cerascreen Histamine Intolerance Test Instructions

: June 12, 2024
: cerascreen

Table of Contents

cerascreen Histamine Intolerance Test
Product Information
Product Usage Instructions
Your test kit contains
Information and tips
Directions for Use
SYMBOL
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

cerascreen Histamine Intolerance Test

The cerascreen® Histamine Intolerance Test is a send-in sampling kit to identify a suspected histamine intolerance. The test is used to determine the concentration of diamine oxidase (DAO), the enzyme that breaks down histamine, in human capillary blood.

Product Information

The Histamine Intolerance Test is a diagnostic test kit provided by Cerascreen. It is designed to help individuals determine if they have histamine intolerance. The test kit includes various components such as alcohol wipes, plasters, swabs, dried blood spot card, lancets, a return envelope, and a test-ID card with a sticker. The kit is valid from October 2022 and has a SKU number of 99090922 CRS3-Histamine_003.

Product Usage Instructions

Before starting the test, make sure to read the instructions for use carefully and follow the listed steps.
Ensure that all necessary conditions for sample taking are fulfilled. Refer to the “Information and instructions” section of the test for detailed information.
Place all contents of the test kit on a clean surface.
Choose a spot for the prick on your preferred hand. The middle or ring finger of the left hand is usually recommended.
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 further 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 completely dry (approximately 15 seconds).
Take the lancet and rotate the protective cover once around. Carefully remove the cover without twisting or pulling excessively.
Using the prepared finger, prick the tip with the lancet to obtain a blood sample. Follow the recommended technique for proper blood collection.
Apply gentle pressure to the finger to encourage blood flow onto the dried blood spot card. Fill the designated circles on the card with the required amount of blood.
After collecting the blood sample, use the provided plaster to cover the pricked area on your finger.
Place the dried blood spot card and other used materials back into the test kit.
Seal the test kit and insert it into the provided return envelope
Fill out the test-ID card with the corresponding sticker and attach it to the return envelope.
Send the return envelope containing the test kit to the specified address for analysis.

Note: If you have any questions or need assistance, please visit the help website at help.cerascreen.com.

Your test kit contains

Information and tips

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

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.
Please 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. You should consume products that do contain histamine. Please also note that certain medication (e.g. antihist-amines) can affect the test result. More information is available in the FAQ section on our website.

GENERAL INFORMATION

Do not take a blood sample immediately after strenuous physical activity.
If you have any difficulties performing the blood sample or if the kit is incomplete, contact our customer service department, who will treat this matter confidentially (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

Directions for Use

Check that all conditions are fulfilled for sample taking. Please read the section “Information and instructions on the test” 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 help@cerascreen.com 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. 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!
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 2 circles. If you fill up more than three circles, your sample will be evaluated, as well.
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. Ensure to place it flat on a dry surface, protected from direct sunlight. Make sure the blood is completely dried before putting the dried blood spot card in the envelope.
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.