GeM | Bidding

Category	Specification	Bid Requirement (Allowed Values)
GENERAL FEATURES	Product Description	HIV Rapid Test Kit
PRODUCT INFORMATION	Type of Kit	HIV1 & HIV2 Antibodies and HIV1 p24 Antigen Detection Rapid Test Kit
Assay Coating	Solid phase coated HIV1 and HIV2 recombinant and/or synthetic peptide antigens and antibody to HIV1 P24
Detection Type	Qualitative
Testing Principle	Lateral Flow Immunochromatographic Assay
Species Reactivity	Human
Type of Sample	Whole Blood, Serum, Plasma
Time to Result	≤ 30 minutes
Ability to evaluate negative or positive test result	Yes
Sensitivity	≥99%, 100% Or higher
Specificity	≥98% Or higher
Contains an internal control dot/band for the confirmation that the test has been performed correctly	Yes
KIT CONTENTS	Kit Contents	Test Card/Cassette with Desiccant, Sample Dropper, Assay Buffer (if any)
PACKAGING	The test kit packed in such a way that there is proivision to conduct single test at a time	Yes
Each test card/cassette with desiccant individually packed in a hermetically sealed and non-permeable pouch	Yes
CERTIFICATIONS & REPORTS	Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date	Yes
Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement	Yes
SHELF LIFE	Shelf life in months from the date of manufacture	18, 24, 36 Or higher
Minimum shelf life of the product at the time of delivery to the consignee	3/4 th of Total Shelf Life
ADVANCE SAMPLE	Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding	Yes

Category

Specification

Bid Requirement (Allowed Values)

GENERAL FEATURES

Product Description

HIV Rapid Test Kit

PRODUCT INFORMATION

Type of Kit

HIV1 & HIV2 Antibodies and HIV1 p24 Antigen Detection Rapid Test Kit

Assay Coating

Solid phase coated HIV1 and HIV2 recombinant and/or synthetic peptide antigens and antibody to HIV1 P24

Detection Type

Qualitative

Testing Principle

Lateral Flow Immunochromatographic Assay

Species Reactivity

Human

Type of Sample

Whole Blood, Serum, Plasma

Time to Result

≤ 30 minutes

Ability to evaluate negative or positive test result

Yes

Sensitivity

≥99%, 100% Or higher

Specificity

≥98% Or higher

Contains an internal control dot/band for the confirmation that the test has been performed correctly

Yes

KIT CONTENTS

Kit Contents

Test Card/Cassette with Desiccant, Sample Dropper, Assay Buffer (if any)

PACKAGING

The test kit packed in such a way that there is proivision to conduct single test at a time

Yes

Each test card/cassette with desiccant individually packed in a hermetically sealed and non-permeable pouch

Yes

CERTIFICATIONS & REPORTS

Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date

Yes

Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement

Yes

SHELF LIFE

Shelf life in months from the date of manufacture

18, 24, 36 Or higher

Minimum shelf life of the product at the time of delivery to the consignee

3/4 th of Total Shelf Life

ADVANCE SAMPLE

Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding

Yes