77093 UL KLM Dep. for Medical Biochemistry Analysis Instrument

Oslo University Hospital, Department of Medical Biochemistry, Unit for special analyses, shall procure a new analysis instrument. The procured instrument shall mainly be used for analysing free light chains Kappa and Lambda with reagents from The Binding Site. Kappa and lambda shall be measured with immunoturbidimetry. The analysis must cover …

CPV: 38000000 Laboratóriumi, optikai és precíziós felszerelések (kivéve szemüvegek), 33000000 Orvosi felszerelések, gyógyszerek és testápolási termékek
A végrehajtás helye:
77093 UL KLM Dep. for Medical Biochemistry Analysis Instrument
Díjat odaítélő szervezet:
Oslo Universitetssykehus HF (hovedenhet)
Díj száma:
77093

1. Buyer

1.1 Buyer

Official name : Oslo Universitetssykehus HF (hovedenhet)
Legal type of the buyer : Body governed by public law
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : 77093 UL KLM Dep. for Medical Biochemistry Analysis Instrument
Description : Oslo University Hospital, Department of Medical Biochemistry, Unit for special analyses, shall procure a new analysis instrument. The procured instrument shall mainly be used for analysing free light chains Kappa and Lambda with reagents from The Binding Site.      Kappa and lambda shall be measured with immunoturbidimetry. The analysis must cover a very broad concentration area, from 1 mg/L to over 100,000 mg/L. This large variation in concentration makes the analysis exposed to antigene excess problems. To ensure reliable results, it is crucial to have a robust and validated antigen excess system, which requires collaboration between the supplier of reagents and the instrument if these are not the same.  Based on the large volume, clinical significance and complexity of the cutting and lambda analyses in relation to kinetics/antigen excess, we believe it is necessary to require an IVDR certified application for analysing the cloak and lambda in serum on the new instrument.   In addition a small number of analyses of the erytrocyte enzymes Glucose 6 phosphate dehydrogenase (G6PD), pyruvatkinase (PK) and colinesterase with dibucain inhibition shall also be carried out. The unit for special analyses has a de facto country function for analysing G6PD and PK.  The department makes approx. 10,000 analyses per annum and needs a high capacity instrument. Optilite from The Binding Site is the only instrument that can provide the necessary performance for the above mentioned reasons.  The terms in PPR § 13-4 (2) are considered fulfilled. Any objections are to be reported to the project manager within 10 days after the published notice.
Procedure identifier : 161307b7-0ea0-482f-af3f-e7dec2a5ba6d
Internal identifier : 77093
Type of procedure : Negotiated without prior call for competition
Main features of the procedure : Oslo University Hospital, Department of Medical Biochemistry, Unit for special analyses, shall procure a new analysis instrument. The procured instrument shall mainly be used for analysing free light chains Kappa and Lambda with reagents from The Binding Site.    Measuring kappa and lambda has important clinical uses and is included in both the diagnostic criteria for multiple myeloma (bone marrow cancer) and in response evaluation when treating multiple myeloma. The multiple myeloma centre at OUS, which is the largest clinical research centre for multiple myeloma in the Nordic region, accounts for well over half of the analyses.   Kappa and lambda shall be measured with immunoturbidimetry. The analysis must cover a very broad concentration area, from 1 mg/L to over 100,000 mg/L. This large variation in concentration makes the analysis exposed to antigene excess problems. To ensure reliable results, it is crucial to have a robust and validated antigen excess system, which requires collaboration between the supplier of reagents and the instrument if these are not the same.  Based on the large volume, clinical significance and complexity of the cutting and lambda analyses in relation to kinetics/antigen excess, we believe it is necessary to require an IVDR certified application for analysing the cloak and lambda in serum on the new instrument.   In addition a small number of analyses of the erytrocyte enzymes Glucose 6 phosphate dehydrogenase (G6PD), pyruvatkinase (PK) and colinesterase with dibucain inhibition shall also be carried out. The unit for special analyses has a de facto country function for analysing G6PD and PK.  The department makes approx. 10,000 analyses per annum and needs a high capacity instrument.  Optilite from The Binding Site is the only instrument that can provide the necessary performance for the above mentioned reasons.   The terms in PPR § 13-4 (2) are considered fulfilled. Any objections are to be reported to the project manager within 10 days after the published notice.

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 38000000 Laboratory, optical and precision equipments (excl. glasses)
Additional classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products

2.1.2 Place of performance

Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway

2.1.4 General information

Legal basis :
Directive 2014/24/EU
Anskaffelsesforskriften - Intention notice

5. Lot

5.1 Lot technical ID : LOT-0000

Title : 77093 UL KLM Dep. for Medical Biochemistry Analysis Instrument
Description : Oslo University Hospital, Department of Medical Biochemistry, Unit for special analyses, shall procure a new analysis instrument. The procured instrument shall mainly be used for analysing free light chains Kappa and Lambda with reagents from The Binding Site.      Kappa and lambda shall be measured with immunoturbidimetry. The analysis must cover a very broad concentration area, from 1 mg/L to over 100,000 mg/L. This large variation in concentration makes the analysis exposed to antigene excess problems. To ensure reliable results, it is crucial to have a robust and validated antigen excess system, which requires collaboration between the supplier of reagents and the instrument if these are not the same.  Based on the large volume, clinical significance and complexity of the cutting and lambda analyses in relation to kinetics/antigen excess, we believe it is necessary to require an IVDR certified application for analysing the cloak and lambda in serum on the new instrument.   In addition a small number of analyses of the erytrocyte enzymes Glucose 6 phosphate dehydrogenase (G6PD), pyruvatkinase (PK) and colinesterase with dibucain inhibition shall also be carried out. The unit for special analyses has a de facto country function for analysing G6PD and PK.  The department makes approx. 10,000 analyses per annum and needs a high capacity instrument. Optilite from The Binding Site is the only instrument that can provide the necessary performance for the above mentioned reasons.  The terms in PPR § 13-4 (2) are considered fulfilled. Any objections are to be reported to the project manager within 10 days after the published notice.
Internal identifier : 77093

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 38000000 Laboratory, optical and precision equipments (excl. glasses)
Additional classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products

5.1.2 Place of performance

Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway
Additional information :

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.10 Award criteria

Criterion :
Type : Quality
Name : Quality
Description : The analyses shall be measured with immunoturbidimetry. Based on the large volume, clinical significance and complexity of the cutting and lambda analyses in relation to kinetics/antigen excess, we believe it is necessary to require an IVDR certified application for analysing the cloak and lambda in serum on the new instrument.
Category of award threshold criterion : Order of importance
Award criterion number : 1
Criterion :
Type : Cost
Name : Price
Description : Price
Category of award threshold criterion : Order of importance
Award criterion number : 2
Justification for not indicating the weighting of the award criteria : There is only one tenderer.

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Oslo Tingrett
Information about review deadlines : 10 days after the published notice.

6. Results

Value of all contracts awarded in this notice : 12 000 000 Norwegian krone
Direct award :
Justification for direct award : The contract can be provided only by a particular economic operator because of an absence of competition for technical reasons
Other justification : Kappa and lambda shall be measured with immunoturbidimetry. Based on the large volume, clinical significance and complexity of the cutting and lambda analyses in relation to kinetics/antigen excess, we believe it is necessary to require an IVDR certified application for analysing the cloak and lambda in serum on the new instrument. Optilite from The Binding Site is the only instrument that can provide the necessary performance. The terms in PPR § 13-4 (2) are considered fulfilled.

6.1 Result lot ldentifier : LOT-0000

At least one winner was chosen.

6.1.2 Information about winners

Winner :
Official name : The Binding Site Danmark Aps
Tender :
Tender identifier : 77093 UL KLM Avd. for medisinsk biokjemi Analyseinstrument
Identifier of lot or group of lots : LOT-0000
Value of the tender : 0 Norwegian krone
The tender was ranked : no
The tender is a variant : no
Subcontracting : No
Contract information :
Identifier of the contract : 77093 UL KLM Avd. for medisinsk biokjemi Analyseinstrument

6.1.3 Non-winning tenderers :

Tenderer :
Official name : The Binding Site Danmark Aps

6.1.4 Statistical information

Summary of the review requests the buyer received :
Number of complainants : 0
Received tenders or requests to participate :
Type of received submissions : Tenders
Number of tenders or requests to participate received : 1

8. Organisations

8.1 ORG-0001

Official name : Oslo Universitetssykehus HF (hovedenhet)
Registration number : 993467049
Postal address : Postboks 4956 Nydalen
Town : OSLO
Postcode : 0424
Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway
Contact point : Miriam Valan
Telephone : 41677060
Roles of this organisation :
Buyer

8.1 ORG-0002

Official name : Oslo Tingrett
Registration number : 926725939
Town : Oslo
Postcode : 0164
Country subdivision (NUTS) : Oslo ( NO081 )
Country : Norway
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : The Binding Site Danmark Aps
Size of the economic operator : Medium
Registration number : 42208825
Town : København
Postcode : 1260
Country subdivision (NUTS) : Byen København ( DK011 )
Country : Denmark
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0000

Notice information

Notice identifier/version : 487c4454-f145-4692-8aac-8cfd5d878100 - 01
Form type : Result
Notice type : Contract or concession award notice – standard regime
Notice dispatch date : 20/08/2025 14:11 +00:00
Notice dispatch date (eSender) : 21/08/2025 06:40 +00:00
Languages in which this notice is officially available : English
Notice publication number : 00548750-2025
OJ S issue number : 160/2025
Publication date : 22/08/2025