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& ! Step 3: Activate the kit Step 1: Before you start efore collecting your sample, activate the kit on the Before you start you must read all of the instructions S including the warnings in relation to the liquid in the LetsGetChecked app or online at sample transport tube. LetsGetChecked.com/activate. If the sample is from a person under the age of 18, please follow the steps to create a guardian account to activate on behalf of the child. Step 2: Arrange a UPS return or drop off It is important to note the numerical code on the label on the Please contact UPS to arrange a pickup, or find a UPS outside of the biohazard bag. This will be required to activate drop off point before you collect your sample. Visit the kit and to ensure the sample is returned in the correct kit box. wwwapps.ups.com/pickup/schedule or call 1-800-742-5877 to schedule a pickup. Visit www.ups.com/dropoff to find a Step 4: Complete the details on the label drop off point. It is important to fill in the label located on the biohazard bag with You should collect the sample on the same day as the the date of collection and the date of birth and gender of the pickup is scheduled for. person that the sample was collected from. Please note that UPS does not operate on Sundays. Do This is essential for the lab to process the sample. not collect sample on Sundays. Please do not remove any labels from the kit components as they are required for sample identification. Please turn this page over to continue.

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LGC_NASAL_SAMPLE_IFU_39_REV8_MAR_2021_FOLD_A3_SPOTS_V9.indd 2 19/05/2021 14:28

Step 11: Place the swab into the sample transport tube

Place the swab into the sample transport tube immediately. Step 5: Wash hands Make sure the swab tip is covered by the liquid in the Wash your hands in warm, soapy water sample transport tube. Carefully break the swab at the and dry thoroughly. marked/scored line against the side of the tube. Note that breaking the swab above the marked line may result in rejection of the sample. Discard the top portion of the swab – do not put it into the tube with the sampleV! ! Step 6: Remove the sample transport tube from kit Remove the sample transport tube from the kit. Step 12: Screw the lid of the sample Screw off the lid and place the tube on a flat surface. transport tube closed Do not spill the contents of the tube. Screw the lid of the sample transport tube tightly If you spill the liquid from the sample transport tube, to close it. and it makes contact with the skin or eyes, rinse with water. If This will ensure that the lid does not come off during irritation persists, seek medical advice. shipping which would prevent the sample from being processed in the lab.

Step 7: Remove the nasal swab from packaging Step 13: Seal the sample transport tube Partially peel open the nasal swab package. in the biohazard bag Remove the swab from the packet. Do not touch the Place the sample transport tube in the biohazard soft tip or lay the swab down on any surface. bag. Do not remove the absorbent pad from the You will need to use this swab on both nostrils. biohazard bag. ! To seal the biohazard bag, remove the strip of plastic and fold down the flap. ! Step 8: Insert the swab into the nostril Place the swab into the nostril until the cotton end Step 14: Place the biohazard bag into the kit box of the swab is no longer visible. Do not continue Place the biohazard bag back into the if there is any pain. LetsGetChecked kit box. Ensure you have folded the Do not reinsert the swab into the nostril after it has biohazard bag flap to seal it. Wash your hands in been placed into the sample transport tube. warm, soapy water and dry thoroughly. Ensure you have completed the label which is located on the biohazard bag.

Step 9: Collect the nasal sample Step 15: Return the sample Keep the swab in place and rotate it for 10 seconds, then Place the kit box in the return envelope provided. gently remove from the nose. Do not force the swab any Send the sample back on the same day with UPS. further up and into the nose at any point. Follow the instructions on the return card in the kit You must collect the sample from both nostrils before box. placing the swab into the sample transport tube. Please note that UPS does not operate on Sundays. Do not collect sample on Sundays.

Step 10: Repeat in the other nostril Gently insert the swab in the vertical position into the other !"#"$%$&'%()(%*'+#"$'%,-.%/0110*%$&'%,.2"3'% ;06%#&061.%@AB%*,"$%/05%$&'%5'#61$#%0/%$&"#%$'#$%,-.%;06% nostril until the cotton end of the swab is no longer visible. 4502".'.%"-%$&'%64%$0%.,$'%76".'1"-'#%&'5'8 #&061.%"<<'.",$'1;%3,11%;065%&',1$&3,5'%4502".'5=%05%"-% Keep the swab in place and rotate it for 10 seconds, then www.cdc.gov/coronavirus/2019-ncov ,%<'."3,1%'<'57'-3;=%3,11%$&'%'<'57'-3;%#'52"3'#C

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LGC-SLV-SPEC-248 Rev.1 Rev.1 LGC-SLV-SPEC-248 D12 A611, Ireland. Ireland. A611, D12 United States. States. United

Park West, Dublin 12, 12, Dublin West, Park New York 11105, 11105, York New

for expiry date. date. expiry for Park West Industrial Park, Park, Industrial West Park Astoria, Astoria,

See side of kit box box kit of side See Unit 32, Lavery Avenue, Avenue, Lavery 32, Unit 1845 Steinway Street, Street, Steinway 1845

PrivaPath Diagnostics Ltd., Ltd., Diagnostics PrivaPath LetsGetChecked Inc, Inc, LetsGetChecked

Manufactured by Manufactured Distributed by Distributed : : : :

of this cover before you take this test. test. this take you before cover this of 2 years and older and years 2 (collected with adult assistance) assistance) adult with (collected

Please read all of the warnings on the inner side side inner the on warnings the of all read Please 12 years and older and years 12 (self-collected under adult supervision) supervision) adult under (self-collected

with your healthcare provider before using this test. test. this using before provider healthcare your with 18 years and older and years 18 (self-collected) (self-collected)

If you have any medical conditions you should consult consult should you conditions medical any have you If This sample collection kit is suitable for the following individuals: individuals: following the for suitable is kit collection sample This

you should seek immediate medical attention. attention. medical immediate seek should you

For use under Emergency Use Authorization (EUA) only. only. (EUA) Authorization Use Emergency under use For If you are experiencing severe symptoms symptoms severe experiencing are you If

Coronavirus (COVID-19) Coronavirus LetsGetChecked Home Collection Kit - Nasal Sample Sample Nasal - Kit Collection Home

Home Collection Kit - Nasal Sample Sample Nasal - Kit Collection Home LetsGetChecked Coronavirus (COVID-19) (COVID-19) Coronavirus LetsGetChecked

Get checked in four simple steps:

Activate your kit online, Collect your sample Your sample is analyzed using the unique ID provided. at home using at the LetsGetChecked Before you start you must read all of the contents inside lab and results are the instructions provided with the kit. this pack. available online typically This sample collection kit is suitable within 24-72 hours. for the following individuals: Adults aged 18+: Self-collect All results are reviewed by (unless unable to do so) Return your sample to a board certifed physician. Teenagers aged 12-17: Self-collect our accredited laboratory If you receive a positive or with adult (18+) supervision invalid test result a registered Children aged 2-11: Adult (18+) using the prepaid nurse will contact you to to collect shipping envelope. provide 1-on-1 support.

FOR USE UNDER EMERGENCY USE AUTHORIZATION ONLY. Kit contents include: LetsGetChecked, Inc o˜ers this product with an FDA Emergency Use Authorization (EUA). 1 x Nasal Swab Sample This means that this product has not been FDA cleared or approved, but has been authorized for 1 x Sample Transport Tube Collection: emergency use by FDA under an EUA. This product has been authorized only for the detection 1 x Biohazard Bag of nucleic acid from SARSCoV-2, not for any other viruses or pathogens. The emergency use of 1 x Test Box Nasal Swab this product is only authorized for the duration of the declaration that circumstances exist justifying 1 x Return Label 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. Contains one single use collection kit. Access to internet/computer/smartphone and If the contents of the sample transport tube are spilled or make contact with the skin or eyes, email account are required to use kit. refer to the warning section for information on actions to take and use a new collection kit.

It’s good to know.™ — consult your pharmacist or visit LetsGetChecked.com/activate If you have any symptoms concerning for ° Cystic fbrosis COVID-19 and any of the following conditions or ° Hypertension or high blood pressure risk factors, which may put you at increased risk ° Neurologic conditions, such as dementia of severe illness from COVID-19, you should ° Liver disease consult with your healthcare provider before using this test: ° Pregnancy ° Pulmonary fbrosis (having damaged or scarred ° Chronic kidney disease lung tissues) ° COPD (chronic obstructive pulmonary disease) ° Smoking ° Immunocompromised state (weakened immune ° Thalassemia (a type of blood disorder) system) from solid organ transplant or bone marrow transplant, immune defciencies, HIV, ° Type 1 diabetes mellitus use of corticosteroids, or use of other immune weakening medicines Regardless of your risk status, if you are ° Obesity (body mass index [BMI] of 30 or higher) experiencing any of the following emergency warning signs for COVID-19, it is recommended ° Serious heart conditions, such as heart failure, that you immediately seek emergency care: coronary artery disease, or cardiomyopathies ° Sickle cell disease ° Trouble breathing ° Type 2 diabetes mellitus ° Persistent pain or pressure in the chest ° Asthma (moderate-to-severe) ° New confusion ° Cerebrovascular disease (a˜ects blood vessels ° Inability to wake up or stay awake and blood supply to the brain) ° Bluish lips or face