DxNtense
NEW
Where Diagnostics Meets Strategy and Innovation
DxNtense
DxNtense is a cutting-edge quantitative analytics service designed to enhance existing quality assurance and quality control (QA/QC) practices for rapid diagnostics tests (RDTs). It compliments traditional qualitative, visually interpreted RDT result interpretations with objective, repeatable, and quantitative measures, and can be tailored for specific client needs.
Current Challenges in RDT QA/QC
Conventional RDT evaluations rely heavily on visual result interpretation, which introduces observer bias and lacks standardization. Sensitivity and specificity are often assessed only during test validation, and results are broadly categorized (e.g., positive or weak positive) without capturing quantitative measures of performance variability over time. This approach fails to track quantitative changes over time, making it difficult to identify early signs of performance drift due to environmental or manufacturing-related variability.
DxNtense
DxNtense offers a transformative shift from qualitative to quantitative QA/QC practices, enabling data-driven insights for RDT performance optimization.
Intended Use Cases for DxNtense
DxNtense is ideal for manufacturers seeking an additional layer of confidence in their existing QA/QC practices with quantitative measures of performance. Use cases include:
● Monitoring RDT performance variability
● Detecting performance drift (e.g., from temperature excursions or aging)
● Supporting WHO-compliant shelf-life and stability studies*
● Comparing output from different production lines
● Enhancing proficiency testing in labs
● Assisting with post market surveillance and root cause analysis
Analytical Output and Capabilities
● Quantifies RDT performance using image analysis, with high repeatability
● Calculates normalized test/control line ratios
● Tracks product consistency and stability over time
● Enables comparative assessments across batches and facilities
Added Value of DxNtense
● Reduces subjectivity and increases reliability in RDT performance evaluation
● Provides continuous, longitudinal insight into test performance
● Improves detection of early performance decline
● Supports regulatory compliance and quality benchmarks
● Enhances overall product confidence and manufacturing transparency
DxNtense provides a more robust alternative, allowing for objective and quantitative evaluation of line intensity
Figures 1 and 2 show two lateral flow tests run with weak positive specimens containing analyte concentrations near the limit of detection. Assigning semiquantitative values (e.g., +1 or +2) to the test line intensity is highly subjective and influenced by the user, lighting conditions, and the reference scale employed. Figure 3 provides an example of such a scale; however, the lack of standardized color intensity scales further complicates consistent result interpretation.
Figure 1. RDT brand A tested with a weak positive (6 replicates)
Figure 2. RDT brand B tested with a weak positive (6 replicates)
Figure 3. Sample color scale for estimating RDT line intensities
(Reference: Matovu et al. Parasites & Vectors (2017) 10:546)
DxNtense adds confidence, consistency, and clarity to RDT quality monitoring—empowering existing manufacturers and new ones entering the market with measurable, actionable data.
Contact us to learn more!
