HISTOPATHOLOGY
Promoting quality As NordiQC recently demonstrated in a poster which was presented at USCAP2024, one of the ways to solve poor staining quality is the implementation of external EQA schemes. In the poster NordiQC demonstrated the impact of tailored advice for failed IHC results. 84% of participants improved their result from fail to pass after implementing recommendations given by NordiQC.6
The Sakura Tissue-Tek Genie comes with ready-to-use reagents and locked in protocols. This closed system approach helps speed up verification and ensures IVDR compliance.
Some reasons for this insufficiency included underdeveloped antibodies, poorly calibrated ready-to-use products, erroneous epitope retrieval, and, most importantly, delayed standardisation. Closer analysis revealed that most laboratories faced challenges with calibrating and validating IHC assays for optimal performance.3
IVDR is adding complexity Adding further to this complexity has been the introduction of the In Vitro Diagnostic Regulation (IVDR), which came into effect in 2017. Although deadlines have been pushed or delayed several times subsequently; laboratories must eventually be able to operate under IVDR. This also implies for
example that IVDs manufactured and used by a laboratory will have to comply with IVDR. When a laboratory develops IVDs in-house (also called laboratory developed tests, LDTs), they must maintain technical documentation and update quality management systems to comply with the IVDR and the national law, including the requirements for manufacturing.4
If
an equivalent CE-marked device is available on the market or the scale of manufacturing of the IVD is industrial, the laboratory cannot use this option provided in the IVDR (Article 5.5), but must CE mark the IVD.5
This places
a huge burden on laboratories that are already very busy, to adapt to the bourgeoning workload.
The diagnostic potential of immunohistochemistry in pathology is universally accepted, but its reliability is compromised by lack of standardisation and occasionally poor performance. Sakura collaborates with NordiQC to optimise the ready to use (RTU) antibodies for Tissue-Tek Genie. NordiQC aims to promote the quality of immunohistochemistry and expand its clinical use by arranging schemes for immunohistochemical proficiency testing. Sakura only releases antibodies to the market when they achieve optimal scores according to NordiQC criteria. Sakura furthermore monitors the performance of its antibodies by participating in the NordiQC assessments. In the most recent NordiQC EQA
results, of the PAX8 antibodies tested only 32% scored optimal, and 22% good; meaning almost 50% of all participants scored borderline or poor. A testimony to a quite challenging antibody. Fig 1 shows a weak to moderate example, illustrating, distinct nuclear staining reaction in the majority of epithelial cells of the proximal, distal/ collecting renal tubules, loops of Henle and the parietal epithelial cells of Bowman’s capsule in the kidney. The Sakura RTU PAX8 antibody scores good or optimal.
Closed system Fig 1. A weak to moderate example of IHC staining using the challenging PAX8 antibody. 38
It is commonplace for many laboratories to alter protocols or dilutions of RTU antibodies to attain the desired results. This process can be time consuming and costly for laboratories that are already stretched. The Sakura Tissue-Tek Genie comes with RTU reagents and locked in protocols that score optimal according to NordiQC standards, meaning there is no need for any changes. This closed system approach helps speed up verification and ensures IVDR compliance. The Tissue-Tek Genie Advanced Staining System is the first and only fully automated, true random access stainer for IHC and in situ hybridisation (ISH). The system enables standardisation
OCTOBER 2024
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