Srphc326049-Hev Igm Elisa Test: 1. Assay Should Be Based On The Principle Of Igm Ca Pture. 2. The Assay Should Detect Igm Anti Hev Antibodies. 3. Should Be Compatible With Plasma And Serum Both. 4. The Kit Size Should Be 96 Tests/Kit (In Strips Of 12X8 Wells Such That Individu Al Strips Can Be Used For Testing And The Same Are Compatible With Automated Elisa Reader An D Washer. 5. The Manufacturer /Authorized Agent Should Ensure Maintenance Of Cold Chain D Uring Storage And Transport Of Kits At 2-8 Degree C. 6. Original Technical Data Sheet Should B E Provided With Each Kit. 7. The Assay Component Should Include Reactive And Non-Reactive Co Ntrols Sufficient For Atleast 4 Runs. 8. The Assay Components Should Be Sufficient For The 96 Tests Provided In Four Runs. 9. The Assay Should Have Sensitivity Greater Than And Equal To 99 % And Specificity Greater Than And Equal To 98%. 10. The Kit Should Have Approval Of The Stat Utory Authority From The Country Of Origin. 11. In Case Of Imported Kits It Should Be Registere D And Licensed By The Dcg(I). 12. In Case Of Indigenous Manufactures Should Be Licensed By The Competent Authority Defined Under Drugs And Cosmetics Act At 1940 And Also Be Evaluated By The Centers Approved By The Government Of India. 13. The Kit Should Have Minimum Shelf Life Of 60% Or 12 Months(Whichever Is More) At The Time Of Delivery To Consignee. Unit:Test The Item B E Supplied With Brand: Mbs/Labgene/Elisa Or Similar ]