Public procurement notice: Contract Notice
Published: 2016-10-20
Buyer: Ss. Cyril and Methodius University Faculty of Medicine Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33140000: Medical consumables | 33696500
Estimated value: 9751460 MKD
Submission deadline: 2016-12-07
Award criteria: Lowest price

Technical requirements: Tests, sets, reagents and supplies for HLA typing and determination of anti-HLA antibodies compatible to luminex platform or equivalent, with assignment of necessary equipment for use.
With the offered tests, sets and reagents for HLA typization and determination of anti-HLA antibodies compatible to the Luminex platform or equivalent (Group 306), must be offered and the necessary equipment to use for a period of 1 (one) year, with the following technical characteristics:
1. Fluoroanalyzer compatible to the platform of Luminex or equivalent which will be used for HLA typization with the following technical characteristics:
— To have the ability for classification of micro-spheres from each sample according to their florescent signal greater than 80 %.
— To have an emission of fluorescence of the background (background) of 575 nm and automatically to be deducted from the intensity of the fluorescence.
— To have a sensitivity to detect 1000 fluorochrome phycoerythrin (PE) xMAR microsphere;To have optics with reporter laser 532 nm, initial power 15.0 ± 5 % mW, maximum 50 mW, dual frequency diode, operating mode with continuous wave (CW).
— To have a classification laser 638 nm, 9.1 ± 6 %, maximum strength of the diode 15 mW, working with a continuous wave (CW).
— To have a classification detector and discriminator of microspheres with avalanche photo diodes (avalanche photo diodes) with the possibility of temperature compensation.
— The device to have capability for analysis of samples from: plates with 96 seats in series, analysis of multiple tests on plate, automatic sampling from plate with 96 seats i.e microtiter plates with flat-bottom, conical, rounded, with filter at the bottom and half plates with height not exceeding 19 mm and plates with 384 seats in series.
— The device to have power to distinguish from 1 to 500 unique xMAR sets microspheres per one sample.
— To have a capacity to detect and distinguish superficial reporter fluorescent emission at 575 nm in size from 1 to 500 unique xMAP sets microspheres in one sample.
— A software program that will serve to obtain results for HLA typization with the offered kits and reagents should have a capacity to do a combination of results obtained with the SSO and SSP technology in order to obtain results with higher resolution. Software should be CE certified (to be with CE mark) or equivalent.
2. Fluoroanalyzer compatible to the platform of Luminex or equivalent, which will be used to determine the anti-HLA antibodies with the following technical characteristics:
— Accuracy and precision: the sampling volume ± 5 %; distribution of microspheres> 80 %; incorrect distribution of microspheres <2 %; Control of temperature 0 ° C to + 2 ° C of whole temperature; internal transmission sample <0.9 %; emission of fluorescence background (background) of 575 nm automatically subtracted from fluorescence intensity.

Eligibility requirements: Statement by the economic operator that it has not been sentenced, in the last 5 years, with effective Court decision for participation in criminal organization, corruption, fraud or money laundering; Certificate that it is not subject to bankruptcy procedure issued by competent authority; Certificate that it is not subject to liquidation procedure issued by competent authority; Certificate for paid taxes, contributions and other public dues by the competent authority in the country where that economic operator is established; Certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction — prohibition to participate in public competitions, public procurement contract award and public-private partnership contract award procedures; Certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction — temporary or permanent prohibition to perform certain professional activity; Certificate that it is not being sanctioned for misdemeanour with an effective Court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing certain activity. Ability for performing professional activity of the economic operator: Document for registered business activity; Certificate that is entered in the Register of legal entities for wholesale of medical devices issued by the Agency for Medicines and Medical Devices. Certificate of registration of the medical device in the register of medical devices available in Republic of Macedonia or Temporary Approval i.e., Final Approval for parallel import of the medical device issued by the Agency for Medicines and Medical Devices. To have obtained the Certificate of registration of the medical device in the register of medical devices available in Republic of Macedonia or Temporary Approval i.e., Final Approval for parallel import of the medical device issued by the Agency for Medicines and Medical Devices.
Certificate of registration of the medical device in the register of medical devices available in Republic of Macedonia or Temporary Approval i.e., Final Approval for parallel import of the medical device issued by the Agency for Medicines and Medical Devices. To have obtained the Certificate of registration of the medical device in the register of medical devices available in Republic of Macedonia or Temporary Approval i.e., Final Approval for parallel import of the medical device issued by the Agency for Medicines and Medical Devices.
Certificate of registration of the medical device in the register of medical devices available in Republic of Macedonia or Temporary Approval i.e., Final Approval for parallel import of the medical device issued by the Agency for Medicines and Medical Devices.
To have obtained the Certificate of registration of the medical device in the register of medical devices available in Republic of Macedonia or Temporary Approval i.e., Final Approval for parallel import of the medical device issued by the Agency for Medicines and Medical Devices.