DiaSys ACE FS
Automated Diagnostic Efficiency
The implementation of modernized enzymatic testing allows clinical laboratories to significantly streamline daily testing schedules for non-routine biomarkers. By utilizing liquid-stable, two-component reagent configurations, facilities can eliminate manual reconstitution steps, decrease pre-analytical preparation times, and reduce reagent waste. These ready-to-use presentations integrate directly onto clinical chemistry analyzers to optimize throughput and provide immediate, automated handling of specialized diagnostic workflows.
| Feature | Value / Outcome |
| Limit of Quantitation (LoQ) | 5 U/L |
| Linearity Range | 5 to 175 U/L |
| Repeatability (Precision) | Less than or equal to 1.60% |
| Deviation from EQA / Recovery of INSTAND Samples | Less than or equal to 17% |
| Human Serum Reference Range | 13.3 to 63.9 U/L |
| Analytical Interference Intercepts | DiaSys ACE FS Tolerance Threshold | Leading Competitor Threshold |
| Conjugated Bilirubin | 30 mg/dL | 6 mg/dL |
| Unconjugated Bilirubin | 12.5 mg/dL | 4.7 mg/dL |
| Hemoglobin | 200 mg/dL | 119 mg/dL |
| Hemolysis | 600 mg/dL | / |
| Lipemia | 1000 mg/dL | 224 mg/dL |
| N-acetylcysteine (NAC) | 500 mg/dL | / |
| Primary Wavelength | 505 nm | 340 nm |
| Article Number | Instrument Platform / Presentation | Presentation Size |
| 17601 99 10 966 | BioMajesty JCA BM 6010/C | 300 tests (configured as 2 x 150) |
| 17601 99 10 926 | respons System Kit | 240 tests (configured as 2 x 120) |
| 17601 99 10 930 | Universal System Kit | 4 x 20 mL + 2 x 10 mL |
| 17600 99 10 046 | TruCal ACE Calibrator | 3 x 1 mL liquid stable |
| 5 9300 99 10 046 | TruLab ACE Level 1 Control | 3 x 1 mL liquid stable |
| 5 9310 99 10 046 | TruLab ACE Level 2 Control | 3 x 1 mL liquid stable |
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- 3-Step Enzymatic Chain Reaction Technology
- Ready-To-Use Liquid Stable Reagents
- High Absorbance Signals at 505 nm
- Low Sample Volume of Only 6 µL
- Fully Automated Analysis
- IVDR Registered Compliance
- 3-Step Enzymatic Chain Reaction Technology
- Ready-To-Use Liquid Stable Reagents
- High Absorbance Signals at 505 nm
- Low Sample Volume of Only 6 µL
- Fully Automated Analysis
- IVDR Registered Compliance
Diagnostic Support & Physiology
Clinical Significance of ACE Activity in Granulomatous Conditions
Angiotensin-converting enzyme (ACE) functions as a key enzymatic component of the renin-angiotensin-aldosterone system (RAAS) to maintain circulatory homeostasis. While localized across the vascular endothelium of multiple organs, its highest concentration occurs within pulmonary capillary beds.
In clinical settings, assessing serum ACE activity serves as a supportive diagnostic aid alongside independent evaluations. Granuloma formations in sarcoidosis typically correlate with distinct enzyme patterns:
- Acute Sarcoidosis: Characterized by elevated ACE activity.
- Alternative Granulomas: Typically display unchanged ACE levels.
- Therapeutic Monitoring: Successful medical management typically results in a normalization of enzyme activity.
Evaluating these patterns provides an objective parameter to assist medical teams in distinguishing sarcoidosis from other granulomatous diseases and monitoring long-term active therapeutic progression.
Assay Technology
Technical Advancements in Automated ACE Analysis
Historically, automated testing relied on the FAPGG substrate method. However, this approach generates relatively low signal responses and is highly susceptible to matrix interferences from lipid and bilirubin concentrations because it reads in the lower ultraviolet spectrum (340 nm). These limitations frequently introduce analytical vulnerability during routine laboratory processing.
DiaSys ACE FS utilizes a modernized, hippuricase-based colorimetric methodology operating via a regulated three-step enzymatic chain reaction:
- Sample ACE breaks down the 4-Hydroxyhippuryl-L-histidyl-L-leucine substrate to yield 4-Hydroxyhippuric acid.
- Hippuricase converts this intermediate compound into 4-Hydroxybenzoic acid.
- Peroxidase (POD) catalyzes dye formulation into a stable quinoneimine dye.
This cascade measures absorbance at 505 nm, moving the analytical signal completely outside the range of common serum interferents. This shift provides high linearity and structural precision from a minimal sample requirement of only 6 qL, which is highly advantageous for volume-restricted pediatric sample workflows.
Operational and Economic Advantages
Onboard Stability
Fluid-stable calibrators and controls remain consistently viable on automated tracking systems, helping laboratories meet stringent internal quality standard audits without premature disposal of materials.
Traceable Standardized Controls
System performance is sustained through dedicated, liquid-stable matrix calibrators and controls that establish reliable baselines across variable multi-instrument networks.
Resource Optimization
Shifting tracking profiles to high-signal enzymatic chemistry preserves system capacity, reduces repeat-testing frequency, and supports cost-effective lifecycle management for diagnostic machinery.
Global Assay Harmonization
Formulated to support international regulatory guidelines and certified manufacturing quality standards, this methodology provides consistent reporting benchmarks across decentralized healthcare systems.
Frequently Asked Questions
Essential technical and clinical guidance for integrating the DiaSys ACE FS assay into automated laboratory testing workflows.
Monitoring serum ACE activity serves as an objective tool used in conjunction with other diagnostic parameters to support the confirmation of sarcoidosis, differentiate it from other granulomatous conditions, and evaluate long-term therapeutic drug efficacy.
Unlike the traditional FAPGG method which reads at 340 nm and suffers from low signal output, DiaSys ACE FS utilizes a modern, three-step enzymatic chain reaction ending in peroxidase-driven dye formation read at 505 nm, which minimizes susceptibility to analytical errors and common sample interferences.
The assay requires an exceptionally low sample input of just 6 µL per test, making it an ideal choice for high-throughput routine testing and highly beneficial when executing volume-restricted pediatric sample workflows.
By establishing its primary measurement spectrum at 505 nm, the assay shifts the signal well away from the lower ultraviolet spectrum where common serum interferents absorb. It features superior tolerance thresholds, including lipemia up to 1000 mg/dL and conjugated bilirubin up to 30 mg/dL.
The assay is supplied as a liquid-stable, ready-to-use, two-component reagent available in dedicated presentations for the BioMajesty JCA BM 6010/C (300 tests) and respons platforms (240 tests), alongside universal multi-purpose system kits.
Yes, DiaSys provides a dedicated TruCal ACE calibrator alongside TruLab ACE Level 1 and Level 2 controls, all configured as liquid-stable presentations to optimize onboard stability and simplify routine laboratory calibration procedures.