Abstract
This document details the analytical validation of the Tashikin Canine Pancreatic Lipase S2 (TKN-cPLI-S2) fluorescence immunoassay. Studies were conducted to determine the assay's precision, accuracy, analytical sensitivity, and resistance to common interferences. The results demonstrate that the assay is a highly precise and reliable method for the quantitative measurement of cPL in canine serum. The assay exhibits excellent correlation with the reference laboratory standard and is robust against common interfering substances, making it a dependable tool for the diagnosis and management of canine pancreatitis.
1. Introduction
The accurate diagnosis of canine pancreatitis is a common and critical challenge in veterinary medicine. Canine pancreatic lipase immunoreactivity (cPLI) is the most specific laboratory indicator for pancreatitis. To provide veterinarians with a tool of the highest confidence, Tashikin has developed the TKN-cPLI-S2 assay. This whitepaper provides transparent validation data on its analytical performance.
2. The NomoFlow™ Platform: The Source of Reliability
The performance documented in this paper is a direct result of the NomoFlow™ manufacturing platform. This proprietary system integrates advanced microfluidics and real-time quality control to ensure unparalleled lot-to-lot consistency in reagent deposition and antibody binding kinetics. This minimizes analytical drift and provides the foundation for the assay's precision and reliability.
3. Materials and Methods
The TKN-cPLI-S2 assay was validated by assessing precision, correlation with a predicate method, and susceptibility to common interfering substances. All studies were conducted using canine serum samples and controls prepared according to CLSI guidelines.
4. Results
Table 1: Precision (Intra- and Inter-Assay)
Precision was determined by running three levels of controls in multiple replicates. Intra-assay precision was assessed in 20 replicates within a single run. Inter-assay precision was assessed across 10 runs over 5 days.
| Control Level | Intra-Assay CV | Inter-Assay CV |
|---|---|---|
| Low (50 µg/L) | 4.1% | 7.5% |
| Mid (250 µg/L) | 3.5% | 6.8% |
| High (800 µg/L) | 3.8% | 7.1% |
Table 2: Method Correlation
A correlation study was performed using 110 canine serum samples, comparing the TKN-cPLI-S2 assay against the commercial Spec cPL® reference method. The results show a high degree of correlation.
| Parameter | Value | Units |
|---|---|---|
| Sample Count (n) | 110 | |
| Correlation Coefficient (R²) | 0.978 | |
| Slope | 1.02 | |
| Intercept | 8.5 | µg/L |
Table 3: Interference Study
The assay showed no significant interference (<10% change) from common endogenous substances at the following concentrations.
| Substance | Concentration | Result |
|---|---|---|
| Hemoglobin | 500 mg/dL | No significant interference |
| Triglycerides (Lipemia) | 1500 mg/dL | No significant interference |
| Bilirubin (Icterus) | 20 mg/dL | No significant interference |
5. Conclusion
The analytical data presented demonstrates that the Tashikin TKN-cPLI-S2 assay is a highly precise, accurate, and robust diagnostic tool. The low coefficients of variation, excellent correlation to the reference standard, and resistance to common interferences provide veterinarians with a high degree of confidence in the results. This level of performance, engineered through the NomoFlow™ platform, makes the assay an essential component for the confident diagnosis and management of canine pancreatitis.