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Sickle Cell Disease Rapid Test Kit (GICA)¹

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Product Description Intended UseThe 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. SummarySickle 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. Test PrincipleSickle 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 whensamplehas been flowed through the cartridge. The presence of hemoglobin variants A, S, and C will be indicated by a red line in that region. Internal Quality ControlTo 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. Warnings and Precautions?Only for in vitro diagnostic use for with human capillary fingerstick or whole blood samples.? This test kit is used for in vitro diagnosis.? Do not use test kit to test patients who have received a blood transfusion in the preceding 6 months.?When performing the test in environments that are 37oC (99oF) or higher and relative humidites of 70% or greater (dew point 31oC/87oF), sample must be added to sample inlet within 5 minutes of removing the cassette from the pouch.? Proper protection should be taken during testing to avoid splashing when adding sample.? Dispose of all used or damaged test cassettes, lancet, Sampler or other kit components as biohazardous materials.? Handle specimens in accordance to the OSHA Standard on Bloodborne Pathogens.? Wash hands thoroughly after handling specimens.? Do not use test cassette, buffer solution, or any other kit components if the pouch is damaged or the seal is broken.? Do not use samples containing lipids, hemolysis, or turbidity which can affect results.? Do not use test cassette, buffer solution or any kit components beyond the indicated expiration date.? Do not disassemble cassettes, which contain dry-loaded reagents that may be biohazardous, allergenic, and/or toxic.? Specimens should be free of visible aggregates and other particulate matter.? Heterophilic Antibody Interference: some individuals have antibodies to mouse, goat, rabbit, or other heterophilic proteins; interferences may occur.? This package the IFU must be read completely before performing the test. Failure to follow directions in insert may yield inaccurate test results.? Test results should be read between 10 and 15 minutes after a specimen is applied to the sample well. Results read after 15 minutes may give erroneous results. Storage Instructions? The test kit should be stored away from direct sunlight at 2oC - 30oC or 35oF - 86oF with a shelf-life of 12 months. Do not freeze.? Do not remove the cassette from sealed pouch until ready for use.? When stored/transported properly, test cassette and Buffer are stable until the marked expiration date. Disposal InstructionsPut all used components back into bio-safety bag.Follow the applicable regulations when disposing. Limitations? Performance of this product has not been established for sickle cell patients with beta-thalassemia.? Performance of this product had not been established for patients who have received blood transfusions within the preceding 6 months.? This product is for qualitative testing only Performance CharacteristicsSickle Cell Disease Rapid Test Kit (GICA) was compared to hemoglobin electrophoresis (REF). Patient samples, K2EDTA, (n = 94) were collected and measured in duplicate on both systems.Sickle Cell Disease Rapid Test Kit (GICA) performance compared to hemoglobin electrophoresis based diagnosis.Method Comparison^ASC is not a valid genotype but can manifest as a phenotype when an SC patient has received a transfusion. Detection LimitThe Sickle Test Kit limit of detection for hemoglobins A, S, and C is determined to be <1 g/dL (%), <1g/ dL, and <1 g/dL, respectively. About MedomicsJiangsu 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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