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Ministry Of Home Affairs

  • Opening Date

    07 Oct 2019

  • Closing Date

    17 Oct 2019

  • Tender Amount

    Refer document

  • EMD

    -

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Summary

Point Of Care Diagnostic Test Kits - Hiv Rapid Test Kits

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Bid Number: GEM/2019/B/379685 Dated: 07-10-2019 Bid Document Bid Details Bid End Date/Time 17-10-2019 17:00:00 Bid Life Cycle (From Publish Date) 90 (Days) Bid Offer Validity (From End Date) 30 (Days) Ministry/State Name Ministry Of Home Affairs Department Name Central Armed Police Forces Organisation Name Indo Tibetan Border Police (itbp) Office Name Commandant 49 Bn Itbp Basar Total Quantity 500 Item Category Point of Care Diagnostic Test Kits - HIV Rapid Test Kits MSE Exemption For Years Of Experience And Turnover Yes Startup Exemption For Years Of Experience And Turnover Yes Bid to RA enabled No Point Of Care Diagnostic Test Kits - HIV Rapid Test Kits ( 500 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) GENERAL FEATURES Product Description HIV Rapid Test Kit * Clinical Purpose To provide diagnosis of HIV infection * PRODUCT INFORMATION Detects HIV 1 Antibodies,HIV 2 Antibodies,HIV 1 p24 Ag HIV 1 Antibodies, HIV 2 Antibodies, HIV 1 p24 Ag The assay should have solid phase/ particles coated HIV 1 and 2 recombinant and/or synthetic peptide antigens Yes * 1 / 6 Test can be performed on Whole Blood,Serum Whole Blood, Serum Type of Test Qualitative Qualitative Testing Principle Agglutination Agglutination Result Time (minutes) 5-10 * Ability to Evaluate Negative or Positive test result Yes * The Assay should have sensitivity of > 99 point 5% and specificity of > 98% Yes * Contains an internal control band/dot for the confirmation that the test has been performed correctly Yes * The control dot/band should be able to detect the presence of human immunoglobulins and should not be just a "procedural control" or meant for merely checking the flow or reagents or integrity of the antigen except in kits using "lateral flow (Immunocytoflow) or flow through (Immunoconcentration) " technology Yes * Storage temperature 2°C to 8°C * The supplier should ensure maintenance of recommended temperature during storage and transportation of Kits The Cumulative time temperature indicator technology used should be pre qualified by WHO Yes * The kit should comply with all provisions of Drugs and cosmentics Act, 1940 and applicable rules there under Yes * 2 / 6 KIT CONTENTS Main items in test kit for performing the test Card * Sample Dropper Provided with each card/device Yes * Dessicant to absorb moisture so that the card do not get spoiled provided with each card Yes * Sample Diluent/Assay Buffer Provided Yes * Packaging insert in English detailing the principle, components, details of antigen for antibody detection of HIV 1 and 2, methodologies, validity criteria, performance c haracteristics,bio- safety, limitations of assay, storage condition, manufacturing and expiry dates and methods of disposal provided with each kit Yes * Provided with HIV positive and negative serum controls sufficient for conducting 20% of the tests (10 % negative and 10 % positive controls) Yes Yes Individually packed sterile disposable lancets and disposable alcohol swabs provided with each test kit No No Other accessories and spares provided if any for standard pack in the kit - * PACKAGING Pack Size 25 Tests pack * The packing and labelling should be as per Drugs and Cosmetics Act, 1940 and applicable rules Yes * 3 / 6 there under Each card (cassette) should have space for patients particulars and date of the test Yes * The test kit should be packed in such a way that there is provision to conduct single test at a time Yes * Each test kit should be individually packed in a hermetically sealed and non-permeable pouch Yes * CERTIFICATIONS & REPORTS The kit should have approval of the statutory authority in its country of origin Yes * The Kit should be registered and licensed in India by DCGI in case of imported kits (Proof of the same to be submitted to buyer on dem

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