REQUEST FOR INFORMATION: reagents for analysis of genetic markers in human DNA

This is not a call for tenders and we are not asking for any offers via this announcement. This request for information does not obligate the procurement unit for any actions. All information presented in this prior information notice is preliminary and indicative. This notice is not binding on any kind of solutions or actions. The suppliers are not paid for responding to this request for information. HUSLAB Laboratory of Genetics at HUS (Helsinki University Hospital) Diagnostic Center is an SFS-EN ISO 15189:2022 accredited laboratory providing diagnostic genetic testing services to all patients at Helsinki University Hospital area. The services include analysis of both constitutional samples and malignancies. The laboratory provides sequencing services mainly using multiple diagnostic laboratory processes. Currently HUSLAB is seeking for quantitative PCR reagents or reagent kits for large scale diagnostic testing for: 1) Lactase Persistence Genotype MCM6 -13910 C>T (rs4988235), 2) Multiplex testing for FII 20210 G>A (rs1799963) and FV 1691 G>A (rs6025) 3) Multiplex testing for HFE c.845G>A, p.(Cys282Tyr) and c.187C>G p.(His63Asp) 4) Human Leukocyte Antigen (HLA) B27 The reagents or reagent kits must be compatible with pipetting using Tecan Fluent pipetting robots and amplification/analysis using Thermo ABI QuantStudio 5,6 or 7 Flex Real-Time PCR cyclers. The source material is DNA isolated from EDTA-blood samples. The expected annual test volumes: 1) MCM6 -13910 C>T: 14 000 – 16 000 tests 2) FII 20210 G>A & FV 1691 G>A: 3 500 – 4 500 tests 3) HFE c.845G>A & c.187C>G: 500 – 1 000 tests 4) HLA-B27: 4 500 – 5 500 tests Procurement unit asks the parties on the market to response to this request for information, if the party can provide the above described products. The procurement unit requests possible suppliers to answer to the following questions: 1) Could you provide reagents / reagent kits for all four tests requested? 2) Are the tests CE-IVDR certified? If no, how does the manufacturer plan to acquire IVDR certification for the test and which tests if not all requested? If yes, is the CE-IVDR class “A” or class “C”? If the CE-IVDR is class “C”, what is the intended use and does the compliance require a specific computer program for analysis? 3) Are the the tests using quantitative PCR ? If yes, explain the detection principle (labelled primers, labelled probes, melting curve etc). 4) Can the multiplexed tests requested be run in a single well? If yes, how are the results identified? 5) Is DNA extracted from EDTA-whole blood using automated isolation methods (Chemagen, Maxwell, QIAsymphony) suitable for tests? If yes, list which methods tested. 6) Are vials and pipetting volumes of the reagents compatible with pipetting robots (Tecan Fluent)? If yes, in both 96- and 384 formats? 7) Are tests compatible with Thermo ABI QuantStudio 5,6 or 7 Flex Real-Time PCR cyclers? If yes, which? If yes, in both 96- and 384 formats? 8) Provide a list of laboratory equipment needed to perform the test. The answers to this request for information are asked to be sent by e-mail to kilpailutus.laboratorio@hus.fi no later than June 6th 2024.