The Approved Guide acknowledges the increasing use of quantitative molecular methods to determine the concentration of microorganisms in patients. The CLSI document MM06 provides guidance for the development and use of quantitative molecular methods, such as nucleic acid probes of target sequences specific to particular microorganisms and nucleic acid amplification techniques, and offers recommendations for quality assurance, proficiency testing, and interpretation of results.
Specifically, topics specific to nucleic acid quantification in diagnostic testing and monitoring in viral diseases include an update on technologies used in molecular quantification, sample processing and preparation, standards, calibrators and reference materials, analytical and clinical validation, reporting and interpretation of results, clinical utility, and manufacturers and recommendations for clinical laboratories.
This standard is intended for manufacturers or laboratories that develop tests, laboratories that perform or intend to perform such tests, clinicians who use the results to diagnose or manage patients, and agencies that regulate their use.
EUROLAB assists manufacturers with CLSI MM06-A2 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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