluid inside

Filter Cap

A small cap with a narrow nozzle and wide base

Materials required but not provided:A clock or timer;

A timer

Recommended materials:Disposable gloves and mask, if swabbing others

Before Getting Started

Step

Check expiration date on the outside of the box. Do not use beyond the expiration date.

Step

Wash hands thoroughly for at least 20 seconds before and after handling nasal swab samples.

Hands washing with soap and water

Step

Before testing, read the Quick Reference Instructions carefully. Bring the test kit to room temperature (59-86°F) when you are ready to begin the test.

Step

Arrange the materials on a clean, dry, flat surface. Your box may contain one or more test kits. Use only one of each individually packaged kit and its components for each test.

DO NOT open the individual pouches until you are ready to begin the test.

Step

Open the foil pouch that contains the extraction buffer tube and filter cap.

A rectangular pouch labeled “Extraction buffer tube & filter cap,” torn open from a notch near one short end. The tube and cap are removed

Step

Pick up the extraction buffer tube and remove the sealing foil of the tube without spilling the buffer solution inside the tube.

Fingers pinch the small tab of the seal and peel it off the top of the tube

Step

Push the extraction buffer tube into the perforated tube holder located at the front of the box, labeled "Insert Tube Here."

The tube holder is a perforated circle on the bottom right corner of the box. A hand pushes the tube through the circle and leaves the tube standing upright

Step

Remove the Test cassette from its foil pouch.

DO NOT remove the test cassette until you are ready to begin the test.

A longer, rectangular, white and blue pouch labeled “O-H-C Osang Healthcare,” torn open across the short end from a notch in the edge near a long blue triangle. The test cassette is removed

Performing The Test

Step

Open swab package from the stick end, and remove the swab by the stick side.

DO NOT touch the swab head. Accidental contamination of the swab head with liquid gel soap can lead to false results.

A hand holds the swab by the thinner stick end

Step

Gently insert the swab head 1/2 to 3/4 inch into a nostril. For young children, swab should not be inserted more than 1/2 inch.

DO NOT insert the swab any farther if you feel any resistance.

Using medium pressure, rub and rotate the swab against the inside of the nostril, making at least 5 circles.

Swab head inserted into a nostril with text, “one half to three fourths of an inch”

NOTE: If you are swabbing others, please wear a face mask. With children, you may not need to insert the swab as far into the nostril. For very young children, you may need another person to steady the child's head while swabbing.

Step

Repeat in the other nostril using the same swab

Swab head moving around the inside of one nostril in circles, and then repeated again in the other nostril

5x each nostril

STOP: Did you swab BOTH nostrils? Inaccurate test results may occur if the nasal sample is not properly collected.

Step

Place the swab into the extraction buffer tube and completely immerse the swab head in the solution.

Vigorously mix the solution by rotating the swab forcefully against the side of the tube at least 10 times, keeping the swab tip submerged in the buffer solution the entire time.

A hand holds the tube, while another hand stirs the swab in circles several times, keeping the swab head at the bottom of the tube

Mix 10x

Step

Remove the swab while squeezing the tube with your fingers to ensure that the sample on the swab is fully mixed into the buffer solution.

A hand squeezes the tube near the middle, while another hand pulls the swab head through the squeezed portion

Squeeze the swab within the tube firmly

Step

Attach the filter cap onto the test tube.

Wide end of the filter cap pressed down into the tube with the narrow tip pointed up

Press cap downwards

Step

Squeeze only 4 DROPS of the buffer solution into the sample well.

Tube and cassette. Text indicates the “Sample well,” the smaller oval depression on the bottom end of the cassette. A hand holds the capped tube straight upside down at 90 degrees so the cap’s tip is just above the well. Four drops fall into the well

4 drops

DO NOT squeeze more than 4 drops from the tube into the sample well.

Step

Set a timer and read the result after 15 minutes

DO NOT disturb the cassette during this time. Inaccurate results can occur if the cassette is disturbed.

A timer shows 15 minutes. The cassette lies flat, and text indicates the “Results window,” the larger oval indentation on the top end of the cassette

Do NOT interpret test result before 15 minutes or after 30 minutes as this may result in false or invalid result.

Interpretation of Results

Test results are read and interpreted visually. Read result at 15-30 minutes with good lighting. Test results should not be read until after the sample has been added and the test has been allowed to run for 15 minutes, and only test lines that appear at the correct position and in the correct color should be read and interpreted.

Front of the test cassette with four evenly spaced horizontal lines across a rectangle in the center of the results window. The window is labeled along the right side with letters that line up with each of the lines. From top to bottom: C, S, B, and A. Lines by the C, S, and A are red, and the line by the B is blue
  • C = Control (red line)
  • S = COVID-19 (SARS-CoV-2) (red line)
  • B = Influenza B (blue line)
  • A = Influenza A (red line)

Look for lines next to ‘C’ (Control), ‘S’ (COVID-19), ‘B’ (Flu B) and ‘A’ (Flu A).

For ease of use, hold test cassette next to the example result images on this sheet

Invalid Results

If a control line is not visible at 'C' after 15 minutes, even if any other line is visible in the results window, the test has failed and is considered invalid.

Invalid. Two results windows. One is blank, and an arrow points at the empty space by the C at the top. The other shows no line by the C, one red line by S, a blue line by the B, and a second red line by A

DO NOT CONTINUE reading the results. Repeat the test with a new sample and new test kit materials.
STOP: If the test is invalid, repeat the test procedure using a new test kit and sample.

Note: The images displayed above are examples only; additional invalid outcomes are possible.

For a complete set of invalid results, see https://www.osangllc.com/products/quickfinder-covid-19-flu-antigen-tests

Negative Results

If the control line at 'C' is visible and you do not see a line at ‘S’, ‘B’, or ‘A’, the test is negative. It means you may not have COVID-19, Flu B or Flu A virus.

If you still have COVID-19, Flu B or Flu A symptoms, you should seek follow-up care with your healthcare provider.

Negative. Results window showing only one red line across the top by the C

Positive Results

If the control line at C is visible, and any other line or multiple lines on S, B and/or A appear, the test is positive.

This virus next to the positive line was detected in your sample.

COVID-19 Positive. Results window showing two lines: one red by C at the top, and one red by S just below that
Flu B Positive. Results window showing two lines: one red by C at the top, and one blue by the B near the middle
Flu A Positive. Results window showing two lines: one red by C at the top, and one red by A at the bottom
Flu B and COVID-19 Positive. Results window showing three lines: one red by C at the top, one red by S just below that, and one blue by the B near the middle
Flu A and COVID-19 Positive. Results window showing three lines: one red by C at the top, one red by S just below that, and one red by A at the bottom
Flu A and Flu B Positive. Results window showing three lines: one red by C at the top, one blue by B near the middle, and one red by A at the bottom
Flu A and B and COVID-19 Positive. Results window showing four lines: one red by C at the top, one red by S just below that, one blue by the B near the middle, and one red by A at the bottom

Consult your healthcare provider to discuss your positive test result. Self-isolate at home per CDC recommendations to stop spreading virus to others.

Additional Information: Reading Results

IMPORTANT:
Do not use the test as the only guide to manage your illness. Consult your healthcare provider if your symptoms persist or become more severe. Individuals should provide all results obtained with this product to their healthcare provider.

After test is completed, dispose of used materials in household trash.

Trash can icon

Storage and Stability

Store kit between 36-86°F in a place out of sunlight. Ensure all test components are at room temperature before use.

Intended use

The QuickFinder™ COVID-19/Flu Antigen Self Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider. Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

Frequently asked questions

  • Q: What does an invalid test result mean?
    A: If the control line (C) is not visible on the test strip, the test is invalid, even if any test line is visible. An invalid test result means that the test is unable to determine if you are infected with influenza or SARS-CoV-2 (COVID) or not. The test needs to be repeated with a new kit and sample.
  • Q: What does a negative result mean?
    A: A negative test result means that COVID-19, Flu A, and/or Flu B viruses were not detected in the sample. A negative result is presumptive because despite a negative result you may still have COVID-19, Flu A, and/or Flu B infection. This is because the amount of virus in your sample may be too low for the test to detect it, which is called a ‘false negative result’. False negative results can occur if you read your test result before the 15 minutes have passed or when your sample has only a low amount of virus in it. Low amount of virus can occur if you take your sample at a time when your symptoms just started appearing, or when you already started to feel better at the end of your infection. There is a higher chance of false negative results with antigen tests compared to laboratory-based molecular tests. If you tested negative and continue to experience COVID-19, Flu A, and/or Flu B-like symptoms, you should therefore seek follow-up care with your healthcare provider who will determine the best course of action. Your healthcare provider can also determine if confirmation of your test result with a molecular assay is necessary.
  • Q: What does a positive result mean?
    A: A positive test result means that any one, or multiple, of the viruses detected by this test were also detected in your sample. It is very likely that you have the respective COVID-19 or influenza infection(s) and are contagious. You should self-isolate following local guidelines. Please contact your physician or healthcare provider to discuss your tests results and followup care. In rare instances, individuals may also have coinfections with other bacteria or viruses that this test is not designed to detect. This means that the virus detected by this test may not be the definitive or the only cause of your disease. There is a very small chance that this test or influenza infection can give you a positive result that is incorrect (a false positive).
  • Q: What if I am uncertain how to interpret my results?
    A: If uncertain how to proceed, contact Technical Assistance at covidhometest@osangllc.com or 844-760-0556 (Mon. to Fri.: 9 a.m to 5 p.m. PST).
  • Q: Do I have to report my results? (optional)
    A: Report your test result(s) at MakeMyTestCount.org – this voluntary and anonymous reporting helps public health teams understand COVID-19 spread in your area and across the country and informs public health decisions. https://report.makemytestcount.org/
  • Q: What is the difference between an antigen and molecular test?
    A: There are different kinds of tests for the COVID-19 and influenza. Molecular tests detect genetic material from the virus. Antigen tests, such as the QuickFinder™ COVID-19/Flu Antigen Self Test, detect proteins from the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test may give you a false negative result.
  • Q: How accurate is this test?
    A: The QuickFinder™ COVID-19/Flu Antigen Self Test was compared to an FDA-cleared highly sensitive SARS-CoV-2 PCR test and an FDA-cleared highly sensitive Influenza A and B PCR test. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at https://www.osangllc.com/products/quickfinder-covid-19-flu-antigen-tests

Limitations

  • The clinical performance of this test was established based on the evaluation of a limited number of clinical specimens collected between October, 2023 to June, 2024. There is a risk of false negative results due to the presence of novel, emerging respiratory virus variants. Test accuracy may change as new virus variants of COVID-19 and influenza emerge. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of COVID-19 and influenza and their prevalence, which change over time. Additional testing with a laboratory-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.
  • A negative test result may occur if the level of antigen if the sample is below the detection limit of the test or if the sample is collected, handled, or transported improperly.
  • There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to the sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in an individual with COVID-19 and influenza as compared to a molecular test, especially in samples with low viral load.
  • False positive test results are more likely when the prevalence of SARS-CoV-2, Flu A/B is low in the community.
  • Persons with risk factors for severe disease from respiratory pathogens (e.g., young children, elderly individuals, chronic lung disease, heart disease, compromised immune systems, diabetes, and other conditions) should contact a healthcare provider.
  • All users should contact a healthcare provider if symptoms worsen.
  • This test is read visually. Because test lines can be very faint, users with conditions affecting their vision - such as far-sightedness, glaucoma, or color blindness - are encouraged to seek assistance to interpret results accurately (e.g., reading glasses, additional light source, or another person). This test has not been validated for use by those with color-impaired vision.
  • This device is qualitative test and cannot provide information on the amount of virus present in the specimen.
  • This test detects both viable (live) and non-viable influenza A, influenza B, and SARS-CoV-2. Test performance depends on the amount of virus (antigens) in the sample.
  • Liquid gel hand soap may cause false negative results with this test.
  • FluMist/FluMist quadrivalent live intranasal influenza virus vaccine may cause false positive influenza A and B results with this test.

Index of Symbols

Symbol Meaning
A filled silhouette of a factory consisting of three peaks next to a taller chimney Manufacturer
An upside-down triangle around a sideways M (the Greek capital letter Sigma) with an n near the bottom point Contains suffcient for <n> tests
A thermometer with a slanting min max line Temperature limit
The number two in a circle crossed out by a slanting line Do not reuse
A box with a damaged edge in a circle, crossed out by a slanting line Do not use if seal or packaging is broken or damaged
A triangle around an exclamation mark Caution
An outlined silhouette of a factory consisting of three peaks next to a taller chimney Date of manufacture
A box around capital REF Catalogue number
An hourglass with the bottom filled in Use-by date
A box around capital LOT Batch code
An open book with a lowercase letter i on one page Consult instructions for use
A box around capital IVD In vitro diagnostic