DESCRIPTION

TARDBP was firstly found as a transcriptional repressor that binds to chromosomally integrated TAR DNA and represses HIV-1 transcription. It was also reported to regulate alternate splicing of the CFTR gene. Neumann et al. (2006) found that a hyperphosphorylated, ubiquitinated, and cleaved form of TARDBP, known as pathologic TDP43, is the major disease protein in ubiquitin-positive, tau-, and alpha-synuclein-negative frontotemporal dementia (FTLD-U) and in Amyotrophic lateral sclerosis (ALS). KE00009 is used to quantify TDP-43 level in vivo and it is suitable for sample of CSF and cell lysates. KE00005 is used to quantify TDP-43 level in vivo and it is suitable for sample of serum or plasma.

PRINCIPLE OF THE ASSAY

Sandwich ELISA structure (Detection antibody labeled with biotin) A capture antibody is pre-coated onto the bottom of wells which binds to analyte of interest. A detection antibody labeled with biotin also binds to the analyte. Streptavidin-HRP binds to the biotin. TMB acts as the HRP substrate and the solution color will change from colorless to blue. A stop solution containing sulfuric acid turns solution yellow. The color intensity is proportional to the quantity of bound protein which is measurable at 450 nm with the correction wavelength set at 630 nm.

PRECISION

Intra-assay Precision (Precision within an assay) Three samples of known concentration were tested 20 times on one plate to assess intra-assay precision. Inter-assay Precision (Precision between assays) Three samples of known concentration were tested in 24 separate assays to assess inter-assay precision.

Intra-assay Precision

Sample	n	Mean (ng/mL)	SD	CV%
1	20	37.2	1.6	4.2
2	20	73.0	2.0	2.8
3	20	144.9	6.5	4.5

Inter-assay Precision

Sample	n	Mean (ng/mL)	SD	CV%
1	24	37.5	3.1	8.4
2	24	72.9	3.2	4.4
3	24	153.8	7.2	4.6

RECOVERY

The recovery of human TDP-43 spiked to three different levels throughout the range of the assay in human cerebrospinal fluid (CSF) and cell lysate were evaluated.

Sample Type		Average% of Expected	Range (%)
Human cerebrospinal fluid	1:2	78	71-87
	1:4	111	100-121
Cell Lysate	1:20	102	90-126
	1:40	81	78-85

LINEARITY

To assess the linearity of the assay, samples (human cerebrospinal fluid) were diluted with Sample Diluent PT 6-em to produce samples with values within the dynamic range of the assay.(The Cell lysate was initially diluted 1:10)

		Human cerebrospinal fluid	Cell Lysate
1:2	Average% of Expected	100	100
	Range (%)	-	-
1:4	Average% of Expected	120	104
	Range (%)	115-125	103-106
1:8	Average% of Expected		88
	Range (%)		85-92

CALIBRATION

This immunoassay is calibrated against a highly purified recombinant human TDP-43 produced at Sunlong Medical™.

Ordering & shipping

• Minimum order: 1 kit
• Lead time: varies with order quantity and specifications. Please consult your local distributor or our sales team for confirmation
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• Price: USD, per kit (48T / 96T options available)