Cns Scp09 Capillary Blood Sample Collection Pack Instruction Manual

CNS SCP09 Capillary Blood Sample Collection Pack

A collection of sterile and non-sterile devices and materials for the collection and mailing of human capillary whole blood sample to Cambridge Nutritional Sciences (CNS) for in vitro diagnostic testing.
Store at 15-25°C. DO NOT FREEZE.
For in vitro diagnostic use only.

INTENDED USE

This sample collection pack is intended to be used to collect a human capillary whole blood sample (from a finger using a sterile retractable lancet) for testing. The pack can be used by lay persons or by healthcare practitioners. Paediatric patients (up to and including age 16) shall have their samples collected by a healthcare practitioner or adult.

INDICATIONS FOR USE

Do not use this sample collection pack if you are taking immunosuppressants (e.g. steroids), cancer therapies, antibody therapy, suffer from clotting disease, or are pregnant or breastfeeding.

PACK STORAGE

Before use, store pack at 15-25°C. Do not freeze. Keep dry and away from direct sunlight.

• KEEP OUT OF REACH OF CHILDREN.

Once you open any of the components, use them immediately.

SAMPLE TYPE

Capillary whole blood
Finger-prick – 100µL (microlitres) sample volume No other sample types may be used as these have not been validated. The blood must be collected into the supplied blood collection tube and returned on the same day. If this is not possible, the blood sample should be stored in the fridge at 2-8°C and posted the next day.

WARNINGS
Read the instructions carefully before performing the sample collection. Failure to follow the instructions may lead to inaccurate test results. Use of any other components except those supplied with the pack will invalidate the results. The components are intended for single use only. Do not use the pack beyond the expiry date. Do not use if any pack components are damaged. Do not use if the product has been exposed to excessive heat or humidity. Do not use any other specimen type than the finger-prick blood sample. Clean up spills immediately and thoroughly using an appropriate disinfectant.

• KEEP OUT OF REACH OF CHILDREN.

CONTENTS OF THE SAMPLE COLLECTION PACK

Before proceeding, check that all the contents required to perform the blood collection are present in the pack. Materials provided (inside plastic clam-pack):

Plastic clam-pack container

• Do not dispose. Sample to be shipped back using the container
  
• 1 blood collection tube (tube and lid)
  
• 1 sample transport tube with lid, containing absorbent cotton pad (do not remove)
  
• 3 alcohol swabs (product may vary)
  
• 3 retractable lancets (colour may vary)
  
• 3 plasters (product may vary)
• 3 sample labels (product may vary)
  
• 1 instructions for use
  
• 1 self-seal plastic pre-paid return envelope
  
• 1 sample information form

If any items are missing or you require additional support, please contact the provider of the sample collection pack or CNS.

SYMBOL LEGEND

The following symbols have been used within the labelling of this product.

• This product fulfils the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.
• Batch code
• Catalogue number
•      Caution
• Consult instructions for use
• Contains sufficient for “n” tests
• Do not re-use
• In vitro diagnostics medical device
• Keep dry
• Manufacturer
• Keep away from sunlight
• Sterilized using irradiation
• Temperature limit
• Use-by date

SAMPLE COLLECTION

IMPORTANT INFORMATION – PLEASE READ BEFORE STARTING

1. Check expiry date on front of pack to ensure pack is valid.
   YYYY-MM
   
2. To ensure sufficient blood sample, make sure you are well hydrated or test may have to be repeated.
   
3. Remove contents from pack. Read procedure carefully and check all contents are present.

   

4. Blood collection may take some time, so please allow for this.
5. Once you start the sample collection, sample must be taken immediately.
   
6. You will need to provide enough blood to fill blood tube to the line (100 microlitres).
   Preparing for the sample collection
   • Failure to provide the information requested, or unclear handwriting, means the sample will be rejected and testing delayed.
     
7. Fill out your name and date of birth on the labels provided using CAPITAL LETTERS. A spare label is provided.
   
8. Fill out all requested details on sample information form using CAPITAL LETTERS.
   
9. Wash your hands using soap and warm water as this will help encourage blood flow.
10. To increase blood flow to the hands, if possible, stand up, hang your hands down below heart level, and clench and unclench your hands several times.
    
11. Pull lid off the blood collection tube and put tube and lid in front of you. This is the tube you will collect your blood in.
    Sample collection
    
12. Select the side of third (middle) or fourth (ring) finger of your non-writing hand. Pricking the side of the ball of the finger is more comfortable and provides a better sample
    
13. Clean selected finger with alcohol swab. Allow some time for the finger to air dry. DO NOT touch the finger to check it is dry.
    
14. Pull off protective cap from lancet.
    
15. Place raised platform end of lancet onto finger and firmly push down and hold lancet in place for 2 seconds. A slight prick may be felt. Discard the used lancet.
    
16. Gently massage finger in direction of puncture site to begin collecting droplets of blood.
    
17. Place finger with blood over the edge of blood collection tube and scrape into tube.
    
18. Tap base of the tube on a hard surface so blood collects at bottom of the tube.
    If blood flow stops
19. Clean and prick another finger using one of the other alcohol swabs and lancets provided and follow steps 12-18.
    
20. Fill blood collection tube to the line on side of the tube (100 microlitres).
    
21. When blood has been collected, push lid onto blood collection tube until you hear a click.
    
22. Wipe finger with alcohol swab or tissue and use plaster supplied to cover puncture site.
    
23. Apply completed sample label to blood collection tube, lengthways, as shown in the image.
    
24. Apply completed sample label to transport tube.
    
25. Place blood collection tube inside transport tube. Do not remove absorbent cotton pad.
    • This step is really important.
      
26. Twist the lid onto the transport tube to secure the sample.
    Sending the sample to the lab
    
27. Place following items into clam-pack:
    • sample transport tube containing blood collection tube
    •  completed sample information form
      
28. Securely close clam-pack and pack into the pre-paid return envelope.
    
29. Please return your sample within 24 hours of collection. Store in fridge until posted.
    
30. Put used and unused lancets in a ‘sharps bin’, but if you cannot, they can go in your household bin.

If you find it hard to obtain a blood sample, please contact the provider of the sample collection pack or CNS.

IMPORTANT CHECKLIST

• Have you filled in your sample information form?
• Have you completed label for blood collection tube?
• Have you completed label for transport tube?
• Have you put blood collection tube into transport tube?
• Have you put blood collection tube with completed sample information form inside clam-pack?
• Have you put the clam-pack inside the pre-paid envelope?

You’re now ready to post
577-31 V5 OCTOBER 2021
CAMBRIDGE NUTRITIONAL SCIENCES
Eden Research Park
Henry Crabb Road, Littleport
Cambridgeshire, CB6 1SE
United Kingdom
+44(0)1353 863279
[email protected]
www.camnutri.com
AN ISO 9001 AND ISO 13485 CERTIFIED COMPANY

References

• CNSLab