ALPCO's Superior Calprotectin Assay: Maximize Efficiency & Accuracy
Automate on Your Current Analyzer Without Sacrificing Clinical Sensitivity or Specificity
The ALPCO Calprotectin Immunoturbidimetric Assay combines the clinical sensitivity and specificity clinicians expect with the efficiency and reproducibility that today’s laboratories require.
Give Your Clients the Clinical Specificity Their Patients Deserve and Reduce False Positives from 26% to 7%!
An increase in clinical specificity, and a decrease in false positives, enables clinicians to better evaluate IBD/IBS patients. Clinicians can schedule follow-up colonoscopies for the patients that need it most and start IBS patients on the right treatment path.
The ALPCO method reduces the number of false positives from 26% to 7% without sacrificing clinical sensitivity.
| ALPCO | Competitor | |
|---|---|---|
| Clinical Sensitivity | 91% | 91% |
| Clinical Specificity | 93% | 74% |
Generate More Definitive Results the First Time
A broader analytical measuring range enables reporting of a quantitative result for a higher percentage of patients. A reduction in the “equivocal” or “grey” zone means a greater number of suspected IBD patients can be scheduled for colonoscopy without waiting for a second calprotectin test.
| ALPCO | Competitor | |
|---|---|---|
| AMR | 11 – 10,000 μg/g | 20 – 8,000 μg/g |
| Likely IBS | <50 μg/g | <80 μg/g |
| Equivocal Zone | 50 - 100 μg/g | 80 - 160 μg/g |
| Likely IBD | >100 μg/g | 7>160 μg/g |
Maintain Consistency in Data Reporting
Testing of in-house reference controls and a well-characterized sample panel with each new calprotectin kit lot maintains consistency over time, ensuring timely, accurate reporting of results.
| ALPCO Reproducibility | ||
|---|---|---|
| # of Samples | Inter-Assay CV | Inter-Lot CV |
| 7 | 3.4% | 4.1% |
Calprotectin Immunoturbidimetric Assay
The ALPCO Calprotectin Immunoturbidimetric Assay combines the clinical sensitivity and specificity clinicians expect with the efficiency and reproducibility that today’s laboratories require.
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.
Take Control of Your Calprotectin Testing
See for yourself why labs are switching to ALPCO’s new FDA-cleared Calprotectin Immunoturbidimetric Assay
Intended Use
The assay is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD) and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.
CE-marked. 510(k) cleared.
Clinical Accuracy & Reproducibility
- Clinical Sensitivity of 91%
- Clinical Specificity of 93%
- Inter-lot CV of only 4%
Compatibility with Existing Analyzers
- No capital purchase required
- High throughput
- Minimal hands-on time
- Ease-of-Use
- Consistency of automated processing
Universal Stool Extraction Device
- Simple workflow
- Consistent sample processing
- No manual weighing
- Several compatible GI assays
| Specifications | |
|---|---|
| Reagent Set | 80-CALPHU-IT200 |
| Calibrator Set | 80-CALPHU-ITCAL |
| Control Set | 80-CALPHU-ITCON |
| Sample Type | Stool |
| 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
