SmarTest® FIT Home test (Preventis®)

PST40111EP

SmarTest FIT - self test

Self-test for faecal haemoglobin levels at home with SmarTest® FIT

The detection of haemoglobin in stool samples can be used as a marker of gastrointestinal bleeding as part of a colorectal cancer screening initiative. Hidden traces of blood in the stool can originate from tumours or polyps (lesions) in the lower gastrointestinal tract so when haemoglobin is detected in stool samples it is indicative of the presence of such lesions and is a trigger for further investigation.

Studies have shown that when FIT (faecal immunochemical test) testing is employed and combined with confirmatory colonoscopy, precancerous lesion can be detected and treated in order to reduce mortality from colorectal cancer.

The Preventis SmarTest® FIT Home test system consists of a rapid immunological test and a smartphone app. The rapid lateral flow test detects human haemoglobin in stool samples using gold-conjugated anti-haemoglobin antibodies. The SmarTest app is then used to scan and analyse the faecal haemoglobin (FIT) test result according to the intensity of the control and test lines on the lateral flow test. The quantitative results of the test are then displayed in the app and available for discussions and follow up with healthcare professionals.

Key Advantages

Precise self test for home FIT testing
Rapid test with quantitative results in 15 minutes
Discreet and pocket sized packaging for testing anywhere.
Store at room temperature, no refrigeration required
Promotes Patient Initiated Follow up (PIFU)

Specifications

Lateral flow test and App

Easy to follow and animated instructions

Individually packaged tests

Storage: 16-30 °C

More Details

Why are FIT tests so important?

Detection of occult blood in stools using FIT tests can identify gastrointestinal bleeding and help form health strategies for colorectal cancer screening. Blood in stools could be caused by tumours or polyps in the intestine, indicating the need for intervention. When occult blood is found in stool samples, it warrants the immediate follow up using confirmatory diagnostic techniques such as colonoscopy to determine whether the bleeding actually originates from a tumour or precursor, or other condition. In combination with colonoscopy, FIT tests have been shown to reduce the risk of death from colorectal cancer.

SmarTest FIT enables individuals to perform quantitative FIT tests at home, which delivers immediate, actionable results, and promotes Patient initiated follow up (PIFU) for faster intervention, without the need for utilising hospital or laboratory resources.

The SmarTest FIT Home test is a self-test for faecal haemoglobin that can be undertaken by individuals in their home or by healthcare professionals in a clinical setting. FIT testing at home may help overcome challenges associated with the cost and time of centralised testing, facilitating rapid turn-around and faster patient initiated follow-up.

Individuals can test their own faecal samples for the presence of haemoglobin at prescribed, regular intervals or as part of an annual health check, or when indicated in the instance of abdominal symptoms.

Preventis SmarTest FIT is a solution to enable individuals to apply a convenient and rapid test for self health promotion.

 

How does SmarTest FIT home test work?

SmarTest FIT® Home test system consists of an immunological rapid test (lateral flow test) and a free to use smartphone app. The rapid test specifically detects human blood (haemoglobin) in stool samples using gold-conjugated anti-haemoglobin antibodies. Simply prepare a stool sample using the sample collection tube provided in the pocket sized test kit and apply three drops to the lateral flow test. After 15 minutes the SmarTest app quantitatively evaluates the result of the rapid test based on the colour intensity of the control and test lines. The result is automatically displayed on the smartphone and saved.

 

What are the advantages of SmarTest FIT?

Preventis SmarTest® FIT Home detects and quantifies tiny amounts of blood in stool samples using innovative and reliable technology. There is no need to take a special diet prior to the test and the test can be used anywhere. Evaluation at home eliminates the need to transport stool samples to the practice or laboratory reducing the turnaround time for test results.

With each test result being available after just 15 minutes, individuals are able to take action on their health without delay. A positive result must lead to further medical clarification – either through referral for further investigation or management by a health professional. Blood in stools can also have other, sometimes less serious causes, such as inflammation or haemorrhoids, but it is important to follow up with a healthcare professional if any test result is positive, or where symptoms persist. If your test result with Preventis SmarTest® FIT Home is positive, consult a medical professional.

 

SmarTest® FIT Home app

  • Free to download and use (Google play / Apple App Store)
  • Fully animated and assistive instructions
  • Automatic timing and scanning of test

Compatible devices list (updated 01/2024)

SmarTest® FIT Home test FAQs

What is a FIT test?

FIT test stands for Faecal Immunochemical test and is the name given to any immunological diagnostic test that uses specific antibodies to detect human haemoglobin, a derivative of red blood cells, in a stool sample. FIT tests are used in colorectal cancer screening and for the investigation of patients presenting with abdominal symptoms suggestive of organic pathology.

How does SmarTest FIT Home test work?

The Preventis SmarTest® FIT Home test system includes a rapid immunological lateral flow test and a smartphone app. The rapid test detects human haemoglobin in stool using gold-conjugated anti-haemoglobin antibodies. The app, installed on a suitable smartphone, is then used quantitatively evaluate the result of the rapid test based on the colour intensity of the control and test lines. The quantitative FIT test result is automatically displayed and saved on the smartphone.

What does a positive SmarTest FIT Home test result mean?

Haemoglobin concentrations > 9.6 µg/g stool are interpreted by the test as positive, which means that human haemoglobin was detected in an amount that warrants further investigation. The presence of blood in stools can have many causes including bleeding intestinal polyps or tumours. However there are other common causes including menstrual bleeding, heavy bleeding of the gums, haemorrhoids, stomach irritations or blood in the urine. The evidence of blood provided by FIT Tests is therefore not directly equivalent to a medical diagnosis of colorectal cancer. SmarTest FIT Home test is just one test in a necessary series of tests to enable the doctor to make a complete diagnosis. It is therefore recommended that positive results are reported to a doctor as soon as possible in order to classify the results of the rapid test.

How accurate is SmarTest FIT Home test?

The analytical sensitivity of SmarTest FIT Home test (limit of detection) is 2.1 µg haemoglobin/g stool. The measuring range is 2.1 to 70 µg/g. In terms of analytical specificity the test shows no cross-reactivity with haemoglobin of animal origin.

With a cut-off at 9.6 µg haemoglobin/g stool SmarTest FIT® Home shows a clinical specificity of 93.0% and a clinical sensitivity of 31.5% for advanced neoplasia (colorectal carcinoma and large adenomas). With this cut-off the expected positive rate in an organised colon cancer screening (= screened representative selection of collected stool samples) is 10.4% [Gies et al., 2018].


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