Simple Plex Human HE4/WFDC2 Cartridge

Catalog #: SPCKB-PS-000542 Datasheet / COA / SDS

Simple Plex Human HE4/WFDC2 assay kit for use on Ella instrument. Contains cartridge, sample diluent SD13, and wash buffer

Catalog #	Availability	Size / Price	Qty
SPCKB-PS-000542
SPCKA-PS-000542
SPCKC-PS-000542

Control Products Available

898121: Simple Plex Control for Human HE4/WFDC2

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Summary Precision Recovery Linearity Data Examples Product Datasheets Preparation and Storage Related Research Areas

Simple Plex Human HE4/WFDC2 Cartridge Summary

Assay Length

90 minutes

Sample Type & Volume Required Per Well*

Serum (25 uL), EDTA Plasma (25 uL), Heparin Plasma (25 uL)

Sensitivity

7.39 pg/mL

Assay Range

13.1 - 20,000 pg/mL (Serum, EDTA Plasma, Heparin Plasma)

Specificity

Natural and recombinant human HE4.

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.

*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.

Product Summary

Simple Plex assay for the detection of human HE4 in serum and plasma (EDTA/Heparin)

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

Serum, EDTA Plasma, Heparin Plasma

	Intra-Assay Precision		Inter-Assay Precision
Sample	1	2	1	2
n	16	16	43	50
Mean (pg/mL)	109	5517	125	5576
Standard Deviation	8.32	185	7.43	226
CV%	7.6	3.4	6	4.1

Recovery

Recovery was not necessary as HE4 shows natural linearity data from a neat sample to a 1:16 dilution.

Linearity

Samples containing and/or spiked with high concentrations of human HE4 were serially diluted with Sample Diluent to produce samples within the dynamic range of the assay