Health And Family Welfare Department Tender

HIV and Syphilis Rapid Diagnosis dual Test Kit Technical Specification of the Kit: 1. The assay should have synthetic and/or recombinant type of the following a. Multiple Treponema pallidum antigens and b. Antigens of HIV 1 (including gp41) and HIV 2 (including gp36) 2. The Kit should be able to individually detect antibodies to HIV 1 & 2 and anti-Treponema pallidum antibodies in human serum/plasma/whole blood (finger prik). 3. The assay may be based on any of the rapid test principles such as flow-through (immunoconcentration) or lateral flow (immunochromatography). 4. The assay should be able to detect all antibodies to all sub types of HIV 1 , HIV 2 & Treponema pallidum for serological diagnosis of syphilis. 5. The assay should have an in-build control for testing the validity of the test procedure. 6. Specifications: a. For HIV, the assay should have sensitivity of 100% and specificity of greater than or equal to 98%. b. For Syphilis, the assay should have sensitivity of greater than or equal to 85% and specificity of greater than or equal to 93%. 7. The kit (indigenous or imported) licensed by the competent authority defined under Drugs and Cosmetics Act at 1940 & Rule 1945 and/or Medical Device Rules 2017. 8. Imported rapid kit should have approval of the statutory authority for in-vitro diagnostics in its country of origin. 9. Total procedure time should not be more than 30 minutes. 10. The kit should have a shelf life of at least 18 months at the time of receipt by the consignee. 11. The manufacturer/ authorized agent should ensure maintenance of cold chain i.e. 2-8 degree Celsius during storage and transport of the kits. Indicator should be provided on the exterior of each kit box to track the cold chain maintenance. 12. The test kit should be packed such that there is provision to conduct single test at a time. 13. The test kit should be available in pack size of 20 test per kit (minimum pack size) to 50 test per kit (maximum pack size) . 14. Adequate literature detailing the principle, components, methodologies, validity criteria, biosafety, performance characteristics, storage conditions, limitation of assay, items required but not provided in the kit, manufacture and expiry dates and methods of disposal should be provided with each kit. 15. The kit should be supplied with sufficient amount of capillaries to deliver the required amount of specimen specified in the kit literature.

ANTI CCP ELISA KIT

Anti DSDNA-(Elisa kit)