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)

Ss. Cyril and Methodius University Faculty of Medicine Skopje

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).

Рок

Рокот за прием на понудите беше 2021-07-01. Набавката беше објавена на 2021-05-31.

Добавувачи

Следните добавувачи се споменати во одлуките за доделување или други документи за набавка:

• Company for trade and services BIOTEK DOO export-import Skopje

Кој?

• Ss. Cyril and Methodius University Faculty of Medicine Skopje

Што?

• Реагенси и контрастни средства › Лабораториски реагенси

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2021-05-31	Оглас за договор
2021-09-16	Оглас за доделување договор

Оглас за договор (2021-05-31)
Предмет
Опсег на набавката
Наслов: Laboratory reagents
Референтен број: 09086/2021
Краток опис:

Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Лабораториски реагенси 📦
Дополнителен CPV: Лабораториски реагенси 📦
Место на извршување
NUTS регион: Северна Македонија 🏙️

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за сите делови
Критериуми за доделување
Најниска цена

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Тело уредено со јавно право
Име на органот кој доделува: Ss. Cyril and Methodius University Faculty of Medicine Skopje
Поштенска адреса: 50 Divizija, No.6
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: http://www.medf.ukim.edu.mk/ 🌏
Е-пошта: j.nabavki@medf.ukim.edu.mk 📧
Телефон: +389 3103728 📞
URL за документи: http://www.e-nabavki.gov.mk 🌏
URL за учество: http://www.e-nabavki.gov.mk 🌏

Референца
Датуми
Датум на испраќање: 2021-05-31 📅
Рок за поднесување: 2021-07-01 📅
Датум на објавување: 2021-06-04 📅
Идентификатори
Број на огласот: 2021/S 107-283332
OJ-S издание: 107
Дополнителни информации

https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/a42acf8a-119a-49c9-8854-85e3338616aa/1

Предмет
Опсег на набавката
Наслов на делот: 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
Број на дел: 1
Краток опис:

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.

Времетраење: 12 месеци
Дополнителни информации:

https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/a42acf8a-119a-49c9-8854-85e3338616aa/1

Наслов на делот: 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
Број на дел: 2
Краток опис:

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.

Место на извршување
Главна локација или место на извршување:

Ss. Cyril and Methodius University, Faculty of Medicine —

Skopje, 50 Divizija No 6, 1000 Skopje, REPUBLIC of NORTH MACEDONIA.

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност:

— 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;

… 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.

Техничка и професионална способност:

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).

Минимално ниво(а) на стандарди:

Извршување на договорот
Услови за извршување на договорот: Performance guarantee: (10.00 %).

Постапка
Правна основа: 32014L0024
Време за прием на понуди: 10:00
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Период на важност на понудата: 6 месеци
Датум на отворање на понудите: 2021-07-01 📅
Време на отворање на понудите: 10:00
Место: Electronically, ESJN (https://www.e-nabavki.gov.mk/); Ss. Cyril and Methodius University, Faculty of Medicine —
Skopje, 50 Divizija No 6, 1000 Skopje, REPUBLIC of NORTH MACEDONIA

Договорен орган
Контакт
Контактна точка: Irena Georgievska
URL на документи: www.e-nabavki.gov.mk 🌏
URL за учество: www.e-nabavki.gov.mk 🌏
URL за документи: www.e-nabavki.gov.mk 🌏

Дополнителни информации
Тело за преглед
Име: State Appeals Commission for Public Procurement
Поштенско место: Skopje
Земја: Северна Македонија 🇲🇰
Интернет-адреса: http://www.dkzjn.gov.mk/ 🌏
Извор: OJS 2021/S 107-283332 (2021-05-31)

Оглас за доделување договор (2021-09-16)
Предмет
Опсег на набавката
Краток опис:

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)

Вкупна вредност на набавката: 12 482 496 MKD 💰
Метаподатоци на огласот
Вид на документ: Оглас за доделување договор

Постапка
Вид на понуда: Не е применливо

Референца
Датуми
Датум на испраќање: 2021-09-16 📅
Датум на објавување: 2021-09-21 📅
Идентификатори
Број на огласот: 2021/S 183-477434
Се однесува на оглас: 2021/S 107-283332
OJ-S издание: 183
Дополнителни информации

https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie-acpp/d05a5598-92e7-4c0d-ace3-9898e5a9f44f

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.

Дополнителни информации:

https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie-acpp/d05a5598-92e7-4c0d-ace3-9898e5a9f44f

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.

Доделување договор
Датум на склучување на договорот: 2021-08-23 📅
Име: Company for trade and services BIOTEK DOO export-import Skopje
Поштенско место: Skopje
Земја: Северна Македонија 🇲🇰
Вкупна вредност на набавката: 12 482 496 MKD 💰
Информации за понудите
Број на примените понуди: 2
Извор: OJS 2021/S 183-477434 (2021-09-16)

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