Rapid COVID-19 Antigen Self Test

Product Information

This product is distributed by [Distributor Name]. It is
intended for in vitro diagnostic use.

User Instructions

Please carefully read the instructions below before performing
the test. Failure to follow the instructions may result in
inaccurate test results.

Before Getting Started

1. Wash or sanitize your hands. Make sure they are dry before
   proceeding.

2. Check the expiration date on the back of the box. DO NOT use if
   expired.

Prepare the Materials

1. Bring the test to room temperature. On a flat level surface,
   retrieve all the materials from the box and place the empty box in
   front of you for further use. Tests are available in 1, 2, 4, and
   25 pack boxes.

2. Arrange the materials on a clean, dry, flat surface. Your box
   may contain more than one test kit. Use only 1 of each of the
   materials provided for each test.

   • MATERIALS PROVIDED:
   • 1x Swab
   • 1x Test Card in Pouch
   • 1x Dropper Top
   • DO NOT open the individual pouches until instructed to do
     so.

3. Open the large test card pouch and place the test card on a
   flat surface.

4. Remove the test tube from its pouch and press it into the
   marked hole on the front of the box.

5. Twist the top off the buffer solution and pour all of it into
   the test tube. If any liquid spills and does not enter the tube,
   discard the test kit and start again with a new test kit.

Performing the Test

1. Open the swab package from its stick end and remove the swab
   without touching the swab head.

2. Swab both nostrils carefully with the soft tip as shown:

   • Step A) Insert 1/2 to 3/4 of an inch. DO NOT insert the swab
     any farther if you feel any resistance.

   • Step B) Using medium pressure, rub and rotate the swab against
     the inside of the first nostril, making at least 5 circles (taking
     about 15 seconds).

   • Make at least 5 big circles for 15 seconds per nostril.

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

3. Completely immerse the swab tip in the solution in the tube and
   mix well by rotating at least 10 times with one hand while holding
   the box with the other. Be sure to mix thoroughly.

4. While holding the swab stable in the liquid, take the test tube
   out of the box. Squeeze and massage the swab 5 times to remove as
   much of the liquid from the swab as possible. Failure to squeeze
   the tube can lead to incorrect results due to excess buffer in the
   swab. Discard the swab.

5. Remove the dropper tip from its pouch and push it securely into
   the tube. Swirl the tube 5 times. Turn the test tube over, hold it
   straight up and down, and gently squeeze 3 drops into the sample
   well on the test card. DO NOT apply the liquid in the rectangular
   results window.

6. Set the timer and read the test result at 15 minutes. DO NOT
   disturb the card during this time. Inaccurate results can occur if
   the card is disturbed/moved or test results are read before 15
   minutes.

Distributed by:

For In Vitro Diagnostic Use
USER INSTRUCTIONS
Carefully read the instructions below before performing the test. Failure to follow the instructions may result in inaccurate test results.
STORAGE AND STABILITY Store kit between36-86°F (2-30°C). Ensure all test components are at room temperature before use. The Speedy Swab Rapid Covid-19 Antigen Self-Test is stable until the expiration date marked on the outer packaging and containers. Do not use beyond the expiration date. For the most current expiration dates of this test, please refer to: https://www.fda.gov /covid-tests.
BEFORE GETTING STARTED

1. Wash or sanitize your hands. Make sure they are dry before proceeding.

2. Check the expiration date on the back of the box.
   DO NOT use if expired.
   PREPARE THE MATERIALS

Bring test to room temperature. On a flat level surface, retrieve all the materials from the box and place the empty box in front of you for further use.

Tests are available in 1, 2, 4, and 25 pack boxes.

4. Arrange the materials on a clean, dry, flat surface.
   Your box may contain more than one test kit. Use only 1 of each of the materials provided for each test.

MATERIALS PROVIDED: 1x Swab
1x Test Card in Pouch

DO NOT open the individual pouches until instructed to do so.

1x Dropper Top

Open large test card pouch 1x Test

and place the test card

Tube

1x Buffer Solution

on flat surface.

Timer Not Included

DO NOT touch any parts on the insides

It is recommended that gloves are used during testing. A face mask should be worn if swabbing

of the test card.

others. Gloves and face mask are

not provided.

6. Remove test tube from it’s pouch. Press the test tube into the marked hole on the front of the box.

7. Twist the top off of the buffer solution and pour all of it into the test tube.
   If any liquid spills and does not enter into the tube, discard test kit, and re-start test using a new test kit.
   PERFORMING THE TEST

8. Open swab package from its stick end and remove the swab from this end.
   DO NOT touch the swab head.

9. Swab both nostrils carefully with the soft tip as shown.
   Step A) Insert 1/2 to 3/4 of an inch DO NOT insert the swab any farther if you feel any resistance. Step B) Using medium pressure, rub
   and rotate the swab against the inside of the first nostril, making at least 5 circles (taking about 15 seconds).
   Make at least 5 big circles
   15 seconds per nostril
   Step C) Repeat in the other nostril. 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 of an inch for very young children, you may need another person to steady the child’s head while swabbing.

STOP Check: Did you swab BOTH nostrils?

NOTE: inaccurate test results may occur if the nasal sample is not properly collected.

10. Completely immerse the swab tip in the solution in the tube and mix well by rotating at least 10 times with one hand while holding the box with the other.

Be sure to mix thoroughly.

11. While holding the swab stable in the liquid, take the test tube out of the box.

Squeeze and massage
swab 5x

Raise the swab tip out of the buffer, holding it in place within the side walls of the tube, and squeeze the tube
5 times to remove as much of the liquid from the swab as possible. Failure
to squeeze the tube can lead to incorrect results due to excess buffer in the swab.

Discard the swab.

Attach tip

12. Remove dropper tip from it’s pouch. Push the dropper tip securely into the tube and swirl 5 times. Turn test tube over, hold it straight up and down, and gently squeeze 3 drops into the sample well on the test card.

Swirl 5x 3 Drops

DO NOT apply the

Results window Sample well

liquid in the rectangular

results window.

13. Set the timer and read the test result at 15 minutes. (Timer Not Included)
    DO NOT disturb the card during this time. Inaccurate results can occur if the card is disturbed/moved or test results are read before 15 minutes.

DO NOT interpret test results after 30 minutes.

NOTE: Inaccurate test interpretations may occur if results are read before 15 minutes or after 30 minutes.

TEST RESULT INTERPRETATION

Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results for COVID-19.

Status on First Second First Day Result Result of Testing Day 1 Day 3
Positive N/A W Syimthptoms Negative Positive
Negative Negative

Third Result Day 5
N/A
N/A
N/A

Positive N/A

N/A

W Syimthpotuotms Negative Positive

N/A

Negative Negative Positive

Negative Negative Negative

Interpretation
Positive for COVID-19 Positive for COVID-19 Negative for COVID-19 Positive for COVID-19 Positive for COVID-19 Positive for COVID-19 Negative for COVID-19

Results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.

NEGATIVE

If the Control (C) line is visible, but the Test (T) line is not visible, the test is negative. To increase the chance that the negative result for COVID-19 is accurate, you should: – Test again in 48 hours if you have symptoms on the first day of testing. – Test 2 more times at least 48 hours apart if you do not have symptoms on the first day of testing.
A negative test result indicates that the virus that causes COVID-19 was not detected in your sample. A negative result is presumptive, meaning it is not certain that you do not have COVID-19. You may still have COVID-19 and you may still be contagious. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR. If you test negative and continue to experience COVID-19-like symptoms, (e.g., fever, cough, and/or shortness of breath) you should seek follow up care with your health care provider.
POSITIVE

If the Control (C) line and the Test (T) line are visible, the test is positive. Any faint visible red test (T) line with the control line (C) should be read as positive. You do not need to perform repeat testing if you have a positive result at any time.
A positive test result means that the virus that causes COVID-19 was detected in your sample and it is very likely you have COVID-19 and are contagious. Please contact your doctor/ primary care physician or your local health authority immediately and adhere to the local guidelines regarding self- isolation. There is a very small chance that this test can give a positive result that is incorrect (a false positive).

INVALID

If the control (C) line is not visible, the test is invalid. Re-test with a new swab and new test device.

AFTER TEST IS COMPLETED,
DISPOSE OF USED MATERIALS
IN HOUSEHOLD TRASH.
Report your test result(s) at www.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.

Distributed by:
In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3 (b)(1), unless the declaration is terminated or authorization is revoked sooner.
· In Vitro Diagnostic (IVD) use only. · For Emergency Use Authorization (EUA) only. · Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results. · An anterior nasal swab sample can be self-collected by an individual age 14 years and older. Children age 2 to 13 years should be tested by an adult. · For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness- andresponse/mcm-legal -regulatory-and-policy-framework/emergency-use- authorization · For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19
INTENDED USE
The Speedy Swab Rapid COVID-19 Antigen Self-Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. The Speedy Swab Rapid COVID-19 Antigen Self-Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. 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. Individuals who test positive with the Speedy Swab Rapid COVID-19 Antigen SelfTest should self- isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary. All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results

should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.
Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider.
Individuals should provide all results obtained with this product to their healthcare provider for public health reporting and to receive appropriate medical care. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.
The Speedy Swab Rapid COVID-19 Antigen Self-Test is intended for non- prescription self-use and/or as applicable an adult lay user testing another person 2 years of age or older in a non-laboratory setting.
The Speedy Swab Rapid COVID-19 Antigen Self-Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved.
HOW TO USE THIS TEST
Serial testing should be performed in all individuals with negative results; individuals with symptoms of COVID-19 and initial negative results should be tested again after 48 hours. Individuals without symptoms of COVID-19, and with initial negative results, should be tested again after 48 hours and, if the 2nd test is also negative, a 3rd time after an additional 48 hours. You may need to purchase additional tests to perform this serial (repeat) testing.
If you test negative but continue to have symptoms of COVID-19, and both your first and second tests are negative, you may not have COVID-19, however you should follow-up with your healthcare provider.
If your test is positive, then proteins from the virus that causes COVID-19 have been found in your sample and you likely have COVID-19.
WARNINGS, PRECAUTIONS,
AND SAFETY INFORMATION
· Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results. · In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. · Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests)
for symptomatic individuals and three times over five days (with at
least 48 hours between tests) for asymptomatic individuals. You
may need to purchase additional tests to perform this serial
(repeat) testing. · If you have had symptoms longer than 6 days you should consider testing at least three times over five days with at least 48 hours between tests. · An anterior nasal swab sample can be self-collected by an individual age 14 years and older. Children age 2 to 13 years should be tested by an adult. · Do not use on anyone under 2 years of age. · Wear a safety mask or other face-covering when collecting a

· Test components are single-use. Do not re-use. · Do not use kit past its expiration date. · Do not touch the swab tip. · Once opened, the test card should be used within 60 minutes. · Do not read test results before 15 minutes or after 30 minutes. Results read before 15 minutes or after 30 minutes may lead to a false positive, false negative, or invalid result. · Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your [e.g., 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 [e.g., e.g., skin, eyes, nose, or mouth], flush with large amounts of water.
If irritation persists, seek medical advice: https://www.poison-
help.org or 1-800- 222-1222.

Chemical Name Proclin 300 Trimethylsilyl acetamide

GHS Code for each Ingredient H317, allergic skin reaction H316, mild skin irritation

Concentrations 0.1% 0.03%

· For more information on EUAs please visit: https://www.fda.gov/emergency- preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency- use-authorization · For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19

FREQUENTLY ASKED QUESTIONS
Q: WHAT ARE THE KNOWN AND POTENTIAL RISKS AND BENEFITS
OF THE TEST? A: 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 potential spread of COVID-19 to your family and others in your community.
For more information on EUAs go here: https://www.fda.gov/emergencypreparedness- and-response/mcm-legal-regulatory- and-policy-framework/emergencyuse-authorization
Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND
MOLECULAR TEST? A: There are different kinds of tests for the SARS-CoV-2 virus that causes COVID-19. Molecular tests detect genetic material from the virus. Antigen tests, such as the Speedy Swab Rapid COVID-19 Antigen Self-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.
Q: HOW ACCURATE IS THIS TEST? A: Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. 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 WWW.SpeedySwab.com.
Q: WHAT IF I HAVE A POSITIVE TEST RESULT? A: A positive result means that it is very likely you have COVID-19 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.
Q: WHAT IF I HAVE A NEGATIVE TEST RESULT? A: A negative test result indicates that antigens from the virus that causes COVID-19 were not detected in your sample. However, if you have symptoms of COVID-19, and your first test is negative, you should test again in 48 hours since antigen tests are not as sensitive as molecular tests. If you do not have symptoms and received a negative result, you should test at least two more times with 48 hours in between tests for a total of three tests. If you have a negative result, it does not rule out SARSCoV-2 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.
Q: WHAT DOES AN INVALID TEST RESULT MEAN? A: An invalid result means the test was not able to tell if you have COVID-19 or not. 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.
LIMITATIONS
· 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 as compared to a molecular test, especially in samples with low viral load. · The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between January to June, 2022. 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 SARSCoV-2 and their prevalence, which change over time. · All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay may be necessary. If you continue to have symptoms of COVID-19, and both your first and second tests are negative, you may not have COVID-19, however you should follow-up with a healthcare provider. · If the test is positive, then proteins from the virus that causes COVID-19 have been found in the sample and you likely have COVID-19. · This test is read visually and has not been validated for use by those with impaired vision or color- impaired vision. · Incorrect test results may occur if a specimen is incorrectly collected or handled.
IMPORTANT
This test is intended to be used as an aid in the clinical diagnosis of infection with the virus that causes COVID-19. Do not use this test as the only guide to manage your illness. Please consult your healthcare provider if your symptoms persist or become more severe, or if you are concerned at any time. Individuals should provide all results obtained with this product to their healthcare provider for public health reporting.

INDEX OF SYMBOLS
Manufacturer Contains sufficient for