Immunoturbidimetric Assay for Fecal Calprotectin
Extraction to Results – Simplify Complexity
Leverage the power of our FDA-Cleared Immunoturbidimetric (IT) Assay for fecal calprotectin designed to integrate seamlessly with your existing clinical chemistry analyzer. Experience a method that is not only time and cost-efficient but also a viable alternative to conventional and send-out methodologies.
See for yourself why labs are switching to ALPCO’s new FDA-cleared Calprotectin Immunoturbidimetric Assay.
One free kit per laboratory. Void where prohibited.
Clinical Accuracy: Results You Can Trust
With confidence in superior performance, clinicians can triage colonoscopies for patients that need it most, and rapidly start IBS patients on the right treatment path.
- Clinical sensitivity of 90.5% - few false negatives
- Clinical specificity of 93.4% - few false positives
Turn-Around Time
Leverage the turn-around time and throughput of existing clinical chemistry analyzers, and increase menu and capacity with limited staffing.
- Testing of >400 samples per hour††
- Time to first result in 10 minutes††
† With automatic 1:10 dilution | †† Based on Beckman AU680
Reliability
Rely upon strong reproducibility and lot-to-lot consistency for high confidence in continually reporting accurate values.
- Analytical Measuring Range (AMR) of 11 -10,000 µg/g†
- Inter-lot variation (CV) of only 4.1%
- Validated sample panel spanning the AMR for lot release testing
Efficiency
Enable efficient and cost-effective testing of low to high test volumes and increase value by converting calprotectin send-outs to in-house testing.
- Compatible with most clinical chemistry analyzers
- Universal stool extraction device
- Only 2 non-reportables (controls) run per day
Reduce False Positives Versus the Leading Immunoturbidimetric Competitor
Switching to ALPCO from the leading Calprotectin Immunoturbidimetric competitor enables reducing false positives by 19%. Clinicians can better evaluate IBD vs non-IBD patients, and schedule colonoscopies with people that need it the most in a overburdened healthcare system.*
*Data based on competitive 510(k), equivalent = positive
EXTRATION TO RESULTS. SIMPLIFY COMPLEXITY.
Calprotectin Immunoturbidimetric Assay
The Calprotectin Immunoturbidimetric Assay is an in vitro diagnostic particle-enhanced immunoassay for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The assay is intended for use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.
| Reagent Set | 80-CALPHU-IT200 |
| Calibrator Set | 80-CALPHU-ITCAL |
| Control Set | 80-CALPHU-ITCON |
| Sample Type | Stool |
| Sample Size | 15mg** |
| LLOQ – ULOQ | 11 – 10,000 μg/g |
| Time to First Result* | 10 mins |
| Tests per Hour* | >400 (following first result) |
| Tests per Reagent Set* | 200 |
* Specifications based on Beckman AU680 Analyzer after first hour
** Automatically metered by FDA-cleared extraction device