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QuikRead go iFOBT

QuikRead go iFOBT is an immunochemical FIT test for detection and quantification of human haemoglobin in faeces in case of suspected bleeding from the lower gastrointestinal tract. The measurement is carried out with the QuikRead go instrument which can be connected to HIS/LIS systems, if needed.

Generally
Technical data
Additionally needed materials
Faecal occult blood (FOB) testing and colorectal cancer
Documents and materials

Generally

This ready-to-use kit and its straightforward test procedure together with the instrument provide an accurate result in less than three minutes.

The results can be obtained as qualitative or as quantitative, numerical results.

When used as a qualitative test the samples containing human haemoglobin above 15 µg/g faeces (75 ng/ml) are recognized as positives.

The quantitative measurement range starts from 10 µg/g faeces (50 ng/ml) and concentrations up to 200 µg/g faeces (1000 ng/ml) are shown as numerical result. Concentrations above this are displayed as > 200 µg/g (>1000 ng/ml).

QuikRead go iFOBT provides you with

Adaptiveness

Quantitative results enable use of national recommendations
Results can be weighed against each patient's age and gender or possible risk factors
Flexible test procedure is easy to fit into the daily routines of laboratories and in point-of-care
Five (5) days sample stability in the sampling vial at 18-25°C allows convenient sampling at home and time to return the sample to the analyzing site

Objectiveness

Numerical results in range of 10-200 µg/g (50-1000 ng/ml)
Instrument settings allow choosing a qualitative result with a cut-off of 15 µg/g
Instrument read results make visual result interpretation unnecessary

Reliability

Automated test procedure includes only few manual steps
Handy and hygienic sampling vial regulates the quantity of the sample

Proven QuikRead quality

No need for manual calibration of the test
Results are automatically stored in the instrument’s memory
User and patient information can be stored with the results and sent to LIS/HIS when required
Connectivity and bi-directional data exchange allow to manage several instruments centrally

Test results should never be used alone, without a complete clinical evaluation.

QuikRead go iFOBT is not registered in the USA.

Technical data

Products available	151051 QuikRead go iFOBT, 50 tests
Use	For in vitro diagnostic use
Method	Immunoturbidimetric
Sample type	Faeces
Instrument information	QuikRead go Instrument
Time to result	Less than 3 minutes
Reading of the result	Instrument read
Storage	2 - 8 °C
Shelf life	14 months
Transportation	2 - 8 °C
Size and weight	10 x 14 x 8 cm, 452 g
Full export carton of kits	24
Additionally needed	With QuikRead go iFOBT 151051 QuikRead go Instrument 133893 QuikRead iFOB Sampling Set (50 sampling tubes) 151052 QuikRead FOB Positive Control 06027 QuikRead go iFOBT Control Quantitative 152390 With QuikRead go iFOBT 136189 QuikRead go Instrument 133893 QuikRead FOB Sampling Set 138822 QuikRead FOB Positive Control 06027 QuikRead FOB Control Quantitative 144675
Country of origin	Finland
Registration	Not registered in the USA
Registered trademark	QuikRead go is a registered trademark of Aidian Oy

Additionally needed materials

QuikRead iFOB Sampling Set and QuikRead FOB Sampling Set contains 50 sampling tubes with buffer, instructions for use, patient labels and patient instructions. These tubes are designed to collect the defined faeces amount into the buffer and to dispense the correct volume of sample solution into the test cuvette. The sampling tubes are intended for use with QuikRead go iFOBT or QuikRead FOB quantitative tests.

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QuikRead FOB Positive Control is intended for high concentration quality control of QuikRead FOB quantitative and QuikRead go iFOBT assays. If the qualitative measurement is in use, the result should be “Positive” and when the test is used as quantitative, the result should be > 1000 ng/ml or > 200 µg/g

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QuikRead go iFOBT Control Quantitative and QuikRead FOB Control Quantitative kits are intended for low concentration quality control of QuikRead FOB quantitative or QuikRead go iFOBT assays. The control should provide a “Positive” result when the qualitative measurement is used and when the quantitative measurement is used, the result should be within the range indicated on the control vial label.

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Faecal occult blood (FOB) testing and colorectal cancer

Faecal occult blood can be a sign of colorectal cancer

Colorectal cancer (CRC) is a cancer of the colon, rectum, or anus. According to the World Health Organization (WHO), CRC is currently the third most common cancer and the second most common cancer-related cause of death worldwide. Around 1.9 million CRC cases are diagnosed annually.¹

Many genetic and environmental factors and clinical conditions increase the risk for CRC. The development of CRC is slow, it usually takes 10-15 years, and it mainly affects individuals older than 50 years old. CRC usually begins with the growth of noncancerous cell clumps, called polyps, in the mucous membrane of the colon. Over time, some of these polyps and adenomas may turn into cancer.

Many people do not experience symptoms in the early stages of CRC. However, the blood vessels of colorectal polyps or cancers are often fragile and easily bleed into the colon or rectum. In healthy individuals, small quantities of lower gastrointestinal bleeding may occur, but it may also be a symptom of a gastrointestinal disorder. In addition to polyps, adenomas, and CRC tumours, other conditions, such as ulcerative colitis and Crohn’s disease, may cause bleeding in the lower intestine. This bleeding is rarely visible by the naked eye in the stool, but the hemoglobin of the faecal occult blood can be detected by the faecal immunochemical test (FIT), such as QuikRead go iFOBT.

Faecal immunochemical test levels correlate with the cancer severity

The faecal hemoglobin concentrations are generally higher in men than women and increase by age². FIT levels also correlate with the cancer severity³. In symptomatic patients, point of care (POC) QuikRead go iFOBT provides quantitative information on excessive bleeding and aids in triaging patients for further gastrointestinal tract investigations, such as colonoscopy. Negative results assist in the identification of patients who would unlikely benefit from the colonic investigation, or they can be assigned for lower priority. Thus, negative iFOBT results may reduce unnecessary colonoscopies.⁴ A POC FIT allows immediate test results that can be used for faster decision making and improved risk-stratification of the patients.

Early detection of colorectal cancer improves the chance of survival

The early detection of CRC or its precursors significantly improves the chance for survival, requires less invasive treatment, and reduces treatment costs. Screening of people at moderate risk for CRC have been shown to reduce CRC mortality and incidence.⁵ Screening of CRC using FIT tests is recommended currently by the Council of Europe in the EU countries and by the American College of Physicians in the USA for individuals between 50-74 years old^5,6.

Adjustable cut-off in colorectal screening

The quantitative FIT result enables adjustment of cut-offs according to the patient need or to meet recommendations in the national screening programs in the different countries. The optimal cut-off can be adjusted based on available endoscopic resources, CRC prevalence in the population, and expected participation rate in the screening program⁷. FIT cut-offs of 20-30 µg/g are recommended when the health care system can organize colonoscopies for approximately 5% of the screened (and FIT positive) patients aged 50-74 years⁸.

References

World Health Organization. Global Cancer Observatory database. https://gco.iarc.fr/ Accessed 25.2.2022.
McDonald PJ et al. Faecal hemoglobin concentration by gender and age; implications for population – based screening for colorectal cancer. Clin Chem Lab Med. 2012; 50:935-40.
Navarro M et al. Fecal hemoglobin concentration, a good predictor of risk of advanced colorectal neoplasia in symptomatic and asymptomatic Patients. Front Med (Lausanne) 2019; 6:31.
Mclean W et al. Diagnostic accuracy of point of care faecal immunochemical testing using a portable high-speed quantitative analyser for diagnosis in 2-week wait patients. Colorectal Disease 2021; 00:1–11.
European commission. European guidelines for quality assurance in colorectal cancer screening and diagnosis – First Edition. Segnan N, Patrick J, von Karsa L (eds.), 2010, Luxenbourg.
Rex D et al. Colorectal Cancer Screening: Recommendations for Physicians and Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol 2017; 112:1016-1030.
Grazzini G et al. Immunochemical faecal occult blood test: number of samples and positivity cutoff. What is the best strategy for colorectal cancer screening? Br J Cancer 2009; 100:259-265.
Hamza S et al. Diagnostic yield of a one sample immunochemical test at different cut-off values in an organised screening programme for colorectal cancer. Eur J Cancer 2013; 49:2727-2733.