cerascreen Vitamin B12 Test Send-In Sampling Kit Instruction Manual

: June 12, 2024
: cerascreen

Table of Contents

cerascreen Vitamin B12 Test Send-In Sampling Kit
Product Information
Product Usage Instructions
Your Test Kit Contains
Information and tips
General Information
Directions for use
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

cerascreen Vitamin B12 Test Send-In Sampling Kit

cerascreen-Vitamin-B12 -Test-Send-In-Sampling-Kit-product-
image

Product Information

The product is a Vitamin B12 Test Kit designed to analyze the concentration of the B12 binding protein complex holo-transcobalamin in human capillary blood. The kit includes all the necessary components for collecting a blood sample and sending it to the partner diagnostics laboratory for analysis.

Manufacturer: www.cerascreen.co.uk
SKU: 9909769
Address: 19059 Schwerin, Germany
Valid from: December 2022

Product Usage Instructions

Before starting, make sure it is between Sunday and Tuesday to ensure timely sample processing.
Activate the test by entering the test ID provided.
Read and follow the detailed information provided in step 2+3 for more information on test activation and sample submission.
Wait for at least four weeks after any vitamin B12 injections before conducting this test. Oral supplements will not affect the test result.
Take the lancet:
Rotate the protective cover once around its axis.
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 and hold the lancet diagonally on the tip of your finger.
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 collecting the blood, wipe off the first drop with the swab (NOT the alcohol wipe). Wait until a big drop has formed again.
Hold your finger diagonally at the edge of the upright blood collection tube so that the blood can run into it. Continue massaging your finger to keep the blood flow going. This process may take several minutes.
Only finish taking the sample when the blood volume reaches 300. Otherwise, the laboratory cannot analyze the sample. Tap the tube gently numerous times against the table so that the blood runs downwards.
After taking the blood, use the swab and plaster to clean and cover the wound.
Close the tube by firmly pressing the cap onto the opening until it clicks into place. Shake the tube well.
Remove the square code adhesive label from the test-ID card and stick it on the filled tube.
Slide the filled blood collection tube into the larger transport tube without removing the absorbent felt. Seal the transport tube well.
Place the transport tube containing the blood collection tube into the return envelope. Close the envelope carefully and send it immediately by post free of charge.
Dispose of the used parts of the test kit in the transparent plastic bag in the household waste.

Please follow all instructions carefully to ensure accurate test results.

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 fi nd more detailed information in step 2+3.
Please note that in the event of vitamin B12 injections, you should wait for at least four weeks after the injection before conducting this test. Supplements taken orally will not affect your test result.

Legend

In vitro diagnostics
Follow the instructions for use
For single use only
Store at a temperature between 2 °C and 30 °C
Contains 1 kit
Manufacturer
Expiration Date
Conformité Européenne
Batch Number
Item Number
Pharmaceutical Registration Number
Attention!

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 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.
Unfortunately, it is not possible to analyze blood samples of volumes under 300 µl.

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

Step 1
Check that all conditions are fulfilled for sample taking. Please read the section ‚Information and tips’ carefully.
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 six-digit 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 fi nger of the left hand usually works best.
Step 5
Open the blood collection tube and place it on a flat surface. Make sure it cannot fall over.

cerascreen-Vitamin-B12 -Test-Send-In-Sampling-Kit-18

Step 6
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 7
Swing your preferred arm around in a circle 5 to 10 times, fully extended if possible, in large movements to stimulate blood circulation.
Step 8
Remove the alcohol wipe from its film and use it to dis-infect the tip of the preferred finger. Wait until the finger is dry again (15 sec).
Step 9
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 10
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 finger tip 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!
Step 11
Press the thumb of your other hand below the sampling spot and pull back on the skin slightly.
Step 12
Encourage blood flow by standing up and holding your hand below the heart. Gently mas-sage your finger from the palm of your hand to your fingertip until a drop of blood forms.
Step 13
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 14
Hold your finger diagonally at the edge of the upright blood collection tube so that the blood can run into it. Continue massaging your finger to keep the blood flow going. This process may take several minutes.
Step 15
Only finish taking the sample when the blood volume reaches the 300 μl mark. Otherwise, the laboratory cannot analyse the sample. Tap the tube gently numerous times against the table so that the blood runs downwards.
Step 16
After taking the blood, use the swab and plaster to clean and cover the wound.
Step 17
Close the tube by firmly pressing the cap onto the opening until it clicks into place. Shake the tube well.

cerascreen-Vitamin-B12 -Test-Send-In-Sampling-Kit-30

Step 18
Remove the square code adhesive label from the test-ID card and stick it on the filled blood collection tube – NOT on the transport tube.
Step 19
Slide the filled blood collection tube into the larger transport tube without removing the absorbent felt. Seal the transport tube well.
Step 20
Place the transport tube containing the blood collection tube into the 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.

The cerascreen® Vitamin B12 Test is a send-in sampling kit to determine your vitamin B12 level. The test is used to analyse the concentration of the B12 binding protein complex holo-transcobalamin in human capillary blood. The sample is analysed in our specialised cerascreen® partner diagnostics laboratory.

Manufacturer:
cerascreen® GmbH
Güterbahnhofstraße 16
19059 Schwerin
Germany

www.cerascreen.co.uk
SKU: 9909769
CRS3-Vit B12_EN_007
Valid from December 2022

Supplier: plaster C, swab C: Hartmann, Paul-Hart-mann-Straße 12, 59522 Heidenheim, Germany | lancets
C 0050: Becton Dickinson GmbH, Tullastrasse 8–12, Post-fach 101629, 6900 Heidelberg, Germany | blood collection
tube C : Sarstedt AG & Co.KG, Sarstedtstraße 1,51588 Nümbrecht, Germany