Calprotectin Products for Patient Self-Testing

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Introducing IBDoc® Calprotectin Home Test

Alpha Laboratories has expanded the offering of Calprotectin tests with the launch of the BÜHLMANN IBDoc® which is the first CE marked Calprotectin home test. Utilising sophisticated technology contained within smartphones, the IBDoc enables patients to perform quantitative calprotectin tests at home.

Under the guidance of clinicians, regular monitoring is now possible for IBD patients in the comfort of their own home. This approach allows for a customised, patient centric method for therapy and disease management helping to predict possible relapse and assisting with therapy optimisation.

Read the NICE Medtech innovation briefing [MIB132] on Calprotectin Home Testing

  • First CE marked Calprotectin Home Test
  • Excellent correlation with laboratory based tests
  • Quantitative rapid test with measurement of calprotectin in the range 30 – 1000µg/g
  • Simple sample preparation devices minimises pre-analytical errors
  • All components contained within the kit to perform a test with simple instructions:
    – Pictorial IFU guide
    – Two stool collection papers
    – Camera calibration card/ reading template
    – CALEX value extraction device
    – Individually sealed test cassette
  • User friendly App with Phone calibration

Key Literature

IBDoc Home Test – Step by Step Instructions

Setting up an IBDoc Account:

Click here to take a look at our Step-by-Step guide to setting up an account on the IBDoc App:

Download the IBDoc App Set-up Instructions

Performing a Test:
Original Packaging Format

Performing a Test:
New Packaging May 2020

Read the Patient Blog: IBDoc and Me

Having struggled with his disease for the last 25 years, Lee Stanley hoped that being able to use the IBDoc would help him to self manage the condition whilst expanding his extremely limited diet. After all, there is only so much chicken, carrot and rice that one person can take!

However, at the time there were no clinics offering IBDoc that Lee could access.

Lee has recently gained access to the IBDoc and is now doing a monthly blog to chart his experience over the next year.

Join Lee on his journey and see how he gets on performing his own calprotectin tests.

Click Here to Read His Blog
Lee Stanley

Buy Online

IBDoc® Home Test
Product Code Description Pack Size
LF-IBDOC8 IBDoc Home Test Kits 8
BI-IBDOC IBDoc Starter Pack Each
Click Here to Buy IBDoc Online

IBDoc provides a customised, patient centric approach for management of disease and therapy.

Easy as 1-2-3 

The new BÜHLMANN IBDoc® system, now available from Alpha Laboratories, provides sophisticated technology that enables your IBD patients to perform quantitative calprotectin testing themselves, in just three easy steps, reading the results using their smartphones.

  1. Process the sample with the CALEX® Valve extraction device.
  2. Apply the extracted sample to the calprotectin cassette.
  3. Use the smartphone CalApp® to read and calculate the result and send it to the gastroenterologist via the secure IBDoc® Portal.

More Regular Patient Monitoring

IBDoc provides a practical way for more frequent monitoring of patients in the privacy of their own home.

Under the guidance of clinicians, more regular patient monitoring can help predict potential relapse and assist in therapy optimisation. This approach allows for a customised, patient centric approach for management of disease and therapy.

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IBDoc® Test Procedure

IBDoc Test Procedure Step 1

1. Prepare the Test

To start the test procedure the patient logs into the downloaded CalApp on their smartphone with their IBDoc account username and password.  They then collect a stool sample with the easy to use faecal collection paper sheet included in the IBDoc Test Kit.

IBDoc Sample Extraction

2. Extract the Sample

The sampling pin of the CALEX Valve extraction device is dipped into the stool sample a few times with a twisting motion. This collects a defined amount of stool in the grooves of the CALEX Valve pin. The pin is placed back into the tube through the upper funnel.

IBDoc Loading Test Cassette

3. Load the Test Cassette

The CALEX Valve tube is applied onto the test cassette and a precise amount of extract is released by turning the lever. After a few seconds, when the membrane strip of the cassette gets visibly soaked, the lever is closed.

Faecal calprotectin Home Testing

4. Read the Test Cassette

Results are read using the smartphone camera. Placing the camera above the cassette focuses and automatically takes a picture. The image is analysed through a sophisticated image processor and a quantitative result is calculated by the CalApp.

IBDoc Generating Result

5. Save the Test Result

Using a traffic light code system the result is classified as NORMAL, MODERATE, or HIGH. All the results performed on one smartphone are saved locally and can be accessed at any future time.

IBDoc Result Sent to Clinician

6. Doctor Is Notified

The result taken with the CalApp is automatically transferred to the IBDoc Portal and the patient’s doctor is immediately notified. Depending on the test result the doctor can communicate with the patient to advise on further therapeutic steps to be taken.

Easy Sample Extraction and Dispensing

The CALEX® Valve allows patients to process their own samples without the need for vortex mixing, centrifuging or pipetting. The valve at the base of the device dispenses a precise amount of liquid onto the lateral flow test device. After 12 minutes the calprotectin assay result is read using the smartphone and the data is transmitted to the clinician via a secure web portal.

Personal Portal for Direct Management by the Clinician

The IBDoc Portal is a secure, encrypted, user friendly application for clinical professionals to manage their IBD patients.
Each patient test profile can be tailored by the clinician:

  • Threshold values for the traffic light system.
  • Choose for the patient to see the traffic light interpretation, the actual calprotectin value or hide the results completely.
  • Set the frequency of the tests for the patient.

Excellent Correlation of Results 

IBDoc provides consistent results that correlate with other BÜHLMANN Calprotectin assays:

  1. BÜHLMANN Quantum Blue® fCAL
  2. BÜHLMANN fCAL® ELISA
  3. BÜHLMANN fCAL® turbo
Head to Head Comparison of Three Stool Calprotectin Tests for Home Use

Faecal home tests are being used more frequently as part of

My Year with IBDoc
My Year with IBDoc®

Lee Stanley, long term Crohn’s sufferer shares his experience of managing

Mercy_IBD-Team
Calprotectin Self-Testing Four Years On

The Benefits for Patients and Healthcare Staff of Routine IBDoc® Use

Calprotectin Home Testing
Introducing Patient Home Tests for Calprotectin in a Routine District General Hospital

Gastrointestinal/IBD Nurse of the Year 2018 introduces calprotectin home testing at her

IBDoc® Self-care/Point of care Calprotectin Test: Early Value in a District General Hospital

Pearl Avery from Dorset County Hospital  shows very interesting data on

Dorset-County-Hospital
IBDoc®: Early Value in a District General Hospital Inflammatory Bowel Disease Service

At the European Crohn’s and Colitis Organisation, 13th Congress in Vienna in February

Cost Effective Monitoring

Using IBDoc Faecal Calprotectin Testing Post Induction of anti-TNF Therapy G.

fCAL turbo vs. IBDoc
Calprotectin Home vs. Laboratory Test

Mary O’Connell née Deasy, Biochemistry Department, Mercy University Hospital, Cork, Ireland

Usability of a home-based test for the measurement of faecal calprotectin in IBD patients

In this video Caroline Bello from the University Hospital in Liege,

Is the IBDoc available over the counter?

No, it is only available through clinicians

What phones can the IBDoc be used with?

The IBDoc can only be used with approved phones. The list is continuously updated and currently includes:

Phone
iPhone 4s
iPhone 5
iPhone 5s
iPhone 5c
iPhone 6
iPhone 6 plus
iPhone 6s
iPhone 7
iPhone 7 plus
iPhone SE (2016)
iPhone 8
iPhone 8 Plus
iPhone X
iPhone Xs, Xr, Xs Max
iPhone 11
iPhone 11 Pro
iPhone 11 Pro Max
iPod Touch 5th Generation
Samsung Galaxy S3
Samsung Galaxy S3 Note
Samsung Galaxy S4
Samsung Galaxy S4 mini
Samsung Galaxy S5
Samsung Galaxy S5 mini
Samsung Galaxy S6
Samsung Galaxy S7
Samsung Galaxy S7 edge
Samsung Galaxy S8
Samsung Galaxy S8 plus
Samsung Galaxy S9
Samsung Galaxy S9 plus
Samsung Galaxy S10
Samsung Galaxy S10 Plus
Samsung Note 8
Samsung Note 9
Samsung Galaxy A3 (2014)
Samsung Galaxy A3 (2016)
Samsung Galaxy A5
Samsung Galaxy A5 (2017)
Samsung Galaxy A8 (2018)
Samsung Galaxy J3 (2016)
Samsung Galaxy J5 (2017)
Samsung Galaxy J6
Samsung Galaxy J6 plus (2018)
Samsung Galaxy J7 (2017)
Samsung Galaxy Core Prime
Alcatel OneTouch Idol3
HTC One
Huawei P8 Lite
Huawei P8 Lite (2017)
Huawei P10
Huawei P10 Lite
Huawei P20
Huawei P20 Lite
Huawei P20 Pro
Huawei Honor 9
Huawei Nexus 6P
Huawei Mate 20
LGE G3
LGE G4
LGE G6
LGE G7 ThinQ
Motorola Moto G5 plus
Motorola Moto G6
Nokia 8
Nokia 5.1 Plus
Nokia 6.1
OnePlus 3T
OnePlus 5T
OnePlus 6
OnePlus 6T
Sony Xperia Z3 Compact
Sony Xperia Z4 Compact
Sony Xperia XA
Google Pixel 2/2 XL
Google Pixel 3/3 XL
Why are some phones not able to be used with the App?

Phones have very different technology and imaging capabilities, even within a single manufacturer – the difference between an old iPhone 4 and the newer iPhones is huge, but between the various manufacturers the differences can be even greater. However, the result needs to be interpreted the same whatever phone is in use. A calibration, validation and registration process therefore needs to be completed before a phone can be approved for use with the IBDoc. When new phones are released by the manufacturer there is a delay whilst this is completed before the phone can be used with the App.

If you look at the graph below you can see what difference this makes:

Key:

Red lines are different uncalibrated Smartphone results reading the same test
Blue lines are the same Smartphone results after they have been calibrated
Grey line is the laboratory Reference ELISA result
Bold Yellow line is the average of the uncorrected results
Bold Pale Blue line is the average of the corrected results

How do I know what model number my phone is?

Click the links below for help on how to find your phone’s model number:
Apple iPhone
Samsung
All models

What if I upgrade my phone?

If the phone is changed to another approved phone from the list then the same user ID and password will apply. The local results history will be lost as this is stored on the phone, however it is still visible in the portal.

What happens if I don’t have a WiFi connection?

The result is stored until WiFi is re-established and then the result is sent to the portal.

How secure is the data?

There is a two way encrypted communication between the App and the portal with test results backed daily. No patient information is visible to anyone other than the clinic.

What will I see on completing a test?

In all instances the clinical team will receive the numerical result, but here are three options for patients to view results:

  • A red/amber/green traffic light system and the actual result (between 30 – 1000µg/g)
    • <30µg/g means that the result was below 30µg/g
    • >1000µg/g means that the result was higher than 1000µg/g
  • Just the red/amber/green categorisation
  • A blue screen with ‘Test Done’

Which option you see will depend on your clinical team – they will determine this when they set up an account for you.

What level are the traffic light thresholds set at?

The categories are defaulted to:

Level Colour
<100 ug/g Green
100 – 300 ug/g Amber
>300 ug/g Red

The levels are customisable by the clinician for each individual patient.

What happens if I get a red result?

Contact the clinic in the morning using the information provided under the help/ contact information section for advice.

Which languages are available on the IBDoc App?

The IBDoc App is currently available in 22 languages

  • English
  • German
  • French
  • Italian
  • Spanish
  • Portuguese
  • Greek
  • Norwegian
  • Swedish
  • Dutch
  • Danish
  • Finnish
  • Slovenian
  • Serbian
  • Estonian
  • Hungarian
  • Czech
  • Croatian
  • Polish
  • Hebrew
  • Chinese
  • Arabic

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IBDoc® Tutorial Videos for Healthcare Professionals

How to Create a Clinical User

Learn how to set-up a new account for a Clinical User.

The new user will then be able to use the IBDoc® account to manage patients.

How to Create a Patient

Watch this tutorial to learn the different possibilities when creating a patient account.

Patient basic settings can be modified to better satisfy your needs.

IBDoc® Calprotectin Home Test – Information for Your Patients