COVID-19 / Flu A&B Home Test QUICK REFERENCE INSTRUCTIONS

For in vitro diagnostic use.
For over-the-counter (OTC) use.
For use with anterior nasal swab specimens.

Carefully read all instructions before performing the test. Failure to follow the instructions may result in an incorrect test result. Refer to the Instructions for Use (IFU) for detailed information.

Link, Wellife home page
QR Code linking to WELLlife COVID-19/Flu A&B Home Test Product Page

Scan here to visit the product page

An anterior nasal swab sample can be self-collected by individuals aged 14 years or older. Children aged 2-13 years should be tested by an adult.

Warnings and Precautions

  • Do not use the test if you have had symptoms for more than 4 days or no symptoms at all.

  • Do not use if any of the test kit contents or packaging is damaged or opened.

  • When collecting a sample, only use the swab provided in the kit.

  • All test components are single-use. Do not reuse the test cassette, processing solution, or swab.

  • Testing should be performed in an area with good lighting.

  • Do not open the test contents until ready for use. If the test cassette is open for an hour or longer, invalid test results may occur.

  • Do not use this test if you have been vaccinated with the FluMist/FluMist quadrivalent live intranasal influenza virus vaccine within the last two weeks.

  • Do not conduct this test if you are prone to nose bleeds or have a nose injury.

  • Do not use this test if you are using nasal corticosteroids.

  • Do not use this test if you are using zinc-based throat sprays.

  • Remove any piercings from your 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 below).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 .

Scrollable Table
Chemical name Harms (GHS Code) for each ingredient Concentration
ProClin 300 Causes skin irritation (H315)
Causes eye irritation (H320) 		0.05%

For the most up-to-date information on COVID-19, please visit: cdc.gov/COVID19.

MATERIALS PROVIDED

Materials required but not provided: Timer or watch.

PREPARING FOR THE TEST

NOTE: Do not open the test materials until ready for use. If the test cassette is open for an hour or longer, invalid test results may occur.

1

WELLlife home test kit box showing a QR code and product information fields including REF number, LOT number, and expiration date. Symbols indicate the reference code, lot number, and a sand timer icon representing the expiration date formatted as YYYY-MM-DD.

Check the expiration date of the test printed on the bottom of the outer box.

2

Ensure all test components are at room temperature (15-30°C/59-86°F) before use.

3

Illustration of two hands being washed with soap, showing lather and bubbles to indicate hand hygiene.

WASH your hands with soap and water for 20 seconds or use hand sanitizer and dry them thoroughly.

4

Illustration of a rectangular box marked with a red circle labeled 'TUBE HOLDER.

LOCATE the tube holder on the box
(look for the red circle on the kit's box).

5

Step-by-step illustration showing (a) inserting a buffer tube into the circle labelled tube holder and (b) twisting to remove the cap from the buffer tube.

a) INSERT the buffer tube into the tube holder. Ensure that the buffer tube is stable and upright.
b) REMOVE the large cap from the buffer tube and set it aside for later use.

6

Illustration showing a test cassette being pulled out of its sealed pouch, with a purple arrow indicating the direction to pull out.

REMOVE test cassette from sealed pouch and lay it on a flat surface.

Sample Collection

7

Illustration of two hands pulling apart the packaging to open a swab wrapper, revealing the swab inside. A double-headed purple arrow indicates the pulling direction.

REMOVE the swab from the pouch.

⚠️ Be careful not to touch the swab tip (soft end) with your hand.

8a

Illustration showing a swab inserted into the right nostril, with arrows indicating it should be rotated five times inside the nostril.

a) CAREFULLY INSERT the swab no more than 3/4 inch (1.5 cm) into the nostril. Slowly rotate the swab at least 5 times against the nostril wall.

⚠️ Do not insert the swab any further if you feel any resistance.

8a

Illustration showing a swab inserted into the left nostril, with arrows indicating it should be rotated five times inside the nostril.

b) REMOVE the swab and repeat in the other nostril using the same swab.

⚠️ Check: Did you swab 5x BOTH nostrils?

NOTE: If you are swabbing others, please wear a face mask. With children, the maximum depth of insertion into the nostril may be less than ½ to ¾ of an inch, and you may require another adult to hold the child’s head while swabbing. NOTE: Failure to swab properly may cause false negative results. ​

Running the Test

9

Illustration showing a swab being stirred inside a buffer tube in a circular motion ten times, with two purple arrows indicating the circular motion and the text '10 circles' on the right.

IMMERSE the swab into the buffer tube and SWIRL the swab in the buffer. Ensure the sample is mixed thoroughly by making at least 10 circles.

⚠️ Sample must be adequately mixed into the buffer, otherwise, incorrect results may occur.

10

Illustration showing a swab left standing inside a buffer tube placed in a tube holder, with the instruction to leave it for 1 minute.

LEAVE the swab in the buffer tube for 1 minute. A timer is recommended for this step.

11

Illustration showing the sides of a buffer tube being squeezed with two purple arrows pointing inward, indicating to press the tube while removing the swab.

After 1 minute, PINCH the tip of the swab from the outside of the tube to remove any excess liquid from the swab.
REMOVE and DISCARD the swab.

12

Two-step illustration: (a) shows twisting the dropper cap back onto the buffer tube; (b) shows removing the small tip from the dropper cap to prepare for dispensing.

a) HOLD the buffer tube upright and SCREW the large cap back onto the tube. Ensure a tight fit to prevent leaking.
b) TWIST to open the small cap at the top of the tube.

13

Illustration showing a buffer tube squeezing four drops into the sample well of a WELL life test cassette. Arrows point to the sample well and result window, with the instruction '4 drops' and squeeze arrows on the tube.

INVERT: the buffer tube and SQUEEZE 4 drops of test sample into the sample well on the test cassette. Then DISCARD the buffer tube.

  • NOTE: Incorrect results may be observed if <4 drops of sample are added.
⚠️ Sample must be applied to the test cassette within one hour of completing step 8.

14

Illustration of a clock showing a 10-minute countdown, with the text '10 minutes' below.

START timer.
Read results at 10 minutes.

⚠️ Do not interpret results before 10 minutes or after 20 minutes. Inaccurate test interpretations may occur.

INTERPRETING YOUR RESULTS

Look for lines next to ‘C’(Control), ‘F-A’, ‘F-B’ and ‘CoV’ C = Control Line F-A = Flu A Test Line F-B = Flu B Test Line CoV = COVID-19 Test Line A red line should always appear at the ‘C’ position; this is a control line and signals that the test is working properly.

INVALID RESULT

Illustration showing multiple examples of invalid test results for a multi-line diagnostic cassette. Each test strip is missing the control line despite any other line patterns. A red arrow points to the control portion of the cassette, showing that it is blank. The word 'Invalid' is written below all examples.

Check to see if a pink to red line is visible at the control line ‘C’ in the results window. If a line is not visible at “C", even if any other line is visible in the results window, the result is considered invalid.

⚠️ If you do not see a C line, DO NOT CONTINUE reading the results. It means your test is invalid. Repeat the test with a new sample and new test kit materials.

NEGATIVE RESULT

Test cassette showing a single line at the control line (C) position with no visible lines at F-A, F-B, or CoV. Labeled 'Negative' below the image.

If a control ‘C’ line is visable and you do not see a line at ‘F-A’ , ‘F-B’ or ‘CoV’ , it means the test is negative. The Flu A, Flu B or COVID-19 virus have not been detected.

If respiratory symptoms persist, you should seek follow-up care with your healthcare provider.

POSITIVE RESULT

Illustration showing seven different positive test result patterns on diagnostic cassettes. Each cassette includes a control line (C) and various combinations of lines at F-A, F-B, and CoV positions. The results shown are labeled as: COVID-19 Positive, Flu A Positive, Flu B Positive, Flu A + COVID-19 Positive, Flu B + COVID-19 Positive, Flu A + Flu B Positive, and Flu A + B + COVID-19 Positive. The Flu A Positive correlating to any pink F-A lines, the Flu B Positive correlating to any pink F-B lines, and COVID-19 Positive correlating to any pink CoV lines.

If the control line at 'C' is visible and any other line or multiple lines on ‘F-A’, ‘F-B’ and/or ‘CoV’ are visible, the test is positive for that virus.

NOTE: Any pink to red test line, no matter how faint, should be considered a positive result when the control line is also present.

UNDERSTANDING YOUR RESULTS

Invalid Result: The test could not tell whether or not you have COVID-19, influenza A (Flu A), or influenza B (Flu B). The test needs to be repeated with a new kit and sample. Negative Result: The virus from COVID-19, Flu A, and/or Flu B were not detected in the sample. A negative result does not mean it is certain that you do not have COVID-19, Flu A and/or Flu B 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 seek follow-up care with your healthcare provider. All negative results should be treated as presumptive and confirmation with a molecular assay may be necessary. Negative results do not rule out SARS-CoV-2, Flu A, and/ or Flu B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Positive Result: The SARS-CoV-2, Flu A and/or Flu B virus(es) were detected in your sample. It is very likely that you have the respective infection(s) and are contagious. Please contact your healthcare provider or your local health authorities and follow local guidelines for self isolation. There is a small chance that this test can give you a positive result that is incorrect (a false positive). Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

RESULTS REPORTING

Report your test result(s) at MakeMyTestCount.Org–this voluntary and anonymous reporting helps public health teams understand COVID-19 spread across the country and informs public health decisions.

INTENDED USE

The WELLlife™ COVID-19 / Flu A&B Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARSCoV-2 nucleocapsid antigen 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 providers. 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.

Storage and Stability

  • Store the test kit between 36-86°F (2-30°C) in a place out of direct sunlight.
  • Reagents and devices must be used at room temperature (59-86°F/15-30°C).
  • The unsealed cassette is valid for 1 hour. It is recommended to use the test kit immediately after opening. The expiration date is on the package. Do not use beyond the expiration date.

LIMITATIONS

  • The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between December 2023 and March 2024. The clinical performance has not been established for all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation.  Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
  • A negative test result may occur if the level of antigen in the sample is below the detection limit of the test or if the sample is collected or handled 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, influenza A, and/or influenza B is low in the sample.
  • Persons with risk factors for severe disease from respiratory pathogens (e.g. young children, elderly individuals, individuals suffering from chronic lung disease, heart disease, a compromised immune system, diabetes, and other conditions) should contact a healthcare provider; users should also contact a healthcare provider if symptoms persist or 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 a 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 and may or may not correlate with viral culture results performed on the sample.
  • Hand soap and hand sanitizers 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.
  • Zinc-based throat sprays may cause false positive influenza A results with this test.
  • Nasal corticosteroids may cause false negative results with this test.
  • This test does not distinguish between SARS-CoV and SARS-CoV-2.

FREQUENTLY ASKED QUESTIONS

Potential risks include:

  • Possible discomfort during sample collection.
  • Possible incorrect test result (see Warnings and Result Interpretation sections for more information).

Potential benefits include:

  •  The results, along with other information, can help you and your healthcare provider make informed recommendations about your care. 
  • The results of this test may help limit the spread of COVID-19 and flu to the family of the tested individual and others in your community.

There are different kinds of tests for the viruses that cause COVID-19 and the flu. Molecular tests detect genetic material from the virus. Antigen tests, such as the WELLlife™ COVID-19 / Flu A&B Home Test, detect proteins from the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.

A positive result means that it is very likely you have COVID-19 or influenza because proteins from the virus that causes COVID-19 were found in your sample. You should self-isolate from others and contact a healthcare provider for medical advice about your positive result.

A negative test result indicates that antigens from the virus that causes COVID-19 or influenza were not detected in your sample. If you have a negative result, it does not rule out SARS-CoV-2 or influenza infection; you may still be infected and you may still infect others. It is important that you work with your healthcare provider to help you understand the next steps you should take.

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 Instructions for Use (IFU), available at: https://wondfousa.com/.

An invalid result means something with the test did not work properly. If the test is invalid, a new swab should be used to collect a new nasal specimen and you should test again with a new test.

Contact Wondfo Product Support at +1 (888) 444-3657 (9:00 a.m. to 5:30 p.m. CDT M-F) or wondfo@wondfousa.com.

IMPORTANT: Do not use this 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.

If uncertain how to proceed, contact Technical Assistance at +1 (888) 444-3657 (9:00 a.m. to 5:30 p.m. CDT M-F) or wondfo@wondfousa.com.

INDEX OF SYMBOLS

Black circled number two with a diagonal line crossing through it, representing a 'Do not reuse' icon.

Do not re-use

Black hourglass outline with the bottom half filled in, representing a 'Use-by date' icon.

Use-by date

Black umbrella with six water droplets hitting the top, representing a 'Keep dry' icon.

Keep dry

Black rectangle around the letters "LOT", representing the "Batch Code" icon.

Batch code

Black book outline with a letter "i" on the right page, representing "Consult instructions for use" icon.

Consult instructions for use

Black outline of a sun shining over a black outline of a house below, representing 'Keep away from sunlight' icon.

Keep away from sunlight

Black outline of a thermometer halfway filled in, with a diagonal line across labelled with 30°C/86°F and 2°C/36°F on the other end, representing 'Store at 36~86°F/2~30°C' icon.

Store at 36~86°F/2~30°C

A filled silhouette of a factory consisting of three peaks next to a taller chimney

Manufacturer

Black rectangle around the letters 'REF', representing the 'Catalogue number' icon.

Catalogue number

Black circling of a black cube outline with a cracked line within the cube being crossed out with a diagonal line, representing 'Do not use if package is damaged' icon.

Do not use if package is damaged

Black rectangle around the letters 'REF', representing the 'Catalogue number' icon.

In Vitro diagnostic medical device

SUPPORT

If you have questions regarding the use of this product, or if you want to report a problem with the test, please contact Wondfo Product Support at +1 (888) 444-3657 (9:00 a.m. to 5:30 p.m. CDT M-F) or Wondfo USA Co., Ltd. Product Support website: https://wondfousa.com/.

A filled silhouette of a factory consisting of three peaks next to a taller chimney

Wondfo USA Co., Ltd.

6720 Cobra Way, San Diego, CA 92121 +1 (630) 468-2199 www.wondfousa.com Made in USA

Rev. B1
Rel.: 2025/04/28