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Consulting Services
Artificial Sputum
Leading the fight against tuberculosis through cutting-edge research and global collaboration.
Artificial Sputum
Reliable and accurate diagnostic methods are fundamental to effective TB control. Before new TB diagnostic tools can be introduced into routine practice, they must undergo rigorous pre-clinical validation to ensure sensitivity, specificity, and reproducibility. External Quality Assessment (EQA) is also essential for maintaining the high performance of existing TB diagnostics within laboratory networks.
MUCAS is an innovative artificial sputum formulation, designed to closely mimic real patient sputum while ensuring standardized and reproducible quality control for both pre-clinical validation of novel diagnostic methods and EQA panels. The formulation, currently in the process of patenting, enables the blind testing of known M. tuberculosis strain panels, providing an effective means of assessing diagnostic accuracy, compliance with quality assurance procedures, and laboratory performance.
This approach ensures controlled, reproducible, and standardized conditions, making MUCAS an optimal tool for validating new TB diagnostic assays and strengthening quality assurance across TB laboratory networks.
Notably, a study published in PLoS One in 2020 demonstrated that MUCAS closely resembles human sputum, making it suitable for quality control of PCR assays in TB diagnostics. The study highlighted that MUCAS-based panels provide a reliable medium for evaluating the analytical sensitivities of molecular diagnostics, thereby reinforcing the importance of such artificial sputum formulations in maintaining high diagnostic standards.
Approach:
Pre-Clinical Validation of Novel Diagnostics
- Production of MUCAS-based artificial sputum spiked with M. tuberculosis strains at defined concentrations for assay evaluation.
- Use of MUCAS in analytical validation studies of new molecular, culture-based, and rapid diagnostic tests.
- Assessment of limit of detection, precision, and robustness in controlled environments.
EQA Panel Development and Implementation
- Production of standardized EQA panels using MUCAS-based artificial sputum containing reference M. tuberculosis strains.
- Distribution of EQA panels to participating laboratories under strict biosafety and transport conditions.
- Testing of EQA panels with existing diagnostic platforms (e.g., culture, GeneXpert, other molecular assays).
Performance Evaluation and Certification
- Collection of laboratory test results and comparison against reference values.
- Evaluation of diagnostic performance, including sensitivity, specificity, and reproducibility.
- Issuance of official certificates of compliance for laboratories that successfully pass EQA assessments.
Service Packages offered:
Preparation of defined MUCAS panels
Spiked with standard M. tuberculosis strains
Validation Study Support
Consulting on pre-clinical study design, protocol development, and data interpretation for new TB diagnostic tools
EQA Panel Implementation
Support in scaling up MUCAS-based EQA panels for regional and national TB laboratory networks
Certification of EQA Participation
Issuance of certificates upon successful completion of EQA assessments, ensuring compliance with laboratory quality assurance standards
Past Experience:
MUCAS-based EQA panels and pre-clinical validation studies have been successfully implemented in multiple National Reference Laboratories (NRLs), demonstrating high reproducibility, ease of implementation, and adaptability across different TB diagnostic platforms.
The approach has been applied in:
National Reference Laboratory (NRL), Dushanbe, Tajikistan
National Reference Laboratory (NRL), Tashkent, Uzbekistan
National Reference Laboratory (NRL), Kyiv, Ukraine
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For inquiries or more information, please reach out to us at:
+49 89 1259996-0
info@imlred.de