cerascreen CRS3 Food Allergy Test Instruction Manual

: June 5, 2024
: cerascreen

Table of Contents

Allergy Test
Information and tips
Directions for Use
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Instructions for Use

cerascreen CRS3 Food Allergy Test - Fig

Allergy Test

The cerascreen® Allergy Test is a send-in home test kit, which screens for suspected sensitivities. The test is used to determine IgE antibodies in capillary blood.
The sample is analyzed in vitro in our specialized cerascreen® partner diagnostics laboratory.

Your test kit contains

Information and tips

Read the instructions for use carefully before you begin and follow the listed steps.
Warnings

Do not use this kit if you suffer from a blood-borne contagious illness such as hepatitis or HIV.
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.

Risks and side effects
After taking a sample of your blood, pressure sores may occur around the wound for a few days, and/or bruise forms at the injection site. Additionally, the puncture site may be visible for a few days.

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.
Note that a significant result can be only achieved if you came into regular contact with the allergen in the days before (about 2 weeks). Please also note that some medicines (for example antihistamines) may influence the outcome. For more information, please see our website‘s FAQ page.
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.
Do not take a blood sample immediately after strenuous physical activity.
This is a blood sample collection kit for personal single use only!
If you have any questions, please visit our help website: help.cerascreen.com.

Directions for Use

Check that all conditions are fulfilled for sample taking. Please read the section “Information and tips” carefully.
If you are a new customer, create your user account on my.cerascreen.com or in my cerascreen® App. In our “Frequently Asked Questions” in [email protected] you will find a guide for that. To create your result report, log in via my cerascreen® App (Android, iOS) or on my.cerascreen.com. Insert your six-digit ID number according
to your test-ID card under “Activate Test”and follow the instructions.
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.
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.
Swing your preferred arm around in a circle 5 to 10 times, fully extended if possible, in large movements to stimulate blood circulation.
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).
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.
Place your hand on a firm surface. Place the lancet diagonally on the tip of your finger as shown in the illustration. Only use the side of the fingertip pad as the puncture site to minimize discomfort. Press the lancet firmly against the finger until it releases.
CAUTION: The lancet can only be released once!
Press the thumb of your other hand below the sampling spot and pull back on the skin slightly.
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.
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.
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.
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.
Repeat this process until you have completed four circles.
After taking the blood, use the swab and plaster to clean and cover the wound.
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.
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.
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. 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.

IVD	In-vitro diagnostics
Manufacturer
Conformité Européenne
LOT	Batch Number
For single use only
Contains 1 kit
Expiration Date
SKU	Item Number
Read the Instructions for Use before taking the sample.
Store at a temperature between 2 °C and 30 °C
PZN	Pharmaceutical Registration Number