High Throughput Calprotectin Testing with ALPCO Immunoturbidimetric Assay
Capture the Efficiency and Flexibility of High Throughput Random Access Testing
Utilize Your Existing Clinical Chemistry Analyzer
For laboratories with a compatible clinical chemistry analyzer, on-boarding of the calprotectin immunoturbidimetric assay is simple.
- No capital purchase or additional instrument space required
- Minimal assay training and hands-on time
- ALPCO assistance with validation kits and well-characterized samples
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. The broad analytical measuring range (AMR) enables reporting of a quantitative result for a higher percentage of patients. For users switching from manual ELISA, automated testing reduces the potential for operator error and decreases inter-operator and inter-assay variability.
| Performance | |
|---|---|
| Clinical Sensitivity | 91% |
| Clinical Specificity | 93% |
| Inter-lot Variability | 4.1% |
| AMR | 11 – 10,000 μg/g |
Increase Laboratory Efficiency
Complete a single test in less than ten minutes or perform hundreds of tests in an hour. Random access enables efficient testing of any number of samples, easily accommodating growing test volumes. With large capacities for samples, reagents, and consumables, many analyzers offer hours of walk-away testing time, enabling laboratories to do more with limited staff.
Improve Turn-Around Time
Unlike traditional ELISA, only two non-reportables (control samples) are run per day. Testing of only a handful of samples is cost-effective, increasing the number of days that calprotectin testing can be performed and decreasing the time to result … even at low volumes.
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
