Characteristics to Consider when Selecting a Positive Control Material for an In Vitro Assay

Published

September 29, 2021

Author(s)

Elijah Petersen, Andrew Nguyen, Jeffrey Brown, John T. Elliott, Amy Clippinger, John Gordon, Nicole Kleinstreuer, Matthias Roesslein

Abstract

The use of in vitro assays to inform decision-making requires robust and reproducible results across studies, laboratories, and time. Experiments using positive control materials are an integral component of an assay procedure to demonstrate the extent to which the measurement system is performing as expected. This paper reviews ten characteristics that should be considered when selecting a positive control material for an in vitro assay: 1) the biological mechanism of action, 2) ease of preparation, 3) chemical purity, 4) verifiable physical properties, 5) stability, 6) ability to generate responses spanning the dynamic range of the assay, 7) technical or biological interference, 8) commercial availability, 9) user toxicity, and 10) disposability. Examples and a case study of the monocyte activation test are provided to demonstrate the application of these characteristics for identification and selection of potential positive control materials. Because specific positive control materials are often written into testing standards for in vitro assays, selection of the positive control material based on these characteristics can aid in ensuring the long-term relevance and usability of standard methods.

Citation

Altex-Alternativen Zu Tier Experimenten

Pub Type

Journals

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Citation

Petersen, E. , Nguyen, A. , Brown, J. , Elliott, J. , Clippinger, A. , Gordon, J. , Kleinstreuer, N. and Roesslein, M. (2021), Characteristics to Consider when Selecting a Positive Control Material for an In Vitro Assay, Altex-Alternativen Zu Tier Experimenten, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=931927 (Accessed October 20, 2025)