COVID-19 Screening Sample Collection Kit

Attach URN Label Here

CAT. NO.: EV4426
GTIN: 05055273216844

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.

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).

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.

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 a nd 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.

YOUR KIT INCLUDES: Figure 1:

1 Swab (A)
1 Sample Collection Tube (B)
D
1 Transportation Tube (C)
3 Unique Reference Number Labels (URN) (D)
1 Pathoseal Bag (E)
1 UN3373 Box (F) A C E F G

1 Large UN3373 Return Envelope (G)

• 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.

It is crucial that you register your URN at https://www.randoxhealth.com/register-kit

This 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.

FORM NO. 13274-GP

Page 1 of 2 REVISION (2)

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

 Sample Collection Guidelines
1
Before starting, wash your hands thoroughly, for at
least 20 seconds, using hand wash & warm water,
or use hand sanitiser.
2 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).
3 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.
6 Nasal swab: Remove swab from the mouth and gently
1 Inch insert swab into nostril about 1 inch (2.5cm) or until some
resistance is met. Rotate the swab 5 times against the nasal
x5
walls and repeat in the other nostril.
7 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.
8

4 Wash hands again

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

5 Throat swab: Holding the swab in your dominant hand,

open your mouth (use a mirror for guidance) and gently WATCH THE
rub the swab over both tonsils and the back of the throat. INSTRUCTION VIDEO
Take care not to touch your tongue, teeth, or gum, or any
household surfaces.

Packing Instructions Return Instructions

1 Please arrange delivery via courier of your completed kit to the address
Place the labelled sample collection tube (B) containing the printed on the UN3373 Return Envelope (G).
swab sample into the transportation tube (C) and seal.
Please ensure your chosen courier is able to handle biological samples
according to UN3373 requirements. We recommend you select a
2 Place the transportation tube (C) into the labelled pathoseal tracked service.
bag (E) and seal the pathoseal bag by removing the metallic Individuals in Northern Ireland can also deposit completed kits at
silver strip. Ensure the blue adhesive strips make a tight seal dedicated collection points found at various Council Building locations.
of the bag. Please visit https://www.randoxhealth.com/kitreturn/ to locate your
nearest collection point.
3 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.

Notification of Results Check List

Once your sample has been tested, your results will be emailed to you,
using the email address provided when you registered your kit. Have you registered your kit at :
https://www.randoxhealth.com/register-kit?
The following result outcomes are possible:
1. Your result is POSITIVE for COVID-19 Have you applied a URN label to Sample Collection
2. Your result is NEGATIVE for COVID-19 Tube (B), Pathoseal Bag E and to this sheet?

3. Your result is UNCLEAR and a new sample is required for testing -

Have you arranged your return method?
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)

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County

Antrim, BT29 4QY, Northern Ireland
FORM NO. 13274-GP
Randox Teoranta, Meenmore, Dungloe, Donegal, F94 TV06, Ireland Page 2 of 2 REVISION (2)

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