Public procurement notice: Contract Notice
Published: 2021-06-04
Buyer: Ss. Cyril and Methodius University Faculty of Medicine Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696500
Submission deadline: 2021-07-01
Award criteria: Lowest price

Technical requirements: Automatic Viral Nucleic Acid Extraction Tests DNA/RNA Compatible with abGenix Automatic Extraction Instrument or Equivalent, and Real-time Polymerase Chain Reaction Tests Compatible with Real-Time PCR DTPrime Instrument or Equivalent Qualitative for Detection of Covid-19 (SARS-CoV2)
Automatic viral nucleic acid extraction tests DNA/RNA compatible with abGenix automatic extraction instrument or equivalent, and real-time polymerase chain reaction tests compatible with Real-Time PCR DTPrime instrument or equivalent qualitative for detection of Covid 19 (SARS-CoV2).
Molecular Multiplex Kit (One-step Fabrication) for Detection of SARS-CoV-2 and SARS-like Coronaviruses Application and Compatible with Real-Time PCR DTPrime Instrument or Equivalent
Molecular multiplex kit (one-step fabrication) for detection of SARS-CoV-2 and SARS-like coronaviruses application and compatible with Real-Time PCR DTPrime instrument or equivalent and embedded DTMaster software or equivalent from the kit with the existing software, with a decision for placing on the market of a medical device or temporary or permanent approval for parallel import, in accordance with the Law on Drugs and Medical Devices. The kit must be applicable to specimens of human origin: nasopharyngeal and oropharyngeal swab, bronchioalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, nasal canal aspiration, and sputum. PCR — the mixture should be pre-prepared in microtubes (with a volume of 0.2 ml) with paraffin and include: mineral oil (to prevent evaporation during the amplification process), Taq/RT enzyme that serves for reverse RNA transcription in one-step complementary DNA, RNA-IC (internal control) suitable and compatible with the DNA/RNA automatic nucleic acid extraction kit, RT-PCR SARS CoV 2 buffer and positive control. The kit should provide the detection of genes: E gene, N gene and gene for SARS-like coronaviruses. Detection of these genes is compatible with fluorescent dyes: FAM, HEX, ROX and Cy5 or equivalent. Analytical sensitivity to be a minimum of 10 copies/μl.
Automatic viral nucleic acid extraction tests High-yield, high-quality DNA / RNA from serum, plasma, nasopharyngeal swabs, and other types of liquid extracts compatible with the abGenix automatic Extraction
Automatic viral nucleic acid extraction tests High-yield, high-quality DNA/RNA from serum, plasma, nasopharyngeal swabs, and other types of liquid extracts compatible with the abGenix automatic extraction instrument, or equivalent, already containing reagents required for the extraction process (magnetic particles, cell lysing reagent, isolated nucleic acid purification reagents (DNA/RNA), nucleic acid elution buffer). The nucleic acid extraction process should be based on the principle of magnetic or paramagnetic particles. The kit to ensure the extraction of nucleic acid from a minimum of 200 μl sample and obtaining a final eluate of at least 80 μl. The kit should also contain plastic tips for the automatic built-in pipettes in the system, which are for single use. No need for special media and swabs. To have a CE IVD mark or equivalent, as well as a decision for placing on the market of a medical device or temporary or permanent approval for parallel import, in accordance with the Law on Drugs and Medical Devices.
— statement that in the last 5 years no effective court verdict has been pronounced for committed criminal act from Article 88 paragraph 1 of the PPL;
— certificate for paid taxes, contributions and other public duties 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, contract award procedures and PPP 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 misdemeanor with an effective court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing professional activity.
IV.2.2) Ability of the economic operator to perform business activity — Document for registered activity.
— certificate for wholesale of medical devices in accordance with the law on drugs and medical devices.
Samples, description and/or photographs of products that are subject to delivery, and the authenticity of which the economic operator is obliged to confirm if requested by the contracting authority: catalog with photographs, description and indication of which position of the technical specification the offer refers to, and whose authenticity the economic operator is obliged to confirm (if requested by the contracting authority).


Eligibility requirements: — statement that in the last 5 years no effective court verdict has been pronounced for committed criminal act from Article 88 paragraph 1 of the PPL; — 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 duties 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, contract award procedures and PPP 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 misdemeanor with an effective court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing professional activity. IV.2.2) Ability of the economic operator to perform business activity — Document for registered activity. — certificate for wholesale of medical devices in accordance with the law on drugs and medical devices.