Epitope Diagnostics, Inc.

7110 Carroll Road, 92121 San Diego, CA
USA
Telephone +1 858 6937877
Fax +1 858 6937678
cs@epitopediagnostics.com
http://www.epitopediagnostics.com

Product Categories

Product categories

03 Diagnostic Tests
03.02 Immunochemistry testing, immunology testing
03.02.02 Diagnostic rapid tests

Diagnostic rapid tests

03 Diagnostic Tests
03.02 Immunochemistry testing, immunology testing
03.02.03 Diagnostic tests for cancer

Diagnostic tests for cancer

Human Pepsinogen I ELISA Kit
Human Chromogranin A ELISA Kit

2 Products

03 Diagnostic Tests
03.02 Immunochemistry testing, immunology testing
03.02.04 Other equipment for immunochemistry and immunology

Other equipment for immunochemistry and immunology

03 Diagnostic Tests
03.04 Microbiology testing
03.04.02 Parasitology testing in microbiology

Parasitology testing in microbiology

Fecal Ova/Parasite Concentration Kit

03 Diagnostic Tests
03.04 Microbiology testing
03.04.03 Rapid tests in microbiology

Rapid tests in microbiology
Our products

Product category: Parasitology testing in microbiology
Fecal Ova/Parasite Concentration Kit
Description
The EDI Fecal Ova/Parasite Concentration Kit is a device that easily processes stool samples and to concentrate ova/parasite for further use and microscopic examination.

This kit is for laboratory professional use.

Background
Fecal sample ova/parasite concentration is a routine procedure for improving detection rate or reducing false negative results during parasite screening. Traditionally, the concentration procedure used in laboratories requires the use of either ethyl acetate as a lipid removing agent and formalin as a fixative. This process involves the use of either expensive brass sieves or even tea strainers as the filter element. Tea strainers have a large open pore structure of at least 600 microns and, due to the shape of the strainer, inconsistent pore size. Fecal matter is filtered directly through the mesh in a dead stop manner, and hence, there is the tendency for occlusion of the filter. A secondary filter layer may also form, particularly fibers, in the sediment. The net result is a reduction in egg yield and sample clarity.

This device is intended for easy, effective, and clean processing of fecal samples, concentrating ova/parasites for microscopic examination.

Product category: Diagnostic tests for cancer
Human Pepsinogen I ELISA Kit
Description
This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative measurement of human pepsinogen I levels in serum. Pepsinogen I levels are a useful tool in the determination the functional states of acid-secreting gastric mucosa.

This pepsinogen I ELISA kit is for in-vitro diagnostic use.

Background
Pepsinogen consists of a single polypeptide chain of 375 amino acid residues with an average molecular weight of 42 kDa. Pepsinogen I is synthesized at gastric cheif cells and mucous neck cells, while pepsinogen II is also produced by clear mucous cells of antrum, etc. The clinical applications of measuring pepsinogen I and II are a useful aid in the diagnosis of severe atrophic gastritis and stomach cancer. It has been suggested that the measurement of serum pepsinogens serve as a “serological biopsy” for predicting the presence of atrophic gastritis or superficial gastritis.

Atrophic Gastritis: It has been found the serum pepsinogen I levels falling lower than 20 ng/ml was highly specific for severe atrophic gastritis. It was also observed that serum pepsinogen I levels fell with increasing severity of mucosal damage in such cases. The diagnostic sensitivity and specificity of serum pepsinogen I levels for advanced atrophic corpus gastritis are about 92% and 90% respectively. On the other hand, the decrease in serum pepsinogen I levels in patients with pernicious anemia and atrophic gastritis was found to be associated with normal or raised pepsinogen II levels. Therefore, a pepsinogen I/pepsinogen II ratio is significantly lower than those with superficial gastritis or normal remnant mucosa.

Stomach Cancer: Low serum pepsinogen I levels were found in patients with gastric cancer, with a threefold higher incidence. Other studies have concluded that low serum pepsinogen I levels may identify persons at increased risk for intestinal types of stomach cancer.

Duodenal Ulcers: A low serum pepsinogen I level can exclude a diagnosis of duodenal ulcer. Although a high pepsinogen I level has less clinical use for establishing this diagnosis, the combination of hypergastinemia and a highly evelated serum pepsinogen I level strongly suggests the possibility of Zollinger-Ellison syndrome.

Product category: Diagnostic tests for cancer
Human Chromogranin A ELISA Kit
Description
This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative measurement of human chromogranin A levels in EDTA-plasma and serum samples. This assay exclusively measures human chromogranin A without the high dose “hook” effect up to 1,000,000 ng/ml. This test may be used as an aid for detecting pheochromocytoma and neuroendocrine tumors in patients.

This chromogranin A ELISA kit is for in-vitro diagnostic use.

Background
Chromogranin A is a 49 kDa acidic protein that consists of 439 amino acids encoded on chromosome 14. Chromogranin A has been identified in a number of normal and neoplastic endocrine tissues. It is demonstrated that an elevated level of circulating chromogranin A is a marker for tumors of neuroendocrine origin. However, the most significant clinical use of chromogranin A is related to the diagnostic procedure in patients with pheochromocytoma. The following is a short summary of the potential usages of chromogranin A.

1. A very sensitive (83%) and highly specific (96%) marker in the evaluation of actual or suspected pheochromocytoma. Drugs commonly employed in the diagnosis or treatment of pheochromocytoma have little effect on plasma chromogranin A levels, which is a great advantage over the measurement of catecholamines.
2. To ascertain the source of a tumor. A high chromogranin A level indicates that the tumor arises from neuroendocrine tissues.
3. Endocrine tumors that do that produce their specific hormones, for example, calcitonin negative but

ad: contact information

About Us

Company details
Mission
Epitope Diagnostics Inc. (EDI) strives to develop, manufacture, and market the highest quality and most innovated in-vitro diagnostics (IVD) products to the global research, pharmaceutical, and healthcare community. We seek to become a major contributor in resolving the unmet medical needs of the world.

History
Located in America’s finest city and one of the biotech hubs of the U.S., Epitope Diagnostics, Inc. was established in 2003. Since then, EDI has developed and launched many innovative ELISA and rapid test kits that meet the needs of healthcare communities worldwide. For instance, EDI launched the world’s first commercial test for the determination of alpha-1-HS-glycoprotein, the human fetuin-A ELISA kit. Many clinical studies were performed using this test which led to the publication of more than 20 scientific papers.

In 2004, EDI was accredited by the State of California Department of Health Services, Food and Drug Branch, as a certified and licensed medical device manufacturer. A year later, EDI developed and innovative, odorless, and self-contained rapid test platform specifically for stool sample-based rapid tests. This innovative device has been patented (US 7,780,915), FDA 510(k) cleared, and CLIA-waived since 2005. This platform has gone on to be the basis of all our rapid test kit, including the European CE certified OTC kit, EpiTuub iFOB test.

ad: company

Endoscopy Development Company, LLC
Enova Illumination Inc.
Enterprise Florida Inc.
Equitech-Bio Inc.
Ercon Inc.
Excite Medical
Enterprise Florida Inc.
Enova Illumination Inc.
Endoscopy Development Company, LLC
EMulate Therapeutics
Emergo by UL

Equitech-Bio Inc.
Ercon Inc.
Excite Medical
EyeTech Digital Systems
Fabrication Enterprises Inc.