Fecal Immunochemical Tests Performance Characterized for CRC
|
By LabMedica International staff writers Posted on 14 Mar 2019 |

Image: The Fecal Immunochemical Test has been shown to detect colorectal cancer up to two years earlier than colonoscopy alone (Photo courtesy of Pinnacle BioLabs).
Many patients experience fear and anxiety before undergoing colonoscopy, which may result in negative experiences. Some doctors believe that having fecal immunochemical test (FIT) as an option might result in more people getting screened for colon cancer.
The FIT is designed to detect the protein hemoglobin, which is found in red blood cells. People who test positive with the FIT need to get a colonoscopy to determine whether they have cancer or pre-cancerous lesions, but those who test negative only need to keep getting the FIT each year to make sure they do not develop colon cancer.
Scientists at the Indiana University School of Medicine (Indianapolis, IN, USA) and their colleagues analyzed data from 31 studies that included more than 120,000 average risk patients who had a stool test and then a colonoscopy. They determined that the fecal immunochemical test is sufficient to screen for colon cancer. Currently, 35% of people who should receive colonoscopies do not. The FIT may also be a better option for screening people under age 50, the currently recommended age for colonoscopy. Recent studies have shown that colon cancer is striking younger and younger people and in response, the American Cancer Society has suggested lowering the age for a first colonoscopy to 45.
The team included 31 studies (120,255 participants; 18 FITs) and all were judged to have low to moderate risk of bias. Performance characteristics depended on the threshold for a positive result. A threshold of 10 µg/g resulted in sensitivity of 0.91 and a negative likelihood ratio of 0.10 for colorectal cancer (CRC), whereas a threshold of greater than 20 µg/g resulted in specificity of 0.95 and a positive likelihood ratio of 15.5. For advanced adenomas, sensitivity was 0.40 and the negative likelihood ratio was 0.67 at 10 µg/g, and specificity was 0.95 and the positive likelihood ratio was 5.86 at greater than 20 µg/g. Studies had low to high heterogeneity, depending on the threshold.
Although several FITs had adequate performance, sensitivity and specificity for CRC for one qualitative FIT were 0.90 and 0.91, respectively, at its single threshold of 10 µg/g; positive and negative likelihood ratios were 10.13 and 0.11, respectively. Comparison of three FITs at 3 thresholds was inconclusive: CIs overlapped, and the comparisons were across rather than within studies. Thomas F. Imperiale, MD, a gastroenterologist and the lead author of the study, said, “This non-invasive test for colon cancer screening is available for average risk people. They should discuss with their providers whether it is appropriate for them. The one downside to the at-home stool test is that it needs to be done yearly. But if used each year, the test is good enough to catch the vast majority of cancers.” The study was published on February 26, 2019, in the journal Annals of Internal Medicine.
Related Links:
Indiana University School of Medicine
The FIT is designed to detect the protein hemoglobin, which is found in red blood cells. People who test positive with the FIT need to get a colonoscopy to determine whether they have cancer or pre-cancerous lesions, but those who test negative only need to keep getting the FIT each year to make sure they do not develop colon cancer.
Scientists at the Indiana University School of Medicine (Indianapolis, IN, USA) and their colleagues analyzed data from 31 studies that included more than 120,000 average risk patients who had a stool test and then a colonoscopy. They determined that the fecal immunochemical test is sufficient to screen for colon cancer. Currently, 35% of people who should receive colonoscopies do not. The FIT may also be a better option for screening people under age 50, the currently recommended age for colonoscopy. Recent studies have shown that colon cancer is striking younger and younger people and in response, the American Cancer Society has suggested lowering the age for a first colonoscopy to 45.
The team included 31 studies (120,255 participants; 18 FITs) and all were judged to have low to moderate risk of bias. Performance characteristics depended on the threshold for a positive result. A threshold of 10 µg/g resulted in sensitivity of 0.91 and a negative likelihood ratio of 0.10 for colorectal cancer (CRC), whereas a threshold of greater than 20 µg/g resulted in specificity of 0.95 and a positive likelihood ratio of 15.5. For advanced adenomas, sensitivity was 0.40 and the negative likelihood ratio was 0.67 at 10 µg/g, and specificity was 0.95 and the positive likelihood ratio was 5.86 at greater than 20 µg/g. Studies had low to high heterogeneity, depending on the threshold.
Although several FITs had adequate performance, sensitivity and specificity for CRC for one qualitative FIT were 0.90 and 0.91, respectively, at its single threshold of 10 µg/g; positive and negative likelihood ratios were 10.13 and 0.11, respectively. Comparison of three FITs at 3 thresholds was inconclusive: CIs overlapped, and the comparisons were across rather than within studies. Thomas F. Imperiale, MD, a gastroenterologist and the lead author of the study, said, “This non-invasive test for colon cancer screening is available for average risk people. They should discuss with their providers whether it is appropriate for them. The one downside to the at-home stool test is that it needs to be done yearly. But if used each year, the test is good enough to catch the vast majority of cancers.” The study was published on February 26, 2019, in the journal Annals of Internal Medicine.
Related Links:
Indiana University School of Medicine
Latest Clinical Chem. News
- New PSA-Based Prognostic Model Improves Prostate Cancer Risk Assessment
- Extracellular Vesicles Linked to Heart Failure Risk in CKD Patients
- Study Compares Analytical Performance of Quantitative Hepatitis B Surface Antigen Assays
- Blood Test Could Predict and Identify Early Relapses in Myeloma Patients
- Compact Raman Imaging System Detects Subtle Tumor Signals
- Noninvasive Blood-Glucose Monitoring to Replace Finger Pricks for Diabetics
- POC Breath Diagnostic System to Detect Pneumonia-Causing Pathogens
- Online Tool Detects Drug Exposure Directly from Patient Samples
- Chemical Imaging Probe Could Track and Treat Prostate Cancer
- Mismatch Between Two Common Kidney Function Tests Indicates Serious Health Problems
- VOCs Show Promise for Early Multi-Cancer Detection
- Portable Raman Spectroscopy Offers Cost-Effective Kidney Disease Diagnosis at POC
- Gold Nanoparticles to Improve Accuracy of Ovarian Cancer Diagnosis
- Simultaneous Cell Isolation Technology Improves Cancer Diagnostic Accuracy
- Simple Non-Invasive Hair-Based Test Could Speed ALS Diagnosis
- Paper Strip Saliva Test Detects Elevated Uric Acid Levels Without Blood Draws
Channels
Molecular Diagnostics
view channel
Diagnostic Device Predicts Treatment Response for Brain Tumors Via Blood Test
Glioblastoma is one of the deadliest forms of brain cancer, largely because doctors have no reliable way to determine whether treatments are working in real time. Assessing therapeutic response currently... Read more
Blood Test Detects Early-Stage Cancers by Measuring Epigenetic Instability
Early-stage cancers are notoriously difficult to detect because molecular changes are subtle and often missed by existing screening tools. Many liquid biopsies rely on measuring absolute DNA methylation... Read more
“Lab-On-A-Disc” Device Paves Way for More Automated Liquid Biopsies
Extracellular vesicles (EVs) are tiny particles released by cells into the bloodstream that carry molecular information about a cell’s condition, including whether it is cancerous. However, EVs are highly... Read more
Blood Test Identifies Inflammatory Breast Cancer Patients at Increased Risk of Brain Metastasis
Brain metastasis is a frequent and devastating complication in patients with inflammatory breast cancer, an aggressive subtype with limited treatment options. Despite its high incidence, the biological... Read moreHematology
view channel
New Guidelines Aim to Improve AL Amyloidosis Diagnosis
Light chain (AL) amyloidosis is a rare, life-threatening bone marrow disorder in which abnormal amyloid proteins accumulate in organs. Approximately 3,260 people in the United States are diagnosed... Read more
Fast and Easy Test Could Revolutionize Blood Transfusions
Blood transfusions are a cornerstone of modern medicine, yet red blood cells can deteriorate quietly while sitting in cold storage for weeks. Although blood units have a fixed expiration date, cells from... Read more
Automated Hemostasis System Helps Labs of All Sizes Optimize Workflow
High-volume hemostasis sections must sustain rapid turnaround while managing reruns and reflex testing. Manual tube handling and preanalytical checks can strain staff time and increase opportunities for error.... Read more
High-Sensitivity Blood Test Improves Assessment of Clotting Risk in Heart Disease Patients
Blood clotting is essential for preventing bleeding, but even small imbalances can lead to serious conditions such as thrombosis or dangerous hemorrhage. In cardiovascular disease, clinicians often struggle... Read moreImmunology
view channelBlood Test Identifies Lung Cancer Patients Who Can Benefit from Immunotherapy Drug
Small cell lung cancer (SCLC) is an aggressive disease with limited treatment options, and even newly approved immunotherapies do not benefit all patients. While immunotherapy can extend survival for some,... Read more
Whole-Genome Sequencing Approach Identifies Cancer Patients Benefitting From PARP-Inhibitor Treatment
Targeted cancer therapies such as PARP inhibitors can be highly effective, but only for patients whose tumors carry specific DNA repair defects. Identifying these patients accurately remains challenging,... Read more
Ultrasensitive Liquid Biopsy Demonstrates Efficacy in Predicting Immunotherapy Response
Immunotherapy has transformed cancer treatment, but only a small proportion of patients experience lasting benefit, with response rates often remaining between 10% and 20%. Clinicians currently lack reliable... Read moreMicrobiology
view channel
Comprehensive Review Identifies Gut Microbiome Signatures Associated With Alzheimer’s Disease
Alzheimer’s disease affects approximately 6.7 million people in the United States and nearly 50 million worldwide, yet early cognitive decline remains difficult to characterize. Increasing evidence suggests... Read moreAI-Powered Platform Enables Rapid Detection of Drug-Resistant C. Auris Pathogens
Infections caused by the pathogenic yeast Candida auris pose a significant threat to hospitalized patients, particularly those with weakened immune systems or those who have invasive medical devices.... Read morePathology
view channel
Engineered Yeast Cells Enable Rapid Testing of Cancer Immunotherapy
Developing new cancer immunotherapies is a slow, costly, and high-risk process, particularly for CAR T cell treatments that must precisely recognize cancer-specific antigens. Small differences in tumor... Read more
First-Of-Its-Kind Test Identifies Autism Risk at Birth
Autism spectrum disorder is treatable, and extensive research shows that early intervention can significantly improve cognitive, social, and behavioral outcomes. Yet in the United States, the average age... Read moreTechnology
view channel
Robotic Technology Unveiled for Automated Diagnostic Blood Draws
Routine diagnostic blood collection is a high‑volume task that can strain staffing and introduce human‑dependent variability, with downstream implications for sample quality and patient experience.... Read more
ADLM Launches First-of-Its-Kind Data Science Program for Laboratory Medicine Professionals
Clinical laboratories generate billions of test results each year, creating a treasure trove of data with the potential to support more personalized testing, improve operational efficiency, and enhance patient care.... Read moreAptamer Biosensor Technology to Transform Virus Detection
Rapid and reliable virus detection is essential for controlling outbreaks, from seasonal influenza to global pandemics such as COVID-19. Conventional diagnostic methods, including cell culture, antigen... Read more
AI Models Could Predict Pre-Eclampsia and Anemia Earlier Using Routine Blood Tests
Pre-eclampsia and anemia are major contributors to maternal and child mortality worldwide, together accounting for more than half a million deaths each year and leaving millions with long-term health complications.... Read moreIndustry
view channelNew Collaboration Brings Automated Mass Spectrometry to Routine Laboratory Testing
Mass spectrometry is a powerful analytical technique that identifies and quantifies molecules based on their mass and electrical charge. Its high selectivity, sensitivity, and accuracy make it indispensable... Read more
AI-Powered Cervical Cancer Test Set for Major Rollout in Latin America
Noul Co., a Korean company specializing in AI-based blood and cancer diagnostics, announced it will supply its intelligence (AI)-based miLab CER cervical cancer diagnostic solution to Mexico under a multi‑year... Read more
Diasorin and Fisher Scientific Enter into US Distribution Agreement for Molecular POC Platform
Diasorin (Saluggia, Italy) has entered into an exclusive distribution agreement with Fisher Scientific, part of Thermo Fisher Scientific (Waltham, MA, USA), for the LIAISON NES molecular point-of-care... Read more







