| Customization: | Available |
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| Classification: | Ivd |
| Type: | Rapid Test Kit |
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The Sickle Cell Disease Rapid Test Kit is a lateral flow chromatographic qualitative immunoassay to aid in the rapid diagnosis of sickle cell disorders of hemoglobins A, S, and C using fingerstick or venipuncture whole blood samples. User will be a clinical professional such as a doctor, physician assistant, nurse, clinical or medical assistant, or laboratory technician.
Sickle Cell Disease, an inherited blood disorder, often causes red blood cells to become sickle-shaped through the presence of the abnormal hemoglobin S variant. The more rigid sickle-shaped blood may have difficulty passing through small blood vessels, blocking the normal blood flow, damaging tissues, and ultimately leading to many of the complications of Sickle Cell Disease. Additionally, red blood cells containing mostly hemoglobin S live only about 16 days compared to 120 days for normal red blood cells.
Several types of Sickle Cell conditions exist, with the most common being Sickle Cell Trait (HbAS), Sickle Cell Disease (HbSS), Sickle-Hb C Disease (HbSC), and Sickle-Hb C Trait (HbAC). Early diagnosis (preferably as a newborn) of Sickle Cell Disease is important to initiate life saving health maintenance therapies such as penicillin prophylaxis, vaccination against pneumococcus bacteria, folic acid supplementation, pain management mediations, blood transfusions, and hydroxyurea. While Sickle Cell Trait is not a type of disease, harmful complications are possible in extreme environments (increased atmospheric pressure, high altitudes, low oxygen levels, intense athletic competition, or dehydration).Carriers of Sickle Cell Trait should be identified to be cautious of such situations as well as for genetic counseling and family planning.
Sickle Cell Disease Rapid Test Kit (GICA) is a rapid, qualitative lateral flow immunoassay kit for the identification of sickle cell disorder of hemoglobins A, S, and C. A small amount of blood, five microliters, is taken by fingerstick or venipuncture using the provided Sampler. The Sampler is placed into the buffer to release hemoglobin by lysing erythrocytes.Three drops of mixed sample buffer added to the sample inlet of the test cassette.Read the results within 10-15 minutes. A total of four detection lines are possible, with the control (Ctrl) line appearing whensample
To ensure assay validity, a procedural "Control" line containing monoclonal goat anti-mouse IgG antibody is incorporated in the nitrocellulose membrane. For a test result to be valid there must be a visible red Control line.During the testing procedure, Colloidal gold-labeled Monoclonal IgG released from the conjugate pad will be captured by the antibody immobilized in the Control line and form a red Control line for samples that are either positive or negative. If the Control line does not appear; the test is invalid and a new test must be performed. If the problem persists, please contact your local vendor or Medomics for technical support.
•Only for in vitro diagnostic use for with human capillary fingerstick or whole blood samples.
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About Medomics
Jiangsu Medomics Medical Technology Co., Ltd., is located at Biotech and Pharmaceutical Valley of the National Jiangbei New Area, Nanjing, Jiangsu Province. It is an international high-tech enterprise driven by innovation in the area of medical devices R&D, production and sales. Medomics focuses on diagnosis of microorganisms, tumors and some rare diseases, mainly engaged in the research and development, production and sales of in vitro diagnostic reagents and automatic instruments.
Medomics owns two R&D centers in China and the US, independent intellectual property rights of fluorescent staining technology, protein labeling technology, time-resolved immunofluorescence detection technology, image processing and analysis technology and other innovative technology platforms, as well as a total of more than 10,000 square meters of GMP purification production workshop that meets the product standards of FDA, CE and CFDA. Until now, Medomics has more than 100 employees across the world and R&D personnel accounts for over 50%. Medomics also has a multidisciplinary expert team with abundant experience in the industry, including senior experts in immunology, microbiology, applied physics, polymer materials, medical imaging, optical systems, etc. The members of the technical team are led by doctors from many famous institutions, such as Osaka University, North Carolina University, University of Nebraska Lincoln, Zhejiang University, Sichuan University and other institutions.
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