Description

Cell line controls for immunohistochemistry and in situ hybridization.

Research Use Only.

APPLICATION
This product is comprised of three human cell lines with low, intermediate and high expression of the nuclear proliferation marker Ki67. It is suitable for use as a same slide control material in immunohistochemistry. The control is intended for analytical assessment of reagent and instrument performance only.
The control can be used in combination with Visiopharm QualitopixTM image analysis. Before use, every block should be validated to establish a two standard deviation QC threshold for each cell line in QualitopixTM. If any cell line falls out of the two standard deviation boundaries, staining must be reviewed. If consecutive QualitopixTM scores fall out of the boundary, the results of the test sample should be re-evaluated and the reagents and instrument investigated.

MATERIALS
Three formalin fixed paraffin embedded cell lines.
Cell line A: Urinary bladder carcinoma
Cell line B: Breast ductal carcinoma
Cell line C: Colorectal adenocarcinoma
Cells are fixed in 10% neutral buffered formalin and paraffin wax embedded.
Sections are cut at 4μm, mounted on positively charged slides and dried overnight at 37°C.

Cell microarrays (CMA) contain cores that are 1.5-2mm in diameter and 3-3.5mm in length. It is possible to obtain over 300 sections depending on thickness.

If any of the cell lines in the control fail to demonstrate the expected staining, results of the test sample should be re-evaluated.

Storage and Handling
Store at 2-8°C. Do not freeze (for expiration date please see the product label)

WARNINGS AND PRECAUTIONS
1. The product is intended for research use only.
2. This product is not a diagnostic aid.
3. It is the responsibility of the end user to determine suitability with their reagents and procedures within their laboratory.
4. Do not use after expiration date printed on product labels. The user must validate any storage conditions other than those specified in the package insert.