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 

3.

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. 

DO NOT open the individual 

pouches until instructed to

do so.

MATERIALS PROVIDED:

1x Swab

1x Test Card in Pouch

1x Test 

Tube

1x Dropper

Top

1x Buffer 

Solution

Timer Not Included

It is recommended that gloves 

are used during testing. A face 

mask should be worn if swabbing

others. Gloves and face mask are

not provided.

5.

Open large test card pouch

and place the test card 

on flat surface. 

DO NOT touch any 

parts on the insides 

of the test card.

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 1⁄2 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. 

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.

Squeeze 

and massage 

swab 5x

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.

DO NOT apply the 

liquid in the rectangular

results window.

Attach tip

Swirl 5x

3 Drops

Results window Sample well

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 Day 

of Testing

First Second 

Result Result

Day 1 Day 3

Third 

Result

Day 5

Interpretation

Positive N/A N/A Positive for 

COVID-19

With

Symptoms Negative Positive N/A Positive for 

COVID-19

Negative Negative N/A Negative 

for COVID-19

Positive N/A N/A Positive for 

COVID-19

Without

Symptoms

Negative Positive

Negative Negative

N/A

Positive

Positive for 

COVID-19

Positive for 

COVID-19

Negative Negative Negative 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.
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

Distributed by: 

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.poisonhelp.org or 1-800- 222-1222. 

Chemical Name GHS Code for 

each Ingredient Concentrations

Proclin 300 H317, allergic skin

reaction 0.1%

Trimethylsilyl 

acetamide

H316, mild skin 

irritation 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 Date of manufacture

Contains sufficient for

<n> tests

Catalogue number

Temperature limit Use-by date

Do not reuse Batch code

#33 - 01/23
Speedy Swab Rapid COVID-19 Antigen Self-Test

Test Card

For the most current expiration dates of this test, 

please refer to: https://www.fda.gov/covid-tests. 
Speedy Swab Rapid COVID-19 Antigen Self-Test

1 Test/Box – Outer box

Instructions for use in box

Positive result

For In Vitro Diagnostic Use

gov/covid-tests. fda.. xpiration dates of this test, please refer to: https://www For the most current e

. VID-19 reasons to suspect CO

without symptoms or other epidemiological 

6 days of symptom onset, or individuals 

VID-19 within the first with symptoms of CO

tests. The test is authorized for individuals 

over five days with at lest 48 hours between 

nasal swabs when tested at least three times 

-2 in anterior VARS-Co protein antigen from S

uses antibodies to detect nucleocapsid 

est is a lateral flow immunoassay that Self-T

VID-19 Antigen apid CO wab R The Speedy S
Speedy Swab Rapid COVID-19 Antigen Self-Test

2 Test/Box – Outer box

Instructions for use in box

Positive result

gov/covid-tests. fda.. xpiration dates of this test, please refer to: https://www For the most current e

. VID-19 reasons to suspect CO

without symptoms or other epidemiological 

6 days of symptom onset, or individuals 

VID-19 within the first with symptoms of CO

tests. The test is authorized for individuals 

over five days with at lest 48 hours between 

nasal swabs when tested at least three times 

-2 in anterior VARS-Co protein antigen from S

uses antibodies to detect nucleocapsid 

est is a lateral flow immunoassay that Self-T

VID-19 Antigen apid CO wab R The Speedy S
Speedy Swab Rapid COVID-19 Antigen Self-Test

4 Test/Box – Outer box

Instructions for use in box

Positive result

gov/covid-tests. fda.. xpiration dates of this test, please refer to: https://www For the most current e

. VID-19 reasons to suspect CO

without symptoms or other epidemiological 

6 days of symptom onset, or individuals 

VID-19 within the first with symptoms of CO

tests. The test is authorized for individuals 

over five days with at lest 48 hours between 

nasal swabs when tested at least three times 

-2 in anterior VARS-Co protein antigen from S

uses antibodies to detect nucleocapsid 

est is a lateral flow immunoassay that Self-T

VID-19 Antigen apid CO wab R The Speedy S
Speedy Swab Rapid COVID-19 Antigen Self-Test

25 Test/Box – Outer box

Easy esults Quick R Self-test

Scan for IFU 

For the most current expiration dates of this test, please refer to: https://www.fda.gov/covid-tests. 

Positive result

Instructions for use in box

The Speedy Swab Rapid COVID-19 Antigen Self-Test 

is a lateral flow immunoassay that uses antibodies to 

detect nucleocapsid protein antigen from SARS-CoV-2 

in anterior nasal swabs when tested at least three 

times over five days with at lest 48 hours between 

tests. The test is authorized for individuals with 

symptoms of COVID-19 within the first 6 days of 

symptom onset, or individuals without symptoms or 

other epidemiological reasons to suspect COVID-19. 
Speedy Swab Rapid COVID-19 Antigen Self-Test

1 Test/Box – Outer box

LFA0401-1N - 1 Test/Box - 500 Test Kits/Carton LFA0401-1N - 1 Test/Box - 500 Test Kits/Carton 

2 Test/Box – Outer box

2

LFA0401-2N - 2 Tests/Box - 500 Test Kits/Carton 

2

LFA0401-2N - 2 Tests/Box - 500 Test Kits/Carton 

4 Test/Box – Outer box

LFA0401-4N - 4 Tests/Box - 100Test Kits/Carton LFA0401-4N - 4 Tests/Box - 100 Test Kits/Carton 

25 Test/Box – Outer box

LFA0401-25N - 25 Tests/Box - 40 Test Kits/Carton LFA0401-25N - 25 Tests/Box - 40 Test Kits/Carton 

For Emergency Use Authorization (EUA) only.