Epitote Diagonostics

Epitote Diagonostics

Epitope Diagnostics Inc. is a certified medical device manufacture company that focuses on niche immunoassays for the global diagnostics and research industries. The company specializes in ELISA kits, rapid tests, and antibodies.
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Covid-19 Epitote Diagonostics

Clinical Laboratory

COVID-19 IgG ELISA Kit
KT-1032 EDI Novel Coronavirus COVID-19 IgG ELISA Kit

The KT-1032 EDI Novel Coronavirus COVID-19 IgG Enzyme Linked Immunosorbent Assays (ELISA) kit is intended for the qualitative detection of COVID-19 IgG antibody in human serum. The test utilizes an immunocomplex of “COVID-19 recombinant antigen – human anti- COVID-19 IgG antibody – HRP labeled anti-human IgG tracer antibody” which is formed if there is coronavirus IgG antibody present in the tested materials.
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COVID-19 IgM ELISA Kit
KT-1033 EDI Novel Coronavirus COVID-19 IgM ELISA Kit

The KT-1033 EDI Novel Coronavirus COVID-19 IgM Enzyme Linked Immunosorbent Assays (ELISA) kit is intended for the qualitative detection of COVID-19 IgM antibody in human serum. The test utilizes an immunocomplex of “COVID-19 recombinant antigen – human anti- COVID-19 IgM antibody – HRP labeled anti-human IgM tracer antibody” which is formed if there is coronavirus IgM antibody present in the tested materials.
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COVID-19 Nucleocapsid IgG Quantitative ELISA Kit
KT-1034 EDI COVID-19 Nucleocapsid IgG Quantitative ELISA Kit

The KT-1034 EDI COVID-19 Nucleocapsid IgG Quantitative Enzyme Linked Immunosorbent Assays (ELISA) kit is intended for the quantitative detection of COVID-19 IgG antibody in human serum. The test utilizes an immunocomplex of “COVID-19 recombinant antigen – human anti- COVID-19 IgG antibody – HRP labeled anti-human IgG tracer antibody” which is formed if there is coronavirus IgG antibody present in the tested materials.
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Quantitative SARS-CoV-2 Spike Protein IgG ELISA Kit
KTR-1035 EDI Quantitative SARS-CoV-2 Spike Protein IgG ELISA Kit

The KTR-1035 EDI Quantitative SARS-CoV-2 Spike Protein IgG ELISA Kit is an Enzyme-Linked Immunosorbent Assay (ELISA) kit for the quantitative measurement of novel COVID-19 human IgG antibody to SARS-CoV-2 in human serum. The assay is validated manually, but can be adapted to an automated instrument.
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Quantitative SARS-CoV-2 Neutralizing Antibody ELISA
KTR-1036 EDI Quantitative SARS-CoV-2 Neutralizing Antibody ELISA

The KTR-1036 EDI Quantitative SARS-CoV-2 Neutralizing Antibody ELISA kit is intended for the quantitative measurement of the neutralizing antibody to SARS-CoV-2 receptor binding domain (RBD) of its spike protein in human serum. The assay utilizes the microplate-based enzyme immunoassay technique and requires only 50 μL of human serum for measurement in duplicate.
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Total Thyroxine Assay
Total Thyroxine CLIA Kit

Total Thyroxine CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human total Thyroxine in serum. This fast, 10-minute assay uses 15 µL of sample and achieves a dynamic range from 2.5 to 300 ng/mL. Supplied with 100 tests per kit, it supports efficient high-throughput thyroid testing with storage at 2–8°C.
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Total Triiodothyronine Assay
Total Triiodothyronine CLIA Kit

Total Triiodothyronine CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human total Triiodothyronine concentration in serum. Featuring a dynamic range of 0.2–8.0 ng/mL and high sensitivity (0.25 ng/mL), the kit processes 100 tests with results in just 10 minutes. It requires 50 µL of serum and is designed for 2–8°C storage, offering fast, reliable thyroid diagnostics.
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Human Insulin ELISA Kit
Human Insulin ELISA Kit

The Human Insulin ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative measurement of human insulin in serum, plasma, or urine. With a sensitivity of 0.1817 mIU/L and a dynamic range up to 138 mIU/mL, this sandwich ELISA delivers results in under two hours. Using only 100 µL of sample, the 96-test kit supports efficient and accurate insulin monitoring and requires 2–8°C storage for stability.
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Clinical Laboratory

Total Thyroxine Assay
Total Thyroxine CLIA Kit

Total Thyroxine CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human total Thyroxine in serum. This fast, 10-minute assay uses 15 µL of sample and achieves a dynamic range from 2.5 to 300 ng/mL. Supplied with 100 tests per kit, it supports efficient high-throughput thyroid testing with storage at 2–8°C.
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Total Triiodothyronine Assay
Total Triiodothyronine CLIA Kit

Total Triiodothyronine CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human total Triiodothyronine concentration in serum. Featuring a dynamic range of 0.2–8.0 ng/mL and high sensitivity (0.25 ng/mL), the kit processes 100 tests with results in just 10 minutes. It requires 50 µL of serum and is designed for 2–8°C storage, offering fast, reliable thyroid diagnostics.
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Human Insulin ELISA Kit
Human Insulin ELISA Kit

The Human Insulin ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative measurement of human insulin in serum, plasma, or urine. With a sensitivity of 0.1817 mIU/L and a dynamic range up to 138 mIU/mL, this sandwich ELISA delivers results in under two hours. Using only 100 µL of sample, the 96-test kit supports efficient and accurate insulin monitoring and requires 2–8°C storage for stability.
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Glucagon-Like Peptide-1 Assay
Total GLP-1 ELISA Kit

The Total GLP-1 ELISA Kit ELISA (enzyme-linked immunosorbent assay) kit is designed for the quantitative determination of the sum value of glucagon-like peptide-1 (7-36) and (9-36) [GLP-1 (7-36)] and (9-36) [GLP-1 (9-36)] in plasma samples. This sandwich ELISA offers high sensitivity (0.6 pmol/L) and a dynamic range of 0–54 pmol/L. Requiring just 100 µL of EDTA-plasma, it is ideal for overnight incubation (20–24 hours). The kit includes 96 tests and is stored at 2–8°C, providing researchers with precise, colorimetric detection for GLP-1 studies.
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Human Thyroglobulin Assay
Human Thyroglobulin CLIA Kit

The Human Thyroglobulin CLIA Kit is a chemiluminescence immunoassay for quantifying thyroglobulin in serum. With a sensitivity of 0.1 ng/mL and a dynamic range of 0.1-500 ng/mL, it supports thyroid cancer monitoring and autoimmune thyroid disease evaluation. The assay’s high accuracy and automated processing enhance clinical diagnostics.
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Human Growth Hormone Assay
Human Growth Hormone (HGH) ELISA Kit

The Human Growth Hormone (HGH) ELISA Kit is a quantitative immunoassay for detecting HGH in serum. With a sensitivity of 0.087 ng/mL and a dynamic range of 0-64 ng/mL, it supports the diagnosis of pituitary disorders. Requiring just 50 µL of sample, the 1-hour 15-minute assay provides reliable results for clinical and research applications related to growth hormone deficiencies and excesses.
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Fibroblast Growth Factor-21 Assay
Human Intact FGF-21 ELISA Kit

The Human Intact FGF-21 ELISA Kit quantifies Fibroblast Growth Factor-21 in serum or plasma, aiding in the diagnosis of metabolic disorders, including non-alcoholic fatty liver disease and type 2 diabetes. With a detection range of 0-2000 pg/mL and high specificity, this 2-hour 20-minute sandwich ELISA delivers precise, clinically relevant data. It provides valuable insights into energy metabolism and insulin resistance.
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Insulin Assay
Human Ultra-Sensitive Insulin ELISA Kit

The Ultra-Sensitive Insulin ELISA Kit quantitatively measures low insulin levels in human serum or plasma. With a sensitivity of 0.0322 mLU/L and a dynamic range of 0-7.60 mLU/mL, it supports metabolic and diabetes research. Using a sandwich ELISA method, this kit provides precise, reproducible results in just 2 hours 20 minutes. Optimized for clinical and research applications, it ensures accurate assessment of insulin secretion.
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Gastrin-17 ELISA
Human Gastrin-17 CLIA Kit

The Human Gastrin-17 CLIA Kit is designed for precise measurement of Gastrin-17 levels in human serum or plasma. Gastrin-17 is an important biomarker for diagnosing and monitoring gastric disorders, including gastric ulcers and gastritis. This kit offers high sensitivity and accuracy, supporting effective clinical diagnosis and treatment strategies.
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CEA CLIA
Human Carcinoembryonic Antigen CLIA Kit

The Human Carcinoembryonic Antigen (CEA) CLIA Kit offers a highly sensitive method for detecting CEA levels in human serum or plasma. This biomarker is crucial for cancer monitoring, particularly for colorectal, lung, and breast cancers. The kit provides reliable, accurate results, aiding in early cancer detection and management.
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C-Peptide ELISA
Ultra Sensitive C-Peptide ELISA Kit

The Ultra Sensitive C-Peptide ELISA Kit is designed for the precise detection of C-peptide levels in human serum or plasma. This highly sensitive test helps monitor insulin secretion, assess pancreatic function, and manage conditions like diabetes. It ensures accurate, reliable results with minimal sample volume for efficient diagnostics.
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Human Adrenocorticotropic Hormone ELISA
EDI ACTH ELISA Kit

The EDI Human Adrenocorticotropic Hormone (ACTH) ELISA Kit is a high-performance diagnostic tool designed to accurately measure ACTH levels in human serum or plasma. This kit offers reliable results for assessing adrenal function, aiding in the diagnosis of conditions like Cushing's syndrome and Addison’s disease. It ensures precise and efficient testing with minimal preparation.
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Human Insulin CLIA
Human Insulin CLIA Kit

The Human Insulin CLIA Kit is designed, developed, and produced for the quantitative measurement of human insulin levels in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of insulin.
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25-Hydroxy Vitamin D CLIA
Human 25-Hydroxy Vitamin D CLIA Kit

The Human 25-Hydroxy Vitamin D Chemiluminescence Immunoassay (CLIA) kit intended for the quantitative measurement of total 25-hydroxy vitamin D2 and D3 concentration in human serum.
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Fetuin-A ELISA
High Sensitive Human Fetuin-A ELISA Kit

The High Sensitive Human Fetuin-A ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human fetuin-A, also known as alpha-2-HS glycoprotein (AHSG), in serum. The measurement of fetuin-A aids in the diagnosis of some cancers and genetically inherited deficiencies of this serum protein.
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Myeloperoxidase ELISA
Quantitative Serum/Plasma Myeloperoxidase ELISA Kit

The Quantitative Serum/Plasma Myeloperoxidase ELISA (enzyme-linked immunosorbent assay) Kit is intended for the quantitative measurement of human myeloperoxidase (MPO) levels in serum and EDTA-plasma samples. MPO serves as a sensitive predictor for cardiovascular disease.
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Anti-IgE Antibody ELISA
Serolisa Human Anti-IgE Antibody ELISA Kit

The Serolisa Human Anti-IgE Antibody ELISA Kit is intended for the quantitative determination of human anti-human IgE antibody levels in human serum or plasma samples. The test may be useful for detecting patients who have developed antibodies (mainly IgG) to their own IgE.
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Human Folate Chemiluminescence Immunoassay
Human Folate CLIA Kit

The Human Folate CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human folate concentration in serum. The assay utilizes competitive binding mechanisms for testing and the test result is automatically calculated by the system according to the working curve.
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ProGRP Chemiluminescence Immunoassay
Pro-Gastrin-Releasing Peptide CLIA Kit

The Pro-Gastrin-Releasing Peptide CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of Pro-gastrin-releasing peptide (ProGRP) concentration in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of ProGRP.
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Alpha Fetoprotein Chemiluminescence Immunoassay
Human Alphafetoprotein CLIA Kit

The Human Alphafetoprotein CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human Alpha Fetoprotein (AFP) in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of AFP.
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C-Peptide Assay
Human C-Peptide ELISA Kit

The Human C-Peptide ELISA Kit is intended for use in the quantitative determination of low picogram levels of human connecting peptides in serum and/or plasma. Testing for C-peptide levels can help find the cause of low blood sugar (hypoglycemia) and aid in distinguishing type 1 from type 2 diabetes.
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Anti-TPO Autoantibody Assay
Human Anti-TPO IgG ELISA Kit

The Human Anti-TPO IgG ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative detection of human anti-TPO autoantibody (IgG) in serum. The presence of this autoantibody together with clinical findings and other laboratory tests is a useful aid in the diagnosis of autoimmune thyroid diseases such as Hashimoto's Thyroiditis and Graves' disease. The test is developed with proprietary technology that leads to a very low reaction background in normal populations and thus increases the clinical diagnostics sensitivity and specificity.
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Ferritin Assay
Human Ferritin CLIA Kit

The Human Ferritin CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human ferritin concentration in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of Ferritin.
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Vitamin B12 Assay
Human Vitamin B12 CLIA Kit

The Human Vitamin B12 CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human Vitamin B12 in serum samples. The assay utilizes the competition law for testing and the test result is automatically calculated by the system according to the working curve.
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D-Dimer Test
Human D-Dimer CLIA Kit

The Human D-Dimer CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human D-Dimer concentration in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of D-Dimer.
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Procalcitonin Test
Human Procalcitonin CLIA Kit

The Human Procalcitonin CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human Procalcitonin concentration in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of PCT and runs on the ECL100 or ECL 25 analyzer.
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Cancer Antigen Test
Human Cancer Antigen 50 CLIA Kit

The Human Cancer Antigen 50 CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human Cancer Antigen 50 concentration in serum samples. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of CA50 and can be run on the ECL100 or ECL 25 analyzer.
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Immunochemical Fecal Occult Blood Rapid Test Kit
EpiTuub FOB Test Device

The EpiTuub Fecal Occult Blood (FOB) Test Device is a rapid immunological test intended for the qualitative detection of fecal occult blood in feces by professional laboratories and physician office laboratories. The test is intended for the determination of gastrointestinal (GI) bleeding, found in several gastrointestinal disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.
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HE4 Assay
Human Epididymal Protein 4 (HE4) CLIA Kit

The Human Epididymal Protein 4 (HE4) CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human epididymal protein 4 (HE4) in serum. The assay utilizes a two-site “sandwich” technique with two antibodies that bind to different epitopes of HE4.
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Cancer Antigen 242 Assay
Human Cancer Antigen 242 CLIA Kit

The Human Cancer Antigen 242 CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative measurement of human Cancer Antigen 242 in serum. The two-site sandwich assay to determine the level of CA 242 has a total incubation time of 15 minutes.
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Fecal Sample Collection Kit
q-FOB

The q-FOB fecal sample collection kit is a device intended for human fecal sample collection and extraction. The extracted sample can be used directly for detection of fecal occult blood by the quantitative determination of human hemoglobin levels in stool samples by professional laboratories.
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Chromogranin A Test
EDI Human Chromogranin A CLIA Kit

The EDI Human Chromogranin A CLIA Kit is a Chemiluminescence Immunoassay (CLIA) intended for the quantitative determination of human chromogranin A (CgA) levels in serum using the ECL100 or ECL25 Immunoassay analyzer. The test may be used as an aid for detecting patients with pheochromocytoma and neuroendocrine tumors (such as carcinoids, etc.).
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H. pylori Test
H. pylori Antigen Rapid Test Kit

The H. pylori Antigen Rapid Test Kit is an immunochromatographic assay for the qualitative determination of Heliccobacter pylori antigen in feces. The kit containing a fecal collection tube and test cassette is compatible with the EPC-100 Rapid Test Cassette Reader.
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Fecal Calprotectin Test
Quantitative Fecal Calprotectin ELISA Kit

The Quantitative Fecal Calprotectin ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human calprotectin (neutrophil cytoplasmic protein A100A8/A9) levels in stool samples. The test is useful for detecting inflammatory bowel disease (IBD) such as ulcerative colitis and Crohn's disease.
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Giardia Lamblia Diagnostic Test
Human Anti-Giardia lamblia IgM ELISA Kit

The Human Anti-Giardia lamblia IgM ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative detection of anti-Giardia lamblia IgG antibody in serum or plasma. The assay is a useful tool in for detecting Giardia lamblia infections in acute or chronic gastroenteritis.
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NSE ELISA Kit
Human Neuron Specific Enolase ELISA Kit

The Human Neuron Specific Enolase ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human neuron specific enolase (NSE) levels in patient serum samples. The test may be used as an aid for detecting neuroendocrine differentiated tumors in patients, such as small cell lung cancer, neuroblastoma, melanoma, and sminoma, as well as injury to the central nervous system.
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Intact Brentuximab Vedotin “Sandwich” Test
EDI Intact Brentuximab Vedotin ELISA Kit

EDI Intact Brentuximab Vedotin ELISA Kit is a highly sensitive “sandwich” test intended for use in the quantitative determination of intact brentuximab vedotin levels in serum or plasma. It is useful for clinical monitoring of therapeutic drug (brentuximab vedotin) concentrations for precision treatment.
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FOB Test
q-FOB Quantitative Fecal Occult Blood Test Kit

The q-FOB Quantitative Fecal Occult Blood Test Kit is an ELISA (enzyme-linked immunosorbent assay) kit intended for the quantitative determination of human hemoglobin levels in stool samples. The ELISA kit is for in-vitro diagnostic use and specifically measures human hemoglobin without cross-reaction with animal blood. It is useful for detecting the severity of gastrointestinal bleeding and aiding the screening for colorectal adenoma/polyps and cancer, as well as other inflammatory bowel diseases such as Crohn's disease, ulcerative colitis, etc.
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Trastuzumab Emtansine Test
EDI Trastuzumab Emtansine EIA Kit

The EDI Trastuzumab Emtansine EIA Kit is intended for use in the quantitative determination of Trastuzumab emtansine in human serum sample. The kit is for in-vitro diagnostic use and is useful for clinical monitoring of the therapeutic drug concentration for precision medical treatment.
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Pepsinogen I Test
Human Pepsinogen I ELISA Kit

The Human Pepsinogen I 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.
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Human Anti-Müllerian Hormone ELISA Test
Human Anti-Müllerian Hormone ELISA Kit

Human Anti-Müllerian Hormone ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human anti-Müllerian hormone (AMH) levels in serum and lithium heparin plasma samples. AMH, which is uniquely produced by granulosa cells of ovarian follicles during folliculogenesis, is currently the best measure of ovarian reserve in the clinical setting and may also be used to predict ovarian response in IVF as well as to monitor patients with a history of granulosa cell tumors.
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Human Fetuin-A ELISA Test
Human Fetuin-A ELISA Kit

The Human Fetuin-A ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human fetuin-A, also known as alpha-2-HS glycoprotein (AHSG), in serum, plasma, cell culture supernatant, tissue extraction, and urine. The measurement of fetuin-A in serum or plasma aids in the diagnosis of some cancers and genetically inherited deficiencies of this serum protein.
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Human Pepsinogen II ELISA Test
Human Pepsinogen II ELISA Kit

The Human Pepsinogen II ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative measurement of human pepsinogen II levels in serum. The determination of human serum pepsinogen II level allows calculation of the ratio of pepsinogen I/II, which is a reportedly useful tool to aid diagnosis of the functional states of acid-secreting gastric mucos.
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Quantitative SARS-CoV-2 Neutralizing Antibody ELISA
KTR-1036 EDI Quantitative SARS-CoV-2 Neutralizing Antibody ELISA

The KTR-1036 EDI Quantitative SARS-CoV-2 Neutralizing Antibody ELISA kit is intended for the quantitative measurement of the neutralizing antibody to SARS-CoV-2 receptor binding domain (RBD) of its spike protein in human serum. The assay utilizes the microplate-based enzyme immunoassay technique and requires only 50 μL of human serum for measurement in duplicate.
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Quantitative SARS-CoV-2 Spike Protein IgG ELISA Kit
KTR-1035 EDI Quantitative SARS-CoV-2 Spike Protein IgG ELISA Kit

The KTR-1035 EDI Quantitative SARS-CoV-2 Spike Protein IgG ELISA Kit is an Enzyme-Linked Immunosorbent Assay (ELISA) kit for the quantitative measurement of novel COVID-19 human IgG antibody to SARS-CoV-2 in human serum. The assay is validated manually, but can be adapted to an automated instrument.
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COVID-19 Nucleocapsid IgG Quantitative ELISA Kit
KT-1034 EDI COVID-19 Nucleocapsid IgG Quantitative ELISA Kit

The KT-1034 EDI COVID-19 Nucleocapsid IgG Quantitative Enzyme Linked Immunosorbent Assays (ELISA) kit is intended for the quantitative detection of COVID-19 IgG antibody in human serum. The test utilizes an immunocomplex of “COVID-19 recombinant antigen – human anti- COVID-19 IgG antibody – HRP labeled anti-human IgG tracer antibody” which is formed if there is coronavirus IgG antibody present in the tested materials.
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COVID-19 IgM ELISA Kit
KT-1033 EDI Novel Coronavirus COVID-19 IgM ELISA Kit

The KT-1033 EDI Novel Coronavirus COVID-19 IgM Enzyme Linked Immunosorbent Assays (ELISA) kit is intended for the qualitative detection of COVID-19 IgM antibody in human serum. The test utilizes an immunocomplex of “COVID-19 recombinant antigen – human anti- COVID-19 IgM antibody – HRP labeled anti-human IgM tracer antibody” which is formed if there is coronavirus IgM antibody present in the tested materials.
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COVID-19 IgG ELISA Kit
KT-1032 EDI Novel Coronavirus COVID-19 IgG ELISA Kit

The KT-1032 EDI Novel Coronavirus COVID-19 IgG Enzyme Linked Immunosorbent Assays (ELISA) kit is intended for the qualitative detection of COVID-19 IgG antibody in human serum. The test utilizes an immunocomplex of “COVID-19 recombinant antigen – human anti- COVID-19 IgG antibody – HRP labeled anti-human IgG tracer antibody” which is formed if there is coronavirus IgG antibody present in the tested materials.
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