Controls for Research Use Only

More About Research Use Only

Materials and chemicals are labeled For Research Use Only (RUO) to indicate that the products have not been approved for In Vitro Diagnostic (IVD) testing by the FDA and may only be used for research and not for manufacturing or product testing. RUO also indicates that the materials are not to be used to manufacture any products for human use without validation. The validation and qualification of RUO materials can be costly, so choose the appropriate equipment and lab materials for any pilot projects to help ensure that the end-product is FDA-compliant. Not all RUO materials have an IVD version available.

Controls for RUO

Controls for RUO are reference materials used to assess the performance and accuracy of tests and assays. RUO controls help researchers develop, optimize, and validate procedures before they are approved for use in clinical settings.

Advantages of Controls for RUO

Controls for RUO are used to support the research and development phase of diagnostic assays. They allow laboratories to fine-tune and customize their testing protocols without the stringent regulatory constraints associated with IVD products.

RUO controls may also offer cost savings compared to IVD products. The regulatory processes and compliance requirements associated with IVD products can substantially increase their price. In contrast, RUO controls are not burdened by the same regulatory expectations, making them more cost-effective for research and development purposes.

With these and other advantages in mind, it's important to emphasize that RUO controls are not intended for clinical diagnosis. IVD products undergo rigorous testing, regulation, and approval processes to ensure their accuracy and reliability in clinical settings. The decision between RUO controls and IVD products depends on the research stage, objectives, and the specific requirements of the laboratory or healthcare facility.

The following controls for RUO products are available through the Fisher Healthcare brand.

ZeptoMetrix NATtrol Controls for Respiratory Virus Nucleic Acids

ZeptoMetrix™ NATtrol™ Controls for Respiratory Virus Nucleic Acids are designed for use in evaluating and monitoring the performance of nucleic acid tests for determination of the presence of respiratory virus nucleic acids.

ZeptoMetrix NATtrol Strep A External Run Controls

ZeptoMetrix NATtrol Strep A External Run Controls and verification panels can be used with a variety of molecular platforms. NATtrol Strep A Positve Controls include specific strains of Streptococcus.

Thermo Scientific AcroMetrix COVID-19 RNA Controls

Thermo Scientific™ AcroMetrix™ COVID-19 RNA Controls are multiplex synthetic, dual-concentration RNA transcript controls to validate and monitor the performance of molecular tests for detecting COVID-19 using Bio-Rad™ Droplet Digital™ PCR (ddPCR™) technology.

ZeptoMetrix NATtrol SARS-CoV-2 External Run Controls

ZeptoMetrix NATtrol SARS-CoV-2 External Run Controls are reliable and easy-to-use non-infectious positive and negative controls for SARS-CoV-2 test development, validation, and ongoing quality control.