North Macedonia – Laboratory reagents – Procurement of PCR and RT-PCR tests, nucleic acid extraction reagents, and molecular tests compatible with CFX-96, QS 5, or equivalent instruments

Procurement of PCR and RT-PCR tests, nucleic acid extraction reagents, and molecular tests compatible with CFX-96, QS 5, or equivalent instruments

Lots Lot 1 — 1: Kit of reagents for detection and typing of at least 10 viral and 6 bacterial pathogens of respiratory tract infections (detailed in the technical specification) Lot 2 — 2: Kit of reagents for detection and typing of at least the following viral causes of meningitis: HSV-1, HSV-2, VZV, EBV, CMV, HHV-6, and HHV-7, as specified in the technical specification Lot 3 — 3: Kit of reagents for simultaneous qualitative detection of HIV-1/2. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 4 — 4: Kit of reagents for detection and typing of at least four viral causes of diarrhoea in human specimens: group A rotavirus (RotV), enteric adenovirus (AdV), norovirus GI/GII (NoV-GI/GII), and astrovirus (AstV), as specified in the technical specification Lot 5 — 5: Kit of reagents for qualitative detection of HCV genotypes 1a, 1b, 2, 3a, 4, 5a, and 6. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 6 — 6: Kit of reagents for detection of Epstein–Barr virus. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use.

Lot 7 — 7: Kit of reagents for one-step reverse transcription and real-time PCR (SuperScript III Platinum).

Lot 8 — 8: Kit of reagents for DNA extraction and for qualitative and quantitative detection and genotyping of at least 21 HPV types, including at minimum the low-risk and high-risk HPV types listed in the technical specification. Lot 9 — 9: Kit of reagents for qualitative detection of CMV. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 10 — 10: Kit of reagents for qualitative detection of HBV. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use.

Lot 11 — 11: SDS-free gel loading dye (6×) for visualisation and further processing of amplicons obtained by real-time PCR, or equivalent.

Lot 12 — 12: Recombinant RNase inhibitor for PCR (2,000 units), or equivalent.

Lot 13 — 13: Hot-start Taq polymerase capable of high-fidelity amplification of amplicons up to 30 kb in length, or equivalent.

Lot 14 — 14: Reagents for quantitative detection of VZV DNA. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 15 — 15: Kit of reagents for detection of norovirus. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 16 — 16: Kit of reagents for detection of viral pathogens in wastewater, including a kit for extracting DNA and RNA from the same sample and an RT-qPCR kit for detection of SARS-CoV-2, as detailed in the technical specification. Lot 17 — 17: Kit of reagents for detection of CCHF virus. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 18 — 18: Kit of reagents for detection and typing of Hanta viruses that cause haemorrhagic fever with renal syndrome (HFRS), including the Dobrava–Belgrade, Seoul, Hantaan, and Puumala strains. The kit must include an internal control and be compatible with a real-time PCR instrument, as detailed in the technical specification. Lot 19 — 19: Kit of reagents for detection of West Nile virus (WNV). The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 20 — 20: Kit of reagents for detection of Borrelia burgdorferi. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 21 — 21: Kit of reagents for detection of human parvovirus B19 in various human specimens. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 22 — 22: Kit of reagents for detection of Dengue virus. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 23 — 23: Kit of reagents for detection of Tick Born Encephalitis (TBE) virus in various human specimens. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 24 — 24: Kit of reagents for detection of Coxiella burnetii (Q fever) in various samples. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 25 — 25: Kit of reagents for detection of Chikungunya virus in various samples. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 26 — 26: Kit of reagents for detection of Zika virus in various samples. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 27 — 27: Kit of reagents for detection of RSV and differentiation of its two subgroups, RSV A and RSV B, in various samples. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 28 — 28: Kit of reagents for detection of poliovirus in various samples. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 29 — 29: Kit of reagents for detection of Chlamydophila psittaci (EAE) in human specimens. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 30 — 30: Kit of reagents for detection of Helicobacter pylori and its resistance to clarithromycin. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 31 — 31: Kit of reagents for real-time multiplex PCR detection and identification of sexually transmitted pathogens in vaginal, cervical, and urethral swabs and urine specimens. The kit must detect at least 13 pathogens, as detailed in the technical specification. Lot 32 — 32: Kit of reagents for real-time multiplex PCR detection and identification of the vaginal microbiome. The kit must detect at least 17 microorganisms in the vaginal microbiome and quantitatively differentiate Lactobacillus iners from non-iners lactobacilli, as detailed in the technical specification. Lot 33 — 33: Kit of reagents for real-time multiplex PCR screening of specimens for at least 15 microorganisms present in the male urogenital microbiocenosis, as detailed in the technical specification. Lot 34 — 34: Kit of reagents for RT-PCR detection of at least 43 targets, total bacterial load, and difficult-to-culture microorganisms in human biological specimens, with a lysozyme pretreatment kit, as detailed in the technical specification. Lot 35 — 35: Kit of reagents for automated extraction of DNA and RNA from various samples for pathogen detection, compatible with RBC MagCore I, RBC MagCore Plus II, or equivalent instruments. An instrument must be supplied for use. Lot 36 — 36: Kit of reagents for manual extraction of viral DNA from various samples (plasma, serum, and other fluids). The extracted DNA must be suitable for use with any real-time PCR assay for pathogen detection, as detailed in the technical specification. Lot 37 — 37: Kit of reagents for automated extraction of DNA from various samples for pathogen detection, compatible with RBC MagCore I, RBC MagCore Plus II, or equivalent instruments. An instrument must be supplied for use. Lot 38 — 38: Kit of reagents for automated extraction of RNA from various samples for pathogen detection, compatible with RBC MagCore I, RBC MagCore Plus II, or equivalent instruments. An instrument must be supplied for use. Lot 39 — 39: Kit for extraction of viral DNA and RNA in strip or plate format, compatible with an AbGenix or equivalent instrument. An instrument must be supplied for use. Lot 40 — 40: Kit of reagents for manual extraction of viral DNA and RNA from various samples (plasma, serum, and other fluids). The extracted DNA and RNA must be suitable for use with any real-time PCR assay for pathogen detection, as detailed in the technical specification. Lot 41 — 41: Kit of reagents for manual extraction of viral RNA from various samples (plasma, serum, and other fluids). The extracted RNA must be suitable for use with any real-time PCR assay for pathogen detection, as detailed in the technical specification.

Lot 42 — 42: dNTP mix (dATP, dTTP, dCTP, and dGTP) with a minimum volume of 200 µL and a concentration of 10 mM for each dNTP.

Lot 43 — 43: 10× TBE buffer, pH 8.3

Lot 44 — 44: Tris-HCl buffer, 200 mM, pH 7.0

Lot 45 — 45: Taq DNA polymerase with MgCl₂, at least 250 units (100 tests).

Lot 46 — 46: Universal master mix, TaqMan or equivalent, with a maximum volume of 5 mL.

Lot 47 — 47: Non-alkaline, non-corrosive, non-carcinogenic DNA and RNA decontamination spray for removing nucleic acids from any surface, intended for use in PCR cabinets. Lot 48 — 48: Tests for detection of HPV E6/E7 mRNA in high-risk HPV types, supplied with a compatible kit for RNA extraction from swabs, blood, or tissue. An internal control must be included. The tests must be compatible with a QuantStudio 5, CFX96, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 49 — 49: Kit of reagents for simultaneous qualitative detection of enteroviruses, including Coxsackieviruses, Echoviruses, and other enteroviruses. The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 50 — 50: Kit of reagents for detection of Hanta- Andes hantavirus, which causes hantavirus pulmonary syndrome (HPS). The kit must include an internal control and be compatible with a QuantStudio 5, CFX96, DTLite, or equivalent real-time PCR instrument. An instrument must be supplied for use. Lot 51 — 51: Kit of reagents for real-time PCR detection and identification of microorganisms associated with periodontitis. The kit must detect at least seven targets, include an internal control, and be compatible with a real-time PCR instrument, as detailed in the technical specification. Lot 52 — 52: Kit of reagents for real-time PCR detection and identification of the oral microbiome (normal and/or altered microflora). The kit must detect at least seven targets, include an internal control, and be compatible with a real-time PCR instrument, as detailed in the technical specification.

Lot 53 — 53: 5 fluorescently labeled nucleotide sequences (colours FAM, VIC, TET, HEX, ROX)

Lot 54 — 54: Double-labeled nucleotide sequences (colours: FAM, VIC, TET, HEX, TET, ROX; Quenchers: span>0.01 scale - nucleotides

Lot 55 — 55: Dual-labelled minor groove binder (MGB) probes, 0.01 scale

Lot 56 — 56: Primers with standard purification, specified at 100 pmol, with further details provided separately

Lot 57 — 57: Kit of reagents for detection and identification of norovirus GI and GII and hepatitis A virus in water and food, compatible with ISO 15216. The kit must include an RNA extraction kit for water and food samples, as detailed in the technical specification.

Lot 58 — 58: Highly purified, nuclease-free water for PCR

Lot 59 — 59: Genetic panel for detection of HLA class II variants associated with predisposition to coeliac disease in human specimens. An internal control and an extraction kit must be included, as detailed in the technical specification. Lot 60 — 60: Kit of reagents for detection of fructose and lactose intolerance in human specimens. An internal control and an extraction kit must be included. The extraction and real-time PCR kits must be mutually compatible, as detailed in the technical specification.

Buyer: PHI Institute of Public Health of Republic of North Macedonia Skopje

Buyer country: MKD

Procedure: open

CPV code: 33696500

Full notice, tender documents and how to bid are on the official TED page (link above).