Alpha Laboratories CALEX Faecal Calprotectin Extraction Device

Alpha Laboratories CALEX Faecal Calprotectin Extraction Device

USER MANUAL

Direct Sampling with the CALEX® Extraction Device

Your Test

Your healthcare professional has asked you to do an elastase test. This is used to determine how well your pancreas is working and if your body is having trouble digesting food properly.

Intended Use

A single use, home faecal Elastase kit for collection and transportation to the laboratory for analysis.

What Sample is Required?

A formed faecal sample (solid or semi-solid) is preferable for this test. Elastase is a digestive enzyme that is naturally passed in the faeces if your pancreas is working properly.
Avoid using a liquid or watery faeces, as it may dilute the enzyme and lead to inaccurate results. If possible, wait until a more formed faecal sample can be collected.

Contents:

  • 1x CALEX device
  • 1x Instruction for use (this document) with detachable label
  • 1x clear plastic bag

Key Things to Remember

  • Do NOT use the CALEX beyond the stated expiry date.
  • A formed sample is ideal.
  • The faecal sample must not come in contact with the toilet water due to bleaches and disinfectants.
  • Do not get urine in the sample as this will dilute it.
  • Read the instructions carefully before you start.

How to Collect Your Sample

BEFORE YOU BEGIN…

Write the date of sample collection on the label. Also write your name, date of birth and NHS number if this is not already on the tube.

Alpha Laboratories CALEX Faecal Calprotectin Extraction Device

1. COLLECT THE FAECAL SAMPLE

There are a number of ways to collect your faecal sample:

  • A clean takeaway container, paper/foil plate.
  • Loosely draped cling film placed over the toilet towards the back to form a dip. (Do not flush after use).
  • A plastic bag or glove covering your hand.
  • Use a solid sample where possible.

Calprotectin Extraction Device

2. PREPARE THE CALEX CAP

Holding the CALEX Cap tube with the white cap pointing upward remove the sampling pin by simultaneously turning clockwise and pulling up the white cap.

Calprotectin Extraction Device

3. TAKE THE SAMPLE

Dip the sampling pin into the faeces and twist. Repeat this process three to five times in different places in the sample. Scan the QR code to watch a video on how to deal with different sample consistencies.

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Calprotectin Extraction Device

4. CHECK THE SAMPLE

Make sure all the grooves are completely filled on the end of the sampling pin.

Calprotectin Extraction Device

5. RE-SEAL THE CALEX CAP

Replace the sampling pin back into the CALEX Cap tube and push firmly into the locking position (you will feel and hear two clicks).

6. DO THIS ONLY ONCE

Once complete do not remove the sample pin or repeat the collection process as this will lead to inaccurate or incorrect results. Please return your sample in the plastic bag provided as quickly as possible to your GP or hospital laboratory.

DO NOT UNSCREW THE BLUE CAP and DO NOT EMPTY THE LIQUID FROM THE CALEX CAP

Liquid contains preservative which may cause allergic skin reactions.

If skin irritation or rash occurs: Get medical advice/attention.

Checklist

  • Ensure the white cap is replaced securely (you will hear two clicks).
  • Ensure the CALEX® tube is clearly labelled with your name, date of birth, NHS number, date of sample collection and indicate if the sample was liquid (Yes/No).
  • Put the CALEX® tube and the GP request form into the plastic bag and return as directed to the GP or hospital laboratory, as quickly as possible.

Access to Alternative IFU Formats

Scan the QR code to visit our website where you can find different versions of the IFU, including:

Narrated step-by-step.

Explanations of the advisory symbols used within the kit can be found on the website: www.alphalabs.co.uk/kit-symbols

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Calprotectin Extraction Device

Alpha Laboratories Ltd
40 Parham Drive, Eastleigh, Hampshire, SO50 4NU, UK
Tel: 023 8048 3000 | Email: kits@alphalabs.co.uk
Web: www.alphalabs.co.uk

Registered in England 1215816

Please Do NOT send the completed sample to this address

Product Specifications:

  • Intended Use: Home faecal Elastase kit for collection and transportation to the laboratory for analysis
  • Sample Requirement: Formed faecal sample (solid or semi-solid)
  • Contents: 1x CALEX device, 1x Instruction for use, 1x clear plastic bag
  • Key Reminders:
    – Do not use the CALEX beyond the expiry date Use a formed sample
    – Avoid contact with toilet water or urine Read instructions carefully

Frequently Asked Questions (FAQ):

Q: Can I reuse the CALEX device for multiple samples?

A: No, the CALEX device is for single-use only. Reusing it can lead to inaccurate results.

Q: What should I do if I accidentally get urine in the sample?

A: If urine gets in the sample, discard it and collect a new sample to ensure accurate testing results.

Q: How should I store the collected sample before sending it to the laboratory?

A: Store the collected sample in the provided clear plastic bag and return it to your GP or hospital laboratory as soon as possible.

Documents / Resources

Alpha Laboratories CALEX Faecal Calprotectin Extraction Device [pdf] User Manual
CALEX Faecal Calprotectin Extraction Device, CALEX, Faecal Calprotectin Extraction Device, Calprotectin Extraction Device, Extraction Device, Device

References

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