Christin Domin explains how two experts have verified an IVD kit for the analysis of 28 trace elements in serum and plasma for the use with ICP-MS devices.
The laboratory is a highly sensitive area. Especially in the field of human and in vitro diagnostics (IVD), precision and rapid feedback of reliable results to physicians are essential. High standards for quality and safety as well as smooth processes in the trade of in vitro diagnostics are essential to meet these requirements and ensure a high level of health protection for patients and users. That is why the European Union adopted a new directive for in vitro diagnostic devices in 2022: IVD Regulation EU 2017/746 (IVDR) has far-reaching impact on all laboratories performing IVD testing.
To comply with the new directive, laboratories will have to meet stricter requirements in the future. These include, among other things, compliance with quality management guidelines, for example through regular monitoring of the tests as well as documentation of the results. Another important concern of the new directive is the promotion of innovation in the field of IVD. Laboratories should be enabled to introduce new technologies more quickly and thus improve patient care.
The IVDR stipulates that laboratories must give preference to products available on the market when performing IVD tests. If available, materials must be used that have already been validated by the manufacturer for the intended use.
Although the new directive is certainly welcome, it means a considerable amount of work. Laboratories will need to adapt their processes and procedures to the new requirements and improve their quality management systems. Financing these measures is also a challenge.
Why certified products?
For the analysis of human body fluids and tissue, different techniques are used depending on the analytes. Inductively coupled plasma-mass spectrometry (ICP-MS) is the method of choice for determining metal concentrations in human samples. The main advantages of ICP-MS are its multi-element capability, the short measuring times and thus a high sample throughput, as well as the significantly higher sensitivity compared to other techniques of elemental analysis.
Many laboratories are therefore increasingly relying on ICP-MS, which is replacing atomic absorption spectrometry (AAS), the method predominantly used in the past, in this field of application.
What does the IVDR mean for laboratories using ICP-MS equipment?
Although there are no standardised methods specifically for ICP-MS, the IVDR requires laboratories to use products that are certified for the respective analysis according to the IVDR whenever possible. The use of so-called in-house IVD or laboratory-developed tests (LDT), i.e., test methods developed in-house by the respective laboratory, is only permitted when certified products are not available or available products do not offer an equivalent level of performance.
These requirements are forcing many laboratories to reorganise their analytical techniques and processes. With the expiry of the previous EU Directive IVDD in 2025, i.e., the sole validity of the IVDR, but at the latest with the expiry of the last transition period in 2028, all specifications of the IVDR must be complied with.
The perfect match
To enable their customers to work more economically and IVDR-compliant in the future, Analytik Jena and its partner Recipe have verified an IVD kit for use with the PlasmaQuant MS devices. The ClinMass Complete Kit enables the IVDR-compliant quantitative analysis of the following chemical elements in human plasma and serum with the PlasmaQuant MS series: Ag, Al, As, Au, Ba, Be, Bi, Cd, Co, Cr, Cu, Fe, Hg, I, Li, Mg, Mn, Mo, Ni, Pd, Pt, Sb, Se, Sn, Ti, Tl, V, Zn.
The IVD kit contains all solutions and calibrators needed for the analysis of 28 trace elements in serum and plasma using ICP-MS with a rapid sample introduction system. The only preparation steps required are reconstitution of the controls and calibrators and dilution of the samples, controls and calibrators with the dilution medium.
Verification of the use of the ClinMass Complete Kit with the PlasmaQuant MS achieved recoveries between 90% and 110% for most trace elements and recoveries within the control range for all 28 elements investigated. This clearly shows that ready-to-use IVD kits validated for ICP-MS/MS analysis of serum and plasma can also be used with the PlasmaQuant MS, a single quadrupole ICP-MS.
With the IVD kit and the PlasmaQuant MS, users benefit from simpler workflows in combination with low operating costs, as the ICP-MS systems from Analytik Jena require only about half as much argon as comparable devices. With 100 samples to be measured per day, considering the average market price for argon bottles over a 10-year period results in a cost saving of up to €60,000 in total.
Christin Domin is with Analytik Jena.