What is the minimum required dilution (MRD) for bio-process samples?

Name: Simple Plex CHO HCP 3G-1 Cartridge
Brand: ProteinSimple
SKU: SPCKB-OT-003714

All samples require a minimum 2-fold dilution for use in Simple Plex assays, but further dilution may be needed for optimal performace. An appropriate dilution factor for each process matrix should be determined experimentally by assessment of sample linearity and spike recovery.

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ProteinSimple, part of Bio-Techne | Catalog # SPCKB-OT-003714

Product Datasheet / COA

Simple Plex CHO HCP 3G-1 assay kit for use on Ella instrument. Contains cartridge, sample diluent SD19, and wash buffer.

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Key Product Details

Assay Length:	90 minutes
Sample Type & Volume Required Per Well:	Bioprocess Samples (25 uL)
Sensitivity:	0.11 ng/mL
Assay Range:	0.26 - 403 ng/mL (Bioprocess Samples)
Simple Plex CHO HCP 3G-1 Cartridge Summary:	Simple Plex assay is for the detection of Chinese Hamster Ovary Host Cell Protein (CHO HCP) in Bioprocess samples in Sample Diluent SD19. This assay uses Cygnus Technologies 3rd Generation CHO antibodies.

*The Sample Volume represented is based on the amount of sample incorporated into the reaction after taking into account the assay’s minimum required dilution for a given matrix. Serial dilution may be necessary to achieve some of the final sample volumes represented.

View Full Technical Details for Simple Plex CHO HCP 3G-1 Cartridge

Technical Data
Citations / FAQs

Product Specifications for Simple Plex CHO HCP 3G-1 Cartridge

Assay Type	Automated sandwich ELISA
Format	Microfluidic cartridge containing three Glass Nano Reactors (GNR)
Specificity
Cross-reactivity	< 0.5% cross-reactivity observed with available related molecules. < 50% cross-species reactivity observed with species tested.
Interference	No significant interference observed with available related molecules.

Precision

Intra-Assay Precision (Precision within an assay) Each control was tested 16 times in one assay

Inter-Assay Precision (Precision between assays) Replicates of each control were tested in multiple assays performed by at least three technicians using two lots of reagents

Bioprocess Samples

	Intra-Assay Precision		Inter-Assay Precision
Sample	1	2	1	2
n	16	16	44	43
Mean (ng/mL)	3.12	158	3.42	162
Standard Deviation	0.217	14	0.343	23.4
CV%	6.9	8.9	10	14.4

Recovery

Recovery at three different spiked concentrations within the range of the assay was evaluated.

Sample Type	Average % Recovery	Range %
High (n=4)	110	104-116
Low (n=4)	96	76-111
Mid (n=4)	101	92-110

Linearity

Samples containing and/or spiked with high concentrations of CHO HCP were serially diluted with Sample Diluent to produce samples within the dynamic range of the assay.

Scientific Data Examples for Simple Plex CHO HCP 3G-1 Cartridge

	Simple Plex CHO HCP 3G-1 Assay Standard Curve Data shown represents typical performance results for Lower Limit of Quantitation (LLOQ) and Upper Limit of Quantitation (ULOQ) for Simple Plex CHO HCP 3G-1 Assay. Assay range is 0.26-403 ng/mL.

Preparation and Storage

Stability & Storage

Store the unopened product at 2 - 8 °C. Do not use past expiration date.

Background: Host Cell Protein/HCP

Item	Value
Long Name	Host Cell Protein
Alternate Names	HCP

FAQs for Simple Plex CHO HCP 3G-1 Cartridge

Compatible Instruments

Ella - Automated Immunoassay Platform | ProteinSimple

Ella from ProteinSimple, a Bio-Techne brand. Get single or multiplex immunoassay results in less than 90 minutes that are consistent and highly reproducible.

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Product Documents for Simple Plex CHO HCP 3G-1 Cartridge

Product Datasheets

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COA

Protocols & Manuals

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