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

Name: Simple Plex HEK 293 HCP 3G Cartridge
Brand: ProteinSimple
SKU: SPCKB-OT-007066

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-007066

Product Datasheet / COA

Simple Plex Host Cell Protein/HCP 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:	0.2 ng/mL
Assay Range:	1.64 - 400 ng/mL (Bioprocess Samples)
Simple Plex HEK 293 HCP 3G Cartridge Summary:	Simple Plex assay for the detection of Human Embryonic Kidney Host Cell Protein (HEK 293 HCP 3G) in bioprocess samples.

*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.

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Technical Data
Citations / FAQs

Product Specifications for Simple Plex HEK 293 HCP 3G Cartridge

Assay Type	Automated sandwich ELISA
Format	Microfluidic cartridge containing three Glass Nano Reactors (GNR)
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 8 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	8	8	81	79
Mean (ng/mL)	3.16	147	3.36	141
Standard Deviation	0.38	7.3	0.48	14.9
CV%	12	5	14.3	10.6

Recovery

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

Sample Type	Average % Recovery	Range %
Bioprocess Samples (n=12)	111	100-123

Linearity

Samples containing and/or spiked with high concentrations of HEK 293 HCP 3G were serially diluted with Sample Diluent to produce samples within the dynamic range of the assay.

Scientific Data Examples for Simple Plex HEK 293 HCP 3G Cartridge

	HEK HCP Simple Plex Assay

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 HEK 293 HCP 3G 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 HEK 293 HCP 3G Cartridge

Product Datasheets

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COA

Protocols & Manuals

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