Evolution and Characteristics of the Monocyte Activation Test (MAT)

Spreitzer, Ingo

doi:10.1007/978-3-030-17148-3_14

Cited by 3 publications

(2 citation statements)

References 25 publications

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“…Nevertheless, for large volume parenterals, the sensitive MAT-setups (in range of 3-6 pg/ml) offer the opportunity for pyrogen testing, where the RPT was not sensitive enough. 97 In head-to-head comparisons, MAT showed the same results as RPT when RPT was clearly negative or positive, whereas in cases where RPT result gave borderline results (and thus required a repeated test), MAT was able to discriminate, with false-negative results never occurring; this is critical for the safety of users, as falsepositives are preferable to false-negatives in an assay used to predict tolerability. Taken together, these findings show that the MAT is more sensitive than RPT and may detect pyrogenicity earlier than RPT.…”

Section: Discussionmentioning

confidence: 97%

Outer membrane vesicles: moving within the intricate labyrinth of assays that can predict risks of reactogenicity in humans

Rossi

Citiulo

Mancini

2020

Human Vaccines & Immunotherapeutics

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Outer membrane vesicles (OMV) are exosomes naturally released from the surface of Gram-negative bacteria. Since the '80s, OMVs have been proposed as powerful vaccine platforms due to their intrinsic self-adjuvanticity and ability to present multiple antigens in natural conformation. However, the presence of several pathogen-associated molecular patterns (PAMPs), especially lipid A, has raised concerns about potential systemic reactogenicity in humans. Recently, chemical and genetic approaches allowed to efficiently modulate the balance between reactogenicity and immunogenicity for the use of OMV in humans. Several assays (monocyte activation test, rabbit pyrogenicity test, limulus amebocyte lysate, human transfectant cells, and toxicology studies) were developed to test, with highly predictive potential, the risk of reactogenicity in humans before moving to clinical use. In this review, we provide a historical perspective on how different assays were and can be used to successfully evaluate systemic reactogenicity during clinical development and after licensure.

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Section: Discussionmentioning

confidence: 97%

Outer membrane vesicles: moving within the intricate labyrinth of assays that can predict risks of reactogenicity in humans

Rossi

Citiulo

Mancini

2020

Human Vaccines & Immunotherapeutics

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“…Recently, the European Pharmacopoeia authorized two additional techniques for determining LPS activity: the recombinant factor C (rFC), a recombinant protein from the LAL enzymatic cascade, and the monocyte activation test (MAT) [48]. In MAT assays, monocytes are activated by endotoxins and the release of the pro-inflammatory interleukins is assayed by ELISA [49]. All these techniques aim to determine the endotoxin activity and do not only reflect the quantity of LPS molecules.…”

Section: Introductionmentioning

confidence: 99%

Diversity, Complexity, and Specificity of Bacterial Lipopolysaccharide (LPS) Structures Impacting Their Detection and Quantification

Dardelle,

Phelip,

Darabi

et al. 2024

IJMS

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Endotoxins are toxic lipopolysaccharides (LPSs), extending from the outer membrane of Gram-negative bacteria and notorious for their toxicity and deleterious effects. The comparison of different LPSs, isolated from various Gram-negative bacteria, shows a global similar architecture corresponding to a glycolipid lipid A moiety, a core oligosaccharide, and outermost long O-chain polysaccharides with molecular weights from 2 to 20 kDa. LPSs display high diversity and specificity among genera and species, and each bacterium contains a unique set of LPS structures, constituting its protective external barrier. Some LPSs are not toxic due to their particular structures. Different, well-characterized, and highly purified LPSs were used in this work to determine endotoxin detection rules and identify their impact on the host. Endotoxin detection is a major task to ensure the safety of human health, especially in the pharma and food sectors. Here, we describe the impact of different LPS structures obtained under different bacterial growth conditions on selective LPS detection methods such as LAL, HEK-blue TLR-4, LC-MS2, and MALDI-MS. In these various assays, LPSs were shown to respond differently, mainly attributable to their lipid A structures, their fatty acid numbers and chain lengths, the presence of phosphate groups, and their possible substitutions.

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Assessment of Pyrogenic Response of Medical Devices and Biomaterials by the Monocyte Activation Test (MAT): A Systematic Review

Gimenes,

Spoladore,

Paranhos

et al. 2024

IJMS

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Pyrogens are fever-inducing substances routinely investigated in health products through tests such as the Rabbit Pyrogen Test (RPT), the Limulus Amebocyte Lysate (LAL), and the Monocyte Activation Test (MAT). However, the applications of the MAT for medical devices and biomaterials remain limited. This work aimed to overview the studies evaluating the pyrogenicity of medical devices and biomaterials using the MAT, highlighting its successes and potential challenges. An electronic search was performed by December 2023 in PubMed, Scopus, and Web of Science, identifying 321 records which resulted in ten selected studies. Data were extracted detailing the tested materials, MAT variants, interferences, and comparisons between methods. Methodological quality was assessed using the ToxRTool, and the results were synthesized descriptively. The selected studies investigated various materials, including polymers, metals, and natural compounds, employing the different biological matrices of the MAT. Results showed the MAT’s versatility, with successful detection of pyrogens in most materials tested, though variability in sensitivity was noted based on the material and testing conditions. Challenges remain in optimizing protocols for different material properties, such as determining the best methods for direct contact versus eluate testing and addressing the incubation conditions. In conclusion, the MAT demonstrates significant potential as a pyrogen detection method for medical devices and biomaterials. However, continued research is essential to address existing gaps, optimize protocols, and validate the test across a broader range of materials.

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Evolution and Characteristics of the Monocyte Activation Test (MAT)

Cited by 3 publications

References 25 publications

Outer membrane vesicles: moving within the intricate labyrinth of assays that can predict risks of reactogenicity in humans

Outer membrane vesicles: moving within the intricate labyrinth of assays that can predict risks of reactogenicity in humans

Diversity, Complexity, and Specificity of Bacterial Lipopolysaccharide (LPS) Structures Impacting Their Detection and Quantification

Assessment of Pyrogenic Response of Medical Devices and Biomaterials by the Monocyte Activation Test (MAT): A Systematic Review

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