Shanghai Excell Biological Technology Co., Ltd.

ResiQuant® Recombinant Protein A Residue Detection Kit（ELISA Method）is used to quantitatively detect the residual natural or recombinant Protein A content in biopharmaceutical samples. Protein A includes natural Protein A, recombinant Protein A, and alkali-resistant recombinant Protein A which structure is significantly different from natural Protein A, such as GE’s MabSelect SuReTM Protein A. This product can quantitatively detect shed natural Protein A and recombinant Protein A, if you need detect alkaline-resistant recombinant Protein A, please choose our CRP00-302* series and CRP00-303* series kits.

Product Advantages
1.Wide detection range: work range is 13.7-10000 pg/mL;
2.Easy to operate: Treat samples in a boiling water bath or mental bath;
3.Save time: sample processing only takes 10 minutes, and detection experiment takes about 2.5 hours;
4.High Sensitivity: the detection limit is 7 pg/mL, and the lower limit of quantification is 13.7 pg/mL;
5.High Precision: Intra-batch deviations were all ≤20%;
6.High Accuracy: sample spike recovery rate is in the range of 80%-120%;
7.Good Repeatability: within in the quantitative limit range, the CV values of sample concentrations within and between plates are ≤20%;

Serial Number	Performance Project		Recombinant Protein A Residue Detection Kit	Alkali-Resistant Protein A Residue Detection Kit	Alkali-Resistant Protein A Residue Detection Kit (2G)
1	Detection Method		HRP-labeled double-antibody sandwich two-step method
2	Quantitative Range		13.7-10000pg/mL	13.7-10000pg/mL	4.9-1200pg/mL
3	Limit Of Detection（LOD）		Can be detected when ≥7 pg/mL	Can be detected when ≥6.6 pg/mL	Can be detected when≥2.5 pg/mL
4	Limit Of Quantitative（LOQ）		13.7 pg/mL	13.7 pg/mL	4.9 pg/mL
5	Precision	Intra-batch variation	CV ＜ 20%
		Inter-batch variation	CV ＜ 25%
6	Recovery Rate		80%-120%
7	Storage Conditions		Please store Substrate Solution away from light at 2-8℃
8	Detection Time		About 2.5 hours

In the production and purification process of antibody products, Protein A affinity chromatography resin is a commonly used tool to separate and purify antibodies. However, during the antibody purification process, Protein A will fall off, causing antibody products contains Protein A, thus affecting the purity and potency of the product, causing major problems to the pharmaceutical industry. For example, the 2020 edition of the Chinese Pharmaceutical stipulates that the Protein A residue detected by enzyme-linked immunoassay for nimotuzumab injection should not be higher than 0.001% of the total protein, so the Protein A residue in biological products must be detected. Protein A includes natural Protein A, recombinant Protein A, and alkali-resistant recombinant Protein A which structure is significantly different from natural Protein A, such as GE’s MabSelect SuReTM Protein A. This product can quantitatively detect shed natural Protein A and recombinant Protein A, if you need detect alkaline-resistant recombinant Protein A, please choose our CRP00-302* series and CRP00-303* series kits.

Please Attention! Before using this kit for the first time, it is recommended to complete a product suitability study to confirm whether there is interference in the sample matrix and the appropriate dilution conditions for sample detection.

Catalog No.	Size
CRP00-3011	48 T
CRP00-3012	96 T

ResiQuant® Recombinant Protein A Residue Detection Kit （CRP00-3011）

ResiQuant® Recombinant Protein A Residue Detection Kit （CRP00-3011）

Catalog No.

Size

CRP00-3011

48 T

CRP00-3012

96 T

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