Purchase of Tests Equivalent to ELISA Apparatus and Service to ELISA Apparatus

PHI Institute of Public Health of Republic of Macedonia Skopje

Purchase of tests equivalent to ELISA apparatus and service to ELISA apparatus.

Рок

Рокот за прием на понудите беше 2019-04-17. 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: 21/2019
Краток опис: Purchase of tests equivalent to ELISA apparatus and service to ELISA apparatus.
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/007dcc07-d192-4469-b6d5-ac53fe9b7567/1 🌏
URL за учество: https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/007dcc07-d192-4469-b6d5-ac53fe9b7567/1 🌏

Референца
Датуми
Датум на испраќање: 2019-04-03 📅
Рок за поднесување: 2019-04-17 📅
Датум на објавување: 2019-04-08 📅
Идентификатори
Број на огласот: 2019/S 069-163761
OJ-S издание: 69
Дополнителни информации

https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/007dcc07-d192-4469-b6d5-ac53fe9b7567/1

Предмет
Опсег на набавката
Проценета вкупна вредност: 3 817 312 MKD 💰
Наслов на делот: 1
Број на дел: 1
Краток опис: 562 ELISA tests for the determination of HSV IgG.
Времетраење: 12 месеци
Дополнителни информации:

https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/007dcc07-d192-4469-b6d5-ac53fe9b7567/1

Наслов на делот: 2
Број на дел: 2
Краток опис: 5425 ELISA tests for the determination of Mumps IgG.
Наслов на делот: 3
Број на дел: 3
Краток опис: 547 ELISA tests to determine anti-HIV 1/2.
Наслов на делот: 4
Број на дел: 4
Краток опис: 5562 ELISA tests for Borrelia IgG.
Наслов на делот: 5
Број на дел: 5
Краток опис: 6191 ELISA tests for the determination of Epstein Barr virus VCA IgM.
Наслов на делот: 6
Број на дел: 6
Краток опис: 5214 ELISA tests for the determination of VZV IgG, Enzygnost or equivalent.
Наслов на делот: 7
Број на дел: 7
Краток опис: 563 ELISA tests for determination of HSV IgM with IgG/RF absorption included.
Наслов на делот: 8
Број на дел: 8
Краток опис: 5940 ELISA tests for Enterovirusi (Rota, Norwalk, adenovirus) IgM.
Наслов на делот: 9
Број на дел: 9
Краток опис:

5213 ELISA tests for the determination of VZV IgM with IgG/RF absorption included, Enzygnost or equivalent.

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

5426 ELISA tests for the determination of Mumps IgM with IgG/RF absorption included, Enzygnost or equivalent.

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

5216 ELISA test kit for the determination of Measles IgG semi-quantitative, with microtiter strips of 8 wells that can be separated, coated with antigens of the measles virus.

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

5218 ELISA test kit for the determination of Rubella IgG, semi-quantitative, with microtiter strips of 8 wells that can be separated, wrapped with antigens of rubella virus.

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

5215 ELISA test kit for the determination of serum or plasma Measles IgM, semi-quantitative, including IgG/RF absorbent, with 8-well microtitre strips of 8 wells, wrapped with antigens of the measles virus, according to https://www.who.int/immunization/monitoring_surveillance/burden/laboratory/Annex_4.1.pdf?ua=1

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

5217 ELISA test kit for the determination of Rubella IgM with IgG/RF absorbent, semi-quantitative, with 8-well microtitre strips of 8 wells, enveloped with antigens of rubella virus.

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

5556 ELISA test kit from the fourth generation to detect antibodies to all genotypes of hepatitis C virus (HCV) in human serum or plasma. Eligible ELISA whales should be on the list of recommended manufacturers according to the World Health Organization (WHO) Recommended Test Document available at: https://www.who.int/diagnostics_laboratory/evaluations/190304_prequalified_product_list.pdf?ua= 1

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

5197 ELISA test kit from the fourth generation for the detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV-1 and HIV-2, as well as antibodies to HIV 1 subtype O, in serum or plasma. Eligible ELISA whales should be on the list of recommended manufacturers according to the World Health Organization (WHO) Recommended Testing Paper available at: https://www.who.int/diagnostics_laboratory/evaluations/190304_prequalified_product_list.pdf?ua=1 https: //www.th

Наслов на делот: 17
Број на дел: 17
Краток опис: 6701 RF absorbent 20 ml.
Наслов на делот: 18
Број на дел: 18
Краток опис: 8928 ELISA for the determination of IgG antibodies to Francisella tularensis.
Наслов на делот: 19
Број на дел: 19
Краток опис: 8927 ELISA for the determination of IgM antibodies to Francisella tularensis.
Наслов на делот: 20
Број на дел: 20
Краток опис: 6975 ELISA tests to determine the Denque virus IgG, Euroimmun or equivalent.
Наслов на делот: 21
Број на дел: 21
Краток опис:

6581 'ELISA tests for the detection of a Denque virus IgM with IgG/RF absorption included, Euroimmun or equivalent.

Наслов на делот: 22
Број на дел: 22
Краток опис: 6971 ELISA tests to determine TBE IgG.
Наслов на делот: 23
Број на дел: 23
Краток опис: 6595 ELISA tests for determining the HDV antigen.
Наслов на делот: 24
Број на дел: 24
Краток опис: 6974 ELISA tests for determining Q fever IgG.
Наслов на делот: 25
Број на дел: 25
Краток опис: 9474 ELISA tests for the determination of anti HBs antibodies.
Наслов на делот: 26
Број на дел: 26
Краток опис: 7520 ELISA tests for the Parvovirus B19 IgG.
Наслов на делот: 27
Број на дел: 27
Краток опис: 8969 ELISA tests for determining the anti-Hantane DobravaIgG.
Наслов на делот: 28
Број на дел: 28
Краток опис:

8970 ELISA tests for the determination of anti-Hantane Good IgM, with IgG/RF absorbent included.

Наслов на делот: 29
Број на дел: 29
Краток опис: 8968 ELISA tests for determining anti-Hantane Puumala IgG.
Наслов на делот: 30
Број на дел: 30
Краток опис:

8967 ELISA tests for the detection of anti-Hantane Puumala IgM, including IgG/RF absorbent.

Наслов на делот: 31
Број на дел: 31
Краток опис:

7407 ELISA tests for the determination of Epstein Barr virus EA IgM, including IgG/RF absorbent.

Наслов на делот: 32
Број на дел: 32
Краток опис: 6344 ELISA tests for the determination of Epstein Barr virus VCA IgG.
Наслов на делот: 33
Број на дел: 33
Краток опис: 7405 ELISA tests for the determination of Epstein Barr virus EBNA IgG.
Наслов на делот: 34
Број на дел: 34
Краток опис:

7406 ELISA tests for the determination of Epstein Barr virus EBNA IgM, including IgG/RF absorbent.

Наслов на делот: 35
Број на дел: 35
Краток опис: 7518 ELISA tests to determine the age of West Nile virus IgG.
Наслов на делот: 36
Број на дел: 36
Краток опис: 6580 ELISA tests for determining TBE IgM with IgG/RF absorption included.
Наслов на делот: 37
Број на дел: 37
Краток опис:

6972 ELISA tests for the determination of HDV IgM with IgG/RF absorption included.

Наслов на делот: 38
Број на дел: 38
Краток опис:

6596 ELISA tests for the determination of HEV IgM with IgG/RF absorption included.

Наслов на делот: 39
Број на дел: 39
Краток опис: 6973 ELISA tests for determining Q fever IgM with included IgM/RF absorbent.
Наслов на делот: 40
Број на дел: 40
Краток опис: 5561 ELISA tests for Borrelia IgM with IgG/RF absorbent included.
Наслов на делот: 41
Број на дел: 41
Краток опис:

7519 ELISA tests for the determination of Parvovirus B19 IgM with IgG/RF absorbent.

Наслов на делот: 42
Број на дел: 42
Краток опис:

6579 ELISA tests to determine the West Nile virus IgG, Euroimmun, Focus or equivalent.

Наслов на делот: 43
Број на дел: 43
Краток опис:

8966 ELISA tests to determine the anti-ZIKS virus antibody IgG, Euroimmun or equivalent.

Наслов на делот: 44
Број на дел: 44
Краток опис:

8965 ELISA tests for the determination of anti-ZIKS virus antibody IgM, including IgG/RF absorbent, Euroimmun or equivalent.

Наслов на делот: 45
Број на дел: 45
Краток опис:

7408 ELISA tests to determine the Interferon gamma response to Cytomegalovirus peptide antigens.

Наслов на делот: 46
Број на дел: 46
Краток опис:

6578 ELISA tests for determining the West Nile virus IgM with IgG/RF absorption included, Euroimmun, Focus or equivalent.

Наслов на делот: 47
Број на дел: 47
Краток опис:

566 ELISA test kit for the detection of hepatitis B viral antigen (HBs antigen) of the VI generation. Eligible ELISA kits should be on the list of recommended manufacturers according to the World Health Organization (WHO) Recommended World Health Organization (WHO) test document available at: https://www.who.int/diagnostics_laboratory/evaluations/190304_prequalified_product_list.pdf?ua= 1

Наслов на делот: 48
Број на дел: 48
Краток опис: 9473 Elisa tests for the determination of antibodies to Coxsackie viruses IgG.
Наслов на делот: 49
Број на дел: 49
Краток опис:

9472 Elisa tests for the determination of antibodies to coxaxi viruses IgM, including IgG/RF absorbent.

Наслов на делот: 50
Број на дел: 50
Краток опис: 6377 ELISA Kit Gliadin — sandwich method of the R5 antibody.
Наслов на делот: 51
Број на дел: 51
Краток опис: 7220 Cocktail solution for Gliadin ELISA Kit.
Наслов на делот: 52
Број на дел: 52
Краток опис:

9300 T2/HT-2 Toxin, range 37–500 ppb, detection limit LOD (29 ppb) without step for pipetting the р-р antibody, without preparation of the stock р-р without incubation of dark and without manual mixing of the plates

Наслов на делот: 53
Број на дел: 53
Краток опис:

9298 Deoxivalenol (ELISA) range, 250–5 000 ppb, detection limit LOD (200 ppb) without step for pipetting the p-r for the antibody, without preparation of the stock р-р without incubation of dark and without manual mixing of the plates.

Наслов на делот: 54
Број на дел: 54
Краток опис:

9299 Zearalenone (ELISA) range, 25–1 000 ppb, detection limit LOD (20 ppb) without step for pipetting the pH for an antibody without preparation of the stock р-р without incubation of dark and without manual mixing of the plates.

Наслов на делот: 55
Број на дел: 55
Краток опис:

9296 Aflatoxini total (ELISA) range 1–20 ppb, detection limit LOD (1 ppb) without step for pipetting the p-r for the antibody, without preparation of the stock р-р without incubation of dark and without manual mixing of the plates

Наслов на делот: 56
Број на дел: 56
Краток опис:

9295 Ohratoxin A (ELISA) range 2–40 ppb, detection limit LOD (1,9 ppb) without step for pipetting the p-r for the antibody, without preparation of the stock р-р without incubation of dark and without manual mixing of the plates.

Наслов на делот: 57
Број на дел: 57
Краток опис:

9297 Fumonisin (ELISA) range 250–5 000 ppb, detection limit LOD (200 ppb) without step for pipetting the p-r for the antibody, without preparation of the stock р-р without incubation of dark and without manual mixing of the plates.

Место на извршување
Главна локација или место на извршување:

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

… Skopje.

… 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 misdemeanour 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 — According to the determination of the ability to perform professional activity of the economic operators, the contracting authority also requires evidence issued by a competent authority 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 wholesale medical decision funds in accordance with the law on drugs and medical devices.

Техничка и професионална способност:

— statement that the offered ELISA kits for the detection of anti-HIV antibodies, anti-HIV antibodies in combination with the p24 antigen, anti-HCV antibodies and HBs antigen are in accordance with the World Health Organization (WHO) recommended list of tests available on the website of the WHO: https://www.who.int/diagnostics_laboratory/evaluations/190304_prequalified_product_list.pdf?ua=1

— statement that the offered all tests are sensitivity ≥ 100, and specificity ≥ 98 %,

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

— statement that the offered items have Material Safety Data Sheet (MSDS),

— statement that the offered temperature storage of reagents is 2 to 8

— statement that the proposed expiry date of reagents from the moment of delivery to the laboratory will be more than 6 months,

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

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

— a statement of timely and quality delivery

Минимално ниво(а) на стандарди:

The offered ELISA kits for the detection of anti-HIV antibodies, anti-HIV antibodies in combination with the p24 antigen, anti-HCV antibodies and HBs antigen according to the list of World Health Organization (WHO) recommended tests available on the website of the WHO: https://www.who.int/diagnostics_laboratory/evaluations/190304_prequalified_product_list.pdf?ua=1

(this is not required for items of No. 18,19,50 and 51 and Lot 010074-2) and — All tests should be sensitized ≥ 100, and specificity ≥ 98 % (this is not required for items with rows No. 18,19,50 and 51 and lot 010074-2) — Test kits have included quality controls (no items are required for items No.1,19,50,50 and 51 and Lot 010074-2).

— Provide material safety data sheet (MSDS) (this is not required for items with line no. 18,19,50 and 51 and lot 010074-2),

— The storage temperature of the reagents is from 2 to 8

— The products for in vitro diagnostics and with the CE marking (this is not required for items with order No. 18,19, 50 and 51 and lot 010074-2) — deliveries of the subject of procurement to bidders or candidates made in the last 3 years; timely and quality delivery.

— a copy (true to the original) of the ISO 9001 and ISO 13485 compliance certificate

Постапка
Правна основа: 32014L0024
Информации за електронска аукција:

https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/007dcc07-d192-4469-b6d5-ac53fe9b7567/1

Време за прием на понуди: 12:00
Јазици на кои може да се поднесат понуди или барања за учество: англиски 🗣️
македонски 🗣️
Датум на отворање на понудите: 2019-04-17 📅
Време на отворање на понудите: 12:00
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/007dcc07-d192-4469-b6d5-ac53fe9b7567/1 🌏

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 069-163761 (2019-04-03)

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