Which type of reagents are used for research purposes only?

Prepare for the AAB Molecular Diagnostics Test with focused study materials and practice questions. Gain insights into questions, formats, and key topics to excel in your exam and advance your career in molecular diagnostics.

The correct answer is "RUO," which stands for "Research Use Only." These reagents are specifically intended for use in research settings and are not approved for diagnostic or therapeutic purposes in humans. They are often utilized in laboratories to explore new technologies, validate new assays, or conduct preliminary studies that can provide insights leading to further developments in molecular diagnostics.

RUO reagents are important because they allow researchers to experiment and gather data without the stringent regulatory requirements placed on diagnostic products. This flexibility can accelerate the pace of innovation in the field of molecular diagnostics.

In contrast, ASR (Analyte Specific Reagent) is designed for the laboratory use of specific analytes and is subject to quality controls set by regulatory bodies. GMP (Good Manufacturing Practice) denotes products that are manufactured under stringent regulations for clinical use, ensuring safety and efficacy. IUO (Investigational Use Only) refers to products under investigation that may be used in clinical trials but are not yet approved for general clinical use. These categories emphasize the varying levels of regulatory compliance and intended use, highlighting the research-specific focus of RUO reagents.

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