CTL-MAT Monocyte Activation Test (MAT) Kit

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CTL-MAT kit overview
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Kit contents​: Everything you need to go.

Performance: Most sensitive & reactive assay.

Supply scale: 2,000 MAT kits per batch.

Method: 4 simple steps

Delivery: Global, robust and reliable.

Storage conditions

Support: We're with you at every turn.

The CTL-MAT kit includes everything you need to start,
right at the very top.

You can have peace of mind knowing that CTL-MAT kit you buy from us has been manufactured and composed with complete Ph. Eur. compliance while being product-specific validation and routine testing ready.

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Pooled PBMC

1 ml (5 million cells)

of cryopreserved

4 or 8 donor pooled PBMC.

EDQM Endotoxin Standard

International endotoxin standard Lipopolysaccharides E. Coli (LPS).

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96-Well Microplate

Culture plate for incubating product, standard and PBMC.

2 x Non-Endotoxins

Includes both heat-killed Staphylococcus aureus (HKSA) and R848 (Resiquimod).

Media A & B

Culture media to

dilute standards and products.

Human IL-6 ELISA Kit

Contains all reagents, coated microplate and IL-6 standard.

 

Picture perfect performance,
every time.

ANALYSIS: SAME BATCH

Intra-batch

reproducibility of results

See above for standard curves of 4 PBMC vials from 1 unique batch of the CTL-MAT PBMC.

ANALYSIS: 3 DIFFERENT BATCHES

Inter-batch

reproducibility of results

See image above for standard curves of PBMC vials from 3 different batches of the CTL MAT PBMC.

ANALYSIS: 7 DIFFERENT EXPERIMENTS

Reproducibility across independent experiments

Average results of 7 experiments carried-out at different sites & times using different PBMC batches.

01
Reactivity

0.5 EU/ml of LPS can produce an IL-6 concentration of up to 10,000 in the CTL-MAT kit picogram/ml

02
Sensitivity

The CTL-MAT kit has a Lower Limit of Detection (LoD) of 0,004 EU/ml – the highest of any MAT kit.

 

2,000... 
and counting

PBMC supply that's scalable for the masses.

Unlike any other monocyte activation test vendor, our supply sites in Europe and the U.S. benefit from large-scale state-of-the-art manufacturing that can successfully deliver up to 2,000 vials of 4-donor pooled cryopreserved CTL-MAT PBMC per batch.

 

How the CTL-MAT Monocyte Activation Test kit works

Step 1

Product incubation
Your parenteral product sample or medical device is incubated with the CTL-MAT kit PBMC.

Step 2

PBMC activation
Overnight, the toll-like receptors of the monocytes recognise the presence of pyrogens and activate the signalling pathways that launch the human immune system response. In turn, this activates the release of cytokines.

Step 3

Cytokine detection
The next morning, the CTL-MAT kit's human IL-6 ELISA is used as a readout to detect and quantify the concentration of released cytokines.

Step 4

Data analysis
Using the LPS standard curve, we convert the measured cytokine concentration captured by the CTL-MAT kit's human IL-6 ELISA to the Endotoxin Equivalent Units/ml present in the product. 

 

CTL-MAT delivered worldwide
Dispatching from either Europe or U.S., our global network of best-in-class couriers minimizes any risk of unnecessary delays at customs, anywhere.

We'll deliver anywhere, lightning fast.

Express delivery for smaller orders
We can have shipments of ≤ 20 CTL-MAT kits to you within 3 days of a signed quotation.

Fast-track larger shipments
Our quick manufacturing turnaround times mean you can be confident that any order of > 20 CTL-MAT kits will be with you within 3 weeks of a signed quotation.

 
CTL-MAT PBMC QC

  • Number of pooled donors: 4 or 8

  • Manufacture time: < 4 hours

  • Donor identification: Anonymised

  • Donors tested for: HBsAg, HBcAb, HTLV I/II, HIV I, HCV, WNV and other common pathogens

Storage conditions

 

  • 96-Well Plate: Room temperature

  • Human IL-6 ELISA kit:  4°C

  • Media A & B:  -20°C

  • LPS, HKSA & R848: ≤ -40°C

  • PBMC: -80°C (< 30 days); -140°C to -180°C LN2 vapour phase (> 30 days)

 
 

"We've got your back – supporting you every step of the way, and then some."

Early on we'll share a list of materials and equipment (and vendors) you'll need to get going and then we'll schedule either in-house or online MAT training depending on your team's experience. As well as helping you devise a protocol tailored to your specific product, we'll schedule either bi-weekly or monthly consultations to walk you through feasibility testing, product-specific validation and routine testing. Finally, you can count on us when it comes to the nitty-gritty of data processing and analysis.

We'll deliver results that others simply can't.

GMP

Global, experienced, lightning fast.

Want to get started with MAT but don't have the in-house expertise or would prefer to first investigate feasibility before investing?

MAT CRO

Services

#1

Head-to-head, we're always picked.

Almost all our biggest partners go through the process of MAT vendor performance comparison. We've always been the kit of choice.

Picked and performing

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You're in the best hands out there.

Call upon a team comprising the very first pioneers of MAT. Whatever your challenge, we've already seen and overcome it.

Years'
experience

Want to test for material-

mediated pyrogenicity?

Simply reach out to us and we’ll schedule an online consultation with our chief scientist. Together we’ll devise a plan to successfully test your medical device – whatever it may be – for material-mediated pyrogens