Health And Family Welfare Department Tender

Anti D Serum (IgM)

Anti D Serum (IgM+IgG)

Anti H Lectin

Bovine Albumin I.P. (10 ml Vial)

CPK Test Kit

De Ionized Water

Drabkin's Solution

Gluteraldehyde Solution 2.45% with activator

Whole Blood Finger-Prick HIV Test kit. Technical Specifications 1. The indigenous HIV antibody rapid test kits should have a valid license issued by the competent authority defined under Drugs & Cosmetics Act. 1940 after appropriate evaluation by the centres approved by DCG(I). The imported rapid test kits should have the approval of the statutory authority in the country of Origin/manufacture and should satisfy the requirements of Drugs and cosmetics act in India. The imported kits should also get evaluated in our country 2. The assay should be able to detect antibodies of HIV-I and HIV-2 and all the subtypes by detection of antibodies by the agglutination, Enzyme Immune Assay or any other principal. 3. The assay should have sensitivity of 99.5% or more and specificity of 98% or more as per data from an identified national reference laboratory. 4. The assay should have solid phase/particles coated with synthetic and/or recombination or both types of antigens of HIV1 & HIV2. 5. Total procedure time should not be more than 30 minutes. 6. The manufactures should ensure that a. The test kit should be packed such that there is a provision to conduct single test at a time. b. The assay components should include HIV positive and negative serum controls sufficient for conducting 20% of the tests (10% negative & 10% positive controls); and c. The pack size of HIV rapid test kits should not be more than 50 tests per kit.

Note : - 1. Quality of the product supplied / to be supplied, may be ascertained by testing / physical examination by the experts at any stage of the tender period. 2. The Items should be US FDA/CE/ ICMR/NIB/CDSCO approved (US FDA/ CE certificate will be applicable only when the Indian Standards like ICMR/NIB/CDSCO is not available). 3. In case of imported items NABL/NIB/NIV/CDL or equivalent authorized Lab accredited by Parent country will be considered. 4. If every supplied batch of the approved vendor contains test report from NIB/NIV/NARI/ICMR then the 2% testing charge will not be deducted from the bill(s).