Consolidate and Improve Calprotectin Testing on Clinical Chemistry Analyzers with ALPCO
Testing Fecal Calprotectin on a CLIA System? Consolidate Testing with the Calprotectin Immunoturbidimetric Assay.
Consolidate Assays on Your Existing Clinical Chemistry Analyzer
For laboratories with a compatible clinical chemistry analyzer, upgrading to the calprotectin immunoturbidimetric assay can improve efficiency and generate additional capacity. Laboratories can potentially eliminate a CLIA system or simply create new capacity on that system by transferring calprotectin to another analyzer.
- Eliminate a CLIA system and associated maintenance time and rental cost
- Free laboratory space and technicians for new testing platforms
- Free space on your CLIA system for additional tests
Ensure Accurate, Reproducible Results
With clinical sensitivity of 91% and clinical specificity of 93%, the ALPCO calprotectin immunoturbidimetric assay offers the efficiency of automation without sacrificing clinical performance. Internal reference controls and a well-characterized sample panel ensure consistency over time for accurate reporting of results.
Precision and reproducibility were evaluated using three lots of reagents and seven stool extracts spanning the AMR of the assay.
| ALPCO Reproducibility | ||
|---|---|---|
| # of Samples | Inter-Assay CV | Inter-Lot CV |
| 7 | 3.4% | 4.1% |
Increase Throughput and Walk-Away Time for Calprotectin Testing*
With large capacities for samples, reagents, and consumables, many clinical chemistry analyzers offer an increase in throughput and decrease in hands-on-time compared with current CLIA systems for stool-based GI testing. Consolidating calprotectin testing on an existing clinical chemistry analyzer enables laboratories to do more with limited staff.
*Throughput and walk-away time will vary by analyzer
Calprotectin Immunoturbidimetric Assay
The 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
