Somru BioScience

Rituximab (Rituxan®) PK

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Catalog #: SB-07-022

SKU: SB-07-022 Category: Tag:

Data Sheet

Rituximab (Rituxan®) – PK ELISA

Catalogue Number: SB-07-022

For the quantitative determination of Rituximab in human serum and plasma

Notice: This product specification data sheet is for information purposes only. Please contact tec@somrubioscience.com for up to date information.

Product Specifications Data Sheet

About The Somru Rituximab ELISA kit is designed to measure rituximab with high specificity and enhanced sensitivity in buffer or biological matrices. This user-friendly assay design utilizes rituximab specific anti-idiotype monoclonal antibody to capture rituximab to the plate and rituximab specific polyclonal antibody for detection without any interference from rheumatoid factors or other anti-TNF alpha therapies.

An alternative method to measure active rituximab capable of binding TNF-alpha is also available. Please contact our technical service team at tec@somrubioscience.com.

Detection method Colorimetric; absorbance at 450 nm with reference absorbance at 650 nm.
Storage Store the unopened kit at 2-8 °C.
Quality Control Samples (QCs) Three levels of QCs are included for custom GLP kits for an additional cost. QCs are prepared by fortifying rituximab in human serum.
Precision The precision was determined by analyzing samples prepared at 1000 ng/mL in 6 replicates on 6 different occasions. Intra-assay precision (coefficient of variation(CV)) ranges from  2% to 6%. Inter-assay precision was at 5%.
Accuracy The accuracy was determined by analyzing three levels of quality control samples in 6 replicates on 6 different occasions. Mean absolute %bias was less than 6%.
Total Error Total Error (TE) was calculated by adding the mean %bias with inter-assay variability (%CV). The TE was found to be 1%.
Selectivity Recovery Selectivity of the assay was evaluated by spiking 10 individual serum lots with 1000 ng/ml of Rituximab. The recovery ranges from 92% to 101%. The mean recovery was 94%.
Sensitivity The limit of detection is 55 ng/mL.
Dilutional Linearity Dilutional linearity was established up to 1000 fold.
Hook Effect No hook effect was observed up to 500 µg/mL of rituximab.
Detection method Colorimetric; absorbance at 450 nm with reference absorbance at 650 nm.
Safety Warnings and Precautions All chemicals should be considered potentially hazardous. We recommend that this product and its components be handled by those trained in laboratory techniques and be used according to the principles of Good Laboratory Practice.

 

Notice: Somru® ELISA kits are custom-made to order. Each kit lot is tested to ensure that it meets specifications before shipment. Minor adjustments to the preparation of reagents may occur due to lot-to-lot variation. Please always refer to the product sheet enclosed with each kit before performing each experiment.

FOR RESEARCH USE ONLY

Category

Pharmacokinetic-(PK)

Species

Size

1 pack ( 2 x 96 wells)

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