Process Record Slide Limited is a startup company in Hong Kong focusing on developing an economically viable on-slide process control and calibrator （PRS） for each IHC staining.
Immunohistochemistry staining was invented in 1941 and is considered a quantitative test. Since then, IHC has never been calibrated or scientifically achieved its designed quantitative function, as it claims.
PRS is to replace on-slide tissue control or cell line as a genuine evidence-based quality indicator and will allow the digital image to have a baseline ruler so that quantitative analysis can be achieved just like we read a map and need to refer to a scaler ruler if we need to find out the distance between 2 cities.
Confirmation through the provision of objective evidence , that the requirements for a specific intended use or application have been fulfilled
Confirmation , through provision of objective evidence , that specified requirements have been fulfilled
4.14.7 Quality Indicators
The laboratory shall establish quality indicators to monitor and evaluate performance throughout critical aspects of pre – examination , examination and post examination processes
5.5.2 Biological Reference Intervals Or Clinical Decision Values
The laboratory shell define the biological reference intervals or clinical decision valuer , document the basis for the reference intervals or decision values and communicate this information to users.
When a particular biological reference interval or decision value is no longer relevant for the population served , appropriate changes shall be made and communicated to the users .
When the laboratory changer an examination procedure or pre examination procedure , the laboratory shall review associated reference intervals and clinical decision values , as applicable .
18.104.22.168 Quality Control Material
The laboratory shall use quality control material that react to the examination system in manner as close as possible to patient sample .
22.214.171.124 Measurement Uncertainty Of Measured Quantity Values
The relevant uncertainty components are those associated with the actual measurement process commencing with the presentation of the sample to the measurement procedure and ending with the output of the measured value .
126.96.36.199 Equipment Calibration And Metrological Traceability
The laboratory shall have a documented procedure for the calibration of equipment that directly or indirectly affects examination results.
188.8.131.52 Alternative Approaches
Whenever an inter – laboratory comparison is not available , the laboratory shall develop other approaches and provide OBJECTIVE evidence for determining the acceptability of the examination result.
FDA is establishing SPECIAL CONTROLS that must be met to assure the digital imaging system’s precision , reliability , and clinical relevance . The risks associated with the use of this technology are similar to that of the use of conventional light microscopy . These special controls are necessary to provide reasonable assurance of safety and effectiveness for this digital imaging system.
“Batch control using a tissue block or cell line will never work well on a non-calibrated automatic stainer. For consistent and high-quality IHC staining, I believe only 100% evidence-based process quality control can comply with the requirement of CLIA or ISO15189. ”
– Denny Lam, CEO
In IHC, is there any objective way to ensure every single slide is stained correctly without a co-resident process quality control?
Supposing we have chosen the suitable primary antibody and the user-applied control tissue has stained as well, how can we determine if the stain color has not been affected by the antigen retrieval process?
Based on today’s technologies, does an evidence-based process quality indicator exist to address the mandatory ISO 15189 or CLIA requirement for IHC staining?
Is a control tissue or cell line a validated material? How can a tissue bank maintain consistent quality for the tissue block?
How does subjective opinion in grading results equate to objective measurement?
Manufacturers of automated strainers have never provided a standard calibrator for their instruments to verify that the product performs correctly. Thus, how can a pathologist provide a valid diagnostic opinion when his patient material contains processing variability?
Usually, how do we know what illumination intensity is considered normalized to view an IHC-stained slide?
On what objective basis can the viewing illumination ensure neither cutoff nor saturation (loss in sensitivity at the bottom end or compression at the top end)?
Can quantitative analysis of the patient tissue sections’ stain color yield antigen density?