Cerascreen 99090759 Coronavirus Antibody Test Instruction Manual

99090759 Coronavirus Antibody Test

Product Information

The product is a Coronavirus Antibody Test kit that allows users
to collect a blood sample for testing. The kit includes the
following components:

  • 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 activate the test by entering your test ID before
    sending the sample.
  • Perform the test no earlier than 14 to 21 days after
    vaccination or coronavirus infection.
  • Do not use this kit if you suffer from a blood-borne contagious
    illness such as hepatitis or HIV.

Product Usage Instructions

  1. Place your hand on a firm surface.
  2. Place the lancet diagonally on the tip of your finger, using
    the side of the fingertip pad as the puncture site.
  3. Press the lancet firmly against the finger until it releases.
    Note: The lancet can only be released once.
  4. Press the thumb of your other hand below the sampling spot and
    pull back on the skin slightly.
  5. 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.
  6. Before collecting the blood, use the swab (NOT the alcohol
    wipe) to wipe off the first drop of blood. Wait until a big drop
    has formed again.
  7. 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.
  8. For the best evaluation of the sample, ensure the blood drop
    covers the circle inside the marking completely.
  9. Repeat this process until you have completed three circles. If
    you fill up more than three circles, your sample will still be
    evaluated.
  10. After taking the blood, use the swab and patch to clean and
    cover the wound.
  11. Remove the square code sticker from the test-ID card and stick
    it on the dried blood spot card in the designated area.
  12. Allow the dried blood spot card to dry for 2 to 3 hours at room
    temperature on a flat, dry surface protected from direct
    sunlight.
  13. Ensure the blood is completely dried before putting the dried
    blood spot card in the envelope.
  14. Place the dried blood spot card in the provided return envelope
    with address. Close the envelope carefully and send it immediately
    by post free of charge.
  15. Check if the test has been activated and dispose of the used
    parts of the test kit in the transparent plastic bag in household
    waste.

For more information, visit www.cerascreen.info

Valid from October 2022 SKU: 99090759
CRS3-Corona_Anti_EN_005

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. 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 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 three circles. If you fill up more than three circles, your sample will be evaluated, as well.
Step 16 After taking the blood, use the swab and patch 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. Ensure to place it flat on a dry surface, protected from direct sunlight.

Step 19 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 return envelope with address. 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 the used parts of the test kit in the transparent plastic bag in the household waste.

The cerascreen® Coronavirus Antibody Test is a sample send-in kit to confirm the presence of SARS-CoV-2 antibodies. Blood is collected from the fingertip. Have your blood tested for antibodies to the coronavirus SARSCoV-2, which causes the respiratory disease COVID-19 (Coronavirus Disease-2019).

The cerascreen® Coronavirus Antibody Test is designed to test for an infection of SARS-CoV-2 in the past and cannot be used to test for a current infection. If your general condition worsens, or if you develop a high fever, have difficulty breathing or a strong cough, CALL or email the responsible authority–this is often the local health authority–in your area or call your doctor. In case of an emergency (respiratory distress) contact the emergeny service right away.

Manufacturer: cerascreen® GmbH Güterbahnhofstraße 16 19059 Schwerin Germany

www.cerascreen.info
Valid from October 2022 SKU: 99090759 CRS3-Corona_Anti_EN_005

Supplier: Plaster C, swab C: Hartmann, Paul-Hartmann-Straße 12, 59522 Heidenheim, Germany | Lancets 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

Coronavirus Antibody Test
INSTRUCTIONS 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

Instructions for Use

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
Perform the test no earlier than 14 to 21 days after vaccination or coronavirus infection.
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.
· The product is for single use only.

· The test kit should be stored between 2 °C and 30 °C. · Do not touch the dried blood spot card within the markings and keep
it dust free. · 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 forms 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 and 30 °C
Contains 1 kit
Manufacturer

Expiration date
Conformité Européenne
Batch number
SKU Item Number
PZN Pharmaceutical Registration
Number Attention!

Step 1 Check that all conditions are fulfilled for sample taking. Please read the section “Information and tips” carefully.

my.cerascreen.co.uk

Step 2 If you are a new customer, create your user account under my.cerascreen.de or in 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 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 finger of the left hand usually work 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!

References

Documents / Resouces

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