[vc_row full_width=”stretch_row_content” gap=”32″ content_placement=”middle” element_id=”705178″ element_css=”.vc-row-331899 .animated-container {background-image:url(https://ihc-prs.com/wp-content/uploads/2018/12/map_transparent_dark.png);}.vc-row-331899 .top-gradient {background:linear-gradient(to bottom, #1f95d5 0%,rgba(255,255,255,0) 100%);}.vc-row-331899 .bottom-gradient {background:linear-gradient(to top, #1f95d5 0%,rgba(255,255,255,0) 100%);}”][vc_column animation_delay=”0″ css_animation=”slideInLeft” width=”1/12″ element_id=”433925″ crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:15:15,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i” offset=”vc_col-lg-12 vc_col-md-12 vc_col-xs-12″][vc_images_carousel images=”19076,18940,18941,18942″ img_size=”full” onclick=”custom_link” autoplay=”yes” wrap=”yes” css_animation=”appear” custom_links=”#E-8_aHR0cHMlM0ElMkYlMkZpaGMtcHJzLmNvbSUyRnNob3AlMkYlMkNodHRwcyUzQSUyRiUyRmloYy1wcnMuY29tJTJGc2hvcCUyRiUyQ2h0dHBzJTNBJTJGJTJGaWhjLXBycy5jb20lMkZzaG9wJTJGJTJDaHR0cHMlM0ElMkYlMkZpaGMtcHJzLmNvbSUyRnNob3AlMkY=”][/vc_column][/vc_row][vc_row gap=”40″ content_placement=”middle” element_id=”814762″ element_css=”.vc-row-331899 .animated-container {background-image:url(https://ihc-prs.com/wp-content/uploads/2018/12/map_transparent_dark.png);}.vc-row-331899 .top-gradient {background:linear-gradient(to bottom, #1f95d5 0%,rgba(255,255,255,0) 100%);}.vc-row-331899 .bottom-gradient {background:linear-gradient(to top, #1f95d5 0%,rgba(255,255,255,0) 100%);}” css=”.vc_custom_1695644425984{padding-top: 36px !important;padding-bottom: 36px !important;}”][vc_column animation_delay=”0″ css_animation=”none” width=”1/2″ element_id=”112739″ crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:15:15,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i” offset=”vc_col-lg-6 vc_col-md-12 vc_col-xs-12″][vc_custom_heading text=”About Us” font_container=”tag:h5|font_size:30|text_align:left|color:%23000000″ google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic”][vc_column_text animation_delay=”0″]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.[/vc_column_text][/vc_column][vc_column animation_delay=”150″ css_animation=”none” width=”1/2″ element_id=”936399″ crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:15:15,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i” offset=”vc_col-lg-6 vc_col-md-12 vc_col-xs-12″ el_id=”video-column”][et_video mp4=”https://ihc-prs.com/wp-content/uploads/2019/02/About-Phcprs-Video.mp4″ embed=”https://ihc-prs.com/wp-content/uploads/2019/02/About-Phcprs-Video.mp4″ modal=”true” image=”18939″][et_gap height=”8″ element_id=”763853″ element_css=”.et-gap-763853 {height:8px;}”][et_gap height=”24″ element_id=”865954″ element_css=”.et-gap-865954 {height:24px;}”][et_button button_text=”More about us” button_link=”https://ihc-prs.com/about-us/” button_size=”large” font_weight=”600″ button_font_size=”16″ button_color=”#212121″ button_border_color=”#212121″ icon_prefix=”ien” icon_name=”ien-earrow-3″ icon_font_size=”8″ icon_margin=”4″ icon_position=”right” button_color_hover=”#000000″ button_back_color_hover=”#1f95d5″ button_border_color_hover=”#1f95d5″ animate_hover=”fill” animation_delay=”0″ element_id=”712966″ element_font=”Theme default:600:latin” element_css=”#et-button-712966 {min-width:200px;font-size:16px !important;font-weight:600;text-transform:none;color:#212121;border-radius:0px;}#et-button-712966 .icon {font-size:8px !important;}#et-button-712966 .icon {margin-left:4px !important;}#et-button-712966:hover {color:#000000;}#et-button-712966 .regular {box-shadow:inset 0 0 0 1px #212121;}#et-button-712966 .hover {background-color:#1f95d5;box-shadow:inset 0 0 0 1px #1f95d5;}#et-button-712966 .et-ink {color:#212121;}#et-button-712966 .et-ink {background-color:#000000;}” button_min_width=”200″ button_border_width=”1″][/vc_column][vc_column][/vc_column][/vc_row][vc_row css_animation=”none” element_id=”187831″ css=”.vc_custom_1694096235277{padding-top: 48px !important;background-color: #1e96d5 !important;}”][vc_column width=”1/2″][et_icon_list][/et_icon_list][et_heading type=”h3″ text_color=”#ffffff” font_weight=”600″ font_size=”24″ margin=”0,0,0,0″ padding=”0,0,0,0″ element_id=”557912″ element_font=”Theme default:600:latin” element_css=”#et-heading-557912 .text-wrapper {background-color:transparent;padding:0;}#et-heading-557912 {color:#ffffff;font-size:24px;font-weight:600;text-transform:none;}#et-heading-557912 a {color:#ffffff;}#et-heading-557912 {margin:0px 0px 0px 0px;}#et-heading-557912 .text-wrapper {padding:0px 0px 0px 0px;}”]It Is Time to Modernize the revolutionary Process Record Slide[/et_heading][vc_wp_text el_id=”define-prs” el_class=”define-prs”]

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

[/vc_wp_text][/vc_column][vc_column animation_delay=”0″ width=”1/2″ element_id=”393897″ crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:i:i,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i”][et_image title=”Prs Image” alignment=”right” element_id=”72362″ image=”18917″][/vc_column][/vc_row][vc_row element_id=”20134″ css=”.vc_custom_1693833915547{padding-top: 48px !important;padding-bottom: 48px !important;background-color: #ffffff !important;}”][vc_column animation_delay=”0″ css_animation=”none” width=”1/2″ element_id=”255361″ el_id=”iso-15189″ crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:i:i,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i”][et_heading type=”h5″ text_color=”#000000″ font_weight=”600″ font_size=”24″ line_height=”0″ margin=”0,0,0,0″ padding=”0,0,0,0″ element_id=”481795″ element_font=”Theme default:600:latin” element_css=”#et-heading-481795 .text-wrapper {background-color:transparent;padding:0;}#et-heading-481795 {color:#000000;font-size:24px;font-weight:600;line-height:0px;text-transform:none;}#et-heading-481795 a {color:#000000;}#et-heading-481795 {margin:0px 0px 0px 0px;}#et-heading-481795 .text-wrapper {padding:0px 0px 0px 0px;}”]ISO 15189 – 2012[/et_heading][et_heading type=”div” text_color=”#000000″ font_weight=”500″ font_size=”18″ line_height=”54″ margin=”0,0,0,0″ padding=”0,0,0,0″ element_id=”446924″ element_font=”Theme default:500:latin” element_css=”#et-heading-446924 .text-wrapper {background-color:transparent;padding:0;}#et-heading-446924 {color:#000000;font-size:18px;font-weight:500;line-height:54px;text-transform:none;}#et-heading-446924 a {color:#000000;}#et-heading-446924 {margin:0px 0px 0px 0px;}#et-heading-446924 .text-wrapper {padding:0px 0px 0px 0px;}”]3.26 Validation[/et_heading][vc_column_text animation_delay=”0″]Confirmation through the provision of objective evidence , that the requirements for a specific intended use or application have been fulfilled[/vc_column_text][et_heading type=”div” text_color=”#000000″ font_weight=”500″ font_size=”18″ line_height=”54″ margin=”0,0,0,0″ padding=”0,0,0,0″ element_id=”11784″ element_font=”Theme default:500:latin” element_css=”#et-heading-11784 .text-wrapper {background-color:transparent;padding:0;}#et-heading-11784 {color:#000000;font-size:18px;font-weight:500;line-height:54px;text-transform:none;}#et-heading-11784 a {color:#000000;}#et-heading-11784 {margin:0px 0px 0px 0px;}#et-heading-11784 .text-wrapper {padding:0px 0px 0px 0px;}”]3.26 Verification[/et_heading][vc_column_text animation_delay=”0″]Confirmation , through provision of objective evidence , that specified requirements have been fulfilled[/vc_column_text][et_heading type=”div” text_color=”#000000″ font_weight=”500″ font_size=”18″ line_height=”54″ margin=”0,0,0,0″ padding=”0,0,0,0″ element_id=”952262″ element_font=”Theme default:500:latin” element_css=”#et-heading-952262 .text-wrapper {background-color:transparent;padding:0;}#et-heading-952262 {color:#000000;font-size:18px;font-weight:500;line-height:54px;text-transform:none;}#et-heading-952262 a {color:#000000;}#et-heading-952262 {margin:0px 0px 0px 0px;}#et-heading-952262 .text-wrapper {padding:0px 0px 0px 0px;}”]4.14.7 Quality Indicators[/et_heading][vc_column_text animation_delay=”0″]The laboratory shall establish quality indicators to monitor and evaluate performance throughout critical aspects of pre – examination , examination and post examination processes[/vc_column_text][et_heading type=”div” text_color=”#000000″ font_weight=”500″ font_size=”18″ line_height=”54″ margin=”0,0,0,0″ padding=”0,0,0,0″ element_id=”168106″ element_font=”Theme default:500:latin” element_css=”#et-heading-168106 .text-wrapper {background-color:transparent;padding:0;}#et-heading-168106 {color:#000000;font-size:18px;font-weight:500;line-height:54px;text-transform:none;}#et-heading-168106 a {color:#000000;}#et-heading-168106 {margin:0px 0px 0px 0px;}#et-heading-168106 .text-wrapper {padding:0px 0px 0px 0px;}”]5.5.2 Biological Reference Intervals Or Clinical Decision Values[/et_heading][vc_column_text animation_delay=”0″]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 .[/vc_column_text][/vc_column][vc_column animation_delay=”0″ css_animation=”none” width=”1/2″ element_id=”384050″ crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:i:i,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i” css=”.vc_custom_1694094360907{margin-top: 24px !important;}”][et_image title=”Prs Image” alignment=”right” element_id=”211296″ image=”18946″][/vc_column][/vc_row][vc_row element_id=”257131″ css=”.vc_custom_1695303078431{padding-top: 48px !important;padding-bottom: 48px !important;background-image: url(https://ihc-prs.com/wp-content/uploads/2019/02/backgound-ihc-prs-scaled-1.jpg?id=18907) !important;}”][vc_column animation_delay=”0″ css_animation=”none” element_id=”611387″ crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:i:i,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i”][vc_row_inner element_id=”414432″ css=”.vc_custom_1693979689706{padding-top: 60px !important;padding-right: 60px !important;padding-bottom: 60px !important;padding-left: 60px !important;background-color: #ffffff !important;}”][vc_column_inner][vc_custom_heading text=”PRS: 100% Process QC of IHC pathology slides is now a reality” font_container=”tag:h4|font_size:36|text_align:left|color:%23000000″ google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic” el_id=”prs-reality-heading”][vc_separator][vc_wp_text el_id=”qc-ihc-pathlogy”]

ISO 15189 – 2012

5.6.2.2 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 .

5.5.1.4 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 .

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

5.6.3.2 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.

[/vc_wp_text][/vc_column_inner][/vc_row_inner][vc_row_inner content_placement=”middle” element_id=”293470″ css=”.vc_custom_1695645247680{padding-right: 54px !important;padding-left: 54px !important;background-color: #ffffff !important;}”][vc_column_inner width=”1/3″][vc_single_image image=”19037″ img_size=”full” alignment=”center” css=”.vc_custom_1695645198160{padding-bottom: 36px !important;}”][/vc_column_inner][vc_column_inner width=”1/3″][vc_single_image image=”19038″ img_size=”full” alignment=”center” css=”.vc_custom_1695645215794{padding-bottom: 36px !important;}”][/vc_column_inner][vc_column_inner width=”1/3″][vc_single_image image=”19039″ img_size=”full” alignment=”center” css=”.vc_custom_1695645222026{padding-bottom: 36px !important;}”][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row element_id=”402703″ el_id=”ihc-essential-prs” css=”.vc_custom_1694006866938{margin-top: 60px !important;margin-bottom: 60px !important;margin-left: 0px !important;}”][vc_column animation_delay=”0″ css_animation=”none” width=”1/2″ element_id=”874942″ crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:i:i,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i”][et_image element_id=”43099″ image=”19089″][/vc_column][vc_column animation_delay=”0″ css_animation=”none” width=”1/2″ element_id=”836034″ crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:i:i,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i”][vc_column_text animation_delay=”0″]

[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_column_text animation_delay=”0″][/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][/vc_column][/vc_row][vc_row disable_element=”yes” element_id=”817625″][vc_column][vc_custom_heading text=”PRS Images” font_container=”tag:h5|font_size:30|text_align:left|color:%23000000″ google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic”][et_gallery size=”thumbnail” columns=”4″ element_id=”956300″ images=”4038,4006,3963,3965,3737″][/vc_column][/vc_row][vc_row css_animation=”none” element_id=”179797″ css=”.vc_custom_1694094055112{padding-top: 60px !important;padding-bottom: 60px !important;background-color: #02b3f9 !important;}”][vc_column width=”1/2″][vc_single_image image=”18949″ img_size=”medium” alignment=”center” onclick=”link_image” css=”.vc_custom_1695303280750{border-radius: 35px !important;}” el_class=”img-rounded”][/vc_column][vc_column width=”1/2″][vc_wp_text el_id=”ceo-quote”]“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[/vc_wp_text][/vc_column][/vc_row][vc_row element_id=”872494″ css=”.vc_custom_1693983054368{padding-top: 72px !important;padding-bottom: 60px !important;background-color: #20739f !important;}” el_id=”faq-row”][vc_column animation_delay=”0″ element_id=”831169″ el_id=”faq-color-white” crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:i:i,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i”][vc_toggle title=”In IHC, is there any objective way….Read More” style=”simple” css_animation=”none” css=”.vc_custom_1694246965099{padding-top: 18px !important;padding-right: 18px !important;padding-bottom: 18px !important;padding-left: 18px !important;background-color: #000000 !important;}” el_class=”faq”]

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

[/vc_toggle][vc_toggle title=”Can quantitative analysis….Read More” style=”round” css_animation=”none” css=”.vc_custom_1694523956299{padding-top: 18px !important;padding-right: 18px !important;padding-bottom: 18px !important;padding-left: 18px !important;background-color: #000000 !important;}” el_class=”faq”]

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?

[/vc_toggle][vc_toggle title=”On what objective basis….Read More” style=”round” css_animation=”none” css=”.vc_custom_1694247074297{padding-top: 18px !important;padding-right: 18px !important;padding-bottom: 18px !important;padding-left: 18px !important;background-color: #000000 !important;}” el_class=”faq”]

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)?

[/vc_toggle][vc_toggle title=”Usually, how do we….Read More” style=”round” css_animation=”none” css=”.vc_custom_1694247083818{padding-top: 18px !important;padding-right: 18px !important;padding-bottom: 18px !important;padding-left: 18px !important;background-color: #000000 !important;}” el_class=”faq”]

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

[/vc_toggle][vc_toggle title=”Manufacturers of automated strainers….Read More” style=”round” css_animation=”none” css=”.vc_custom_1694247092786{padding-top: 18px !important;padding-right: 18px !important;padding-bottom: 18px !important;padding-left: 18px !important;background-color: #000000 !important;}” el_class=”faq”]

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?

[/vc_toggle][vc_toggle title=”How does subjective….Read More” style=”round” css_animation=”none” css=”.vc_custom_1694247101641{padding-top: 18px !important;padding-right: 18px !important;padding-bottom: 18px !important;padding-left: 18px !important;background-color: #000000 !important;}” el_class=”faq”]

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

[/vc_toggle][vc_toggle title=”Is a control tissue or cell….Read More” style=”round” css_animation=”none” css=”.vc_custom_1694247110241{padding-top: 18px !important;padding-right: 18px !important;padding-bottom: 18px !important;padding-left: 18px !important;background-color: #000000 !important;}” el_class=”faq”]

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

[/vc_toggle][vc_toggle title=”Based on today’s technologies….Read More” style=”round” css_animation=”none” css=”.vc_custom_1694247119657{padding-top: 18px !important;padding-right: 18px !important;padding-bottom: 18px !important;padding-left: 18px !important;background-color: #000000 !important;}” el_class=”faq”]

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?

[/vc_toggle][vc_toggle title=”Supposing we have chosen the suitable….Read More” style=”round” css_animation=”none” css=”.vc_custom_1694247130138{padding-top: 18px !important;padding-right: 18px !important;padding-bottom: 18px !important;padding-left: 18px !important;background-color: #000000 !important;}” el_class=”faq”]

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?

[/vc_toggle][/vc_column][/vc_row][vc_row equal_height=”yes” element_id=”227147″ css=”.vc_custom_1695656917018{padding-top: 36px !important;padding-right: 36px !important;padding-bottom: 36px !important;padding-left: 36px !important;}”][vc_column][et_highlight_heading type=”h3″ text_color=”#000000″ border_color=”#ffffff” font_weight=”400″ margin=”0,0,0,0″ element_id=”492675″ element_font=”Theme default:400:latin” element_css=”#et-highlight-heading-492675 .text-wrapper:before {background-color:#ffffff;}#et-highlight-heading-492675 {color:#000000;font-weight:400;text-transform:none;}#et-highlight-heading-492675 {margin:0px 0px 0px 0px;}” title=”Uploaded “PRS“ Images”][/vc_column][/vc_row][vc_row element_id=”257494″ css=”.vc_custom_1695656933058{padding-top: 36px !important;padding-right: 36px !important;padding-bottom: 36px !important;padding-left: 36px !important;}”][vc_column][et_gallery type=”carousel-thumbs” autoplay=”true” element_id=”991139″ images=”18914,18931,18929,18925,18926″][/vc_column][/vc_row][vc_row][vc_column][/vc_column][/vc_row][vc_row][vc_column animation_delay=”0″ text_align=”left” element_id=”884380″ crp=”480:i:i,480-768:i:i,768-1024:i:i,1024-1280:i:i,1280-1366:i:i,1366-1600:i:i,1600-1920:i:i” css=”.vc_custom_1697869079846{padding-top: 24px !important;padding-right: 24px !important;padding-bottom: 24px !important;padding-left: 24px !important;}”][vc_posts_slider count=”3″ interval=”3″ slides_content=”teaser” slides_title=”1″ thumb_size=”thumbnail” title=”Blogs” posttypes=”post” el_id=”blog-section”][/vc_column][/vc_row]