Comparison of LAL and rFC Assays – Participation in a Proficiency Test Program between 2014 and 2019

You can find more about the article here:

https://www.mdpi.com/2076-2607/8/3/418

MAT Proficiency Test Program

We offer quality assurance to laboratories working with Monocyte Activation Test (MAT). Based on our expertise we provide frequently audits of MAT test proficiency. Our Proficiency Test Program (PTP) confidentially verifies working procedures, method and report validation, identifies trends and potential demands for training. This supplies additional value to internal quality assurance.

 Benefits

• Check and validate analysis techniques
• Verify conformity of procedures to requirements of the Pharmacopoeia
• Control and correct possible drift in procedural compliance
• Verify laboratory’s ability to recover correct level of contamination
• Compare results to those of other laboratories and other MAT methods

MAT Proficiency Test Program

We offer quality assurance to laboratories working with Monocyte Activation Test (MAT). Based on our expertise we provide frequently audits of MAT test proficiency. Our Proficiency Test Program (PTP) confidentially verifies working procedures, method and report validation, identifies trends and potential demands for training. This supplies additional value to internal quality assurance.

 Benefits

• Check and validate analysis techniques
• Verify conformity of procedures to requirements of the Pharmacopoeia
• Control and correct possible drift in procedural compliance
• Verify laboratory’s ability to recover correct level of contamination
• Compare results to those of other laboratories and other MAT methods

We proudly announce that we have expanded our ultra-sensitive immunoassay portfolio by the brand-new Quanterix SP-X® Analyzer.

Once again, Microcoat is one of the first laboratories in Europe to offer an advanced new technology to their customers.

The Quanterix SP-X® Imaging and Analysis System is a complete benchtop system that offers true multiplex detection at both acute and baseline levels. Up to 10 parameters can be analyzed with superior sensitivity in this ECL based assay format with a low sample volume of only 25 µL. SP-X combines Simoa ultra-sensitive assay development and optimization with up to 10-plex multiplexing scale and flexibility to combine the analytes of interest.

The SP-X® completes our portfolio of biomarker assays especially in the fields of cytokine quantification, oncology and immune-oncology. Combined with our experience in immunoassay development, the platform enables the development of Simoa-sensitive planar assays meeting your individual requirements.

More than 55 commercial kits available at Quanterix ®.

For more information visit www.quanterix.com.

The PDA Technical Report No. 82 has been published in March 2019.

This report gives guidance on how to perform a Low Endotoxin Recovery (LER) study and shows mitigation strategies of endotoxin masking in biologics. Additionally the report is a good source of background information on bacterial endotoxin testing.

At Microcoat we perform LER studies based on the recommendation of the PDA Technical Report 82.

For more information click here: Service https://www.microcoat.de/laboratory-services/endotoxin-and-pyrogen-test-service-2/#Low-Endotoxin-Recovery-LER

Click here for the PDA Technical Report overview

Endotoxins are cell wall components of Gram-negative bacteria. A release of endotoxins into the human blood stream results in an inflammation reaction that can lead to life-threatening conditions like sepsis. Therefore, control for endotoxin contamination of intravenously administered drugs is crucial.

Drugs are usually tested for putative endotoxin contamination with Limulus-based tests. However, validity of the compendial test procedures is questioned in the case of low endotoxin recovery (LER).

To assure validity, regulatory authorities request hold-time studies of endotoxin in addition to pharmacopoeial requirements. Within these studies, endotoxin is added (spiked) to an undiluted product. The spiked product is held for a certain period of time and subsequently diluted for endotoxin determination. Due to the known heterogeneity of endotoxin the question has been raised as to which source represents the most adequate endotoxin spike.

In the present study, endotoxin hold-time studies were analyzed by using different sources of endotoxin. Highly purified endotoxin, crude endotoxin extracts (Naturally Occurring Endotoxin) from different bacterial species and varied growth conditions as well as endogenous endotoxin contaminations were investigated.

The results clearly demonstrate that endotoxin masking – an effect of LER – is dependent on the endotoxin source used. Various parameters such as bacterial strain and growth conditions lead to different masking susceptibilities. Due to these effects it is impossible to predict the susceptibility of bacterial endotoxin contamination to LER. In order to determine whether a sample is prone to LER, an endotoxin spike that is susceptible to LER is required.