Nano-CheckTM COVID-19 Antigen 

At-Home Test Quick Reference Instruction 

Catalog No. MD-8150

For Use Under an Emergency Use Authorization(EUA) Only 

For In Vitro Diagnostic Use, For Use with Kit provided Swabs

IMPORTANT! 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.

Scan the QR code to watch 

and follow “Nano-Check 

COVID-19 Antigen At-Home 

Test” instruction video on 

smart phone. 

Each step has a corresponding instructional video 

on the website. Watch the video and perform the 

test according to the instructions

Note: Freshly collected specimens should be

processed as soon as possible

Wash hands with soap 

and water or use hand 

sanitizer before starting 

the test.

Remove the test device from the sealed pouch 

immediately before use. Conduct all testing on a 

level surface

Prepare Materials

Open the package, take out the COVID-19

Test device in pouch, empty tube, ampule,

and the Swab. When you are ready to proceed

with the test, open the foil pouch of the

COVID-19 Test Device.

1 Empty Tube 1 Ampule 1 Swab 1 COVID-19 Test Device in Pouch

Please look carefully, there are two lines on the

empty tube. Insert the empty tube through the

circle hole on the side flap of kit box to form a

tube holder. Flip over the TOP part of the

ampule cap, then squeeze the ampule

completely into the empty tube. Close the tube

tightly with the dropper tip.

Please confirm that the liquid level is at or 

above line 1, then go to Step Collect 

Sample.

Note:

It is acceptable if the liquid level is above the

line 1. However, please do not proceed with

this test, if the liquid level is below the line1,

as this may result in false or invalid results.

Collect Sample 

A. Remove the swab from its package,

being careful not to touch the tip of the

swab. Please keep the swab package

for later use.

B. Gently insert the entire absorbent tip of

the swab (about 1 /2 to 3/4 of an inch) into

your nostril.

Note:

With children, the maximum depth of insertion

into the nostril may be less than 3/4 of an inch,

and you may need to have a second person to

hold the child's head while swabbing.

C. Firmly and slowly brush against insides of nostril in a circular

motion against the nasal wall at least 5 times (Take at least 15

seconds to collect the specimen and be sure to collect any nasal

drainage on the swab). Using the same swab, repeat the same

sample collection procedure for the other nostril. Be sure to

brush BOTH nostrils with the SAME SWAB.

Note:

Failure to swab properly may 

cause false negative results.

Process Sample

A. Tap the tube vertically on the

table and remove the dropper tip

to open the tube.

B. Insert the swab into the tube until the swab

head touches the bottom of the tube. Hold the

swab head at the bottom of the tube tightly by

squeezing the tube. Then stir the swab at least

15 times.

C. Squeeze the sides of the tube to express as

much liquid as possible from the swab head,

and then remove the swab.

Note:

If you don't squeeze the swab head, there may not be 

sufficient sample material to perform the test properly 

(i.e., potentially resulting in a false negative result).

D. Firmly close the dropper tip, put the swab 

back into the package. Safely dispose of the 

swab and the package.

Add Sample 

Hold the tube vertically to dispense the

sample. Add 2 drops of sample to the

Sample loading hole of the COVID-19 Test

device.

Note: A false negative or invalid result may occur 

if too little solution is added to the test device.

Wait 15 Minutes

Wait 15 minutes after adding sample to the 

Sample loading hole and read the results at 

15 minutes visually.

Note: 

Do NOT interpret your test result until

after your 15-min timer has completed, as

the Ag line may take as long as 15 minutes

to appear.

Read Result

Results should not be read after 30 minutes

(Result shown at 2x magnification).

Note: A false negative or false positive result

may occur if the test result is read before 15

minutes or after 30 minutes.

Note: The Ag line can 

be extremely faint 

Test Result Interpretation

OR

Repeat testing is needed to improve test accuracy. Please follow the table below when

interpreting test results

Status on First 

Day of Testing

First Result

Day 1

Second Result 

Day 3

Third Result

Day 5 Interpretation

With 

Symptoms

Positive N/A N/A Positive for COVID-19

Negative Positive N/A Positive for COVID-19

Negative Negative N/A Negative for COVID-19

Without

Symptoms

Positive N/A N/A Positive for COVID-19

Negative Positive N/A Positive for COVID-19

Negative Negative Positive 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.

COVID-19 Positive (+) Result

If the Control (C) line and the Test (Ag) line are 

visible, the test is positive. Any faint visible 

colored Test (Ag) line with the control line (C) 

should be read as positive.

Repeat testing does not need to be 

performed if patients have a positive result at 

any time.

A positive test result means that the virus that

causes COVID-19 was detected in the sample,

and it is very likely the individual has COVID-19

and is contagious. Please contact the patient’s

doctor/primary care physician (if applicable)

and the local health authority immediately and

instruct your patient to 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).

Below are photos of actual positive tests. 

Please note that the Ag line may be faint.

COVID-19 Negative (-) Result

If the Control (C) line is visible, but the Test (Ag) 

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 the individual has 

symptoms on the first day of testing.

• Test 2 more times at least 48 hours apart if 

the individual does 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 the sample. A negative result

does not rule out COVID-19. There is a higher chance of false

negative results with antigen tests compared to laboratorybased tests such as PCR tests. If the test is negative but COVID19-like symptoms, e.g., fever, cough, and/or shortness of

breath continue, follow up testing for SARS-CoV-2 with a

molecular test or testing for other respiratory disease should

be considered. If applicable, seek follow up care with the

primary health care provider.

Invalid Result If the control (C) line is not visible, the test is invalid. 

Re-test with a new swab and new test device

Invalidresult means that the test did not 

function correctly. You will need to retest 

with a fresh sample, new ampule, and 

new test device. 

If upon retesting, the test result is still 

invalid, contact our technical support

Dispose the test kit

After test is completed, dispose the kit 

components in trash and wash your 

hands.

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

Manufactured for Nano-Ditech Corp.

259 Prospect Plains Road, Building K. Cranbury, NJ 08512, USA

1-855-297-7877 https://www.nanoditech.com/

P/N EP-3438-QR0 (May 2023) 

Cat. No. ND-MD8150
Index of Symbols 

I REF ! Cata log number Ill In vitro Diagnostics Olli 

ILOTI Batch code Temperature limit & 

Consult Instructions for use 

Caution 

.. Manufacturer ~ Use-by date 1i~ 

+ • 

Keep dry ® Do not re-use ~ 

Keep away from sun light 

Note 

w Conta ins Sufficient for < n > Tests @ Do not use if package is damaged 

ND1.1 NANO-DITECH CORPORATION 

Nano-CheckTM COVID-19 Antigen 

At-Home Test Quick Reference Instruction 

Catalog No. MD-8150 

The Nano-CheckTM COVID-19 Antigen At-Home Test is only for in vitro diagnostic use under the Food and 

Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved. 

Please read this instruction for use before using the test. For use with direct anterior nasal swab specimens. 

INTENDED USE 

The Nano-CheckTM COVID-19 Antigen At-Home Test is a lateral flow immunoassay intended for the qualitative 

detection of nucleocapsid protein antigen from SARS-CoV-2. 

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 Nano-CheckTM COVID-19 Antigen At-Home Test does not differentiate between SARS-CoV or SARS-CoV-2. 

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in 

anterior nasal (nares) samples 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 and the agent detected may not be the definitive cause of disease. Individuals who test positive with 

Nano-CheckTM COVID-19 Antigen At-Home Test 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 Nano-CheckTM COVID-19 Antigen At-Home 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 

Nano-CheckTM COVID-19 Antigen At-Home Test is only for in vitro diagnostic use under the Food and Drug 

Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved. 

FREQUENTLY ASKED QUESTIONS 

WHAT ARE THE KNOWN AND POTENTIAL RISKS AND BENEFITS OF THE 

TEST? 

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/emergency-preparedness-and-response/mcmlegal-regulatory-and-policy-framework/emergency-use-authorization 

WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR 

TEST? 

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 Nano-CheckTM COVID-19 Antigen At-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. 

HOW ACCURATE IS THIS TEST? 

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 https://www.nanoditech. 

com. 

WHAT IF I HAVE A POSITIVE TEST RESULT? 

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.. 

WHAT IF I HAVE A NEGATIVE TEST RESULT? 

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 SARS-CoV-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. 

WHAT DOES AN INVALID TEST RESULT MEAN? 

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. 

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 

WARNING, 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. 

• An anterior nasal (nares) swab sample can be self-collected by an individual age 14 years and older. 

Children aged 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 specimen from a child or another individual. 

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

• Test components are single-use. Do not re-use. 

• Do not touch the swab tip. 

• Once opened, the test card should be used within 90 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 negative, false positive, or invalid result. 

• Ensure that there is sufficient lighting for testing and interpretation. 

• When collecting an anterior nasal (nares) swab sample, only use the swab provided in the kit. 

• Do not use kit past its expiration date. For information about current expiration dates for at-home OTC 

COVID-19 diagnostic tests, visit At-Home OTC COVID-19 Diagnostic Tests. 

• 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. 

• Freshly collected specimens should be processed as soon as possible. 

• This product is only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. 

• Testing should be performed in an area with good lighting and room temperature condition. 

• Dispose of all materials in household waste. 

• Wash hands thoroughly or use hand sanitizer before and after the test. 

• Failure to follow the instructions for use may adversely affect test performance and/or invalidate the test 

result. Make sure to swirl and plunge the swab up and down in extraction buffer while squeezing the sides of 

the tube for 15 times; squeezing the swab head at least once or more in the reagent tube during the swab 

removal procedure. Insufficient swirling or squeezing of the swab head may produce false negative results. 

• 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 

Chemical Name Harms (GHS Code) for each ingredient Concentration 

Gentamicin Skin sensitization (H317) 4% 

Sodium Azide Acute Tox. 2 (Oral), H300, Acute Tox. 1 (Dermal), H310 0.09% 

• 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 

LIMITATIONS 

• The performance of this test was established based on the evaluation of a limited number of clinical 

specimens collected between June 2022 and July 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 SARS-CoV-2 and their prevalence, which change over time. 

• 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. 

• 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 

the individual likely have COVID-19. 

• These test results are shown as lines of color. Because these 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). 

• Incorrect test results may occur if a specimen is incorrectly collected or handled. 

• This test detects both viable (live) and nonviable 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 same 

sample. 

• Test results must be evaluated in conjunction with other clinical data available to the physician. 

• Positive test results do not exclude co-infection with other pathogens. 

• Negative test results are not indicative of the presence/absence of other viral or bacterial pathogens. 

• If the differentiation of specific coronaviruses and strains is needed, additional testing, in consultation with 

state or local public health departments, is required. 

• False negative results may occur in individuals who have indicated or whose clinical status or history would 

indicate they are currently taking high doses of biotin. There was no interference up to 3,500 ng/mL of biotin 

in the samples. 

STORAGE CONDITIONS 

Store the Nano-CheckTM COVID-19 Antigen At-Home Test between 36-86°F (2-30°C) in a place out of direct 

sunlight and out of reach of children. Reagents and devices must be used at room temperature 65-86 °F (18-

30 °C) before use. The unsealed cassette may be used for 1.5 hours. It is recommended to use the test kit 

immediately after opening. The expiration date assigned at manufacturing is on the outer package box. For 

information about current expiration dates for Nano-CheckTM COVID-19 Antigen At-Home Test, visit At-Home 

OTC COVID-19 Diagnostic Tests. 
Scan the QR code to watch and follow the "NanoTest" CheckTM COVID-19 Antigen At-Home

instruction video on smart phone.

For more information on expiration dating for COVID-19 

antigen tests, please refer to http://www.fda.gov/covidtests

For Emergency Use Authorization (EUA) only

For in vitro diagnostic use

In the USA, this product has not been FDA cleared or 

approved, but has been authorized by FDA under an EUA

(2D-Data

Matrix)

The Nano-CheckTM COVID-19 Antigen At-Home Test is a lateral flow assay 

intended for the qualitative detection of nucleocapsid protein antigen from 

SARS-CoV-2.

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.

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.

Determining a negative result requires multiple tests. You may need to purchase 

additional tests to perform serial (repeat) testing. This test is more likely to give you a 

false negative result when you have COVID-19 than a lab-based molecular test.

00895160002780 GTIN(01): 

 HTxxxx Lot No.(10):

Mfg date(11): yymmdd

17): yymmdd Use by(

*Not Provided: Timer

2 x COVID-19 Test Device l 2 x Ampule l 2 x Empty Tube l 2 x Swab l 1 x Quick Reference Instructions