Calprotectin Products for Patient Self-Testing

IBDoc_patient_self_test

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

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.

IBDoc_Step1
IBDoc_Step2
IBDoc_Step3

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
Hope on the Horizon for IBD Patients

Crohn’s sufferer Lee Stanley from Manchester writes about his experience of

Mercy_Hospital
Calprotectin Patient Self-Testing in Practice

NEW User Report: Monitoring calprotectin concentrations is important as an indicator

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,

Home vs. Hospital Based Analysis of Stool Calprotectin

Comparison of Two Diagnostic Methods for Monitoring Inflammatory Bowel Disease. In

Is the IBDoc available over the counter?

No, it is only available through clinicians

Is the IBDoc available through private clinics?

Clinics offering IBDoc for private testing:

London Gastroenterology Centre

Alexandra Guilfoyle Tel: 020 7183 7965 or email: alexandra@gastrolondon.org.uk

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 Model Number
iPhone 4S iPhone4, 1
iPhone 5 iPhone5, 1
iPhone 5C iPhone5,3 /iPhone5,4
iPhone 5S iPhone5, 2
iPhone 6 iPhone7, 2
iPhone 6 Plus iPhone7, 1
iPhone 6S iPhone8, 1
iPhone 7 iPhone9, 1/iPhone9, 3
iPhone 7 Plus iPhone9, 2/iPhone9, 5
iPhone SE iPhone8, 4
iPod Touch 5th Generation iPhone5G
Samsung Galaxy S3 GT-I9300/ GT-I9300I
Samsung Galaxy S4 GT-I9505/ GT-I9515
Samsung Galaxy S5 SM-G900F
Samsung Galaxy S5 Mini GT-I8200N
Samsung Galaxy S6 SM-G920F
Samsung Galaxy S7 SM-G930F
Samsung Galaxy S7 Edge SM-G935F
Samsung Galaxy S8 GT-G950F
Samsung Galaxy S8 Plus SM-G955F
Samsung Galaxy A3 (2014 & 2016) SM-A300FU/ SM-A310F
Samsung Galaxy A5 SM-A500FU
Samsung Galaxy Core Prime LTE SM-G360F
HTC One HTC ONE (M7)
LG G3 LG-D855
LG G4 LG-H815
Sony Xperia Z3 Compact E5823
Sony Xperia Z4 Compact D5803
Sony Xperia XA F5121
Huawei P8 Lite ALE-L21
Huawei P10 VTR-L09
Huawei Nexus 6P Nexus 6P
OnePlus 3T ONEPLUS A3003
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 level are the traffic light thresholds set at?

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.

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.