Reagents for analysis of genetic markers in human DNA

Lyhyt kuvaus

Laboratory of Genetics at HUS (Helsinki University Hospital) Diagnostic Center is an SFS-EN ISO 15189:2022 accredited laboratory providing diagnostic genetic testing services to all patients at Helsinki University Hospital area. The services include analysis of both constitutional samples and malignancies using multiple automated diagnostic laboratory processes.

Currently Laboratory of Genetics is seeking for a Mastermix / Supermix reagent used in large scale testing using quantitative PCR. The process is a LDT process. The source material in most cases is DNA isolated from EDTA-blood samples.

The reagents offered must be compatible with pipetting using Tecan and Hamilton pipetting robots and amplification/analysis using Thermo ABI QuantStudio series and Roche LightCycler series Real-Time PCR cyclers. The expected annual test volume is 40-45 000 reactions / year

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The procurement shall comply with the Act on Public Procurement and Concession Contracts (1397/2016, referred to as the Public Procurement Act). The procurement value exceeds the EU threshold value. The procedure shall be an open procedure as defined in section 32 of the Public Procurement Act.

PROCESSING OF TENDERS

The procedure shall include the following phases:

The Procurement authority

1) Opens the tenders
2) Verifies the suitability of the tenderers
3) Verifies the conformance of the tenders to the call for tenders
4) Compares the tenders
5) Requests and checks the certificates and statements regarding the suitability of the winning tenderer
6) Makes the procurement decision and informs all tenderers of the decision
7) Makes the agreement with the selected tenderer

The Procurement authority may wholly or partially interrupt the procurement procedure for legitimate and justifiable reason
(Section 125 of the Act on Public Contracts). No compensation will be paid to companies for participating in the tendering process.

LANGUAGE OF THE PROCUREMENT PROCEDURE

The procurement documents are available in English. If the tenderer needs the documents in another language, the tenderer is
responsible for the translation and its costs. Tenders and all attachments to the tender must be drawn up in English.

PARALLEL AND ALTERNATIVE TENDERS

Submitting parallel and alternative tenders is prohibited.

SUBCONTRACTING

The tenderer may use subcontractors. The tenderer is responsible for the work of the subcontractor as if it were their own in
relation to the client. The client will sign the procurement contract only with the company that submitted the tender.
Subcontractors used in the procurement must be named.

The following information must be provided for the named subcontractors:

The official name and business ID of the subcontractor
The role of the subcontractor in the procurement
Contact information (including the country, if other than Finland)

Information about the subcontractor must be provided in a separate attachment, which will be uploaded as part of the tender. This requirement also applies to resource subcontractors. Named subcontractors are considered the tenderer's resources. Therefore, the tenderer must commit to ensuring that the named subcontractors in the tender are available for the execution of the procurement if the tenderer is selected.

The Procurement authority may require a security clearance, as defined by the Security Clearance Act, for the The Procurement
authority's and the The Procurement authority's subcontractors’ personnel, as stated in the contract terms.
The winning tenderer must provide certificates and reports about the subcontractors participating as
requested, as required in the call for tender, before signing the contract.

Luettelo ja lyhyt kuvaus valintaperusteista

References: The tenderer must have full responsibility for the references provided, but the tenderer may have used
subcontractors for the deliveries. If the tenderer is a consortium, not all members of the consortium need to meet
the set reference requirements; it is sufficient that the members of the consortium together meet them or that one
member of the consortium meets them. If the tenderer uses a resource subcontractor, the resource subcontractor
does not need to meet the set reference requirements; it is sufficient that the tenderer and the resource
subcontractor together meet them.

Deliveries made to the tenderer himself, companies of the same group, offered subcontractors or members of the
group are not accepted as references. The same reference may only be presented once.
The contracting authority will check the references from the reference laboratory.Self-made references or
references produced and implemented for an organization within the tenderer’s own corporate structure are not
accepted. No more than three (3) years must have elapsed since the end of the reference contract, calculated from
the deadline for submitting tenders.

The reference must meet the following mandatory requirements:

1. The tenderer must have at least two (2) references indicating experience in delivering the offered qPCR reagents
to diagnostic or service laboratories in the EU/EEA, Great Britain or Switzerland.
2. The offered products are used in the customer laboratory for diagnostic genotyping of human samples using
Taqman probe-based assays.
3. The use of qPCR reagents in the customer laboratory has continued for at least 6 months and included at least
2 deliveries.