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  1. Udbud
  2. Laboratorieudstyr, optisk- og præcisionsudstyr

Fakta om udbudet

EU-nr
2017/S 179-365998
Offentliggjort
19.09.2017
Udbudstype
Forhåndsmeddelelse

Udbyder

Region Hovedstaden

Human Papillomavirus (HPV) analysis systems for primary screening

Region Hovedstaden

Prior information notice

This notice is for prior information only

Supplies

Directive 2014/24/EU

Section I: Contracting authority

I.1) Name and addresses
Region Hovedstaden
29190623
Kongens Vænge 2
Hillerød
3400
Denmark
Contact person: Claus Jørgen Eskerod
Telephone: +45 38665809
E-mail: claus.joergen.eskerod@regionh.dk
NUTS code: DK01

Internet address(es):

Main address: http://www.regionh.dk

I.2) Joint procurement
I.3) Communication
Additional information can be obtained from the abovementioned address
I.4) Type of the contracting authority
Regional or local authority
I.5) Main activity
Health

Section II: Object

II.1) Scope of the procurement
II.1.1) Title:

Human Papillomavirus (HPV) analysis systems for primary screening.

II.1.2) Main CPV code
38000000
II.1.3) Type of contract
Supplies
II.1.4) Short description:

Announcement of validation criterions required for Human Papillomavirus (HPV) analysis systems for consideration in the impending EU tender for Primary HPV screening in the capital Region of Denmark, 2018.

II.1.5) Estimated total value
II.1.6) Information about lots
This contract is divided into lots: no
II.2) Description
II.2.1) Title:
II.2.2) Additional CPV code(s)
24000000
II.2.3) Place of performance
NUTS code: DK01
Main site or place of performance:

Amager and Hvidovre Hospital, Department of Pathology.

II.2.4) Description of the procurement:

With the expectation that human papillomavirus (HPV) primary screening by 2018 will substitute the current clinical liquid cytology based screening as the primary screening modality for women 30 years or older, the Capital Region of Denmark announces an impending EU tender thus regarding. For this, it is announced that candidate HPV assays systems are required to, but not limited to, provide evidence that the assay:

1. Satisfies the ‘Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older’1 on SurePath™ collected screening samples.

For non-DNA HPV assays, furthermore:

2. Evidence of a 5 year negative predictive value non-inferior to DNA based assays.

SurePath™ liquid cytology media is currently in use in the Capital Region of Denmark and will not be part of the tender.

1 (published in Int. J. Cancer., 124 (2009), pp. 516-520.).

II.2.14) Additional information
II.3) Estimated date of publication of contract notice:
01/04/2018

Section IV: Procedure

IV.1) Description
IV.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: yes

Section VI: Complementary information

VI.3) Additional information:
VI.5) Date of dispatch of this notice:
15/09/2017

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