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Cytokine detection ELISA kits

SCytokine detection ELISA kits
Background
During the last decade, cell therapy has been known as the "third industrial revolution" leading biomedicine due to the increasing potential in the treatment of genetic diseases, cancer, tissue damage, diabetes and other diseases. With the support from policies and capital and the dramatic performance of CAR-T products on the market, cell and gene therapy become more and more popular.
However, different from other drugs, the quality of cell therapy products varies significantly between batches and patients due to the high personalization. Therefore, how characterizing the quality and potency of CAR-T products and monitoring the safety during clinical application effectively becomes one of the most significant challenges in the CGT products development process.
Cytokines are kinds of polypeptides and small molecules secreted by cells in vivo and play an important role in cell signal transduction. There are hundreds of different types of cytokines, including interleukin (IL), interferon (IFN), chemokine, tumor necrosis factor (TNF), colony stimulating factor (CSF), etc. In the development and evaluation of CAR-T therapy, cytokines although play an important role.
Features
To satisfy the needs for detecting the level of cytokines during the development of cell therapy products, ACRO group had developed a series of ELISA kits as high-efficiency, high-throughput, and low-cost solutions for cytokine detection, including the RUO version (For research use only) from ACROBiosystems and ClinMax version (For pre-clinical and clinical research) from its subsidiary ACRODiagnostics, meeting different requirements during quality control, preclinical and clinical research.

Calibrated by the international standards NIBSC/ WHO;

Low matrix interference confirmed in cell culture medium and serum samples;

Two versions to match different needs of research and clinical trials respectively;

Based on ACRO's reagents platform with high performance and supply capacity ;

Strict quality control to make sure the sensitivity, specificity, accuracy, linearity and inter/intra precision.

RUO & ClinMax, which is more suitable for your current application?


RUOClinMax
Validation experimentSensitivity
Precesion(Inter/Intra)
Linear range
Accuracy
SpecificityIL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-gamma, GM-CSFL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 p70, IL-13, IL-15, IL-17, GM-CSF, TNF-alpha, IFN-gamma etc.
Linearity
External Interference
Endogenous Interference
Hook effect
ReferenceGeneral Rules 9012 of Chinese PharmacopoeiaValidation of analytical methods for biological samples in ICH  M10, IVD
Detection Time<4h<2h
CalibratorNot dilutedDiluted
traceabilityNIBSC / WHONIBSC / WHO
Control material 
Manufacture in GMP  
 

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PPLICATIONS
Residue Detection
In the stage of quality control of CGT products, the process residues such as cytokines used for cell culture should be tested. The CQA and release criteria are determined according to the results of process verification and the risk of cytokines residue.

Product List:

MoleculeCat. No.Product Description
IL-2CRS-A003Human Interleukin-2(IL-2) ELISA Kit
IL-7CRS-A006Human Interleukin-7(IL-7) ELISA Kit
IL-15CRS-A009Human Interleukin-15(IL-15) ELISA Kit
IL-21CRS-A010Human Interleukin-21(IL-21) ELISA Kit
T cells’ Function Evaluation
The activation of T cells is one of the most important factors to evaluate the efficacy of CGT products. The concentrations of cytokines stimulated by activated T cells are generally used to determine the activation of T cells, such as IFN-γ, IL-2, GM-CSF and TNF-α.

Product List:

MoleculeCat. No.Product Description
IFN-γCRS-A001Human Interferon-γ(IFN-γ) ELISA Kit
TNF-αCRS-A002Human Tumor Necrosis Factor Alpha(TNF-α) ELISA Kit
IL-2CRS-A003Human Interleukin-2(IL-2) ELISA Kit
GM-CSFCRS-A013Human Macrophage Colony Stimulating Factor 2(GM-CSF) ELISA Kit

Validation Data:

Sensitivity:

CRS-A001

For each experiment, each ELISA plate needs to set the standard curve. The following CRS-A001 standard curve data is for reference only.The  limitation of detectable dose (LOD) of Cat. No. CRS-A001 was determined as 3.072pg/mL in three independent experiments.

Precesion:

CRS-A001

It has been verified that the intra/inter-precision of Human Interferon-γ (IFN-γ) ELISA Kit (Cat. No. CRS-A001) are less than 10%.

Cytokine Release Syndrome(CRS)Testing
Cytokine release syndrome (CRS) is one of the most common side effects in immunotherapy, which is a group of clinical syndromes caused by excessive activation of immune cells and the rapid release of pro-inflammatory factors. The FDA determined CRS as a black box warning for all CAR-T cells therapies and required risk assessment and mitigation strategies when approving CAR T cells. Therefore, it is necessary to predict the CRS to evaluate the immunotoxicity of drugs.
To meet the needs of CRS testing in pre-clinical and clinical trials, ACRODiagnostics developed a series of ClinMax™ cytokine detection kits, aiming to provide more reliable analytical reagents and solutions for clinical trials.
ClinMax
ClinMax™, which is a clinical reagents brand created by ACRODiagnostics belonging to ACROBiosystems Group, strictly follows the industry guidelines and quality management system.
ClinMax™ is aiming to provide customers with high-performance, high-quality analytical reagents and solutions in the pre-clinical and clinical stages, speeding up the process of drug development and launch. ClinMax, for better clinical sample analysis!

Features:

Fast: One-step detection in 2 hours with high sensitivity;

High quality: Certified by ISO13485/9001, manufacture in GMP grade;

High compatibility: Validation in a variety of biological samples to meet the needs of sample testing under different conditions;

Complete validation: Following ICH and IVD requirement, adding more verification of hook and multiple matrix effects.

Product List:

MoleculeCat. No.Product Description
IFN-γCEA-C006ClinMax™ Human Interferon-γ(IFN-γ) Quantitative ELISA Kit Calibrated to the WHO ( NIBSC code 87/586)
TNF-αCEA-C010ClinMax™ Human Tumor Necrosis Factor alpha(TNF-α) Quantitative ELISA Kit Calibrated to the WHO ( NIBSC code  12/154 )
IL-2CEA-C008ClinMax™ Human Interleukin 2(IL-2) Quantitative ELISA Kit Calibrated to the WHO ( NIBSC code 86/500 )
IL-4CEA-C003ClinMax™ Human Interleukin 4(IL-4) Quantitative ELISA Kit Calibrated to the WHO ( NIBSC code 88/656 )
IL-6CEA-C001ClinMax™ Human Interleukin 6(IL-6) Quantitative ELISA Kit Calibrated to the WHO ( NIBSC code 89/548 )
IL-8CEA-C004ClinMax™ Human Interleukin 8(IL-8) Quantitative ELISA Kit Calibrated to the WHO ( NIBSC code 89/520 )
IL-10CEA-C010ClinMax™ Human Interleukin 10(IL-10) Quantitative ELISA Kit Calibrated to the WHO ( NIBSC code 93/722 )
IL-1betaCEA-C002ClinMax™ Human Interleukin 1 beta(IL-1β) Quantitative ELISA Kit Calibrated to the WHO ( NIBSC code 86/680 )
GM-CSFCEA-C007ClinMax™ Human Macrophage Colony Stimulating Factor 2(GM-CSF) Quantitative ELISA Kit Calibrated to the WHO ( NIBSC code 88/646 )

Validation Data:

Typical Data:

CEA-C010

The standard curve of ClinMax™ Human Interleukin 10 (IL-10) Quantitative ELISA Kit(Cat. No. CEA-C010

Linearity

CEA-C010

Three human serum samples with high concentrations of IL-10 were diluted 1:2, 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 with dilution buffer to produce samples with values within the dynamic range and then assayed.

Hook effect

CRS-A001

Cat.No. CEA-C010 is not affected by IL-10 with a concentration up to 10ng/ml.

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