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About Us

Introducing PRS – the Process Record Slides – the new, innovative quality control measure for immunohistochemistry (IHC) staining that ensures accuracy and reproducibility of results while meeting the requirements of ISO 15189.

Traditional tissue controls can be limited by issues such as lack of standardization, batch-to-batch variability, and potential misuse by pathologists. PRS provides a reliable alternative by consisting of primary and secondary protein targets with known antigen expression levels that are certified as an ISO 13485 medical device.

Unlike traditional tissue controls, PRS can be standardized, providing a reference material with known properties appropriate for the examination. This ensures that each IHC staining run is checked for accuracy and reproducibility, rather than relying on the accuracy of previous batches.

It Is Time to Modernize the revolutionary Process Record Slide

What is Process Record Slide (PRS) ?

  1. PRS provides the most powerful and versatile performance IHC valuation possible
  2. Process Quality Control from every PRS slide
  3. Foundation to provide diagnostics decisioning with an Antigen
  4. Density Ruler for each slide: Pathologist and Artificial Intelligence
  5. Co-resident control tissue CANNOT provide a Process QC
    valuation because there is no known density of antigen sites.
  6. Transforms IHC from Subjective to Precision Objective Decisioning
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ISO 15189 – 2012
3.26 Validation

Confirmation through the provision of objective evidence , that the requirements for a specific intended use or application have been fulfilled

3.26 Verification

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 .

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PRS: 100% Process QC of IHC pathology slides is now a reality

ISO 15189 – 2012 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 . 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 . Equipment Calibration And Metrological Traceability
The laboratory shall have a documented procedure for the calibration of equipment that directly or indirectly affects examination results. 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.

Pass Release FDA allows marketing of first whole slide imaging system for digital pathology on 12 April 2017

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.

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  • The First IHC Process Quality Control slide manufactured according to ISO13485
  • The first IHC PQC slide to separate primary antibody ,  secondary stain , and antigen retrieval behaviors
  • The first IHC PQC slide with the ability to evaluate the  functional primary antibody concentration vs. the applied concentration >> allows for measured degradation tracking of the primary antibody instead of the arbitrary usage time now used.
  • The first IHC PQC slide , when digitally imaged , can develop a quantitative link between antigen density and color density of the tissue
  • The first IHC PQC that can establish an antigen density baseline to go along with the physical morphology of the tissue section for use in Al training and eventual usage in diagnostic aid
  • The only solution by which tele – diagnostic images can be color matched automatically while also regenerating the antigen & color density scales at the receiving end.
  • The first IHC PQC slide , when always used in stainers . can result in consistent staining performance via Levey – Jennings tracking feedback
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“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….Read More

In IHC, is there any objective way to ensure every single slide is stained correctly without a co-resident process quality control?

Can quantitative analysis….Read More

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?

On what objective basis….Read More

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)?

Usually, how do we….Read More

Usually, how do we know what illumination intensity is considered normalized to view an IHC-stained slide?

Manufacturers of automated strainers….Read More

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?

How does subjective….Read More

How does subjective opinion in grading results equate to objective measurement?

Is a control tissue or cell….Read More

Is a control tissue or cell line a validated material? How can a tissue bank maintain consistent quality for the tissue block?

Based on today’s technologies….Read More

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?

Supposing we have chosen the suitable….Read More

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?

Uploaded ``PRS`` Images

Get In Touch
email : denny@ihc-prs.com
contact : +852 69528252