Public procurement notice: Contract Notice
Published: 2021-09-17
Buyer: JZU Centar za javno zdravje Prilep
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33670000
Submission deadline: 2021-10-13
Award criteria: Lowest price

Technical requirements: Molecular multiplex kit in one step for detection of SARS-CoV-2 and SARS-like coronaviruses. The putty must be applicable to the following samples of human material: nasopharyngeal and oropharyngeal swab, bronchioalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, nasal canal aspiration and sputum. PCR - the mix must be pre-prepared in microtubes (with a volume of 0.2 ml) with paraffin. The kit must include: mineral oil to prevent evaporation during the amplification process, Taq / RT enzyme which serves for reverse transcription of RNA into complementary DNA in one step, RNA-IC (internal control) appropriate and compatible with the kit for automatic viral nucleic acid DNA / RNA extraction for ab Genix apparatus or equivalent, RT-PCR SARS CoV 2 buffer and positive control. The whale must have a CE certificate. The kit must include detection of the following genes: E gene, N gene and gene detection for SARS-like coronaviruses. The detection of the above genes is compatible with the following fluorescent dyes: FAM, HEX, ROX and Cy5. Analytical sensitivity should be a maximum of 10 copies / µl. The kit is applicable and compatible with a Real-Time PCR DTPrime instrument or equivalent with DTmaster software or equivalent for automatic interpretation of results. To have a CE IVD mark or equivalent, and to be registered as a medical device at the Agency for Drugs and Medical Devices of the Republic of Macedonia. Northern Macedonia
Kit for rapid automatic extraction of viral nucleic acid (DNA / RNA) with high yield and high quality from serum, plasma, nasopharyngeal swab and other types of samples in liquid state. The kit should contain pre-prepared plates, which contain in advance all the necessary reagents for the extraction process (magnetic particles, cell lysis reagent, purified reagents for isolated nucleic acid DNA / RNA, nucleic acid elution buffer, binding buffer ), without the need for additional sample preparation steps. The nucleic acid extraction process should be based on the principle of magnetic or paramagnetic particles. The whale should be able to extract nucleic acid from a maximum of 200 µl sample, and obtain a final eluate of a maximum of 80 µl. One plate to contain a minimum of 16 nucleic acid extraction positions for a minimum of 16 patients in one release. The kit should also contain plastic tips for the automatic pipers installed in the system, and they should be used for one use. The kit must be compatible with the abGenix automatic extraction instrument or equivalent. The whale should have its own specially created and validated protocol that is embedded in the instrument for automatic extraction. The validated protocol for the automatic nucleic acid extraction kit should have a maximum duration of 10 minutes. To have a CE IVD mark or equivalent, and to be registered as a medical device at the Agency for Drugs and Medical Devices of the Republic of Macedonia. Northern Macedonia.
A set of reagents for automatic extraction of viral nucleic acid DNA / RNA with high yield and high quality from serum, plasma, nasopharyngeal swab and other types of liquid samples
A set of reagents for automatic extraction of viral nucleic acid DNA / RNA with high yield and high quality from serum, plasma, nasopharyngeal swab and other types of liquid samples. The kit should contain pre-prepared comics, which contain in advance all the necessary reagents for the extraction process (magnetic particles, cell lysis reagent, purified reagents for isolated nucleic acid DNA / RNA, nucleic acid elution buffer, buffer for ). The whale must include proteinase K in lyophilized form and an appropriate medium for its dissolution. The nucleic acid extraction process should be based on the principle of magnetic or paramagnetic particles. The whale should be able to extract nucleic acid from a maximum of 200 µl sample, and obtain a final eluate of a maximum of 80 µl. A comic book should contain a maximum of one extraction, and come with a comic book adapter with a maximum of 8 positions in one adapter. The kit should also contain plastic tips for the automatic pipers installed in the system, and they should be used for one use. The kit must be compatible with the abGenix automatic extraction instrument or equivalent. It is mandatory to have a created and validated protocol (which is pre-installed in the appropriate instrument for automated extraction with a maximum duration of 30 minutes). No special media and swabs required. To have a CE IVD mark or equivalent, and to be registered as a medical device at the Agency for Drugs and Medical Devices of the Republic of Macedonia. Northern Macedonia.
Sterile filter extensions, with a volume of 10-200 microliters, packed in original boxes from the manufacturer.
Sterile filter extensions, with a volume of 0.5-10 microliters with an extension length of 43-48 mm, packed in original boxes from the manufacturer.
Polypropylene test tubes (Ependorf type) of 1.5ml with cap with writing part, resistant to low temperatures and in original packaging

Eligibility requirements: As in the tender documentation.