Srphc326132-Leptospira Igm Elisa :1.Kit Should Be Able To Detect Igm Antibodies Ag Ainst Leptospira Antigen In Human Serum. 2. Should Be A Solid Phase Enzyme-Linked Immunosorb Ent Assay (Elisa) Based On The Sandwich Principle. 3. Should Be Compatible With All Common Eli Sa Reader. 4. The Assay Component Should Include Reactive And Non- Reactive Controls. 5.Test Should Have A Sensitivity Of Greater Than And Equal To 97% And Specificity Of Greater Than An D Equal To 99%. 6.Adequate Documents Detailing Principle Components Bio Safety Methodologi Es Limitations Of Assays Manufacturing & Expiry Dates Should Be Provided With Each Kit. 7. The Kit To Be Procured Should Have Approval Of The Statutory Authority In Its Country Of Origin. 8. In Case Of Imported Kits It Should Have Been Registered And Licensed In India By Dcg (I). 9. In C Ase Of Indigenous Manufacturers They Shall Have License Issued By The Competent Authority D Efined Under Drugs And Cosmetics Act 1940 After Appropriate Evaluation By The Centers Appro Ved By Dcg (I). 10. The Kit Should Have Minimum Shelf Life Of 18 Months 1To 30 Degree Celsius. 11 . Kit For 96 Tests. Unit:Test The Item May Be Supplied With Brand: Standard Diagnostics/J Mitra/Athene See Or Similar. ]