For sure, the work performed by the C-STFT project, particularly the new FT4 and TSH calibration basis with the potential of more uniform RIs, will have a beneficial impact on future thyroid function testing and will facilitate interpretation of laboratory data. Standardized/harmonized assays are definitely fit to address modern clinical and public health needs and increase the confidence in safely using laboratory data for clinical decision making (see Aim of the project).
Notwithstanding these tremendous benefits, there is also a reverse side to the medal. For example, there is the concern that the changes in numerical measurement values and RIs after standardization and harmonization might be a potential source for misinterpretation of laboratory data. Therefore, the next challenge for the C-STFT – together with the laboratory community and IVD industry – is to mitigate this risk by informing/preparing all stakeholders-users of laboratory results (clinicians, patients) about the changes to expect. Another matter of concern, particularly for IVD manufacturers, are the regulatory requirements that go hand in hand with recalibration of assays.
To anticipate on these challenges, the C-STFT started an outreach program to establish a relationship with an as broad as possible spectrum of stakeholders (28), (29) and (30). For example, the committee visited or contacted major regulatory agencies (such as the US and Chinese FDA, the Japan Ministry of Health) to learn about the requirements they will ask from the IVD manufacturers who recalibrated their assays. Also the clinical community (general practitioners, endocrinologists, thyroidologists, nurses (see Clinicians) as well as patient organizations (The Thyroid Foundation International) were contacted in written form (letters in different clinical journals). This was done to increase awareness on the achieved milestones, but also to seek input for a risk-benefit analysis. In parallel questionnaires were sent to representatives of different national laboratory societies-member of the IFCC to learn about the actions they undertake when there are major changes in laboratory reports after fundamental changes in the calibration of commercial test systems. Other relevant actions of C-STFT to come into contact with involved stakeholders are attending symposia and giving lectures.
From these preliminary interactions, it can be concluded at this point in time that the benefits of standardization/harmonization are considered utmost valuable by all stakeholders, however, in their opinion, the potential risks for patient safety and clinical outcomes arising from major changes in numerical values and RIs should not be underestimated. On the other hand it is comforting to hear that users of laboratory data mostly are familiar with handling changes in numbers and RIs, as there seem to exist well-established communication chains amongst stakeholders. The communication sources that are used comprise peer-reviewed literature, local or national workshops, newsletters, circulars spread through the intranet or LIS, oral communications in internal staff meetings, etc. Therefore, it can with caution be concluded that it is unlikely that changes will not be captured.
Notwithstanding these above positive conclusions at this point in time, the C-STFT is committed to work in the future intensively on well preparing healthcare providers/receivers before final implementation of the standardized/harmonized assays.