In Europe, colorectal cancer (CRC) is the most prevalent of all tumours, with 520,000 cases diagnosed per year, and second only to lung cancer in terms of deaths. However, it can be avoided or treated if identified in the early stages of the so-called adenoma-carcinoma sequence. Due to its simplicity and proven superior performance, the faecal immunochemical test (FIT) is currently considered the best non-invasive faecal occult blood (FOB) test. Human haemoglobin is detected with high specificity by using antibodies. If the result is positive, this allows additional diagnostic measures like colonoscopy to be taken at an early stage, possibly preventing colorectal cancer.

For a clinical setting with medium to high laboratory throughput needs, we offer an automated, quantitative FOB solution, which has been specially designed for use with the dedicated stand-alone faecal analysers SENTiFIT 270 Analyser and SENTiFOB Analyser, or total lab automation (TLA) walk-away solutions. This creates a flexible solution for screening and symptomatic testing for every clinical laboratory or hospital.

The FOB Gold system comprises a tube for sample collection and a next-generation immunological latex reagent for the detection of faecal occult blood on your dedicated faecal analyser. The combination makes the laboratory workflow particularly easy and efficient. Its high-quality diagnostic performance has been demonstrated by multiple studies and has been proven in national and international screening programmes.

Hygienic and simple – the FOB Gold pierceTube

2-in-1 collection tube: easy, safe and hygienic
Pierceable lid is secured by a tight seal
Standardised sample volume
Enhanced haemoglobin stability in the buffer (32 days at 2-8 °C / 14 days at 24-32 °C)
Directly ready for analysis upon arrival in the lab – no sample preparation

Safe and reliable – the FOB Gold reagents

Latex agglutination assay for turbidimetric reading
Highly sensitive haemoglobin detection with FOB Gold latex reagent
No dietary restrictions before testing nor drug interference upon analysis
Quantitative results with respective calibration curve allow a defined cut-off value

SENTiFIT^® and FOB GOLD^® are trademarks in various jurisdictions, which are exclusively licensed to Sentinel CH. SpA. w ww.sentineldiagnostics.com

Features

Advantages for the laboratory

Minimum sample handling: the tube is used to collect the faeces and is analysed directly on the stand-alone analysers SENTiFIT 270 Analyser and SENTiFOB Analyser, or on a walk-away TLA solution
Standardised faeces sampling: always collect the correct sample volume
Stable haemoglobin: 32 d at 2-8°C, 14 d at 28-32°C – simplifies lab
management
Easily identify patients thanks to barcoded tube labels
The faeces collection tube conforms to transportation regulations for UN3373 classification (biological substance transport)

More information on FIT for CRC screening

Technical Specifications

Sample stability	32 days at 2-8°C or 14 days at 24-32°C
Compressive strength	The SENTiFIT pierceTube meets packaging regulation P650 of ADR [Accord européen sur le transport des marchandises dangereuses par route, European Agreement concerning the International Carriage of Dangerous Goods by Road] and IATA [International Air Transport Association
Test tube	SENTiFIT pierceTube
Reagents	SENTiFIT 270 Analyser: SENTiFIT FOB Gold latex Wide (R1 and R2); FOB Gold Screen Diluent SENTiFOB Analyser: FOB Gold NG Wide (R1 and R2); FOB Gold Screen Diluent
QC and calibrator	SENTiFIT 270 Analyser: FOB Gold Control Set Wide (levels 1 and 2); FOB Gold Calibrator Wide SENTiFOB Analyser: FOB Gold Control Set Wide (levels 1 and 2); FOB Gold Calibrator Wide
Analysis system	SENTIFIT 270 Analyser SENTIFOB Analyser