Emergo Europe, Prinsessegracht 20, 2514AP The Hague, The Netherlands

Anti-Cytokeratin Pan Principles of the Procedure

Antigen detection by immunohistochemistry (IHC) is a two-step
[C11] process wherein the primary antibody binds to the antigen of
interest and that binding is detected by a chromogen. The primary
Catalog No. Description antibody may be used in IHC using manual techniques or BioGenex
6 ml of Ready-to-Use Antibody for use with Automated Staining System. Positive and negative controls should
AM357-5M BioGenex Super SensitiveTM Detection always be run simultaneously with all patient specimens.
Systems OR equivalent detection system
10 ml of Ready-to-Use Antibody in a Reagents Provided
barcode labeled vial for use with BioGenex Mouse Monoclonal Antibody to cytokeratins is affinity purified
AM357-10M and diluted in PBS, pH 7.2, containing 1% BSA and 0.09%
Super SensitiveTM Detection Systems and
i6000TM Automated Staining Systems sodium azide.
1 ml of Concentrated Antibody for use with
MU357-UC BioGenex Super SensitiveTM Detection Dilution of Primary Antibody
BioGenex Ready-to-Use antibodies have been optimized for use
Systems OR equivalent detection system
with the recommended BioGenex Detection System and should
0.5 ml of Concentrated Antibody for use
not require further dilution.
MU357-5UC with BioGenex Super SensitiveTM Detection
Systems OR equivalent detection system BioGenex concentrated antibodies must be diluted in accordance
Ready-to-Use Antibody in Barcode labeled
with the recommended protocol when used with the
AX357-YCD vial for use on the Xmatrx Elite/Ultra recommended BioGenex Detection System.
Staining System, 160 tests
Ready-to-Use Antibody in Barcode labeled Recommended Protocol
AX357-50D vial for use on the Xmatrx Elite/Ultra Refer to the following table for conditions specifically
Staining System, 50 tests recommended for this antibody. Refer to the BioGenex website
for guidance on specific staining protocols or other requirements.
Clone Species Ig Class
C11 Mouse IgG1
BioGenex
Parameter
Recommendations
Intended Use Breast Cancer as available with
For In Vitro Diagnostic Use. This antibody is designed for the Control Tissue Biogenex FB-357M* &
specific localization of cytokeratins in formalin-fixed, paraffin- FG-357M*
embedded (FFPE) tissue sections. Evaluation must be performed Recommended Dilution for
1:50-100 in HK156
by a qualified pathologist. Concentrated Antibody
Recommended Pretreatment EZ-AR2 (HK522-XAK)
Summary and Explanation (Manual/i6000)**
Human keratins are a family of water-insoluble proteins with Recommended EZ-AR2 Elegance
molecular weights ranging from 40kD to 68kD. They form a part Pretreatment (Xmatrx) (HX032-YCD)
of the cytoskeleton of epithelial cells. This monoclonal Antibody Incubation
cytokeratin antibody can be used to detect cytokeratins 4, 5, 6, 8, 30-60 min at RT
(Manual/i6000)
10, 13, and 18 in simple or stratified epithelium in most Antibody Incubation
vertebrates, including humans. It can be used as a marker for 30-60 min at 25°C
(Xmatrx)
carcinoma as well as some special types of tumors which have Use BioGenex Two-Step OR
an epithelial component or differentiation. Cytokeratin Detection System for One-Step Super Sensitive™
antibodies have been widely used as markers to differentiate Manual, Xmatrx & i6000 Polymer-HRP IHC Detection
epithelial tumors from nonepithelial tumors. systems*** System/DAB; see p. 2 for more
infor mation
Storage and Handling
Store at 2-8°C. Fresh dilutions, if required, should be prepared *FB: positive control barrier slides, FG: positive control non-
prior to use and are stable and steady for up to one day at room barrier slides. Xmatrx requires barrier slides.
temperature (20-26°C). Diluted antibody preparations can be **Pretreatment times will vary based on individual microwave power.
refrigerated or frozen for extended shelf life. ***For automation systems (Xmatrx-Elite, Xmatrx-Ultra &
i6000 Diagnostics), refer to the factory protocols provided with
the instrument.

Category Antibodies Revision No. I

Document No. 932-357M-EN Release Date 15-Jun-2021

48810 Kato Road, Suite 100E & 200E, Fremont, CA 94538, Tel: +1 (800) 421-4149, Fax: +1 (510) 824-1490, support@biogenex.com, www.biogenex.com
 Emergo Europe, Prinsessegracht 20, 2514AP The Hague, The Netherlands

Detection Two-Step One-Step Link and Limitations of the Procedure

System HRP Kit HRP Kit Label Kit Improper tissue handling and processing prior to immunostaining
QD440-XAKE can lead to inconsistent results. Variations in embedding and
(1000 Test) QD630-XAKE QP300-XAKE fixation or the nature of the tissue may lead to variations in results.
QD430-XAKE (1000 Test) (1000 Test) Endogenous peroxidase activity or pseudo peroxidase activity in
(1000 Test) erythrocytes and tissue biotin may result in non-specific staining
Manual based on the detection system employed. Tissues containing
QD420-YIKE
(500 Test) QD620-XAKE QP900-9LE Hepatitis B Surface Antigen (HBsAg) may give false positive
QD400-60KE (500 Test) (500 Test) with horseradish peroxidase systems . Improper counterstaining
(60 Test) and mounting may compromise the interpretation of results.
Xmatrx - QD550-YCDE QD610-YADE
N/A Bibliography
Automation (200 Test) (200 Test)
i6000 - QD410-YAXE QD610-YAXE 1. Corson, JM. Pathol Annual 21 (Part 2):47-81, 1986.
N/A 2. Schlegel, R, et al. Am J Pathol 101:41, 1980.
Automation (200 Test) (200 Test)
3. Schlegel, R, et al. Lab Invest 42:91, 1980.
For more information, visit www.biogenex.com.
4. Vojtesek B, et al. Folia Biol 35:373-382, 1989.
5. Kovarik J, et al. Int J Cancer Suppl: 50-55, 1988.
Precautions 6. Center for Disease Control. Decontamination of Laboratory
This product contains sodium azide at concentrations of less than Sink Drains to Remove Azide Salts. Center for Disease
0.1%. Sodium azide is not classified as a hazardous chemical at Control Manual Guide--Safety Management, No. CDC-22,
the product concentrations, but proper handling protocols should Atlanta, Georgia. April 30, 1976.
be observed. For more information, a Safety Data Sheet (SDS) 7. Kiernan JA. Histological and Histochemical Methods:
for sodium azide is available upon request. Dispose of unused Theory and Practice. New York: Pergamon Press 1981.
reagents according to Local, State and Federal Regulations. 8. Nadji M, Morales AR. Immunoperoxidase, part 1: the
Wear suitable Personal Protective Equipment, do not pipette techniques and its pitfall. Lab Med 1983; 14:767-770.
reagents by mouth, and avoid contact of reagents and specimens 9. Omata M, Liew CT, Ashcavai M, Peters Rl.
with skin and mucous membranes. If reagents or specimens Nonimmunologic binding of horseradish peroxidase to
come in contact with sensitive area, wash with copious amounts hepatitis B surface antigen. A possible source of error in
of water. immunohistochemistry. Am J Clin Pathol. May, 1980;
73(5):626-632.
Quality Control 10. U.S. Congress. Clinical Laboratory Improvement Amendments
Refer to BioGenex detection system documents for guidance on of 1988: Final Rule, 57 FR 7163, February 28, 1992.
general quality control procedures. 11. National Institute for Occupational Safety and Health,
(NIOSH), Rockville, MD. Explosive azide hazard,
Troubleshooting Publication No. 78-127, 1976.
Refer to the troubleshooting section in the documentation for
BioGenex Detection Systems (or equivalent detection systems)
for remedial actions on detection syste m related issues, or In Vitro
Temperature
contact BioGenex Technical Support Department at 1-800-421-4149 Diagnostic
Li mitation
or support@biogenex.com or your local distributor to report Medical Device
unusual staining.
Use By Date Batch Code
Expected Results
This antibody stains cytoplas m in positive cells in formalin-
fixed, paraffin embedded tissue sections. An example image of a Consult
tissue section stained with this antibody can be found on the Non-Sterile Instructions
product page on the BioGenex website. Interpretation of the for Use
staining result is solely the responsibility of the user.
Experimental results should be confirmed by a medically- Representative
established diagnostic product or procedure. in the European Manufacturer
Community
© 2020, BioGenex Laboratories. All rights reserved.

Category Antibodies Revision No. I

Document No. 932-357M-EN Release Date 15-Jun-2021

48810 Kato Road, Suite 100E & 200E, Fremont, CA 94538, Tel: +1 (800) 421-4149, Fax: +1 (510) 824-1490, support@biogenex.com, www.biogenex.com