Page 1 of 2FORM NO. 13274-GP

REVISION (2)

PLEASE REGISTER YOUR KIT USING THE UNIQUE REFERENCE NUMBER (URN) PROVIDED INSIDE YOUR KIT AT RANDOXHEALTH.COM – IF YOU DO NOT REGISTER YOUR KIT, YOU WILL NOT RECEIVE RESULTS.

IMPORTANT – THESE STEPS MUST BE FOLLOWED. FAILURE TO DO SO WILL AFFECT THE OUTCOME OF THE TEST.

Before you start, read all the instructions in this leaflet, and make sure you fully understand how the test should be done. Do not unpack the test kit until you are ready to take the test.

It is crucial that you register your URN at https://www.randoxhealth.com/register-kitThis registration process is essential, as without it, Randox will not be able to provide you with results. You will not be able to receive your results if you have not registered your URN online. By submitting a sample to our laboratory, you are consenting to the testing of that sample.

• Prior to taking your swab sample, please ensure you have arranged the return of your kit via your courier of choice. After taking your sample please endeavour to return your sample as soon as possible.

• For individuals in Northern Ireland, a suitable collection point may be near to you.• Refer to return instructions overleaf for more detail. • Do not use if there are obvious signs of damage to the product. In this case, please contact Randox Laboratories Technical Services,

Northern Ireland +44 (0) 28 94451070.

C E GA

D

F

Figure 1:YOUR KIT INCLUDES:

1 Swab (A)

1 Sample Collection Tube (B)

1 Transportation Tube (C)

3 Unique Reference Number Labels (URN) (D)

1 Pathoseal Bag (E)

1 UN3373 Box (F)

1 Large UN3373 Return Envelope (G)

INTENDED USE

The COVID-19 Screening Sample Collection Kit is intended for use in the collection and transport of nasopharyngeal swabs to be analysed by Randox Laboratories for the detection of the 2019-Novel Coronavirus (SARS-CoV-2).

Attach URN Label HereCOVID-19 Screening Sample Collection Kit

CAT. NO.: EV4426GTIN: 05055273216844

Only take this test if it is addressed to you. This test can be conducted on multiple age levels, please follow this guide for who should administer the test: 18+ Years Old - Self-administer test (unless unable to do so), 12 – 17 Years Old - Self-administer test with adult supervision, 11 Years and Under - Adult to administer test on the child. If for any reason you cannot complete the test continue to self-isolate as a household as per the government guidance.

FORM NO. 13274-GP REVISION (2) Private IFU.indd 1FORM NO. 13274-GP REVISION (2) Private IFU.indd 1 09/10/2020 09:1109/10/2020 09:11

Page 2 of 2FORM NO. 13274-GP

REVISION (2)

Sample Collection Guidelines

Once your sample has been tested, your results will be emailed to you, using the email address provided when you registered your kit.

The following result outcomes are possible:1. Your result is POSITIVE for COVID-19

2. Your result is NEGATIVE for COVID-19

3. Your result is UNCLEAR and a new sample is required for testing - this result occurs when it has not been possible for the laboratory to test your sample (for example, due to failure of an individual to take and send their sample correctly)

Notification of Results

Have you registered your kit at : https://www.randoxhealth.com/register-kit?

Have you applied a URN label to Sample Collection Tube (B), Pathoseal Bag E and to this sheet?

Have you arranged your return method?

Check List

WATCH THE INSTRUCTION VIDEO

Nasal swab: Remove swab from the mouth and gently insert swab into nostril about 1 inch (2.5cm) or until some resistance is met. Rotate the swab 5 times against the nasal walls and repeat in the other nostril.

1 Inch

x5

6

Remove swab from the nose, and while holding the swab, remove the lid from the sample collection tube (B) and immediately place the swab into the tube with the fabric tip down, again taking care not to touch any other surfaces. Break, snap or cut swab to fit inside the sample collection tube, and then replace the sample collection tube lid, ensuring it is securely fastened.

7

Wash hands again

8

Before starting, wash your hands thoroughly, for at least 20 seconds, using hand wash & warm water, or use hand sanitiser.

1

Fully attach one adhesive URN label to the sample collection tube (B) and another to the pathoseal bag (E). Attach the remaining URN label to these kit instructions and keep for your own reference.

3

Open the package containing the swab (A) and remove without touching the soft tip.

4

Throat swab: Holding the swab in your dominant hand, open your mouth (use a mirror for guidance) and gently rub the swab over both tonsils and the back of the throat. Take care not to touch your tongue, teeth, or gum, or any household surfaces.

5

Remove the supplies from the kit (see Figure 1): 1 swab (A), 1 sample collection tube (B), 1 transportation tube (C), 3 URN labels (D), 1 pathoseal bag (E), 1 large postal envelope (G) and 1 UN3373 Box (F).

2

Please arrange delivery via courier of your completed kit to the address printed on the UN3373 Return Envelope (G).

Please ensure your chosen courier is able to handle biological samples according to UN3373 requirements. We recommend you select a tracked service.

Individuals in Northern Ireland can also deposit completed kits at dedicated collection points found at various Council Building locations. Please visit https://www.randoxhealth.com/kitreturn/ to locate your nearest collection point.

Return InstructionsPacking Instructions

Place the transportation tube (C) into the labelled pathoseal bag (E) and seal the pathoseal bag by removing the metallic silver strip. Ensure the blue adhesive strips make a tight seal of the bag.

2

Insert the sealed pathoseal bag into the UN3373 box (F) and place the box into the UN3373 return envelope (G) provided. Seal the UN3373 return envelope by removing the metallic silver strip and wipe down the exterior of the bag.

3

Place the labelled sample collection tube (B) containing the swab sample into the transportation tube (C) and seal.

1

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, Northern Ireland

Randox Teoranta, Meenmore, Dungloe, Donegal, F94 TV06, Ireland

FORM NO. 13274-GP REVISION (2) Private IFU.indd 2FORM NO. 13274-GP REVISION (2) Private IFU.indd 2 09/10/2020 09:1109/10/2020 09:11