A publication in Clinical Immunology1 has highlighted that TruCulture can be used to standardize the immune monitoring process. This independent validation study supported research conducted by the Milieu Intérieur in defining boundaries of a healthy immune response.2,3
Immune functional assays (IFAs) are needed to help determine the immune response of patients against various diseases and can possibly be correlated to treatment response. IFAs aid in monitoring multiple diseases including detecting latent tuberculosis infection using T cell mediated immunity assays. They can also help in determining vaccine response of individuals.
However, variables encountered during sample collection and processing for a majority of traditional IFAs can lead to non-reproducible results. Some examples of these variables include comparing samples collected with differing anticoagulants, temperature variables during shipping/handling, and PBMC isolation variances. Another concern is the inter-individual variability exhibited by human immunity.
These studies show that TruCulture minimizes these IFA variances because:
- Whole blood is collected directly from patients and is cultured in the closed syringe-based system
- Limits technical manipulation bias
- Only requires 24-48 hours of incubation time for stimulation
To demonstrate that TruCulture is a standardized method, cytokine and transcriptomic assays and gene expression analysis were performed on healthy human subjects using Null (no stimulant), staphylococcal enterotoxin B (SEB), and lipopolysaccharide (LPS) TruCulture tubes. Results were then compared to the previously described data set by Urrutia et al2. Results showed a strong correlation between the two independent studies using healthy individuals for transcriptomic response and interferon gamma response. A correlation was observed between gene expression and protein measurements with a correlation coefficient of <0.64 with a p-vale of <.0005 for both cohorts.
TruCulture has again been shown to be a robust, standardized method for immune function evaluation. Its use in clinical studies will enable researchers to reproducibly ascertain information about innate and adaptive immune responses directly at the clinical site.
References
- Towards standardization of immune functional assays. (2020) Mouton W, et al. Clin Immunol. 2020 Jan;210:108312. doi: 10.1016/j.clim.2019.108312. Epub 2019 Nov 21. PMID: 31760096.
- Standardized whole-blood transcriptional profiling enables the deconvolution of complex induced immune responses. (2016) Urrutia A, et al. Cell Rep. 2016 Sep 6;16(10):2777-2791. doi: 10.1016/j.celrep.2016.08.011. Epub 2016 Aug 25. PMID: 27568558.
- Standardized whole blood stimulation improves immunomonitoring of induced immune responses in multi-center study. (2017) Duffy D, et al. Clin Immunol. 2017 Oct;183:325-335. doi: 10.1016/j.clim.2017.09.019. Epub 2017 Sep 22. PMID: 28943400.