We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Technopath Clinical Diagnostics - An LGC Company

Sentinel Diagnostics

Sentinel Diagnostics develops and manufactures in-vitro diagnostic medical devices for routine analysis and specific ... read more Featured Products: More products

Download Mobile App


ATTENTION: Due to the COVID-19 PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event.

Fecal Immunochemical Test for Hemoglobin Evaluated on Automated System

By LabMedica International staff writers
Posted on 25 Jan 2022
Print article
Image: The SENTIFIT-FOB Gold test is a latex agglutination immunoturbidimetric assay for quantitation of hemoglobin in feces (Photo courtesy of Sentinel Diagnostics)
Image: The SENTIFIT-FOB Gold test is a latex agglutination immunoturbidimetric assay for quantitation of hemoglobin in feces (Photo courtesy of Sentinel Diagnostics)
Colorectal cancer (CRC) is the third most common cancer in men and women and has the second most mortality rate worldwide. Most of the new CRC cases are found in patients presenting with symptoms in primary health care, such as changes in bowel habit and red blood in the feces.

Fecal immunochemical tests (FIT) for detection and quantification of detection of hemoglobin in feces (f-Hb) are well established and have replaced traditional guaiac-based tests in national screening programmes in most European countries. Several quantitative immunochemical tests are available, however only a few tests are available on high throughput automated analyzers.

Medical Biochemists and their colleagues at the Aalesund Hospital (Aalesund, Norway) evaluated, as part of a study, 163 symptomatic patients over 18 years referred to colonoscopy for assessment of lower abdominal symptoms. The study was performed between January 2020 and February 2021. Invitation to colonoscopy together with a collection device and detailed instructions for sampling of feces was sent by mail 2-4 weeks before meeting for colonoscopy. Patients were asked to collect a fecal sample 3-7 days before colonoscopy. There were no dietary restrictions before sampling.

Fecal samples were collected in FOB Gold sample tubes (Sysmex Norge, Oslo, Norway). Samples were analyzed with the SENTIFIT-FOB Gold test (Sentinel Diagnostics, Milano, Italy), which is a latex agglutination immunoturbidimetric assay for quantitation of hemoglobin in feces. The assay was applied on an open channel on the Roche Cobas 8000 c702 automated analyzer (Roche Diagnostics, Oslo, Norway). The time of analysis on the Roche Cobas 8000 system was 10 minutes. Diagnostic accuracy and optimal cutoff of the FIT-assay were determined by comparing fecal hemoglobin (f-Hb) concentrations with colonoscopy findings as reference.

The investigators reported that the SENTIFIT-FOB Gold assay showed an imprecision with a total coefficient of variation (CV%) <10% at all concentrations of quality control material and patient sample pools analyzed. At average f-Hb concentrations of 24 ± 0.8 μg/g and 58 ± 2.3 μg/g in patient sample pools the within-run imprecision (repeatability) was 3.4% and 3.9%, respectively. The accuracy of the assay was performed by comparison of the mean quality control sample hemoglobin concentration with the target specified by the manufacturer. The deviation of the mean from the specified target concentration was <4% in both control samples. The Limit of blank (LoB) and Limit of detection (LoD) were estimated to 1 μg/g and 2 μg/g, respectively when using buffer spiked with standard. Using a real patient sample with low f-Hb concentration the LoD was 2 μg/g.

The authors concluded that the SENTIFIT-FOB Gold assay for quantification of hemoglobin in feces applied on the automated Roche Cobas 8000 analyzer shows adequate analytical and clinical performance which agrees well with the performance of the assay on the SENTIFIT-270 analyzer. This enables effective and efficient use of a quantitative FIT on a high-throughput analyzer in large routine clinical chemistry laboratories. In patients presenting with lower abdominal symptoms a cutoff of 10 μg/g seems to be optimal for referral to secondary care and provides a reliable prediction of the absence of CRC and advanced adenoma. The study was published on January 15, 2022 in the journal Practical Laboratory Medicine.

Related Links:
Aalesund Hospital
Sysmex Norge
Sentinel Diagnostics
Roche Diagnostics

Gold Supplier
Pipette Tips
Sapphire Pipette Tips
Microplate Reader
3-DIFF Hematology Analyzer
Washer Dispenser

Print article


Molecular Diagnostics

view channel
Image: Guidance UTI provides personalized results in less than one day from receipt at lab (Photo courtesy of Pathnostics)

Rapid Result Test for Complicated Urinary Tract Infections Proves Superior to Standard Urine Culture

Complicated urinary tract infections (cUTIs) are a significant burden on individual health and healthcare resources that must be diagnosed and treated early and accurately to reduce the risk of poor outcomes.... Read more


view channel
Image: The CS-2500 analyzer features pre-analytic sample checks and four detection methods simultaneously on a single platform – coagulation end-point, chromogenic kinetic analysis, turbidimetric immunoassay and automated platelet aggregation (Photo courtesy of Sysmex)

Microvascular/Endothelial Dysfunction Contributes to Post-COVID Syndrome Pathogenesis

Post-COVID syndrome (PCS) or Long-COVID is an increasingly recognized complication of acute SARS-CoV-2 infection, characterized by persistent fatigue, reduced exercise tolerance chest pain, shortness of... Read more


view channel
Image: Sales of lateral flow assays in clinical testing are expected to register a CAGR of 5% through 2032 (Photo courtesy of Pexels)

Global Lateral Flow Assays Market to Surpass USD 11.5 Billion by 2032 Due to Evolving Applications

The global lateral flow assays market was valued at USD 7.2 billion in 2021 and is projected to register a CAGR of 4.7% during 2022-2032 to surpass USD 11.7 billion by the end of 2032, driven by the growing... Read more
Copyright © 2000-2022 Globetech Media. All rights reserved.