Datum objave: 22.03.2023. 10:13

(MK) (izmjena) Nabavka kompleta i reagenasa za sekvenciranje nove generacije (NGS) sa opremom za upotrebu

Službeni naziv: Ss. Cyril and Methodius University Faculty of Medicine Skopje
Poštanska adresa: 50 Divizija, No.6
Mjesto: Skopje
NUTS kod: MK Северна Македонија / Severna Makedonija
Poštanski broj: 1000
Država: Sjeverna Makedonija
Osoba za kontakt: Irena Georgievska
E-pošta: j.nabavki@medf.ukim.edu.mk
Telefon: +389 3103728
Internetska(-e) adresa(-e):
Glavna adresa: http://www.medf.ukim.edu.mk/

 

Kits and reagents for next-generation sequencing (NGS) with equipment to use

 

Referentni broj: 02809/2023

Roba

 

Kits and reagents for next-generation sequencing (NGS) with equipment to use

 

17/03/2023

Broj objave u Dodatku SL-u: 2023/S 041-121188

Broj odjeljka: II.2.4

Grupa br.: 6

Mjesto na kojem se nalazi tekst koji je potrebno izmijeniti: II.2.4) Description of the procurement

Umjesto:

 

Whole human exome sequencing, including DNA sample delivery costs, targeted exome size ≥ 36.5 Mb,

coverage of regions in Consensus Coding sequence-CCDS20≥99.9 %, RefSeq ≥ 99.2 % and GeneCode V28 ≥

99, 8 %, mitochondrial DNA coverage = 100 % (16569 bp/ 37 genes), sequencing output size ≥ 12 Gb, number

of aligned reads in targeted regions ≥ 70%, number of sequenced bases with >30x coverage ≥ 95% , number of

sequenced bases with Q30 quality ≥ 85 %). For bioinformatic data processing, comparison should be made to

GRCh37/hg19 or a newer reference genome. Additional data filtering (gene panels) to be possible if necessary

for certain cases. The estimated time for the analysis should be ≤ 20 working days. Final sequencing data

should be in the following file formats (.fastq, .bam, .vcf, .tsv (SNP), .tsv (CNV)). The transfer of the final data

should be done via sFTP or in special cases via HDD.

 

Glasi:

 

Whole Human Exome Sequencing, including cost of DNA sample delivery and including annotation of

variants and reports of large rearrangement regions, size of targeted exome ≥ 36.5 Mb, coverage of regions in

Consensus Coding sequence-CCDS20≥99.9%, RefSeq ≥ 99.2 % and GeneCode V28 ≥ 99.8 %, mitochondrial

DNA coverage = 100 % (16569 bp/ 37 genes), sequencing output size ≥ 12 Gb, number of aligned reads in

targeted regions ≥ 70% , number of sequenced bases with >30x coverage ≥ 95%, number of sequenced bases

with Q30 quality ≥ 85 %). For bioinformatic data processing, comparison should be made to GRCh37/hg19

or a newer reference genome. Additional data filtering (gene panels) to be possible if necessary for certain

cases. The estimated time for the analysis should be ≤ 20 working days. Final sequencing data should be in the

following file formats (.fastq, .bam, .vcf, .tsv (SNP), .tsv (CNV)). The transfer of the final data should be done via

sFTP or in special cases via HDD.)

 

Broj odjeljka: II.2.4

Grupa br.: 7

Mjesto na kojem se nalazi tekst koji je potrebno izmijeniti: II.2.4) Description of the procurement

Umjesto:

 

Analysis of whole genome sequencing data to contain gene and variant information from relevant sources

including but not limited to CIViC, ClinVar, Clinical Genome Database (CGD), Clinical Trials, COSMIC, dbSNP,

Ensembl, InterPro , OMIM (via Ensembl), Orphanet, PFAM, Reactome , RefSeq. To support analysis of SNVs,

Indels, CNVs and insertions in both germline and somatic contexts. To support at least csv/tsv, gff/gtf, vcf files.

To indicate variants with the possibility of assessing their quality using a quality control system. To enable

automated classification of variants according to ACMG, with the possibility of changing the classification by the

user. Be able to create new and edit existing filtering strategies. To allow samples to be reopened for reanalysis.

To enable the organization of the samples in groups with the aim of group-organized analysis of the data.

Access to the cloud for at least two people

 

Glasi:

 

Analysis of whole exome sequencing data to contain gene and variant information from relevant sources

including but not limited to CIViC, ClinVar, Clinical Genomic Database (CGD), Clinical Trials, COSMIC, dbSNP,

Ensembl, InterPro , OMIM (via Ensembl), Orphanet, PFAM, Reactome, RefSeq. To support analysis of SNVs,

Indels, CNVs and insertions in both germline and somatic contexts. To support at least csv/tsv, gff/gtf, vcf files.

To indicate variants (obtained by sequencing) with the possibility of assessment and qualification of their quality using internal standardized operating procedures. To enable automated classification of variants according to

ACMG, with the possibility of changing the classification by the user. Be able to create new and edit existing

filtering strategies. To allow samples to be reopened for reanalysis. To enable the organization of the samples in

groups with the aim of group-organized analysis of the data. Access to the cloud for at least two people. Comply

with European Union In Vitro Diagnostic Medical Devices Directive 98/79/EC, ISO 13485:2016, ISO 14971:2019

or equivalent

 

Broj odjeljka: III.1.1

Mjesto na kojem se nalazi tekst koji je potrebno izmijeniti: III.1.1) Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers

Umjesto:

 

Ability of the economic operator to perform business activity:

— document for registered business activity

- Certificate for wholesale of medical devices in accordance with the Law on Drugs and Medical Devices

 

Glasi:

 

Ability of the economic operator to perform business activity:

— document for registered business activity

- Certificate for wholesale of medical devices in accordance with the Law on Drugs and Medical Devices except

for Lots 6 and 7

 

Broj odjeljka: III.1.3

Mjesto na kojem se nalazi tekst koji je potrebno izmijeniti: III.1.3) Technical and professional ability

Umjesto:

 

List and brief description of selection criteria:

Catalog with photos, description and

indication for which position of the technical specification the bid refers, and whose authenticity the economic

operator is obliged to confirm (if requested by the contracting authority)

Catalog with photos, description and

indication for which position of the technical specification the bid refers, and whose authenticity the economic

operator is obliged to confirm (if requested by the contracting authority)

 

Glasi:

 

List and brief description of selection criteria:

Catalog with photos, description and

indication for which position of the technical specification the bid refers, and whose authenticity the economic

operator is obliged to confirm (if requested by the contracting authority), In accordance with Article 95 paragraph

8 point c of the Law on Public

Procurement: For the item with code number 10148 Lot 6, economic

operators to submit a contract or authorization letter

with a certified laboratory according to the standards for

quality systems specified in point 2.3.3. if the

that way they offer the requested service.

Catalog with photos, description and

indication for which position of the technical specification the bid refers, and whose authenticity the economic

operator is obliged to confirm (if requested by the contracting authority)

In accordance with Article 95 paragraph 8 point c of the Law on Public

Procurement: For the item with code number 10148 Lot 6, economic

operators to submit a contract or authorization letter

with a certified laboratory according to the standards for

quality systems specified in point 2.3.3. if the

that way they offer the requested service

Standards — quality assurance standards: For the code item

10148 Lot 6 to submit a valid accreditation certificate

(International Organization for Standardization-ISO 15189 or

equivalent, and/or Clinical Laboratory Improvement

Amendments-CLIA or equivalent).

 

 

https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie-attachment/f29cd5d8-1541-4657-9c31-551241379bdc