LC-MS/MS instrument for drugs of abuse analysis in human urin

Helse Vest Innkjøp HF

Equipment.
The customer wish to acquire 3 high resolution tandem mass spectrometers equipped with liquid chromatographs (UHPLC). Relevant mass analyzers are quadrupole time of flight (QTOF) and quadrupole-orbitrap. These instruments are hereafter referred to as HRMS instruments.
Two of the three offered HRMS instruments should be of the same model, whilst the third should be offered as an option. The option should give a choice between 2 instruments: one choice being the same model as the previous 2, and the other choice being a more high-end instrument. The high-end instrument should be more sensitive, have higher resolution and/or have higher specificity utilizing techniques such as ion mobility separation.
The tender should also include one tandem quadrupole mass spectrometer equipped with UHPLC, hereafter referred to as a LRMS instrument.
The equipment is to be delivered in the last half of 2016.
The supplied equipment must be delivered as specified with all necessary accessories, including all software. The equipment should be put in place and configured as described in vendor specific protocols and subsequently be operational and ready for use by the customer.
Usage of equipment.
Patterns of drug abuse have been shown to be ever-changing. New drugs emerge every year, and in addition established pharmaceuticals become targets of drug abuse. To reflect this, the Western Norway Reginal Health Authority needs a more flexible analytical repertoire than achievable with its laboratory's current equipment.
There is a need for:
— Increased analytical flexibility;
— Increased specificity and sensitivity;
— Increased capacity and throughput.
Achieving the above will improve diagnostics and follow up of existing patients and help to reveal emerging risk behaviour and thus aid drug preventative work in all layers of society. In addition it will be of national interest to help document drugs of abuse trends over time.
The four new instruments will replace six tandem quadrupole instruments equipped with liquid chromatographs used for specific drugs of abuse analysis in human urine at the Section for Therapeutic Drug Monitoring and Drugs of Abuse Analysis, Laboratory for Clinical Biochemistry, Haukeland University Hospital, Bergen Hospital Trust.
Currently this laboratory routinely analyzes 46 substances consisting of opioids, amphetamines, cocaine and benzodiazepines. Annually this comes to 15 000 — 20 000 patient samples in additions to calibrators and quality control samples. Urine sample work-up consist of mere dilution or enzymatic hydrolysis with subsequent dilution (hydrolyze-dilute and shoot methodology). If possible, for cost and quality purposes, it is desirable to continue using this approach.
The new HRMS instruments are to replace these drugs of abuse analysis. The use of information independent data acquisition will enable the detection of larger number of substances than todays targeted approach. This will enable retrospective data analysis on previous samples without the need for storage and preservation of the physical urine samples. We will still routinely inspect the data in a targeted manner, but retain the possibility to identify other relevant substances in the sample with high accuracy. In this context good tools for identification and structure elucidation of real unknowns in the samples are of interest. This context is also where the option for the high-end HRMS comes into play. Improved specificity through techniques such as ion mobility separation is of special interest, but higher resolution and/or sensitivity is also valued. The primary goal is to reduce the number of false positive sample results.
The LRMS instrument is to be used for drugs of abuse analysis for cannabinoids, EtG/EtS, GHB/GBL, barbiturates and for conformational analysis of the other drugs of abuse in urine. In addition the LRMS instrument is to be used as an additional capacity for therapeutic drug monitoring (TDM) of benzodiazepines, antiepileptic drugs, antidepressants, antipsychotics and substitutional therapy pharmaceuticals in human serum. Annually the number of patient serum samples are 21 000 (in 2015) in addition to calibrators and quality control samples. In its TDM scheme the laboratory currently analyze 77 substances. TDM for antiepileptic drugs are accredited by NS-EN ISO 15189.
For the LRMS instrument an option to increased sample throughput should be offered.
It is of utmost importance that the equipment, and especially the software, is as simple and intuitive as possible for usage by laboratory personnel. There is a need for an efficient and robust workflow not significantly more time consuming that the methodology in current use.
In addition, both HRMS and LRMS instruments will be employed in research and for sanctionary samples in drugs of abuse analysis.

Fristen for mottak av tilbud var 2016-06-22. Anskaffelsen ble publisert 2016-05-04.

Følgende leverandører er nevnt i tildelingsbeslutninger eller andre anskaffelsesdokumenter:

• • AS Sciex AB

• • Helse Vest Innkjøp HF

• • Analyseapparatur › Kromatografer
• • Spektrometre › Massespektrometre

• • Hordaland