The kit enables European Pharmacopoeia compliant in-vitro pyrogen testing. All necessary
components are included: Cryopreserved pooled PBMC, IL-6 ELISA, reference standards, reagents and protocols. All component of the test system are fine-tuned for optimal
performance in MAT and are certified pyrogen free.
||96 well test plate**
Quality without compromise
Each component of the CTL-MAT test kit is fine tuned for optimal performance, and thoroughly quality controlled for such. These kits have been formulated to achieve high reactivity and sensitivity.
Reactivity and sensitivity of CTL-MAT. Typical LPS dose response curve is shown after testing with CTL-MAT Kit. LPS was titrated in the concentration range specified on the X axis. The concentration of IL-6 detected in the culture supernatant after 20 h incubation of the PBMC with LPS is shown on the Y axis. Note the high reactivity, and sensitivity.
The indicator PBMC have been frozen according to Ph. Eur. 2.6.30 according to proprietary protocols that assure that the cryopreserved cells maintain their full functionality after freeze thawing (see representative data below). CTL-MAT offers PBMC suited for MAT testing also independent of its kits, from single donors or pools of 4 or 8 donors.
European Pharmacopeia 2.6.30 specifies requirements for PBMC to be used in MAT. The PBMC provided in CTL-MAT Kits fulfill the mandated criteria:
- PBMC isolation form the Buffy coat of four healthy donors
- The blood donors fulfil the quality criteria according to EP 2.6.30. section 5-3
- Equal number of cells pooled
- Cryopreserved within 4 hours from the blood donation
- LPS standard curve with the frozen pooled PBC after thawing and determine the acceptance criteria for the standard curve described in EP
Intra-batch reproducibility of CTL-MAT results. Four CTL-MAT kits from a single production batch were tested in four independent assays. The PBMC were aliquots of the same pool of 4 donors (Vials 1 -4, specified by symbols). LPS was titrated in the concentration range specified on the X axis. The concentration of IL-6 detected in the culture supernatant after 20 h incubation of the PBMC with LPS is shown on the Y axis. Note the overlapping curves, showing high intra-batch reproducibility of results obtained with CTL MAT kits.