GeM

AOC

Goods

Point of Care Diagnostic Test Kits - HIV Rapid Test Kits

PRODUCT

Point of Care Diagnostic Test Kits - HIV Rapid Test Kits

Medical Health And Family Welfare Department Uttar

Moradabad, Uttar Pradesh

Amount: Refer DocsCloses: 15 Nov 2019Closed

Timeline

Published5 Nov 2019
Closed15 Nov 2019
Awarded21 Nov 2019

Bids

9 Bids21 Nov 2019

#	Company	Offered Item	Amount	Rank	Status
1	Shubham Associates L1₹10.7 LQualified Make: RECKON Model: RECKON SYPHILIS CARD 403 1ST FLOOR D39 KRISHNA VILAS ROAD DEVARAJA MOHALLA MYSORE KARNATAKA 570001 UDYAM KR 22 0081573 29DJPPR5352R1ZX B R \| MYSURU \| KARNATAKA \| 570001	Make: RECKON Model: RECKON SYPHILIS CARD	₹10.7 L	L1	Qualified MSE, Category: General
2	SUN TRADERS L2₹10.8 L+₹5,400 (0.50%)Qualified Make: RECKON Model: RECKON SYPHILIS CARD 184 5TH BLOCK 2ND STAGE NAGARBHAVI BANGALORE KARNATAKA 560072 UDYAM KR 03 0079108 \| BENGALURU URBAN \| KARNATAKA \| 560072	Make: RECKON Model: RECKON SYPHILIS CARD	₹10.8 L+₹5,400 (0.50%)	L2	Qualified MSE, Category: General
3	MAMTA PHARMA L3₹10.8 L+₹7,200 (0.67%)Qualified Make: RECKON Model: RECKON SYPHILIS CARD A 82 HIG MDDA COLONY DLANAWALA DEHRADUN UTTARAKHAND 248001 \| DEHRADUN \| UTTARAKHAND \| 248001	Make: RECKON Model: RECKON SYPHILIS CARD	₹10.8 L+₹7,200 (0.67%)	L3	Qualified MSE, Category: General
4	ADVANTAGE Disqualified Make: SD Model: HIV Test Kit 46 MOTI BUNGALOW MAIN ROAD DEWAS DEWAS MADHYA PRADESH 455001 \| DEWAS \| MADHYA PRADESH \| 455001	Make: SD Model: HIV Test Kit	-	-	Disqualified MSE, Category: OBC
5	CONCEPT DIAGNOSTICS X-RAY & SURGICAL Disqualified Make: ATHENESE Dx Model: Athenese C 175 FIRST FLOOR MAYAPURI INDUSTRIAL AREA PHASE II MAYA PURI MAYAPURI SOUTH WEST DELHI DELHI 110064 \| WEST DELHI \| DELHI \| 110064	Make: ATHENESE Dx Model: Athenese	-	-	Disqualified

Tender Value

Refer Docs

EMD Value

Exempted

Closing Date

15 Nov 2019, 7:00 pmClosed

Work Description

Point of Care Diagnostic Test Kits - HIV Rapid Test Kits

Tender Information

Tender ID

1458048

Reference Number

GEM/2019/B/413012

Tender Type

GeM Contract

Product Category

Point of Care Diagnostic Test Kits - HIV Rapid Test Kits

Form of Contract

GeM Contract

Period of Work

30 days

Location

Uttar Pradesh; Moradabad

Bid Type

PRODUCT

Source Website

Subscribe to view

Awarded Items

GEMC-511687705953124

Awarded to Shubham Associates

₹10.7 L

Products

Product	Brand / Model	HSN	Quantity	Unit Price	Amount
SYPHILIS TEST CARD	RECKON SYPHILIS CARD	-	60,000 pieces	₹17.89	1,073,400

Documents Required

27 documents required · 27 mandatory

RequiredCertificate (Requested in ATC) Bid to RA enabled No Point Of Care Diagnostic Test Kits - HIV Rapid Test Kits ( 60000 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

RequiredHIV 2 Antibodies

RequiredHIV 1 p24 Ag HIV 1 Antibodies

RequiredHIV 2 Antibodies

RequiredHIV 1 p24 Ag The assay should have solid phase/particles coated HIV 1 and 2 Yes * 1/6 recombinant and/or synthetic peptide antigens Test can be performed on Serum

RequiredPlasma Whole Blood

RequiredSerum

RequiredPlasma Type of Test Quantitative Quantitative Testing Principle Immuno Chromatographic Immuno Chromatographic Result Time (minutes) 10-20 * 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 Yes * 2/6 Act

Required1940 and applicable rules there under 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

Requiredcomponents

Requireddetails of antigen for antibody detection of HIV 1 and 2

Requiredmethodologies

Requiredvalidity criteria

Requiredperformance c haracteristics

Requiredbio- safety

Requiredlimitations of assay

Requiredstorage condition

Requiredmanufacturing 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

RequiredNo Individually packed sterile disposable lancets and disposable alcohol swabs provided with each test kit Yes Yes

RequiredNo Other accessories and spares provided if any for standard pack in the kit - * PACKAGING Pack Size 50 Tests Pack * The packing and labelling should be as Yes * 3/6 per Drugs and Cosmetics Act

Required1940 and applicable rules 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 demand) Yes * Indigenous manufacturers should be licensed by the competent authority defined under Drugs and Cosmetics act 1940 NA for imported kits * Availability of valid drug license from competent authority defined under Drugs and Cosmetics Act

Required1940 (Proof of the same to be submitted to buyer on demand) For Manufacture to sale * Drug License Number - * Drug License Date - * Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) GMP * 4/6 GMP/WHO GMP Certification Number - * GMP/WHO GMP Certification Date - * ISO 13485 Certified Manufacturer (Proof of the same to be submitted to buyer on demand) Yes * Product Certifications (Proof of the same to be submitted to buyer on demand) EU-CE (IVD) * Four digit number of notified body If product is EU-CE certified - * Certificatiion Number - * Certificatiion Date - * Certification Issuing Authority - * Availability of Test report from Central GOVT/NABL/ILAC accredited Lab to prove the conformity to the declared specification( proof of the same to be submitted to the buyer on demand) Yes * Availability of Performance Evaluation Report (Proof of the same to be submitted to the buyer on demand) Yes * Performance Evaluation Report issuing body National Insitute of Biological Sciences * Name of the Performance Evaluation Report issuing body if other than specified institute - * SHELF LIFE Shelf Life (in months) 24 12

Required18

Required24

Required30

Required36 The product should not have passed more than 1/6 of the total shelf life at the time of dispatch to the consignee Yes * 5/6 * Specifications highlighted in bold are the Golden Parameters. * Bidders may note that In respect of non-golden Parameters

Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer.

Purchase Preferences

MSE EMD ExemptionStartup Exemption

Items & Quantities

Item	Delivery Location	Qty	Delivery
Point of Care Diagnostic Test Kits - HIV Rapid Test Kits	-	60,000	-

Total: 60,000

Fee & Financial Details

EMD Fee Amount

Exempted

Important Dates

Last Activity

21 Nov 2019

Published

5 Nov 2019

Stage Documents

Award of Contract

contract_GEMC-511687705953124.pdf

GEM_CONTRACT • 0.02 MB

Documents

Tap a document below to read it instantly. You can also download everything as a ZIP if you prefer.

Tender Documents

bid_1458048.pdf

GEM_BID

Work Item Documents

termsCondition.pdf

OTHER

2657c7ca70287299b5181580fdb5a7ab.pdf

OTHER

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Company

Shubham Associates

L1₹10.7 LQualified

Make: RECKON Model: RECKON SYPHILIS CARD

403 1ST FLOOR D39 KRISHNA VILAS ROAD DEVARAJA MOHALLA MYSORE KARNATAKA 570001 UDYAM KR 22 0081573 29DJPPR5352R1ZX B R | MYSURU | KARNATAKA | 570001

SUN TRADERS

L2₹10.8 L+₹5,400 (0.50%)Qualified

Make: RECKON Model: RECKON SYPHILIS CARD

184 5TH BLOCK 2ND STAGE NAGARBHAVI BANGALORE KARNATAKA 560072 UDYAM KR 03 0079108 | BENGALURU URBAN | KARNATAKA | 560072

MAMTA PHARMA

L3₹10.8 L+₹7,200 (0.67%)Qualified

Make: RECKON Model: RECKON SYPHILIS CARD

A 82 HIG MDDA COLONY DLANAWALA DEHRADUN UTTARAKHAND 248001 | DEHRADUN | UTTARAKHAND | 248001

ADVANTAGE

Disqualified

Make: SD Model: HIV Test Kit

46 MOTI BUNGALOW MAIN ROAD DEWAS DEWAS MADHYA PRADESH 455001 | DEWAS | MADHYA PRADESH | 455001

CONCEPT DIAGNOSTICS X-RAY & SURGICAL

Disqualified

Make: ATHENESE Dx Model: Athenese

C 175 FIRST FLOOR MAYAPURI INDUSTRIAL AREA PHASE II MAYA PURI MAYAPURI SOUTH WEST DELHI DELHI 110064 | WEST DELHI | DELHI | 110064

Product

Brand / Model

HSN

Quantity

Unit Price

Amount

SYPHILIS TEST CARD

RECKON SYPHILIS CARD

60,000 pieces

₹17.89

1,073,400

Item

Delivery Location

Qty

Delivery

Point of Care Diagnostic Test Kits - HIV Rapid Test Kits

60,000