Food Allergy Test

Product Information

The product is a Food Allergy Test kit that allows users to
collect a blood sample at home for testing. The kit includes
various components necessary for sample collection and
submission.

Components included in the kit:

1 alcohol wipe
2 plasters
1 swab
1 dried blood spot card
2 lancets
1 return envelope
1 test-ID card with sticker

Important information and tips:

The sample should only be taken between Sunday and Tuesday and
sent off on the same day.
Please enter your test ID to activate the test before sending
your sample.
Ensure all conditions are fulfilled for sample taking by
reading the provided information and tips section.

General Information:

If the collected sample contains less than the required amount
of blood, the test may not provide accurate results.
Individuals with contagious illnesses should take necessary
precautions while handling the kit.
Risks and side effects associated with using the kit are not
specified in the provided text.
For any questions or assistance, visit the help website at
help.cerascreen.com.

Manufacturer Information:

SKU: 99091176 CRS3-LMA_UK_000
Valid from February 2023

Product Usage Instructions

Step 1: Sample Preparation

Check that all conditions are fulfilled for sample taking.
Please read the section “Information and tips” carefully.

Step 9: Lancet Placement

Place your hand on a firm surface. Place the lancet diagonally
on the tip of your finger, using the side of your fingertip to
reduce discomfort. Press the lancet firmly against the finger until
it releases. CAUTION: The lancet can only be
released once!

Step 10: Skin Preparation

Press the thumb of your other hand below the sampling spot and
pull back on the skin slightly.

Step 11: Blood Flow Stimulation

Encourage blood flow by standing up and holding your hand below
the heart. Gently massage your finger from the palm of your hand to
your fingertip until a drop of blood forms.

Step 12: First Blood Wipe

Before collecting the blood, take the swab (NOT the alcohol
wipe) and wipe off the first drop of blood. Wait until a big drop
has formed again.

Step 13: Blood Collection

Let a large blood drop fall onto the marked circle on the dried
blood spot card. If the drop doesn’t fall on its own, hold the
dried blood spot card carefully against the drop without touching
the paper to your finger.

Step 14: Sample Evaluation

For the best evaluation of the sample, the largest possible drop
of blood is required. The blood drop should cover the circle inside
the marking completely.

Step 15: Repeat Blood Collection

Repeat the blood collection process until you have completed
four circles.

Step 16: Wound Care

After taking the blood, use the swab and plaster to clean and
cover the wound.

Step 17: Test-ID Sticker Placement

Remove the square code sticker from the test-ID card and stick
it on the dried blood spot card in the area intended for the
test-ID sticker.

Step 18: Drying Process

Allow the dried blood spot card to dry for 2 to 3 hours at room
temperature. Place it flat on a dry surface, protected from direct
sunlight. Ensure the blood is completely dried before putting the
dried blood card in the envelope.

Step 19: Sample Submission

Place the dried blood spot card in the pre-addressed return
envelope. Close the envelope carefully and send it immediately by
post free of charge.

Step 20: Test Kit Disposal

Please check if the test has been activated and dispose of the
used parts of the test kit in the transparent plastic bag in the
household waste.

For more detailed information and additional instructions, refer
to the user manual or visit the website www.cerascreen.co.uk.

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Instructions for Use
Step 9
Place your hand on a firm surface. Place the lancet diagonally on the tip of your finger as shown in the illustration. Using the side of your fingertip will reduce discomfort. Press the lancet firmly against the finger until it releases. CAUTION: The lancet can only be released once!
Step 10 Press the thumb of your other hand below the sampling spot and pull back on the skin slightly.

Step 11 Encourage blood flow by standing up and holding your hand below the heart. Gently massage your finger from the palm of your hand to your fingertip until a drop of blood forms.
Step 12 Before you start collecting the blood, take the swab (NOT the alcohol wipe) and wipe off the first drop of blood. Wait until a big drop has formed again.

Step 13 Let a large blood drop fall onto the marked circle on the dried blood spot card. In case the drop doesn’t fall on its own from your finger, hold the dried blood spot card carefully against the drop without touching the paper to your finger.
Step 14 For the best evaluation of the sample, the largest possible drop of blood is required. The blood drop should cover the circle inside the marking completely.

Step 15 Repeat this process until you have completed four circles.
Step 16 After taking the blood, use the swab and plaster to clean and cover the wound.

Step 17 Remove the square code sticker from the test-ID card and stick it on the dried blood spot card in the area intended for the test-ID sticker.

23 h

Step 18 Allow the dried blood spot card to dry for 2 to 3 hours at room temperature. Make sure to place it flat on a dry surface, protected from direct sunlight. Make sure the blood is completely dried before putting the dried blood card in the envelope.

Step 19 Place the dried blood spot card in the preadressed return envelope. Close the envelope carefully and send it immediately by post free of charge.

The cerascreen® Food Allergy Test is a send-in blood sampling kit to determine the presence of IgE antibodies in response to 38 specific foods. Discover the concentration of IgE antibodies in your blood as an initial indicator for possible food allergies.

Step 20 Please check if the test has been activated and dispose of the used parts of the test kit in the transparent plastic bag in the household waste.

Manufacturer: cerascreen® GmbH Gueterbahnhofstrasse 16 19059 Schwerin Germany

www.cerascreen.co.uk
SKU: 99091176 CRS3-LMA_UK_000 Valid from February 2023

Supplier: plaster C, swab C : Hartmann, Paul-HartmannStraße 12, 89522 Heidenheim, Germany | lancet C 0050: Becton Dickinson GmbH, Tullastrasse 812, Postfach 101629, 6900 Heidelberg, Germany | dried blood spot card C : Ahlstrom-Munksjö Germany GmbH, Niederschlag 1, 09471 Bärenstein, Germany

Food Allergy Test
DIRECTIONS FOR USE

Your test kit contains

1 alcohol wipe

2 plasters C, 1 swab C

1 dried blood spot card C

2 lancets C 0050

1 return envelope

1 test-ID card with sticker

Information and tips
IMPORTANT
The sample should only be taken between Sunday and Tuesday (at the latest) and sent off on the same day. Please take into account any public holidays.
Please enter your test ID to activate the test before sending us your sample. Our laboratory needs this in order to identify your sample and send you the test result. You will find more detailed information in step 2+3.
Note that a meaningful and conclusive result can only be provided if you maintain a varied diet (for around 2 weeks), before taking the sample. Food intolerances and allergies can only be detected if you have recently consumed those foods. Attention: Do not consume foods that are known to cause a strong reaction within your body (anaphylactic shock may occur!). Also, note that certain medications (e.g. antihistamines) can affect the test result. More information is available in the FAQ section on our website.

General Information
· Read the instructions for use carefully before you begin and follow the listed steps.
· Do not take a blood sample immediately after strenuous physical activity.
· If you have difficulties with the blood collection or the kit is incomplete, contact our customer service (help.cerascreen.com).
· The product is for single use only. · Do not touch the dried blood spot card within the markings and keep
it dust free. · Unfortunately, it is not possible to analyse blood samples that
contain less than the required amount of blood.
Contagious Illnesses
· Do not use this kit if you suffer from a blood-borne contagious illness such as hepatitis or HIV.
Risks and Side Effects
· After taking a sample of your blood, pressure sores may occur around the wound for a few days and/or a bruise may form at the injection site. Additionally, the puncture site may be visible for a few days.
· Note: Any serious incident related to the product should be reported to the manufacturer and to the competent authority of the Member State where the user is established.

Warnings
· Store this kit out of reach of children. · The kit may only be used by adults aged 18 and older. · If you are pregnant or are breastfeeding, use the kit only after
consultation with your medical professional or pharmacist. · If you suffer from a congenital or acquired blood-clotting disorder
or are taking anticoagulant medication, use the kit only after consultation with your medical professional. · Use the lancets only as described in the instructions for use. · If you have problems with the sight of blood or blood sampling, take the sample only in the presence of another person or contact your medical professional or pharmacist.
If you have any questions, please visit our help website:
help.cerascreen.com

Legend
In vitro diagnostics Follow the instructions for use For single use only Store at a temperature between 2 °C & 30 °C Contains 1 kit
Attention!

Manufacturer Expiration Date
Conformité Européenne
Batch Number
Item Number Pharmaceutical Registration Number

Instructions for Use
Step 1 Check that all conditions are fulfilled for sample taking. Please read the section `Information and tips’ carefully.

my.cerascreen.com

Step 2
If you are a new customer, create your user account on my.cerascreen.com or in the my cerascreen® App. In our `Frequently Asked Questions’ in help.cerascreen.com you will find a guide for that.

CONTINUE

Step 3 To create your result report, log in via the my cerascreen® App (Android, iOS) or on my.cerascreen.com. Insert your ID-number according to your test-ID card under `Activate Test’ and follow the instructions.
Step 4 Place all contents of the test kit on a clean surface. Before you begin, choose a spot for the prick. TIP: the middle or ring finger of the left hand usually works best.

Step 5 Wash your hands with soap and warm water. Hold your preferred hand under warm water for at least 15 seconds to stimulate blood circulation. Dry your hand carefully with a clean towel.
Step 6 Swing your preferred arm around in a circle 5 to 10 times, fully extended if possible, in large movements to stimulate blood circulation.

Step 7 Remove the alcohol wipe from its film and use it to disinfect the tip of the preferred finger. Wait until the finger is dry again (15 sec).
Step 8 Take the lancet. (1) Rotate the protective cover once around its axis. (2) Carefully remove the protective cover. CAUTION: Do not use a lancet with a loose or missing protective cover.