Procurement of Tests for RT-RCR Applications on the CF-96 Apparatus and Apparatus IQ 5

PHI Institute of Public Health of Republic of Macedonia Skopje

Procurement of tests for RT-RCR applications on the CF-96 apparatus and apparatus IQ 5.

Рок

Рокот за прием на понудите беше 2019-04-18. Набавката беше објавена на 2019-04-03.

Кој?

• PHI Institute of Public Health of Republic of Macedonia Skopje

Што?

• Реагенси и контрастни средства › Лабораториски реагенси

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2019-04-03	Оглас за договор

Оглас за договор (2019-04-03)
Предмет
Опсег на набавката
Наслов: Laboratory reagents
Референтен број: 38/2019
Краток опис:

Procurement of tests for RT-RCR applications on the CF-96 apparatus and apparatus IQ 5.

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: PHI Institute of Public Health of Republic of Macedonia Skopje
Поштенска адреса: 50 Divizija Br. 6
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: http://www.iph.mk 🌏
Е-пошта: publichealthinstitutemk@gmail.com 📧
Телефон: +389 23125044 📞
Факс: +389 23223354 📠
URL за документи: https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/4e68d475-1b82-4b2c-b90c-1a823cad14af/1 🌏
URL за учество: https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/4e68d475-1b82-4b2c-b90c-1a823cad14af/1 🌏

Референца
Датуми
Датум на испраќање: 2019-04-03 📅
Рок за поднесување: 2019-04-18 📅
Датум на објавување: 2019-04-08 📅
Идентификатори
Број на огласот: 2019/S 069-163756
OJ-S издание: 69
Дополнителни информации

https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/4e68d475-1b82-4b2c-b90c-1a823cad14af/1

Предмет
Опсег на набавката
Проценета вкупна вредност: 5 639 180 MKD 💰
Наслов на делот: 1
Број на дел: 1
Краток опис:

6196 'Reagent kit for the isolation of viral DNA and RNA from different samples (plasma, serum and other liquid fluids). It should be based on the specific connection of DNA and RNA for spin filter, fixed in columns. Required to include: at least 250 stratec columns, binding solution, WBR1, WBR2, EBR, RTA Spin Filter Set, RTA Receiver

Проценета вредност без ДДВ: 5 639 180 MKD 💰
Времетраење: 12 месеци
Дополнителни информации:

https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/4e68d475-1b82-4b2c-b90c-1a823cad14af/1

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

7372 'Kit of ready-made reagent tests in cartridges for the detection and genotyping of at least 21 respiratory pathogens with the principle of Real time multiplex nested PCR technique or the equivalent applicable to existing equipment Biofire Film Array 2.0 system or equivalent

Наслов на делот: 3
Број на дел: 3
Краток опис:

9464 'Kit of ready-made reagent tests set in cartridges for the detection and genotyping of at least 14 causes of meningitis with the principle of Film Array 2.0 Real time multiplex nested PCR technique or equivalent

Наслов на делот: 4
Број на дел: 4
Краток опис:

7369 CMV quantitative detection kit with Real Time compatible CFX 96 system and IQ5 apparatus or equivalent and software for Real Time Instruments or equivalent.

Наслов на делот: 5
Број на дел: 5
Краток опис:

6932 Kit of reagents for qualitative and semi-quantitive detection and typification of HPV virus of at least 19- HPV high risk types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82) and at least 9-HPV low-risk types (6.11, 40, 42, 43, 44, 54, 61, 70) with Real time compatible for the CFX 96 system and the IQ5 or equivalent and software for Real Time Instruments or equivalent.

Наслов на делот: 6
Број на дел: 6
Краток опис:

6925 'Reagent for the isolation of genomic DNA from tissue samples, which can be used with any real-time RIA test for the detection of pathogenic agents. To be based on the specific DNA linkage for a silicate membrane fixed in the columns. Required to include: lysis buffer, BBG solution, proteinase K, WB solution and EB solution.

Наслов на делот: 7
Број на дел: 7
Краток опис:

6931 Reverse transcription reagent kit with Onestep technique for Real Time PCR or equivalent

Наслов на делот: 8
Број на дел: 8
Краток опис:

6929 Reagent kit for the calitative detection of HCV genotypes (1a, 1b, 2,3a, 4,5a, and 6) with the Real Time PCR principle for the IQ5 device

Наслов на делот: 9
Број на дел: 9
Краток опис:

7375 Reagent for the detection of HCV with Real time compatible for the apparatus IQ5 system and CFX 96 system or equivalent and software for Real time instruments or equivalent.

Наслов на делот: 10
Број на дел: 10
Краток опис:

7374 HBV qualitative detection kit with Real time compatible for IQ5 system and CFX 96 system or equivalent and software for Real time instruments or equivalent.

Наслов на делот: 11
Број на дел: 11
Краток опис:

6353 HCV quantitative detection kit with Real time compatible for IQ5 system and CFX 96 system or equivalent and software for Real time instruments or equivalent.

Наслов на делот: 12
Број на дел: 12
Краток опис:

7370 Reagent for quantitative detection of HSV 1/2 with Real time compatible for CFX 96 system apparatus and apparatus IQ5 or equivalent and software for Real time instruments or equivalent.

Наслов на делот: 13
Број на дел: 13
Краток опис:

6923 HHV6 (Human Herpes Virus) detection reagent kit with Real Time compatible CFX 96 system and IQ5 apparatus or equivalent and software for Real Time Instruments or equivalent.

Наслов на делот: 14
Број на дел: 14
Краток опис:

7371 Reagent for qualitative detection of Enterovirus with Real time compatible for CFX 96 system and apparatus IQ5 system or equivalent and software for Real time instruments or equivalent.

Наслов на делот: 15
Број на дел: 15
Краток опис:

9466 Reagent for the detection and quantification of BK-gene Target Small T Antigen (StAg) or equivalent with real-time PCR application of existing equipment RT PCR CFX96 system or equivalent

Наслов на делот: 16
Број на дел: 16
Краток опис:

9465 Kit of ready-tested reagents tested in cartridges for the detection and genotyping of at least 22 causes of gastrointestinal infections with the principle of Film Array 2.0 Real time multiplex nested PCR technique or equivalent

Наслов на делот: 17
Број на дел: 17
Краток опис:

6930 Reagent for detection of EBV (Epstein-Barr virus) with Real time compatible for CFX 96 system apparatus and apparatus IQ5 or equivalent and software for Real time instruments or equivalent.

Наслов на делот: 18
Број на дел: 18
Краток опис:

6195 Reagent for the detection and typing of viral agents-Meningitis Entero-viruses with Real Time compatible devices for CFX 96 system apparatus and apparatus IQ5 system or equivalent and software for Real time instruments or equivalent.

Наслов на делот: 19
Број на дел: 19
Краток опис:

6194 Reagent for the detection and typing of at least the following Meningitis viral causes: HSV 1, HSV 2, VZV, EPB, CMV and HHV-6 with Real Time compatible CFX 96 system and apparatus IQ5 system or equivalent for Real time instruments V2.0 or equivalent.

Наслов на делот: 20
Број на дел: 20
Краток опис:

6924 Reagent kit for the detection and typing of at least four viral diarrhea agents: Group A rotavirus (RotV), Enteric adenovirus (AdV), Norovirus GI / GII (AstroVirus) and Astrovirus (AstV) with Real Time compatible devices CFX 96 system and apparatus IQ5 or equivalent and software for Real time instruments or equivalent.

Наслов на делот: 21
Број на дел: 21
Краток опис:

6193 Reagent kit for the detection and typing of at least 16 respiratory viruses (Adenovirus (AdV), Influenza A virus (FluA), Influenza B virus (FluB), Parainfluenza virus1 (PIV1), Parainfluenza virus2 (PIV2), Parainfluenza virus3 (PIV3) Respiratory syncytial virus A (RSV B), Bocavirus 1/2/3/4 (HBoV), Metapneumovirus (MPV), Parainfluenza virus4 (PIV4), Rhinovirus A / B / C, Coronavirus 229E (CoV 229E), Coronavirus NL63 (CoV NL63), Coronavirus OC43 (CoV OC43), Enterovirus

Наслов на делот: 22
Број на дел: 22
Краток опис:

9459 Gel loading dye (6X), No SDS for visualization of amplicons obtained with real-time RIA and further processing

Наслов на делот: 23
Број на дел: 23
Краток опис: 9460 Rnase inhibitor recombinant for conducting RIA reaction
Наслов на делот: 24
Број на дел: 24
Краток опис: 9461 Hot Start Taq DNA Polymerase (1000 Units), for carrying out a RIA reaction
Наслов на делот: 25
Број на дел: 25
Краток опис:

9462 SuperScript III Reverse Transcriptase 10,000 Units or equivalent, to implement the RIA reaction

Наслов на делот: 26
Број на дел: 26
Краток опис:

6203 'High-quality isolation reagent kit of viral RNA, volume: 200 ul of different samples (plasma, serum and other liquid fluids). It should be based on the specific connection of RNA spin filter, fixed in columns. Required include: Lysis buffer RV, Carrier RNA, Proteinase K, Binding solution, WBR1, WBR2, EBR, RNase free water, RTA Spin Filter Set, RTA Receiver Tubes, Receiver Tubes 2.0 ml and samples for sample elution.

Наслов на делот: 27
Број на дел: 27
Краток опис:

9458 'Reagents for automatic isolation of RNA (ribonucleic acid) from different samples, which can be used with any real-time RIA test for detecting pathogenic agents compatible with MagCore 16 Super or equivalent

Место на извршување
Главна локација или место на извршување:

PHI Institute of Public Health of Republic of Macedonia, 50 Divizija Br. 6, 1000 Skopje

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност: 10 % bank guarantee.
Економска и финансиска состојба:

— statement by the economic operator than it has not been sentenced, in the last 5 years, with effective court decision for participation in criminal organisation, corruption, fraud or money laundering, under Article 88, Paragraph 1 from the Law on public procurement,

— 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,

… 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 certain activity.

Минимално ниво(а) на стандарди:

Document for registered activity as an evidence that it is registered as a physical or legal entity for performing the activity related to the object of the contract or a proof that it belongs to a relevant professional association in accordance with the regulations of the country where it is registered. When determining the ability to perform professional activity of the economic operators, the Contracting Authority also requires evidence issued by a competent body for fulfilling the special conditions for performing the activity prescribed in accordance with the law that refer to the subject of the contract, that is, a Decision for wholesale of medical products in accordance with the law on drugs and medical devices.

Техничка и професионална способност:

— statement that the offered tests for the detection of HIV, HCV and HBV are in accordance with the World Health Organization (WHO) list of recommended tests available on the WHO website: https://www.who.int/diagnostics_laboratory/evaluations/190304_prequalified_product_list.pdf? ua = 1

— statement that the offered Test kits have included quality controls,

— statement that the offered items possess material safety data sheet (MSDS),

— statement that the offered shelf life of the reagents from the moment of delivery in the laboratory will be more than 6 months,

— statement that the products offered are for in vitro diagnostics and CE marking,

— statement that the offered tests are applicable to the existing equipment in the laboratory (CFX96, IQ5, BIOFIRE FILM ARAY 2.0),

— list of main deliveries of the subject of procurement (reference list) bidders or candidates made in the last 3 years or for which such information is available, depending on the date on which the enterprise was established or started, with values, dates, buyers, with a certificate or statement issued by users of goods those,

— a statement of timely and quality delivery.

Минимално ниво(а) на стандарди:

— suggested HIV, HCV and HBV detection tests are in accordance with the World Health Organization (WHO) list of recommended tests available on the WHO website: https://www.who.int/diagnostics_laboratory/evaluations/190304_prequalified_product_list.pdf?ua = 1

— test kits to have quality controls included,

— submit material safety data sheet (MSDS),

— the shelf life of the reagents from the moment of delivery in the laboratory should be more than 6 months,

— industrial products for in vitro diagnostics and CE marking,

— applicable tests of existing equipment in the laboratory (CFX96, IQ5, BIOFIRE FILM ARAY 2.0),

— deliveries of the subject of procurement to tenderers or candidates carried out in the last 3 years,

— timely and quality delivery,

— the manufacturer of the offered items has a certificate for meeting the standards ISO 9001 and ISO 13485.

Постапка
Правна основа: 32014L0024
Информации за електронска аукција:

https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/4e68d475-1b82-4b2c-b90c-1a823cad14af/1

Време за прием на понуди: 10:00
Јазици на кои може да се поднесат понуди или барања за учество: англиски 🗣️
македонски 🗣️
Датум на отворање на понудите: 2019-04-18 📅
Време на отворање на понудите: 10:00
Место: PHI Institute of Public Health of Republic of Macedonia, 50 Divizija Br. 6, 1000 Skopje.

Договорен орган
Контакт
URL на документи: https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/4e68d475-1b82-4b2c-b90c-1a823cad14af/1 🌏

Референца
Дополнителни информации

PHI Institute of Public Health of Republic of Macedonia, 50 Divizija Br. 6, 1000 Skopje.

Дополнителни информации
Тело за преглед
Име: State Commission for Appeals
Поштенско место: Skopje
Земја: Северна Македонија 🇲🇰
Телефон: +389 23251251 📞
Е-пошта: dkzjn@gs.gov.mk 📧
Извор: OJS 2019/S 069-163756 (2019-04-03)

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