Tender For Rate Contract And Supply Of Medical Devices/Consumables For Different Healthcare Facilities Of State Of Bihar Technical Specification of Point of Care Rapid Diagnostic Test Kits (Point of care test screening of Sickle cell disease) 1. Rapid point of care test for detection of Hemoglobin. The test is made up of two indicators, which detect the presence of hemoglobin A and S allowing the user to rapidly distinguish between normal, carrier and sickle cell disease samples. 2. Rapid point of care test to aid in the determination of hemoglobin disorder (Sickle cell trait, sickle cell disease &HbS disease) in clinical and population-based setting. The device must do this by detecting the presence of hemoglobin variants A and S using finger prick, heel prick or venipuncture whole blood samples. 3. Test is to be based on principle of competitive lateral flow immunoassay/ inverse reading using monoclonal antibodies for hemoglobin A and S from whole blood. 4. Suitable for detecting Sickle cell disease in ages 6-Months and above. 5. Stable in field temperatures up to 40°C and no refrigeration required. 6. Overall sensitivity and specificity to be 95% or above. 7. Minimum shelf life of the sealed container should be 24 months. 8. The quoted kit should be validated by ICMR/CDSCO/DCGI and approved by MOHFW/Govt. of India 9. Packing should be equal quantity of lancet, alcohol swabs and plastic dropper pipettes. 10. Result should be in less than 20 minutes. 11. The test result should not get affected due to presence of fetal hemoglobin