IMMUNOHISTOCHEMISTRY (IHC) STAIN

Category

Anatomic Pathology

Sub Category

Surgical/ Histopathology

Synonyms/Aliases

IHC 1 Marker; IHC Single Marker; IHC 2 Markers; IHC 3 Markers; IHC 4 Markers; IHC 5 Markers; IHC 6 Markers; IHC 7 Markers; IHC 8 Markers; IHC 8+ Markers.

Abbreviations

IHC

Type

Individual Tests.

7-14 Days

Results Ready in 7-14 Days

Method

Immunostain (± Reporting)

Temp

Room temperature; refrigerated is also acceptable.

Setup

Mon-Fri

Components Parameters

N/A

Pre-analytic Considerations

N/A

Test Ordering Instructions

Fill out test request form fully & legibly. Provide your contact information & complete history. H&E report required.

Patient preparation

N/A

Sample type

Formalin Fixed, Paraffin Embedded Blocks.

Container/ preservative

Formalin Fixed, Paraffin Embedded Blocks.

Sample volume

Residual tissue must be available on the block.

Rejection criteria

Labeling Issue (Unlabeled/ Mislabeled); Missing Request Form; Mismatch Between Request Form & Sample Details; Wrong Sample Type Or Fixative; Insufficient/ Depleted Sample.

Other Instructions

Routinely, staining & reporting service is offered; however, stain & return service (IHC staining only without interpretation) is available for pathologists for interpretation & reporting at their end. Test may not be performed if no indication is found as determined by the reviewing pathologist. Ancillary tests may be indicated at additional cost as determined by the reviewing pathologist..

Reference intervals

N/A

Clinical Utility

Variable E.g. Diagnosis/ Confirmatory/ Subtyping (E.g. Lymphoid Markers For Confirmation & Subtyping Of Lymphomas; Cytokeratin For Carcinomas; Myogenin Or Desmin For Sarcomas; S100 For Melanomas Etc.); Theranostic Or Prediction Of Response To Targeted Therapy (E.g. ER, PR Results Can Predict Response To Hormonal Therapy; HER2 Results For Response To Herceptin); Prognostic.

Test Limitations/ Confounders

Cost depends on number of IHC markers (resident pathologist available to give advice).

KIDNEY BIOPSY IMMUNOFLUORESCENCE STAIN

Category

Anatomic Pathology

Sub Category

Surgical/ Histopathology

Synonyms/Aliases

renal biopsy immunofluorescence stain

Abbreviations

IF

Type

Individual Test

Result

Results will be ready after 14 days

Method

Immunofluorescence Stain & Reporting

Temp

Transported temprature be at room temperature; refrigerated is also acceptable.

Setup

Mon-Fri All working Days

Components Parameters

N/A

PRE-ANALYTIC CONSIDERATIONS

:

Test Ordering Instructions

Fill out test request form fully & legibly. provide your contact information & complete history. h&e report required.

Patient preparation

N/A

Sample type

Renal biopsy immediately placed in michel's medium/ zeus fixative. confirm that the specimen is immersed in the fixative. label should contain at least 2 patient identifiers, sample & fixative type.

Container/ preservative

Renal biopsy immediately placed in michel's medium/ zeus fixative. confirm that the specimen is immersed in the fixative. label should contain at least 2 patient identifiers, sample & fixative type.

Sample volume

specimen must contain Glomeruli at assessment.

Rejection criteria

Labeling issue (unlabeled/ mislabeled); missing request form; mismatch between request form & sample details; wrong sample type or fixative (formalin fixed samples will be rejected for if studies); empty sample containers.

Other Instructions

This is not a standalone diagnostic test; it should be ordered alongside light microscopy (histopathology examination, h&e stain); electron microscopy, em studies may occasionally be required (samples for em should be in glutaraldehyde as fixative). at collection, aim for ≥3 biopsy specimens & place one in 10% neutral buffered formalin, another in michel's medium & the other in glutaraldehyde. if glomeruli are found to be absent, if studies will be inconclusive.

Reference intervals

N/A

Clinical Utility

Diagnostic or confirmatory

Test Limitations/ Confounders

N/A

MISMATCH REPAIR PROTEIN, IHC

Category

Anatomic Pathology

Sub Category

Surgical/ Histopathology

Synonyms/Aliases

Mismatch Repair (MMR) Protein, IHC

Abbreviations

MMR, IHC

Type

profile/ panel (bundled tests)

Result

Results will be ready after 14 days

Method

immunostain & reporting

Temp

Transported temprature be at room temperature; refrigerated is also acceptable.

Setup

Mon-Fri All working Days

Components Parameters

MSH2, MSH6, MLH1, PMS2mismatch repair proteins

PRE-ANALYTIC CONSIDERATIONS

:

Test Ordering Instructions

Fill out test request form fully & legibly. provide your contact information & complete history. h&e report required.

Patient preparation

N/A

Sample type

Formalin fixed paraffin embedded blocks/ stained slides only

Container/ preservative

Formalin fixed paraffin embedded blocks/ stained slides only

Sample volume

Residual tissue must be available on the block

Rejection criteria

Labeling issue (unlabeled/ mislabeled); missing request form; mismatch between request form & sample details; wrong sample type or fixative; insufficient/ depleted sample.

Other Instructions

N/A

Reference intervals

N/A

Clinical Utility

Evaluation/ Screening Of Lynch Syndrome Or Hereditary Non-polyposis Colorectal Cancer (HNPCC).

Test Limitations/ Confounders

Positive Results Require Follow Up Microsatellite Instability (Msi) Testing For Quantification In Order To Distinguish Between High & LowMSI. High MSI Is Associated With Poorer Prognosis.

PROGRAMMED DEATH LIGAND 1, IMMUNOHISTOCHEMISTRY

Category

Anatomic Pathology

Sub Category

Surgical/ Histopathology

Synonyms/Aliases

PD-L1 IMMUNOHISTOCHEMISTRY

Abbreviations

PD-L1 IHC; PDL1 IHC

Type

Individual Test

Result

Results will be ready after 14 days

Method

immunostain & reporting

Temp

Transported temprature be at room temperature; refrigerated is also acceptable.

Setup

Mon-Fri All working Days

Components Parameters

N/A

PRE-ANALYTIC CONSIDERATIONS

:

Test Ordering Instructions

Fill out test request form fully & legibly. provide your contact information & complete history. h&e report required.

Patient preparation

N/A

Sample type

Formalin fixed paraffin embedded blocks/ stained slides only

Container/ preservative

Formalin fixed paraffin embedded blocks/ stained slides only

Sample volume

residual tissue must be available on the block

Rejection criteria

Labeling issue (unlabeled/ mislabeled); missing request form; mismatch between request form & sample details; wrong sample type or fixative; insufficient/ depleted sample.

Other Instructions

N/A

Reference intervals

N/A

Clinical Utility

Theranostic / Predictive for resonse to PD-l1 targeted therapy e.g. Pembroluzimab (Keytruda).

Test Limitations/ Confounders

N/A

SECOND OPINION (SLIDES AND BLOCKS)

Category

Anatomic Pathology

Sub Category

Surgical/ Histopathology

Synonyms/Aliases

Histopathology Second Opinion Consultation; Surgical Pathology Second Opinion Consultation.

Abbreviations

N/A

Type

Individual Test

Result

N/A

Method

Microscopy and Reporting

Temp

Transported temprature be at room temperature; refrigerated is also acceptable.

Setup

Mon-Fri All working Days

Components Parameters

N/A

PRE-ANALYTIC CONSIDERATIONS

:

Test Ordering Instructions

completely filled request form, any prior diagnosis report, specific diagnostic requests

Patient preparation

N/A

Sample type

Formalin fixed paraffin embedded blocks/ stained slides only

Container/ preservative

Formalin fixed paraffin embedded blocks/ stained slides only

Sample volume

residual tissue must be available on the block

Rejection criteria

Labeling issue (unlabeled/ mislabeled); missing request form; mismatch between request form & sample details; wrong sample type or fixative; insufficient/ depleted sample; broken slides.

Other Instructions

Wet/ unprocessed tissue cannot be submitted for second opinion. If submitted, this is a primary evaluation and test will be registered as histology small/ medium/ large specimen as applicable. If indicated (as determined by the reviewing pathologist), ancillary tests will also be ordered at additional cost.

Reference intervals

N/A

Clinical Utility

diagnostic or confirmatory

Test Limitations/ Confounders

N/A

TISSUE BLOCK/ SLIDE ISSUANCE

Category

Anatomic Pathology

Sub Category

Surgical/ Histopathology

Synonyms/Aliases

N/A

Abbreviations

N/A

Type

N/A (procedure)

Result

N/A

Method

N/A

Temp

N/A

Setup

Mon-Fri All working Days

Components Parameters

N/A

Pre-analytic Considerations

N/A

Test Ordering Instructions

Completely filled tissue block/slide issuance form by the patient, a legal guardian or authorized patient representative. The form will be issued by lab/ front office staff.

Patient preparation

N/A

Sample type

Paraffin embedded blocks/ slides

Container/ preservative

N/A

Sample volume

N/A

Rejection criteria

Slides/ blocks already previously collected; non-authorized patient representative.

Other Instructions

Proof may be required that a patient representative is authorized. Details of the collector will be obtained.

Reference intervals

N/A

Clinical Utility

Provides diagnosis for diseases, from benign to malignant.

Test Limitations/ Confounders

N/A

ER, PR, HER2 IMMUNOHISTOCHEMISTRY (IHC) PANEL

Category

Anatomic Pathology

Sub Category

Surgical/ Histopathology

Synonyms/Aliases

Breast Biomarker Testing; ER, PR, HER2/NEU; ER, PR, ERBB2. HER2 Is Also Known As C-ERBB2, ERBB2, HERCEPT Test.

Abbreviations

ER, PR, HER2

Type

Profile/ panel (bundled tests)

7-14 Days

Results Ready in 7-14 Days

Method

Immunostain (± Reporting)

Temp

Room temperature; refrigerated is also acceptable.

Setup

Mon-Fri

Components Parameters

3 Ihc Markers I.e. Estrogen Receptor (ER), Progesterone Receptor (PR) & Human Epidermal Growth Factor Receptor 2 (HER2).

Pre-analytic Considerations

N/A

Test Ordering Instructions

Fill out test request form fully & legibly. Provide your contact information & complete history. H&E report required.

Patient preparation

N/A

Sample type

Formalin Fixed, Paraffin Embedded Blocks.

Container/ preservative

Formalin Fixed, Paraffin Embedded Blocks.

Sample volume

Residual tissue must be available on the block.

Rejection criteria

Labeling Issue (Unlabeled/ Mislabeled); Missing Request Form; Mismatch Between Request Form & Sample Details; Wrong Sample Type Or Fixative; Insufficient/ Depleted Sample.

Other Instructions

Each of the markers can also be ordered individually.

Reference intervals

Not Applicable

Clinical Utility

Prognostic / Theranostic

Test Limitations/ Confounders

HER2 testing using Fluorescent in SITU Hybridization (fish) is indicated for equivocal (2+) HER2 results on IHC. For optimal results, the wet tissue (primary specimen) should be fixed in Formalin within 30 minutes of removal from the patient and the duration of fixation should be within 6-72 hours (I.e. Not less than 6 hours and not more than 72 hours) to avoid false negative results.

HISTOLOGY, SMALL SPECIMEN

Category

Anatomic Pathology

Sub Category

Surgical/ Histopathology

Synonyms/Aliases

Histopathology Consultation, Wet/ Unprocessed Tissue; Surgical Pathology Consultation, Wet/ Unprocessed Tissue.

Abbreviations

N/A

Type

Individual Test

7-14 Days

Results Ready in 7-14 Days

Method

Grossing, Tissue Processing, Staining And Microscopy

Temp

Room temperature; refrigerated is also acceptable.

Setup

Mon-Fri

Components Parameters

N/A

Pre-analytic Considerations

N/A

Test Ordering Instructions

Fill Out Test Request Form Fully & Legibly. Provide Your Contact Information & Complete History Including Suspected Diagnosis & Relevant Investigation Details (Lab, Imaging). Specify The Exact Sample Type, Procedure Done, Anatomic Site, Laterality Where Applicable (E.g. Left Vs Right) And The Fixative Used.

Patient preparation

N/A

Sample type

A Variety Of Specimens Are Categorized As "Small" Based On Hybrid Criteria (Size/ Complexity/ Cost Of Processing/ Pathologist Time) E.g. Appendix, Bone Biopsy Or Curettings (Bone Resections For Malignancy Are Large Specimens), Branchial Cleft Or Cyst, Breast Biopsy (Mastectomy Specimens Are Large Specimens), Bronchial Biopsy, Cervix Biopsy, Cholesteatoma, Colon Biopsy, Conjunctival Biopsy Or Pterygium, Cornea, Endometrial Curettings, Endoscopic Biopsy, Fallopian Tube, Gall Bladder, Ganglion Cyst, Gastric Biopsy, Gum Or Oral Mucosa Biopsy, Hernia Sac, Hydrocele Sac, Joint & Periarticular Tissue Without Bone, Laryngeal Biopsy, Lung (Needle Or Transbronchial) Biopsy, Lymph Node Biopsy, Nasopharyngeal Biopsy, Oesophageal Biopsy Or Diverticulum, Omentum Biopsy, Oropharyngeal Biopsy, Peritoneal Biopsy, Pleural Or Pericardial Biopsy/ Tissue; Products Of Conception (POCs), Rectal Biopsy, Skin Biopsy, Small Bowel Biopsy, Testis, Testis Biopsy, Thyroglossal Duct, Tongue Biopsy (Tongue With Local Neoplasm Or With Nodes Is Categorized As A Medium Specimen), Tracheal Biopsy, Tonsil Or Adenoids, Ureter Biopsy Or Resection, Urethra Biopsy Or Resection, Vaginal Biopsy Etc.

Container/ preservative

10% Formalin (10% Neutral Buffered Formalin Preferred) In Appropriate Size, Leak Proof Container. Immerse Specimen Into Formalin Within 30 Minutes Of Removal. Ensure Specimen Is Immersed In Fixative & Not Stuck On The Side/ Lid Of The Container.

Sample volume

Volume of formalin to tissue of ≥10:1

Rejection criteria

Labeling Issue (Unlabeled/ Mislabeled Blocks); Missing Request Form; Request Form Not Accompanied By Sample; Mismatch Between Request Form & Sample Details; Missing Age/ Gender; Wrong Sample Type; Incorrect Preservative; Insufficient Sample; Empty Sample Containers.

Other Instructions

Incorrect preservative (e.g. Placing sample for Histology in normal saline) is likely to resut in sample Deterioration/ Putrefaction, Suboptimal evaluation & inability to give a diagnosis.

Reference intervals

Negative for disease / Malignancy

Clinical Utility

Diagnostic, Prognostic Or Confirmatory

Test Limitations/ Confounders

Poorly fixed tissue

HISTOLOGY, MEDIUM SPECIMEN

Category

Anatomic Pathology

Sub Category

Surgical/ Histopathology

Synonyms/Aliases

Histopathology Consultation, Wet/ Unprocessed Tissue; Surgical Pathology Consultation, Wet/ Unprocessed Tissue.

Abbreviations

N/A

Type

Individual Test

14 Days

Results Ready in 14 Days

Method

Grossing, Tissue Processing, Staining And Microscopy

Temp

Room temperature; refrigerated is also acceptable.

Setup

Mon-Fri

Components Parameters

N/A

Pre-analytic Considerations

N/A

Test Ordering Instructions

Fill out test request form fully & legibly. Provide your contact information & complete history including suspected diagnosis & relevant investigation details (lab, imaging). Specify the exact sample type, procedure done, anatomic site, laterality where applicable (e.g. Left vs right) and the fixative used. Time of insertion into fixative is required for Mastectomy specimens.

Patient preparation

N/A

Sample type

A Variety Of Specimens Are Categorized As "Medium" Based On Hybrid Criteria (Size/ Complexity/ Cost Of Processing/ Pathologist Time) E.g. Adrenal Resection, Bile Duct Resection, Breast Biopsy (Not Mastectomy), Carotid Body, Kidney Biopsy (Not Nephrectomy), Brain Or Meningeal Biopsy, Mediastinal Mass, Muscle Biopsy, Ovarian Mass, Parathyroid Gland(S), Placenta, Salivary Gland, Skin Resection Of Malignant Melanoma, Small Bowel Diverticuli, Soft Tissue Lipoma, Testis, Thymus, Thyroid. Also Tongue Or Tonsil With Neoplasm (Local/ With Nodes) Etc.

Container/ preservative

10% formalin (10% neutral buffered formalin preferred) in appropriate size, leak proof container. Immerse specimen into formalin within 30 minutes of removal.

Sample volume

Volume of formalin to tissue of ≥10:1

Rejection criteria

Labeling Issue (Unlabeled/ Mislabeled Blocks); Missing Request Form; Request Form Not Accompanied By Sample; Mismatch Between Request Form & Sample Details; Missing Age/ Gender; Wrong Sample Type; Incorrect Preservative; Insufficient Sample; Empty Sample Containers.

Other Instructions

Incorrect preservative (e.g. Placing sample for Histology in normal saline) is likely to resut in sample Deterioration/ Putrefaction, Suboptimal evaluation & inability to give a diagnosis.

Reference intervals

Negative for disease / Malignancy

Clinical Utility

Diagnostic.

Test Limitations/ Confounders

Poorly fixed tissue

HISTOLOGY, LARGE SPECIMEN

Category

Anatomic Pathology

Sub Category

Surgical/ Histopathology

Synonyms/Aliases

Histopathology Consultation, Wet/ Unprocessed Tissue; Surgical Pathology Consultation, Wet/ Unprocessed Tissue.

Abbreviations

N/A

Type

Individual Test

14 Days

Results Ready in 14 Days

Method

Grossing, Tissue Processing, Staining And Microscopy

Temp

Room temperature; refrigerated is also acceptable.

Setup

Mon-Fri

Components Parameters

N/A

Pre-analytic Considerations

N/A

Test Ordering Instructions

Fill out test request form fully & legibly. Provide your contact information & complete history including suspected diagnosis & relevant investigation details (lab, imaging). Specify the exact sample type, procedure done, anatomic site, laterality where applicable (e.g. Left vs right) and the fixative used. Time of insertion into fixative is required for Mastectomy specimens.

Patient preparation

N/A

Sample type

A Variety Of Specimens Are Categorized As "Large" Based On Hybrid Criteria (Size/ Complexity/ Cost Of Processing/ Pathologist Time) E.g. Whole Organ(S), Large Amputation, Or A Large Biopsy Of Part Of An Organ. Examples: Prostatectomy, Mastectomy, Colectomy, Esophagectomy, Gastrectomy, Extremity (Limb) Amputation Or Disarticulation, Nephrectomy, Laryngectomy, Hepatectomy, Lung Resection, Splenectomy, Hysterectomy (With Or Without Adnexae), Lung (Segment, Lobar Or Total) Resection, Pancreas, Vulvectomy Specimens. Also, Soft Tissue Lesions ≥5 cm In Maximum Dimension, Bone Resections For Neoplasms, Eye Enucleation Or Exenteration, Gall Bladder & Porta Hepatis Radical Resection Etc.

Container/ preservative

10% formalin (10% neutral buffered formalin preferred) in appropriate size, leak proof container. Immerse specimen into formalin within 30 minutes of removal.

Sample volume

Volume of formalin to tissue of ≥10:1

Rejection criteria

Labeling Issue (Unlabeled/ Mislabeled Blocks); Missing Request Form; Request Form Not Accompanied By Sample; Mismatch Between Request Form & Sample Details; Missing Age/ Gender; Wrong Sample Type; Incorrect Preservative; Insufficient Sample; Empty Sample Containers.

Other Instructions

Incorrect preservative (e.g. Placing sample for Histology in normal saline) is likely to resut in sample Deterioration/ Putrefaction, Suboptimal evaluation & inability to give a diagnosis.

Reference intervals

Negative for disease / Malignancy

Clinical Utility

Provides diagnosis for diseases, from benign to malignant.

Test Limitations/ Confounders

Poorly fixed tissue