IHC Lab Changes
- Ki-67 [30-9] available at HMC Histology (December 5th, 2024)
- HER2/neu antibody [clone 4B5], new source (September 5th, 2024)
- STEAP1 by IHC available 9/3 (August 30th, 2024)
- HPV High Risk 18 pool [16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 & 82] (August 19th, 2024)
- INSM1[RBT-INSM1], new source (August 2nd, 2024)
- TSH and LH, new sources (June 28th, 2024)
- PDL1 clone 22C3, 28-8 pharmDx (May 24th, 2024)
- FLOR1 [folate receptor alpha 1] (May 24th, 2024)
- Beta Amyloid Protein clone switch (May 9th, 2024)
- IDH1 [HO9] (October 2nd, 2023)
- CD99: Back on IHC menu (September 15th, 2023)
- H&E Reagent's Source Change (September 11th, 2023)
- Androgen Receptor: New source (July 14th, 2023)
- BAP1 and Calretinin: New antibodies (March 16th, 2023)
- HOXB13- PSMA and SSTR2: New tests (January 13th, 2023)
- BRCA1 discontinued (November 1st, 2022)
- GFAP and MBP: Source/clone change (August 31, 2022)
- SS18-SSX: New antibody (June 7th, 2022)
- SARS CoV-2: New antibody (May 20th, 2022)
- PRAME[EPR20330]: Clone change (March 16th, 2022)
- OCT-4: Clone change (January 4th, 2022)
- PAX8: New clone (November 3rd, 2021)
- INSM1: New marker (November 3rd, 2021)
- SATB2: New source (June 20th, 2021)
- CAMTA1: New marker (June 17th, 2021)
- Pit-1, SF-1 and Tpit: New markers (May 7th, 2021)
- SARS-CoV Spike: New marker (January 11th, 2021)
- S100: Clone change (November 18th, 2020)
- PRAME: New marker (September 10th, 2020)
- Cathepsin K and Fumarate Hydratase: New markers (August 14th, 2020)
- Melan-A, HMB45, MiTF and Sox10 melanocytic markers: Red chromogen ONLY (July 30, 2020)
- IP Prolactin: New source (July 01, 2020)
- Mesothelin [EP140]: New source (May 27th, 2020)
- PSA [EP109]: Source change (April 1st, 2020)
- Phospho TDP43: Source change (April 1st, 2020)
- HSV1 and HSV2 available (February 24th, 2020)
- CD20: Source change (January 3rd, 2020)
- Tri-Methyl-Histone H3 and ATRX available (December 16th, 2019)
- HSVII: Antibody discontinued (October 3rd, 2019)
- Myelin Basic Protein: New clone (August 26th, 2019)
- CCR7: New antibody (August 5th, 2019)
- MNDA: New antibody at SCCA (July 15th, 2019)
- Progesterone Receptor: Clone change (February 8th, 2019)
- LEF-1 (EPR2029Y): New antibody at SCCA (December 28th, 2018)
- Anti Histone H3.3 G34W: New antibody (June 13th, 2019)
- TLE-1: Antibody retired (May 16th, 2019)
- SDHB: New antibody (April 8th, 2019)
- Progesterone Receptor: Clone Change (February 8th, 2019)
- LEF-1: New antibody at SCCA (December 28th, 2018)
- CD7 (LP15): New antibody at SCCA (December 28th, 2018)
- CD2 (AB75): New antibody at SCCA (December 28th, 2018)
- Congo Red Special Stain Kit Formula and Tissue Section Thickness Change (December 14th, 2018)
- CEA (Polyclonal): Antibody Discontinued (December 11th, 2018)
- Validation of IHC stains on post bleached slides (November 27th, 2018)
- BAP1: New antibody (October 1st, 2018)
- CD56 (MRQ-42): New antibody at SCCA (September 27th, 2018)
- Universal IHC orders-Go Live (September 7th, 2018)
- CD21: New Antibody at SCCA (July 17th, 2018)
- CRP, LFABP and DNAJB9: New Antibodies (July 12th, 2018)
- Standardized Histochemical Stain Protocols (June 15th, 2018)
- p16 Antibody: New source (May 31st, 2018)
- CXCL13, HGAL and MUM1: New antibodies at SCCA (April 5th, 2018)
- IgG subtypes IgG1,IgG2, IgG3 and IgG4: New IF antibodies (February 1st, 2018)
- H3 K27M, Brachyury [EPR18113], DNAJB9: New antibodies (January 22nd, 2018)
- Villin: New source (December 18th, 2017)
- TCR delta, Brachyury, CD25, MiTF: New antibodies (December 5th, 2017)
- CMV stain back at UW IHC lab (October 16th, 2017)
- HHV8: Source Change (August 21st, 2017)
- Hepatitis B Surface A: Clone change (August 21st, 2017)
- Brachyury Antibody: Discontinued (August 10th, 2017)
- PDL1 (E1L3N): New test (August 7th, 2017)
- MITF and Mesothelin (K1) antibody: Temporarily discontinued (August 7th, 2017)
- PHF TAU, BAP 1-16, PHF TDP43: New tests (July 25th, 2017)
- Neurofilament (2F11): New source (July 25th, 2017)
- MYOD1: New source (July 11th, 2017)
- CD35: New Source (June 30th, 2017)
- Low Volume antibodies retired (April 27th, 2017)
- Deactivated LIS special stain order codes (April 18th, 2017)
- Discontinuation of auto generated ICC/IHC recuts (March 23rd, 2017)
Periodically the IHC lab must make a change to antibodies, clones and/or sources. When these changes happen an email is sent to all stakeholders as soon as possible. Additionally the changes are posted here as a historical record.
The changes are posted below in descending order. For context the announcement date is included in the heading.
Ki-67 [30-9] available at HMC Histology (December 5th, 2024)
A new clone of Ki-67 antibody, clone 30-9, is added to HMC IHC menu. The new source is fully validated on Roche Benchmark Ultra platform and approved by Dr. Tretiakova for clinical use.
Ordering code in BEAKER: Ki-67[30-9]
- Clone: 30-9
- Pattern of Positivity: Nuclear
- Clinical use: Estimation of proliferation rates/mitotic activity of neoplasia
- Sensitivity: 100%
- Specificity: 100%
HER2/neu antibody [clone 4B5], new source (September 5th, 2024)
- Ordering code in BEAKER: HER2[4B5](on solid tumors
- Clone: 4B5
- Pattern of Positivity: Membranous (basolateral or lateral)
- Clinical use: Prognostic marker for HER2-overexpressing solid tumors: eligibility for Enhertu (Trastuzumab Deruztecan) tumor-agnostic therapy with significantly improved survival
- Sensitivity: 5% (0-25% range depends on organ site); Specificity: 98.5%
- Scoring instructions: Same as for gastric cancer (CAP guidelines); greatest benefit for 3+ tumors demonstrating a strong complete membranous reactivity in ≥10% of tumor cells (resections) or in tumor cell cluster irrespective of % tumor cells stained (biopsies)
- References: PMID: 37870536
STEAP1 by IHC available 9/3 (August 30th, 2024)
STEAP1 antibody is added to HMC IHC/ISH menu . The new source has been fully validated and approved by Dr. Maria Tretiakova for clinical use.
This source will be available for ordering on 9/3/24 and it will be stained using the Roche Benchmark Ultra auto stainer.
- Ordering code in BEAKER: STEAP1
- Clone: D88B27
- Pattern of Positivity: Cytoplasmic & membranous
- Clinical use: Prostate cancer, treatment resistant
- Sensitivity: 67%
- Specificity: 100%
- Scoring instructions: Report % positivity and intensity
- References: PMC11030323
HPV High Risk 18 pool [16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 & 82] (August 19th, 2024)
The new source has been fully validated and approved.
- Ordering code in BEAKER: RISH HPV-HR18 (RISH= RNAscope In Situ Hybridization). The order cord generates 3 slides on each patient tissue.
- Clone: 18 chromogenic probe cocktails (HPV HR18 ACD)
- Pattern of Positivity: Dot-like inclusions
- Clinical use: Identifying HPV-associated head & neck and urogenital neoplasia; differentiating is from HPV-independent neoplasia.
- Sensitivity: 94%
- Specificity: 100%
- Scoring Instructions: Positive – dot-like brown expression pattern specifically localizing within the malignant nuclei.
- Reference: PMID 30890775
INSM1[RBT-INSM1], new source (August 2nd, 2024)
We have switched to a new source of INSM1 antibody.
The new source is fully validated and approved by Dr Tretiakova for clinical use. This change is due to switching from an RUO source to an IVD source.
- Ordering code in BEAKER: INSM1
- Clone:RBT-INSM1
- Pattern of Positivity: Nuclear
- Clinical use: Assessment of neuroendocrine differentiation (benign and malignant tissues)
- Sensitivity: 76%
- Specificity: 91% (cross validation with p16 overexpressing tumors)
TSH and LH, new sources (June 28th, 2024)
New sources of Cell Marque TSH and LH has been validated and replace the old Dako sources, effective 7/1/2024. The reason for this switch was due to vendor (Dako) discontinuing the current sources. The new sources are fully validated and approved by Dr Tretiakova to be added to our menu.
PDL1 clone 22C3, 28-8 pharmDx (May 24th, 2024)
The following markers are added to our IHC/ISH menu. The new source has been fully validated at HMC Histology and approved by Dr. Maria Tretiakova for clinical use. Both are FDA approved tests run on Dako Autostainer Link 48. They are batched run at HMC twice per week on Mondays and Wednesdays and delivered to “Advanced IHC pathologists” on rotation on momentum schedule.
This PDL1 will be reported either as TPS or CPS score depending to the indication provided by Clinician:
- Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity.
- Combined Positive Score (CPS), (tumor cells, lymphocytes, macrophages) divided by total number of viable tumor cells, multiplied by 100)
PD-L1, clone 22C3
- Ordering code in BEAKER: PDL1 22C3 (this panel code will generates 3 slides for each order, one for PDL1 antibody, one for negative control reagent and one for HE recut)
- Clone: 22C3
PD-L1, clone 28-8
FDA approved test run on Dako Autostainer Link 48
-
Ordering code in BEAKER: PDL1 28-8 (this panel code will generates 3 slides for each order, one for PDL1 antibody, one for negative control reagent and one as HE recut)
Clone: 28-8
FLOR1 [folate receptor alpha 1] (May 24th, 2024)
FLOR1 is added to the IHC/ISH menu. The new source has been fully validated at HMC Histology to be run on Roche Benchmark Ultra autostainer. It is approved by Dr. Tretiakova for clinical use.
Ordering code in BEAKER: FLOR1
Clone:FOLR1-2.1 (Ventana RxDx assay)
Pattern of Positivity: Membranous or apical (cancer), Apical (normal fallopian tube)
Clinical use: Identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who may be eligible for treatment with ELAHERE (mirvetuximab soravtansine).
Sensitivity: 100%
Specificity: 100%
Scoring Instructions: FOLR1 expression clinical cut-off is ≥75% viable tumor cells (TC) with membranous staining at moderate or strong intensity levels. PMID 25349970
Beta Amyloid Protein clone switch (May 9th, 2024)
Beta Amyloid Protein 6F/3D was discontinued by Dako. A switch was made to Beta Amyloid Protein clone 4G8 from BioLegend starting on May 13th, 2024. It has been fully validated and approved by Dr. Tretiakova.
IDH1 [HO9] (October 2nd, 2023)
New source of IDH1 is available for use. The new source has been fully validated and approved for clinical use. It replaces IDH1, clone MRQ-67
Ordering code in BEAKER: IDH1
Clone: HO9
Pattern of Positivity: Cytoplasmic
Clinical use: To look for abnormal IDH1, R132H protein expression in gliomas
Sensitivity: 100%
Specificity: 100%
CD99: Back on IHC menu (September 15th, 2023)
The new source has been fully validated and approved by Dr. Tretiakova for clinical use.
CD99 (BSB-9)
Ordering code in BEAKER: CD99
Clone: BSB-9
Pattern of Positivity: Membranous
Clinical use: Ewing Sarcoma
Sensitivity: 93.5%
Specificity: 100%
H&E Reagent's Source Change (September 11th, 2023)
HMC Histology lab transitioned from General Data to StatLab HE reagents.
Androgen Receptor: New source (July 14th, 2023)
New source for Androgen Receptor available as of 7/17.
The new antibody has been fully validated and approved by Dr. Tretiakova for clinical use.
Androgen Receptor (AR)
Ordering code in BEAKER: AR
Clone: AR441
Pattern of Positivity: Nuclear
Clinical use: Prostate carcinoma
Sensitivity: 100%
Specificity: 100%
BAP1 and Calretinin: New antibodies (March 16th, 2023)
Two new IHC antibody sources available for order. They are fully validated and approved for clinical use.
BAP1 (BRCA Associated Protein 1)
Replaced the previously discontinued clone of BSB-109.
- Ordering code in BEAKER: BRCA Associated Protein 1 or BAP1
- Clone: C-4
- Pattern of Positivity: Nuclear (loss of expression)
- Clinical use: Mesothelioma vs. Reactive mesothelium, subset of renal cell carcinomas
- Sensitivity: 100%
- Specificity: 82%
Calretinin
Replaced the previous polyclonal source.
- Ordering code in BEAKER: Calretinin
- Clone: SP13
- Pattern of Positivity: Cytoplasmic/Nuclear
- Clinical use: Mesothelioma, Adrenal cortical tumors
- Sensitivity: 100%
- Specificity: 100%
HOXB13- PSMA and SSTR2: New tests (January 13th, 2023)
New IHC antibodies are available for clinical use. These are fully validated and approved for clinical use.
SSTR2 (Somatostatin Receptor 2)
- Ordering code in BEAKER: SSTR2
- Clone: EP149
- Pattern of Positivity: Cytoplasmic/Membranous
- Clinical use: Brain tumors, neuroendocrine tumors
- Sensitivity: 100%
- Specificity: 100%
HOXB13
- Ordering code in BEAKER: HOXB13
- Clone: D7N80
- Pattern of Positivity: Nuclear
- Clinical use: to distinguish carcinomas with neuroendocrine features of prostatic origin from other primaries
- Sensitivity: 84%
- Specificity: 100%
PSMA (Prostate Specific Membrane Antigen)
- Ordering code in BEAKER: PSMA
- Clone: 3E6
- Pattern of Positivity: Cytoplasmic/Membranous
- Clinical use: Metastatic prostate cancer, diagnostic and theranostic marker
- Sensitivity: 77%
- Specificity: 100%
BRCA1 discontinued (November 1st, 2022)
BRCA1 Associated Protein 1 [BSB109] is discontinued.
GFAP and MBP: Source/clone change (August 31, 2022)
Implemented 09/01/2022. New source/clone for GFAP and MBP antibody.
The new sources have been fully validated and approved by Dr. Tretiakova for clinical use. This change was due to vendor discontinuation of the previous source.
GFAP (Glial Fibrillary Acidic Protein)
- Ordering code in BEAKER: GFAP
- Clone: GA-5
- Pattern of Positivity: Cytoplasmic/Membranous
- Clinical use: Identification of neoplastic and non-neoplastic astrocytes. Helpful diagnostic tool for glial and glioneuronal neoplasms.
- Sensitivity: 100%
- Specificity: 100%
SS18-SSX: New antibody (June 7th, 2022)
New SS18-SSX[E9X9V] antibody.
This antibody has been validated and approved by Dr. Tretiakova for clinical use.
SS18-SSX [E9X9V]
- Ordering code in BEAKER: SS18-SSX
- Clone: E9X9V
- Clinical use: To detect Synovial Sarcoma with SS18-SSX rearrangement
- Pattern of Positivity: Nuclear
- Sensitivity: 90%
- Specificity: 100%
SARS CoV-2: New antibody (May 20th, 2022)
New SARS-CoV-2 Nucleocapsid antibody.
This antibody has been validated and approved by Dr. Tretiakova for clinical use.
SARS-CoV-2 Nucleocapsid
- Ordering code in BEAKER: SARS-CoV2 Nucleocapsid [BSB-134]
- Clone: BSB-134
- Clinical use: To detect COVID19 infected organs.
- Pattern of Positivity: Cytoplasmic
- Sensitivity: 75%
- Specificity: 98%
PRAME[EPR20330]: Clone change (March 16th, 2022)
Clone change for PRAME. This antibody has been validated and approved by Dr. Tretiakova for clinical use.
PRAME
- Ordering code in BEAKER: PRAME
- Clone: EPR20330
- Clinical use: Diagnosis of melanoma versus benign nevi, margin assessment in melanoma excisions; differentiating metastatic melanoma from nodal nevi.
- Pattern of positivity: Nuclear
- Sensitivity: 78 %
- Specificity: 100%
OCT-4: Clone change (January 4th, 2022)
Implemented 12/15/2021. MRQ-10 replaced the previous clone C-10 for OCT-4 antibody. Offered at both HMC and UWMC IHC labs.
This new source has been fully validated and approved by Dr. Tretiakova to be added for clinical use.
OCT-4
- BEAKER ordering code: OCT-4
- Clone: MRQ-10
- Pattern of positivity: Nuclear
- Clinical use: Seminoma and Embryonal Carcinoma
- Sensitivity: 100%
- Specificity: 100%
PAX8: New clone (November 3rd, 2021)
Implemented 11/1/2021. New clone for PAX8 antibody. BC12 replaced the previous clone MRQ-50 with significantly improved specificity. Offered at both HMC and UWMC IHC labs.
PAX8
- BEAKER ordering code: PAX8
- Clone: BC12
- Pattern of positivity: Nuclear
- Clinical use: thyroid, renal, pan-Mullerian marker
- Sensitivity: 100%
- Specificity: 100%
INSM1: New marker (November 3rd, 2021)
New antibody has been fully validated and approved by Dr. Tretiakova for clinical use.
INSM1
- Ordering code in BEAKER: INSM1
- Clone: A-8
- Clinical use: Universal marker of neuroendocrine differentiation
- Pattern of positivity: Nuclear
- Sensitivity: 95.9 %
- Specificity: 100%
SATB2: New source (June 20th, 2021)
Implemented 07/08/2021. New IVD source for SATB2 antibody which replaces the previous RUO source. The antibody is fully validated and approved by Dr. Tretiakova.
SATB2
- BEAKER ordering code: SATB2
- Clone: EP281
- Pattern of positivity: Nuclear
- Clinical use: Colorectal differentiation
- Sensitivity: 90.5%
- Specificity: 83%
CAMTA1: New marker (June 17th, 2021)
The following new IHC antibody has been validated and approved by Dr. Tretiakova for clinical use.
CAMTA1
- Ordering code in BEAKER: CAMTA1
- Clone: Polyclonal
- Clinical use: To diagnose or help exclude epithelioid hemangioendothelioma and differentiate from other vascular tumors (angiosarcoma or eipithelioid hemangioma) vs metastatic carcinoma.
- Pattern of positivity: Nuclear
- Sensitivity: 82 %
- Specificity: 100%
Pit-1, SF-1 and Tpit: New markers (May 7th, 2021)
Three new IHC antibodies are fully validated and have been approved by Dr. Tretiakova.
Pit-1
- Ordering code: Pit-1
- Clone: G-2
- Clinical use: This antibody will be used for definitive classification of pituitary adenomas. The antibody aids in the identification of pituitary adenoma subtypes which show aggressive clinical behavior.
- Pattern of positivity: Nuclear
- Sensitivity: 100%
- Specificity: 100%
SF-1 (Steroidogenic Factor)
- Ordering code: SF-1
- Clone: N1665
- Clinical use: This antibody will be used for definitive classification of sex cord-stromal tumors, adrenal cortical tumors and pituitary adenomas. The antibody aids in the identification of pituitary adenoma subtypes which show aggressive clinical behavior.
- Pattern of positivity: Nuclear
- Sensitivity: 95%
- Specificity: 100%
Tpit (TBX19)
- Ordering code: Tpit
- Clone: OT12G1
- Clinical use: This antibody will be used for definitive classification of pituitary adenomas. The antibody aids in the identification of pituitary adenoma subtypes which show aggressive clinical behavior.
- Pattern of positivity: Nuclear
- Sensitivity: 100%
- Specificity: 100%
SARS-CoV Spike: New marker (January 11th, 2021)
The following new IHC antibody has been validated and approved by Dr. Tretiakova to be added for clinical use.
SARS-CoV Spike
- Ordering code in PowerPath: IP COV-Spike
- Clone: Polyclonal
- Clinical use: To identify COVID 19 infected organs
- Pattern of positivity: Cytoplasmic
- Sensitivity: 75%
- Specificity: 100%
S100: Clone change (November 18th, 2020)
Implemented 11/12/2020 at both HMC and UW IHC lab.
The previous source of S100, offered as cocktail of clone [15E2E2 +4C4.9] from Biocare Medical, has been replaced with single clone [4C4.9] from the same manufacturer. The change was due to manufacturer’s discontinuation of cocktail antibody. The new source has been fully validated and has been approved by Dr. Tretiakova for clinical use.
S100, clone [4C4.9] Ordering code in PowerPath stays the same as before: IP S100 or IP S100-red
PRAME: New marker (September 10th, 2020)
The following new IHC antibody has been validated and approved by Dr. Tretiakova for clinical use.
PRAME
- Ordering code in PowerPath: IP PRAME-Red
- Clone: RBT_PRAME
- Clinical use: Diagnosis of melanoma vs benign nevi, margin assessment in melanoma excisions, differentiating metastatic melanoma from nodal nevi
- Pattern of positivity: Nuclear
- Sensitivity: 78%
- Specificity: 100%
Cathepsin K and Fumarate Hydratase: New markers (August 14th, 2020)
The following new IHC antibodies have recently been validated and approved by Dr. Tretiakova for clinical use.
Cathepsin K [3F9]
- Ordering code in PowerPath: IP Cathepsin K
- Clinical use: Angiomyolipomas (all types), translocation RCC (majority), MTOR/TSC mutated renal tumors including ESC-RCC and high grade oncocytic tumor, melanomas
- Pattern of positivity: cytoplasmic, membranous
- Sensitivity: 92%
- Specificity: 100%
Fumarate Hydratase [J-13]
- Ordering code in PowerPath: IP FH
- Clinical use: FH-deficient RCC; HLRCC (cutaneous and uterine leiomyomas, RCCs)
- Pattern of positivity: loss of cytoplasmic expression
- Sensitivity: 91%
- Specificity: 98.5%
Melan-A, HMB45, MiTF and Sox10 melanocytic markers: Red chromogen ONLY (July 30, 2020)
Implemented by end of July 2020 at both HMC and UWMC IHC lab.
The melanocytic markers Melan-A, HMB45, MiTF and Sox10 will be run with red chromogen ONLY. S100 is available with both brown and red chromogens. This change is due to a Dermatopathology service request and was approved by Drs. Chhieng and Tretiakova.
All the above markers have been re-validated and approved with red chromogen kit.
The available codes will be:
- IP Melan A-Red
- IP HMB45-Red
- IP MITF- Red
- IP SOX10-Red
- IP S100
- IP S100-Red
IP Prolactin: New source (July 01, 2020)
The previous source of Prolactin antibody from Biogenex has been replaced with a new source from Bio SB. This change was due to vendor's discontinuation of previous source.
The new source has been fully validated showing similar quality of staining as original source and has been approved by Dr. Tretiakova for clinical use.
Prolactin [PRL02]
- Ordering code in PowerPath: IP Prolactin
- Clone: PRL02
- Pattern of positivity: Cytoplasmic
- Sensitivity: 100 %
- Specificity: 100 %
- Source: IVD
Mesothelin [EP140]: New source (May 27th, 2020)
The previous source of Mesothelin antibody, from Vector Laboratories, has been replaced with a new source from Cell Marque. This change was due to vendor's discontinuation of previous source.
The new source has been fully validated showing similar quality of staining as original source and has been approved by Dr. Tretiakova for clinical use.
Mesothelin [EP140]
- Ordering code in PowerPath: IP Mesothelin
- Clone: EP140
- Pattern of positivity: Membranous
- Sensitivity: 100%
- Specificity: 84%
- Source: IVD
PSA [EP109]: Source change (April 1st, 2020)
This change was implemented as of April 1st, 2020 in both HMC and UWMC IHC labs.
PSA, polyclonal, from Agilent (Dako), catalog number A0562 replaced with a rabbit monoclonal source from Cell Marque. This change is due to vendor's discontinuation of current source.
The new source has been fully validated showing similar quality of staining as original source and has been approved by Dr. Tretiakova for clinical use.
PSA [EP109]
- Ordering code in PowerPath: IP PSA
- Clone: EP109
- Pattern of positivity: Cytoplasmic
- Sensitivity: 87%
- Specificity: 100%
- Source: IVD
Phospho TDP43: Source change (April 1st, 2020)
This change was implemented as of April 1st, 2020.
Phospho TDP43, from Millipore, catalog number MABN14 replaced with a different source of rat monoclonal source from BioLegend. This change is due to vendor's discontinuation of current source.
The new source has been fully validated showing similar quality of staining as original source and has been approved by Dr. Tretiakova for clinical use.
Phospho TDP43 (Ser409/410)[1D3/TDP-43]
- Ordering code in PowerPath: IP Phos TDP43
- Clone: 1D3
- Pattern of positivity: Cytoplasmic
- Sensitivity: 100%
- Specificity: 80%
- Clinical use: Diagnosis of TDP43 proteinopathies including FTLD-TDP + LATE (Limbic-predominant Age-related TDP-43 Encephalopathy)
HSV1 and HSV2 available (February 24th, 2020)
The following IHC antibodies have been validated and approved by Dr. Tretiakova for clinical use.
Herpes Simplex Virus 1 (HSV1)[10A3]
- Ordering code in PowerPath: "IP HSV1"
- Clinical use: Herpes Simplex 1 infection
- Pattern of Positivity: Cytoplasmic, Nuclear
- Sensitivity: 100%
- Specificity: 100%
Herpes Simplex virus 2 (HSV2)[BSB116]
- Ordering code in PowerPath: Herpes Simplex virus 2 (HSV2)[BSB116]
- Clone: "IP HSV2"
- Clinical use: Herpes Simplex 2 infection
- Pattern of Positivity: Cytoplasmic, Nuclear
- Sensitivity: 100%
- Specificity: 100%
CD20: Source change (January 3rd, 2020)
Implemented January 2nd, 2020 at UW IHC sites. Later implemented at HMC IHC sites.
CD20, clone L26, from Agilent (Dako), catalog number M0755 replaced with CD20, same clone from Cell Marque, catalog number 120M-86. This change is due to vendor's discontinuation of their antibody.
The new source has been fully validated showing similar quality of staining as original source and has been approved by Dr. Tretiakova for clinical use.
CD20 [clone L26]
- Ordering code in PowerPath: IP CD20
- Description: CD20 [L26]
- Pattern of Positivity: Membranous
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
Tri-Methyl-Histone H3 and ATRX available (December 16th, 2019)
The following IHC antibodies are validated and approved by Dr. Tretiakova for clinical use.
Tri-Methyl-Histone H3 (Lys27) [C36B11]
- Ordering code in PowerPath:"IP TrimethylH3"
- Clinical use: Confirmation for the diagnosis of diffuse midline gliomas (a new entity in the 2016 WHO with exceedingly poor prognosis); The identification and/or prognostication of posterior fossa ependymomas, malignant peripheral nerve sheath tumors, and aggressive meningioma subtypes.
- Pattern of Positivity:Loss of Nuclear Expression
- Sensitivity: 100%
- Specificity: 91%
ATRX [02A3]
- Ordering code in PowerPath: "IP ATRX"
- Clinical use: For classification of infiltrating gliomas and diagnosis according to the WHO guideline 2016.
- Pattern of Positivity:Loss of Nuclear Expression
- Sensitivity: 100%
- Specificity: 73%
HSVII: Antibody discontinued (October 3rd, 2019)
HSVII antibody has been discontinued by the vendor and all inventory has expired.
Myelin Basic Protein: New clone (August 26th, 2019)
The new clone of MBP antibody is available again for clinical use. The original source was previously discontinued by the vendor.
This antibody has been validated and approved by Dr Tretiakova to be added for clinical use.
MBP= Myelin Basic Protein [EP207]
- Ordering code in PowerPath: IP MBP
- Clinical use: Demyelination
- Pattern of Positivity: Parenchymal
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
CCR7: New antibody (August 5th, 2019)
The following new antibody has been validated and approved by Dr. Tretiakova and added for clinical use.
CCR7 [15053]
- Ordering code in PowerPath: IP CCR7
- Clinical use: Differential diagnosis of classical Hodgkin Lymphoma from other variants.
- Pattern of Positivity: Cytoplasmic, Membranous
- Sensitivity: 92%
- Specificity: 94%
- Source: RUO
MNDA: New antibody at SCCA (July 15th, 2019)
New IHC antibody added to the list of current antibodies available at SCCA. It has been validated and approved by Dr. Wood for clinical use.
MNDA antibody has two protocols. One protocol is for Tissue, Particle preps, BM aspirates and the second protocol is for decalcified tissue.
MNDA [253A] for Tissue, Particle preps, BM aspirates
- Ordering code in PowerPath: IP MNDA-SCCA
- Description: Myeloid Cell Nuclear Differentiation Antigen [253A]: SCCA
- Clinical use: May act as a transcriptional activator/repressor in the myeloid lineage. Plays a role in the granulocyte/monocyte cell-specific response to interferon. Stimulates the DNA binding of the transcriptional repressor protein YY1
- Pattern of Positivity: Expressed constitutively in cells of the myeloid lineage. Found in promyelocyte stage cells as well as in all other stage cells including peripheral blood monocytes and granulocytes. Also appear in myeloblast cells in some cases of acute myeloid leukemia.
- Sensitivity: 100%
- Specificity: 100%
MNDA [253A] for Decalcified tissue
- Ordering code in PowerPath: IP MNDA on BM
- Description: Myeloid Cell Nuclear Differentiation Antigen [253A] on decalcified bone marrows.
- Clinical use: May act as a transcriptional activator/repressor in the myeloid lineage. Plays a role in the granulocyte/monocyte cell-specific response to interferon. Stimulates the DNA binding of the transcriptional repressor protein YY1.
- Pattern of Positivity: Expressed constitutively in cells of the myeloid lineage. Found in promyelocyte stage cells as well as in all other stage cells including peripheral blood monocytes and granulocytes. Also appear in myeloblast cells in some cases of acute myeloid leukemia.
- Sensitivity: 100%
- Specificity: 100%
Progesterone Receptor: Clone change (February 8th, 2019)
Implemented February 11th, 2019.
Progesterone Receptor, clone PR88, from Biogenex, catalog number MU328-UC replaced with Progesterone Receptor, clone 16 from Leica, catalog number NCL-L-PGR-312.
This change was due to request from breast pathologists with a goal to provide PR antibody that is more commonly used by other institutions and show less interobserver variability as per CAP proficiency testing results, thus improving standards of care.
The new source has been fully validated showing superior quality of nuclear staining and has been approved by Dr. Tretiakova for clinical use.
Progesterone Receptor [clone 16]
- Ordering code in PowerPath: IP PR
- Description: Progesterone Receptor [16]
- Pattern of Positivity: Nuclear
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
LEF-1 (EPR2029Y): New antibody at SCCA (December 28th, 2018)
The new antibody has been validated and approved by Dr. Wood for clinical use.
LEF-1 (EPR2029Y):
- Ordering code in PowerPath: Lymphoid Enhancer Factor-1 [EPR2029Y]: SCCA
- Description: LEF-1 (Lymphoid enhancer binding factor) is transcription factor involved in proliferation and survival of B cells and T cells, which is up-regulated in almost all CLL/SLL, majority of Burkitt lymphoma and a subset of DLBCL. In control tissue (reactive lymph nodes and tonsils), only T cells show expression. Primary use it to help differentiate CLL/SLL from small B cell non-Hodgkin lymphomas, such as marginal zone lymphoma and mantle cell lymphoma.
- Sensitivity: 93%
- Specificity: 97%
- Source: IVD
Anti Histone H3.3 G34W: New antibody (June 13th, 2019)
The following new antibody is now available for clinical use. This antibody has been validated and approved by Dr Tretiakova for clinical use.
Anti HistoneH3.3 G34W or H3F3A G34W [ clone RM263]
- Ordering code in PowerPath: IP GCT H3F3
-
Clinical use: For accurate diagnosis of giant cell tumor of bone
Giant cell tumor of bone (GCTB) is a locally aggressive primary bone tumor with a very high recurrence rate. Recently, a single driver mutation has been identified in 95% of GCTB affecting the H3F3A gene coding for the histone variant H3.3 (H3.3-G34W). Positive nuclear staining with the H3F3A G34W antibody is highly sensitive and specific for the mutation and serves as a powerful diagnostic tool for GCTB to differentiate it from its mimics.
- Pattern of Positivity: Nuclear
- Sensitivity: 91-96%
- Specificity: 95-98%
- Source: RUO
TLE-1: Antibody retired (May 16th, 2019)
Antibody against TLE-1 recently discontinued by vendor will not be re-validated due to low diagnostic value and suboptimal specificity. This message has been approved by Dr Tretiakova.
SDHB: New antibody (April 8th, 2019)
The following new antibody is available now for clinical use. This antibody has been validated and approved by Dr Tretiakova to be added for clinical use.
SDHB (= Succinate Dehydrogenase Subunit B) [21A11AE7]
- Ordering code in PowerPath: IP SDHB
- Clinical use: SDH-deficient tumors (syndromic and sporadic): Pheochromacytomas/paragangliomas, Renal cell carcinomas, pituitary adenoma, GIST, pulmonary chondroma (Carney Triad); PMID: 30217041, 29779206, 29239034
- Pattern of Positivity: Loss of cytoplasmic granular expression
- Sensitivity: 71.4%
- Specificity: 94.8%
- Source: RUO
Progesterone Receptor: Clone Change (February 8th, 2019)
Implemented February 11th, 2019.
Progesterone Receptor, clone PR88, from Biogenex, catalog number MU328-UC replaced with Progesterone Receptor, clone 16 from Leica, catalog number NCL-L-PGR-312.
This change was due to request from breast pathologists with goal to provide PR antibody that is more commonly used by other institutions and show less interobserver variability as per CAP proficiency testing results, thus improving standards of care.
The new source has been fully validated showing superior quality of nuclear staining and has been approved by Dr. Tretiakova for clinical use.
Progesterone Receptor [clone 16]
- Ordering code in PowerPath: IP PR
- Description: Progesterone Receptor [16]
- Pattern of Positivity: Nuclear
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
LEF-1: New antibody at SCCA (December 28th, 2018)
New IHC antibody added to the list of current antibodies available at SCCA. The new antibody has been validated and approved by Dr. Wood for clinical use.
LEF-1 (EPR2029Y)
- Ordering code in PowerPath: IP LEF-1: Lymphoid Enhancer Factor-1 [EPR2029Y]: SCCA
- Description: LEF-1 (Lymphoid enhancer binding factor) is transcription factor involved in proliferation and survival of B cells and T cells, which is up-regulated in almost all CLL/SLL, majority of Burkitt lymphoma and a subset of DLBCL. In control tissue (reactive lymph nodes and tonsils), only T cells show expression. Primary use it to help differentiate CLL/SLL from small B cell non-Hodgkin lymphomas, such as marginal zone lymphoma and mantle cell lymphoma.
- Sensitivity: 93%
- Specificity: 97%
CD7 (LP15): New antibody at SCCA (December 28th, 2018)
New antibody added to the list of current antibodies available at SCCA. It has been validated and approved by Dr. Wood for clinical use.
CD7 (LP15)
- Ordering code in PowerPath: IP CD7 [LP15]: UWMC, SCCA
- Clinical use: Clinical use includes but is not limited to the identification of neoplastic and non-neoplastic T and NK cell populations and some neoplastic myeloid proliferations.
- Pattern of Positivity: Membranous reactivity on T and NK cells.
- Sensitivity: 100%
- Specificity: 100%
CD2 (AB75): New antibody at SCCA (December 28th, 2018)
New antibody added to the list of current antibodies available at SCCA. It has been validated and approved by Dr. Wood for clinical use.
CD2 (AB75)
- Ordering code in PowerPath: IP CD2
- Clinical use: Clinical use includes, but is not limited to the identification of neoplastic and non-neoplastic T and NK cell populations and differentiating between neoplastic and non-neoplastic mast cell proliferations.
- Pattern of Positivity: Membranous reactivity on T and NK cells.
- Sensitivity: 100%
- Specificity: 100%
Congo Red Special Stain Kit Formula and Tissue Section Thickness Change (December 14th, 2018)
The vendor has discontinued the old product and introduced a new and optimized formulation to improve kit performance and staining consistency. During in-house optimization and mini validation process, the best staining results were achieved when changing the section thickness from 10 microns to 8 microns. This is in agreement with the vendor's specification sheet.
The new kit and section thickness have been validated on different tissue types such as cardiac muscle, kidney, skeletal muscle, and brain sections and has been reviewed and approved by Dr. Luis Gonzalez-Cuyar for clinical use. Selected slides were also reviewed by additional faculty members.
Please note that the automated staining protocols are now the same at both sites and that as with other special stains we retain manual staining protocols in case of equipment failure.
CEA (Polyclonal): Antibody Discontinued (December 11th, 2018)
CEA (Polyclonal) antibody has been discontinued by the vendor and all remaining inventory has been used up. The ordering code for this antibody was inactivated.
Monoclonal CEA antibody clone II-7 is still available.
Validation of IHC stains on post bleached slides (November 27th, 2018)
Due to physician request a mini-validation was completed on the effect of melanin bleaching for immunohistochemical studies of heavily pigmented lesions using Potassium Permanganate and Oxalic Acid protocol.
This rapid method is validated and works efficiently for the majority of tested immune markers, however these chemicals can cause significant reduction or loss of expression of some antigens (i.e. Synaptophysin, Melan A red, Neu N, but not HMB45 or S100). Therefore each patients' case should be accompanied by two positive controls: one treated with bleaching solution and one regular control for comparison of possible antigenicity reduction.
When requesting IHC studies on post bleached slide, to ensure both Histology and IHC staff are aware of your special request, add clear instruction for each antibody code that needs to be bleached prior to IHC staining such as "remove melanin prior to IHC staining".
BAP1: New antibody (October 1st, 2018)
The following new antibody is available now for clinical use. This antibody has been validated and approved to be added for clinical use.
BAP1 (or BRCA1 associated protein-1) [BSB-109]
- Ordering code in PowerPath: IP BAP1
- Clinical use: Mesothelioma, Renal Cell Carcinoma, Uveal Melanoma
- Pattern of Positivity: Nuclear (loss of expression)
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
CD56 (MRQ-42): New antibody at SCCA (September 27th, 2018)
The new antibody has been validated and approved by Dr. Wood for clinical use.
CD56 (MRQ-42)
- Ordering code in PowerPath: IP CD56
- Clinical use: Includes, but is not limited to, evaluation of neuroendocrine and mature NK/T cell neoplasms and to differentiation between reactive and neoplastic plasma cell, plasmacytoid dendritic cell, and monocytic proliferations.
- Pattern of Positivity: CD56 is normally expressed on NK cells, a subset of T cells, and neuroendocrine tissue. In addition, it can be aberrantly expressed in the setting of plasma cell neoplasms, myeloid neoplasms, and blastic plasmacytoid dendritic cell neoplasms.
- Sensitivity: 100%
- Specificity: 100%
Universal IHC orders-Go Live (September 7th, 2018)
The project of Universal IHC orders in PowerPath which was presented and discussed at the faculty meeting in August 27th went live on Monday morning, September 10th.
A summary of new features of universal orders are as follows:
- Improved navigation for search of antibody, clone and performing sites
- Option for site-specific order or automated order for optimal triaging of IHC orders and improved TAT
- Re-configured reporting table combining results from UWMC, HMC and SCCA orders
- Enhanced and standardized antibody descriptors (comprehensive information, common antigen names, antibody clones)
- Uniform format of tables and disclaimers (FDA and controls) across all performing sites
CD21: New Antibody at SCCA (July 17th, 2018)
The new antibody has been validated and approved by Dr. Wood for clinical use.
CD21 ( clone 1F8)
- Ordering code in PowerPath: sccaip CD21
- Clinical use: Assessment of follicular dendritic meshworks, diagnosis of follicular dendritic sarcoma
- Pattern of Positivity: Follicular dendritic meshworks will be positive for CD21 in normal nodal or extranodal lymphoid tissue
- Sensitivity: 100%
- Specificity: 100%
CRP, LFABP and DNAJB9: New Antibodies (July 12th, 2018)
Three new antibodies are available now for clinical use. All of them have been validated and have been approved by Dr Tretiakova to be added for clinical use.
CRP ( Anti-C Reactive Protein) [Y284]
- Ordering code in PowerPath: IP CRP
- Clinical use: For subtyping of Hepatocellular Adenoma
- Pattern of Positivity: Cytoplasmic
- Sensitivity: 100%
- Specificity: 100%
- Source: RUO
LFABP (Liver Fatty Acid Binding Protein- N terminal) [polyclonal]
- Ordering code in PowerPath: IP LFABP
- Clinical use: For subtyping of Hepatocellular Adenoma
- Pattern of Positivity: Nuclear/Cytoplasmic
- Sensitivity: 100%
- Specificity: 100%
- Source: RUO
DNAJB9 [polyclonal] by Immunohistochemistry
- Ordering code in PowerPath: IP DNAJB9
- Clinical use: Useful marker in diagnosis of DNAJB9 positive fibrillary glomerulonephritis on formalin fixed kidney
- Pattern of Positivity: Membranous
- Sensitivity: 100%
- Specificity: 100%
- Source: RUO
Standardized Histochemical Stain Protocols (June 15th, 2018)
Effective Monday June 18th, histochemical stain protocols are standardized across our histology labs for each of our most common special stains. Comparison validations were run for each site's special stain protocols and a final choice for each special stain was reviewed by the team and approved for implementation at both sites.
This change aligns well with departmental efforts to standardize protocols across sites and will also allow for a more efficient site back up for unforeseen circumstances (e.g. equipment failure, reagent issues, etc) while maintaining consistent assay quality. Lastly, these combined efforts will save technologist time at different stages of the process, decrease errors associated with hand labeling of slides, and improve overall turn around time.
p16 Antibody: New source (May 31st, 2018)
This antibody is replacing the old source of p16 [E6H4]- CINTEC 9517 from Roche/Ventana. The old source is discontinued by vendor as a class I antibody. The new source has been fully validated and has been approved by Dr. Tretiakova for clinical use.
P16 [16PO4,JC2]
- Ordering code in PowerPath: IP p16
- Clinical use: p16 is a surrogate marker for HPV infection-driven neoplasia in various sites (cervix, oropharynx, anus etc).
- Pattern of Positivity: Nuclear/Cytoplasmic
- Sensitivity: 100%
- Specificity: 99%
- Source: IVD
CXCL13, HGAL and MUM1: New antibodies at SCCA (April 5th, 2018)
Three new IHC antibodies added to the list of current antibodies available at SCCA. The new antibodies have been validated and approved by Dr. Wood for clinical use.
CXCL13 ( clone 53610)
- Ordering code in PowerPath: sccaip CXCL13
- Clinical use: Follicular T cells
- Pattern of Positivity: Cytoplasmic
- Sensitivity: 95%
- Specificity: 100%
HGAL (clone MRQ-49)
- Ordering code in PowerPath: sccaip HGAL
- Clinical use: B cell lymphomas of germinal center origin
- Pattern of Positivity: Cytoplasmic
- Sensitivity: 95%
- Specificity: 95%
MUM1 (clone MUM1p)
- Ordering code in PowerPath: sccaip MUM1
- Clinical use: MUM-1 (Multiple myeloma -1) is a transcription factor (nuclear stain) that regulates B cell development and activation (also referred to as IRF4 / Interferon Regulatory Factor 4). MUM1 can be seen in some normal post germinal center B cells, a subset of activated T cells, and a small subset of later stage, light zone germinal center B cells (mutually exclusive with CD10/BCL6 expression). It is also positive in plasma cells (and plasma cell neoplasms), classical Hodgkin lymphoma, and some B and T cell non-Hodgkin lymphomas. It is primarily used as part of the Han's algorithm in the cell of origin assessment of diffuse large B cell lymphoma. MUM1 is expressed in normal and neoplastic melanocytes but typically negative in other cell types.
- Pattern of Positivity: Nuclear
- Sensitivity: 94%
- Specificity: 100%
IgG subtypes IgG1,IgG2, IgG3 and IgG4: New IF antibodies (February 1st, 2018)
The following new immunofluorescence antibodies are available now for clinical use. All these antibodies have been validated and have been approved by Dr. Tretiakova.
IgG subtypes: IgG1,IgG2, IgG3 and IgG4 by immunofluorescence methodology
-
Ordering code in PowerPath: "IF IgG subtypes" which will order all 4 antibodies included in the panel. Individual codes also has been set up for ordering them separately if needed. The individual codes are as follows:
1- IF IgG1= IgG1 [8c/6-39] by IF
2- IF IgG2= IgG2 [HP-6014] by IF
3- IF IgG3= IgG3 [HP-6050] by IF
4- IF IgG4= IgG4 [HP-6025] by IF
- Clinical use: This panel helps to discriminate between the primary vs secondary forms of membranous nephropathy. This is also used for diagnosis of monoclonal IgG deposition.
- Pattern of Positivity: Granular peripheral capillary wall
- Sensitivity: 83%
- Specificity: 71%
- Source: RUO
H3 K27M, Brachyury [EPR18113], DNAJB9: New antibodies (January 22nd, 2018)
The following new antibodies are available now for clinical use. All these antibodies have been validated and have been approved by Dr. Tretiakova.
H3 K27M (Anti Histone H3, K27M mutant) [polyclonal]
- Ordering code in PowerPath: IP H3K27M
- Clinical use: To diagnose a new subset of diffuse Gliomas (diffuse Midline Glioma, H3 K27 mutant)
- Pattern of Positivity: Nuclear
- Sensitivity: 95%
- Specificity: 100%
- Source: RUO
Brachyury [EPR18113]- offered now at both HMC and UWMC site
- Ordering code in PowerPath: IP Brachy
- Clinical use: To distinguish Chordoma from other epithelioid neoplasms.
- Pattern of Positivity: Nuclear
- Sensitivity: 100%
- Specificity: 100%
- Source: RUO
DNAJB9 [polyclonal] by indirect immunofluorescence
- Ordering code in PowerPath: IF DNAJB9
- Clinical use:Useful marker in diagnosis of DNAJB9 positive fibrillary glomerulonephritis on frozen kidney
- Pattern of Positivity: Glomerular basement membrane staining
- Sensitivity: 100%
- Specificity: 100%
- Source: RUO
Villin: New source (December 18th, 2017)
A new source of Villin antibody which was previously discontinued by the vendor is now available in IHC lab for clinical use. This antibody is replacing the old source of Villin [ID2C3]- PN IM0258 from Beckman Coulter.
The new source has been fully validated and has been approved by Dr. Tretiakova for clinical use.
Villin [CWWB1]
- Ordering code in PowerPath: IP Villin
- Clinical use: Villin antibody labels the luminal brush border area in the GI mucosal epithelium as well as normal kidney. This diagnostic marker is useful in differentiating adenocarcinomas with intestinal and canalicular differentiation from carcinomas of other origins.
- Pattern of Positivity: Cytoplasmic/Membranous
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
TCR delta, Brachyury, CD25, MiTF: New antibodies (December 5th, 2017)
UWMC IHC lab is now offering new sources of antibodies for TCR delta, Brachyury, CD25 and MiTF for clinical use. All these antibodies have been validated and have been approved by Dr. Tretiakova for clinical use.
TCR delta (Tcell receptor delta) [H-41]
- Ordering code in PowerPath: IP TCR delta
- Clinical use: Identification of gamma/delta Tcells in T-cell Lymphoma workup.
- Pattern of Positivity: Membranous
- Sensitivity: 100%
- Specificity: 100%
- Source: RUO
Brachyury [EPR18113]
This antibody is replacing the old source of Brachyury (H-210)- sc-20109 that was previously discontinued by vendor.
- Ordering code in PowerPath: IP Brachy
- Clinical use: To distinguish Chordoma from other epithelioid neoplasms.
- Pattern of Positivity: Nuclear
- Sensitivity: 100%
- Specificity: 100%
- Source: RUO
CD25 [4C9]
This antibody is replacing the old source of CD25 [4C9], from Leica/Novocastra NCL-CD25-305, that was previously discontinued by vendor.
- Ordering code in PowerPath: IP CD25
- Clinical use: CD25, Interleukin-2 receptor alpha chain, is the alpha subunit of the cell surface receptor which regulates regulatory T-cells. CD25 has been detected in various hematological malignancies including adult T-cell Leukemia/Lymphoma, and Hairy Cell Leukemia.
- Pattern of Positivity: Membranous
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
MiTF (Microphthalmia Transcription Factor) [C5/D5]
This antibody is replacing the old source of MiTF [C5+D5], from Invitrogen 18-0369, that was previously discontinued by vendor.
- Ordering code in PowerPath: IP MiTF
- Clinical use: MiTF is a transcription factor implicated in pigmentation, bone development and in mast cells. This antibody has been useful in identifying malignant melanoma and distinguishing mast cell lesions from lesions of myeloid derivation.
- Pattern of Positivity: Nuclear
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
CMV stain back at UW IHC lab (October 16th, 2017)
The IHC stain for CMV which was temporarily routed to SCCA Pathology lab starting Sept 14th, has been troubleshooted and it is offered again at UW IHC lab. New sets of positive controls have been successfully validated and the antibody's performance has been verified.
HHV8: Source Change (August 21st, 2017)
The previous source of Human Herpes Virus 8, clone 13B10, from Leica has been replaced with the same clone from Cell Marque. The change is due to previous vendor's discontinuation of their antibody.
The new source has been fully validated and has been approved by Dr Tretiakova for clinical use.
- Ordering code in PowerPath: IP HHV8
- Pattern of Positivity: Nuclear
- Sensitivity: 100%
- Specificity: 100%
- Source: ASR
Hepatitis B Surface A: Clone change (August 21st, 2017)
The previous source of Hepatitis B surface Antigen, clone S1-210, from Cell Marque has been replaced with clone A10F1 from the same vendor. The change is due to manufacturer discontinuation of previous clone.
The new source has been fully validated and has been approved by Dr. Tretiakova for clinical use.
- Ordering code in PowerPath: IP Hep B Surf
- Pattern of Positivity: Cytoplasmic
- Sensitivity: 100%
- Specificity: 100%
- Source: ASR
Brachyury Antibody: Discontinued (August 10th, 2017)
Brachyury antibody, Santa Cruz sc-20109 is discontinued by the vendor and all inventory has expired.
PDL1 (E1L3N): New test (August 7th, 2017)
A new IHC test has been added to the list of current antibodies. The new antibody is validated and approved by Dr. Tretiakova for clinical use. This antibody was validated in comparison with 3 other FDA-approved PD-L1 antibodies (clones 22C3, 28.8 and SP142) and showed highly concordant results.
PDL1 ( clone E1L3N)
- Ordering code in PowerPath: IP PDL1
- Clinical use: Hodgkin lymphomas, melanomas, NSCLC, advanced bladder cancer, RCC etc
- Pattern of Positivity: Membranous
- Sensitivity: up to 90%
- Specificity: 100%
- Source: RUO
MITF and Mesothelin (K1) antibody: Temporarily discontinued (August 7th, 2017)
MITF and Mesothelin (K1) antibody is discontinued by the vendor and all current inventory has expired.
PHF TAU, BAP 1-16, PHF TDP43: New tests (July 25th, 2017)
Three new IHC antibodies have been added to the list of current antibodies. The new antibodies are validated and approved by Dr. Tretiakova for clinical use.
PHF TAU ( clone AT8)
- Ordering code in PowerPath: IP PHF TAU
- Clinical use: Staging of Alzheimer's disease and differential diagnosis of neurodegenerative disease.
- Pattern of Positivity: Inclusions
- Sensitivity: 100%
- Specificity: 100%
Beta Amyloid,1-16 (clone 6E10)
- Ordering code in PowerPath: IP BAP 1-16
- Clinical use: This antibody will be used to identify diffuse plaques and Cerebral Amyloid Angiopathy in cases of spontaneous lobar hemorrhage and CAA-related angiitis (neurosurgical specimens) and to diagnose and stage Amyloid pathology in cases of suspected Alzheimer's disease. This antibody is also used in the Acute Axonal injury.
- Pattern of Positivity: Inclusions (plaques)
- Sensitivity: 100%
- Specificity: 100%
Phospho TDP43 (clone 1D3)
- Ordering code in PowerPath: IP PHF TDP43
- Clinical use: This antibody will be used in diagnosis of TDP43 apathies including Fronto-Temporal Lobar Degneration associated with TDP pathology or Hippocampal Sclerosis associated with TDP Pathology.
- Pattern of Positivity: Nuclear, Cytoplasmic, Perinuclear and Nuclear Variation
- Sensitivity: 100%
- Specificity: 100%
Neurofilament (2F11): New source (July 25th, 2017)
The previous source of Neurofilament antibody (clone 2F11) from Dako has been replaced with another IVD source from Cell Marque.
The new source has been fully validated for both sites and has been approved by Dr. Tretiakova for clinical use.
Neurofilament (clone 2F11)
- Ordering code in PowerPath: IP Neurofilamnt
- Pattern of Positivity: Cytoplasmic
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
MYOD1: New source (July 11th, 2017)
The previous RUO source for MYOD1 (clone EPR6653) has been replaced with an IVD source from Cell Marque.
The new source has been fully validated and has been approved by Dr. Tretiakova for clinical use.
MYOD1 (clone EP212)
- Ordering code in PowerPath: IP MYOD
- Pattern of Positivity: Nuclear
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
CD35: New Source (June 30th, 2017)
The previous vendor discontinued clone of CD35 (clone RLB25) has been replaced with a different source and clone.
The new source has been fully validated and have been approved by Dr. Tretiakova to be added for clinical use.
CD35 (clone EP197)
- Ordering code in PowerPath: IP CD35
- Pattern of Positivity: Cytoplasmic and Membranous
- Sensitivity: 100%
- Specificity: 100%
- Source: IVD
Low Volume antibodies retired (April 27th, 2017)
Effective April 30th, 2017, low volume antibodies (ordered <12 per year) will no longer be offered at UWMC or HMC IHC lab. Maintenance and validation for these antibodies is costly and they expire before they can be used completely. Their discontinuation has minimal diagnostic impact.
This decision has been discussed with service leaders and clinical faculty. It has been reviewed and approved by Tretiakova, IHC lab Section Director and Vickie Johncox, Administrative Director.
Deactivated LIS special stain order codes (April 18th, 2017)
Effective April 19, 2017, PCS decativated a limited set of special stain order codes. This change facilitates Dako Artisan Link integration. This change was reviewed and approved by Vickie Johncox, SCT(ASCP)cm, Administrative Director; Bernadine Jocson, Anatomic Pathology Supervisor; and Farinaz Shokri, Clinical Laboratory Supervisor.
Deactivated Special Stain Order
Discontinuation of auto generated ICC/IHC recuts (March 23rd, 2017)
Effective March 23rd, 2017, H&E recuts will no longer have an automatically generated order within PowerPath when ordering immunohistochemical and immunocytochemical stains.
This change is reviewed and approved by Dr. Swanson, UWMC Section Director; Dr. Tretiakova, IHC Section Director; Dr. Hoch, Histology Section Director; and Dr. Schmechel, HMC Section Director.
The rationale for this change is preserving tissue in small biopsy blocks for molecular and other studies along with reduction of workload for our histology labs. The sign-out Pathologist may still separately order the H&E recut if it is needed for patient care.
Associated Tests
Code | Name | Specimen | Comments |
---|---|---|---|
669 | MSI by IHC | Cancer tissue |
Last updated 2025-02-06T17:28:58.799159+00:00