cerascreen Food Allergy Test User Guide

: June 12, 2024
: cerascreen

Table of Contents

Your test kit contains
Information and tips
Instructions for Use
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Food Allergy Te s t
DIRECTIONS FOR USE

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.

Your test kit contains

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 analyze 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
| European Conformity
****| 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 fi nd a guide for that.

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.

cerascreen Food Allergy Test - icon9

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 formats film and use it to disinfect the tip of the preferred fi anger.
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.

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.

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 preaddressed return envelope. Close the envelope carefully and send it immediately by post free of charge.

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-Hartmann-
Straße 12, 89522 Heidenheimer, Germany | lancet C 0050:
Becton Dickinson GmbH, Tullastrasse 8–12, Postfach 101629,
6900 Heidelberg, Germany | dried blood spot card C : Ahl-
strom-Munksjö Germany GmbH, Niederschlag 1, 09471 Bä-
Orenstein, Germany