GeM | Bidding

Category	Specification	Bid Requirement (Allowed Values)
GENERAL FEATURES	Product Description	Syphilis Rapid Test Kit
PRODUCT INFORMATION	Type of Kit	Syphilis Antibody Rapid Test Kit
Detects	Total Anti-Treponema Pallidum Antibody (IgG,IgM & IgA)
Detection Type	Qualitative
The assay shall have solid phase coated with synthetic or recombinant type of Treponema Pallidum antigens	Yes
Testing Principle	Lateral Flow Immunochromatographic Assay
Type of Sample	Whole Blood, Serum, Plasma
Time to Result	≤ 30 minutes
Ability to evaluate negative or positive test result	Yes
Sensitivity	≥99% 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	Positive and negative controls provided with each pack of kit	Yes, No
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	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

Syphilis Rapid Test Kit

PRODUCT INFORMATION

Type of Kit

Syphilis Antibody Rapid Test Kit

Detects

Total Anti-Treponema Pallidum Antibody (IgG,IgM & IgA)

Detection Type

Qualitative

The assay shall have solid phase coated with synthetic or recombinant type of Treponema Pallidum antigens

Yes

Testing Principle

Lateral Flow Immunochromatographic Assay

Type of Sample

Whole Blood, Serum, Plasma

Time to Result

≤ 30 minutes

Ability to evaluate negative or positive test result

Yes

Sensitivity

≥99% 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

Positive and negative controls provided with each pack of kit

Yes, No

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

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