QuikRead go iFOBT

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.

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 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

1. World Health Organization. Global Cancer Observatory database. https://gco.iarc.fr/ Accessed 25.2.2022.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.

Marketing and sales materials

QuikRead go iFOBT Brief Instruction (EN)

QuikRead go Family Brochure (EN)

QuikRead go Technical Specifications (EN)

Immunochemical Faecal Occult Blood tests (EN)

QuikRead go iFOB Sampling set ePoster Labquality Days 2018 (EN)

QuikRead go Control Information (EN)

QuikRead go workstation Flyer (EN)

Stories

Immunochemical Faecal Occult Blood tests (EN)

Videos

Instructions for use

(For informative use only. Kindly always refer to the latest package insert in the kit.)

QuikRead go iFOBT IFU (GB, DE, FR, EE) 151051

QuikRead go iFOBT IFU (FI, SE, NO, DK) 151051

QuikRead go iFOBT IFU (CZ, SK, ES, NL) 151051

QuikRead iFOB Sampling Set IFU (GB, DE, FR, NL, ES, EE, CZ, PL, SI, SE, NO, FI, DK) 151052

QuikRead iFOB Sampling Set Patient IFU, 151052

QuikRead FOB Positive Control IFU (GB, DE, FR, NL, ES, IT, CZ, SK, HU, PL, SI, SE, NO, DK, FI), 06027

QuikRead go iFOBT Control Quantitative (GB, FR, DE, NL, ES, IT, SK, CZ, EE, SI, PL, SE, DK, NO, FI), 152390

Revision history QuikRead iFOB Sampling Set (GB, DE, FR, ES, NL, EE, CZ, SK, PL, SE, NO, DK, FI), 151052

Safety Data Sheet

QuikRead go iFOBT 136189, 151051 SDS (EN)

QuikRead iFOB Sampling Set 151052 SDS (EN)

QuikRead FOB Positive Control 06027 SDS (EN)

QuikRead iFOBT Control Quantitative 152390 SDS (EN)