Data Sheet

Data Sheet
Napsin A
Concentrated and Prediluted Monoclonal Antibody
Control Number: 901-388-032415
Catalog Number:
CM 388 AK, CK
PM 388 AA
OAI 388 T60
IPI 388 G10
0.1, 1.0 ml, concentrated
6.0 ml, prediluted
60 tests, prediluted
10 ml, prediluted
Renoir Red
Intended Use:
For In Vitro Diagnostic Use
Napsin A [TMU-Ad 02] is a mouse monoclonal antibody that is intended for laboratory
use in the qualitative identification of Napsin A protein by immunohistochemistry
(IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues. The clinical
interpretation of any staining or its absence should be complemented by morphological
studies using proper controls and should be evaluated within the context of the patient’s
clinical history and other diagnostic tests by a qualified pathologist.
Summary and Explanation:
Napsin A is a pepsin-like aspartic proteinase. It is expressed in type II pneumocytes
and in adenocarcinomas of the lung and kidney (2). Studies have shown that Napsin A
is both more sensitive and specific than TTF-1. When compared to TTF-1, Napsin A
showed a higher specificity (94.3%) for adenocarcinoma in non-small cell lung
carcinoma as compared to TTF-1 (76.1%) (4). Unlike TTF-1, Napsin A is positive in
some renal cell carcinomas (RCC). Several studies have shown that Napsin A was
positive in 83%-90.7% of primary lung adenocarcinomas (1-3). Other neoplastic
tissues such as ovarian cancers show low expression with different staining patterns
from that of primary lung cancer which shows granular cytoplasmic staining in tumor
cells. In studies comparing TTF-1 and SP-A, Napsin A stained more tumor cells and a
higher percentage of lung adenocarcinomas than either of these antibodies. Napsin A is
useful for distinguishing primary lung adenocarcinoma from adenocarcinoma of
unknown origin and is therefore a promising marker for the diagnosis of primary lung
adenocarcinoma (3).
Principle of Procedure:
Antigen detection in tissues and cells is a multi-step immunohistochemical process.
The initial step binds the primary antibody to its specific epitope. A secondary antibody
may be applied to bind the primary antibody, followed by an enzyme labeled polymer;
or an enzyme labeled polymer may be applied directly to bind the primary antibody.
The detection of the bound primary antibody is evidenced by an enzyme-mediated
colorimetric reaction.
Source: Mouse monoclonal
Species Reactivity: Human, others not tested
Clone: TMU-Ad 02
Isotype: IgG1
Total Protein Concentration: ~10 mg/ml. Call for lot specific Ig concentration.
Epitope/Antigen: Synthetic peptide of a part of the N-terminus of human Napsin A
Cellular Localization: Cytoplasmic
Positive Control: Lung adenocarcinoma
Known Applications:
Immunohistochemistry (formalin-fixed paraffin-embedded tissues)
Supplied As: Buffer with protein carrier and preservative
Renoir Red (PD904)
Storage and Stability:
Store at 2ºC to 8ºC. Do not use after expiration date printed on vial. If reagents are
stored under conditions other than those specified in the package insert, they must be
verified by the user. Diluted reagents should be used promptly; any remaining reagent
should be stored at 2ºC to 8ºC.
Protocol Recommendations (intelliPATH and manual use):
Peroxide Block: Block for 5 minutes with Biocare's Peroxidazed 1.
Pretreatment Solution (recommended): Diva
Pretreatment Protocol:
Heat Retrieval Method:
Retrieve sections under pressure using Biocare's Decloaking Chamber, followed by a
wash in distilled water; alternatively, steam tissue sections for 45-60 minutes. Allow
solution to cool for 10 minutes then wash in distilled water.
Protocol Recommendations (intelliPATH and manual use) Cont'd:
Protein Block (Optional): Incubate for 5-10 minutes at RT with Biocare's Background
Primary Antibody: Incubate for 30 minutes at RT.
Probe: Incubate for 10 minutes at RT with a secondary probe.
Polymer: Incubate for 10-20 minutes at RT with a tertiary polymer.
Incubate for 5 minutes at RT with Biocare's DAB -OR- Incubate for 5-7 minutes at RT
with Biocare's Warp Red.
Counterstain with hematoxylin. Rinse with deionized water. Apply Tacha's Bluing
Solution for 1 minute. Rinse with deionized water.
Technical Note:
This antibody has been optimized for use with Biocare's MACH 4 Universal HRPPolymer Detection and intelliPATH Universal HRP Detection Kit. Other Biocare
polymer detection kits may be used; however, users must validate incubation times and
protocols for their specific application. Use TBS for washing steps.
intelliPATH™ Automated Slide Stainer:
IPI388 is intended for use on the intelliPATH™ Automated Slide Stainer. Refer to the
intelliPATH Automated Slide Stainer manual for specific instructions on its use. When
using the intelliPATH, peroxide block with intelliPATH Peroxidase Blocking Reagent
(IPB5000) may be performed following heat retrieval.
Protocol Recommendations (ONCORE Automated Slide Staining System):
OAI388 is intended for use with the ONCORE Automated Slide Staining System.
Refer to the ONCORE Automated Slide Staining System User Manual for specific
instructions on its use. Protocol parameters in the ONCORE Automated Slide Stainer
Protocol Editor should be programmed as follows:
Protocol Name: Napsin A
Protocol Template (Description): Ms HRP Template 1
Dewaxing (DS Option): DS2
Antigen Retrieval (AR Option): AR1, high pH; 101°C
Reagent Name, Time, Temp.: Napsin A, 30 min., 25°C
The optimum antibody dilution and protocols for a specific application can vary. These
include, but are not limited to: fixation, heat-retrieval method, incubation times, tissue
section thickness and detection kit used. Due to the superior sensitivity of these unique
reagents, the recommended incubation times and titers listed are not applicable to other
detection systems, as results may vary. The data sheet recommendations and protocols
are based on exclusive use of Biocare products. Ultimately, it is the responsibility of
the investigator to determine optimal conditions. The clinical interpretation of any
positive or negative staining should be evaluated within the context of clinical
presentation, morphology and other histopathological criteria by a qualified
pathologist. The clinical interpretation of any positive or negative staining should be
complemented by morphological studies using proper positive and negative internal
and external controls as well as other diagnostic tests.
Quality Control:
Refer to CLSI Quality Standards for Design and Implementation of
Immunohistochemistry Assays; Approved Guideline-Second edition (I/LA28-A2).
CLSI Wayne, PA, USA ( 2011.
Page 1 of 2
Napsin A
Concentrated and Prediluted Monoclonal Antibody
Control Number: 901-388-032415
1. This antibody contains less than 0.1% sodium azide. Concentrations less than 0.1%
are not reportable hazardous materials according to U.S. 29 CFR 1910.1200, OSHA
Hazard communication and EC Directive 91/155/EC. Sodium azide (NaN3) used as a
preservative is toxic if ingested. Sodium azide may react with lead and copper
plumbing to form highly explosive metal azides. Upon disposal, flush with large
volumes of water to prevent azide build-up in plumbing. (Center for Disease Control,
1976, National Institute of Occupational Safety and Health, 1976) (5)
2. Specimens, before and after fixation, and all materials exposed to them should be
handled as if capable of transmitting infection and disposed of with proper precautions.
Never pipette reagents by mouth and avoid contacting the skin and mucous membranes
with reagents and specimens. If reagents or specimens come in contact with sensitive
areas, wash with copious amounts of water. (6)
3. Microbial contamination of reagents may result in an increase in nonspecific
4. Incubation times or temperatures other than those specified may give erroneous
results. The user must validate any such change.
5. Do not use reagent after the expiration date printed on the vial.
6. The SDS is available upon request and is located at
Follow the antibody specific protocol recommendations according to data sheet
If atypical results occur, contact Biocare's Technical Support at
1. Hirano T, et al. Usefulness of TA02 (Napsin A) to distinguish primary lung
adenocarcinoma from metastatic lung adenocarcinoma. Lung Cancer. 2003 Aug; 41
2. Ueno T, Linder S, Elmberger G. Aspartic proteinase napsin is a useful marker for
diagnosis of primary lung adenocarcinoma. Br J Cancer. 2003 Apr 22; 88(8):1229-33.
3. Suzuki A, et al. Napsin A is useful to distinguish primary lung adenocarcinoma from
adenocarcinomas of other organs. Pathol Res Pract. 2005;201 (8-9):579-86.
4. Dejmek A, et al. Napsin A (TA02) is a useful alternative to thyroid transcription
factor-1 (TTF-1) for the identification of pulmonary adenocarcinoma cells in pleural
effusions. Diagn Cytopathol. 2007 Aug;35(8):493-7.
5. Center for Disease Control Manual. Guide: Safety Management, NO. CDC-22,
Atlanta, GA. April 30, 1976 "Decontamination of Laboratory Sink Drains to Remove
Azide Salts."
6. Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline-Fourth Edition
CLSI document M29-A4 Wayne, PA 2014.
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