Identifies the hormone produced by parathyroid glands which is expressed in normal parathyroid, parathyroid adenomas, and primary and secondary hyperplasia of parathyroid. Useful in the differential diagnosis of autoimmune disorders involving parathyroid gland resulting in the production of anti-PTH and hypo-parathyroidism.
Detects expression of tropomyosin receptor kinase A, B, and C proteins arising from the NTRK 1, 2, and 3 genes, respectively. NTRK gene rearrangements occur in many different tumor types, often at low frequency, including lung non-small cell carcinomas, colorectal and other GI-related adenocarcinomas, breast carcinomas, melanoma, renal cell carcinomas, and adult brain tumors. IHC screening is not recommended in neuroendocrine tumors, GISTs, gliomas, or adult sarcomas, as these tissues so positive staining in the absence of an NTRK translocation. Instead, molecular testing (i.e. NGS or FISH) for an NTRK gene fusion is recommended to confirm the presence of an NTRK gene fusion. Patients having a tumor harboring an NTRK gene fusion may be responsive to NTRK inhibitor therapy.
This antibody recognizes a capsid protein of human parvovirus B19 and is used to detect parvovirus infected cells.
Identifies a transcription factor essential for kidney development. In the kidneys of a normal adult, this protein expression is limited to the nuclei of collecting ducts and distal tubules (to a lesser extent). It is expressed in early kidney organogenesis as well as in Wilms' tumor and renal cell carcinoma, and can be useful in the diagnosis of renal cell carcinoma.
Identifies a B-cell specific activator protein (BSAP) expressed throughout B-cell maturation prior to the plasma cell stage. PAX-5 is strongly expressed in the great majority of mature and immature B-cell neoplasms and in nodular lymphocyte predominance Hodgkin's lymphoma. It is expressed at decreased intensity in classical Hodgkin's lymphoma, and is not expressed in the great majority of plasma cell neoplasms. It is very specific to B-cell lineage and does not stain T-cells.
Identifies a protein found in cytoplasmic granules of cytotoxic T-lymphocytes (CTLs), which bind to cells that express foreign antigens and induce them to lyse. Perforin expression is significantly induced in CD8 positive T cells, but to a lesser extent in gamma/delta T cells and NK cells, and may be useful in detecting perforin in CTLs in severe cases of graft versus host disease, chronic renal rejection, and peripheral T cell lymphomas. It also may be useful for the detection of NK cell lymphomas.
Available as global and tech-only. Markers are CD19, CD20, CD38, CD45, CD56, CD117, CD138, ckappa, clambda.
CLINICAL SIGNIFICANCE: Useful to aid in diagnosis of plasma cell and B cell neoplasms.
Identifies a 40kDa O-linked sialoglycoprotein expressed by a variety of tissues, including fetal testes and testicular germ cell tumors. Podoplanin is a marker of lymphatic endothelium, as well as neoplasms such as Kaposi's sarcoma. In the context of epithelial tumors, it has been demonstrated to be a highly sensitive marker of mesothelium and mesothelioma, complementing other markers such as calretinin and the Wilms tumor gene product. In neoplastic tissue, immunostaining of lymphatic endothelium can be useful in identifying lymphatic invasion of primary tumors.
Identifies a nuclear hormone receptor that is induced by estrogen receptor (ER) expression and serves as an indicator of an intact ER pathway. PR is expressed in about 60-70% of invasive breast cancers and is a weak prognostic factor but a modest predictive factor that adds to the predictive value of ER for response to endocrine therapies, both in adjuvant and metastatic settings. The primary indication to assess PR in breast cancer is to predict response to hormonal therapies, such as tamoxifen, other selective estrogen receptor modulators (SERMs), and aromatase inhibitors.
Identifies a growth factor secreted by the anterior pituitary that is necessary for the proliferation and differentiation of the mammary glands. The antibody is useful in the detection of prolactin secreting pituitary tumors with or without galactorrhea.
Identifies Keratin 5/14, p63 protein, and P504S and is useful for diagnosing prostatic intraepithelial neoplasia (PIN) and/or prostate carcinoma, especially in difficult cases with limited tissue. P504 stains prostate adenocarcinoma and atypical adenomatous hyperplasia, while p63 and cytokeratin high molecular weight stain basal cells of all normal (negative markers) and benign prostate glands.
Identifies a 100kDa glycoprotein present in high concentration in the prostate gland and its secretions. It is specific to the benign or malignant epithelial cells of the prostate gland and stains prostatic stroma, urethra, and basal cells negatively. PSAP activity is lost in epithelial cells injured due to inflammation, infarction, etc. and in areas of squamous metaplasia of the prostatic acini show loss of PSAP activity. Nearly all metastases of prostatic carcinomas, irrespective of site, demonstrate PSAP activity.
Identifies a glycoprotein restricted to the cytoplasm of acinar and ductal epithelia of normal, benign, or malignant prostate tissue. It is a highly sensitive and specific marker of metastatic prostate adenocarcinoma. PSA from prostatic cancer has been shown to be immunologically and biochemically similar to that of normal prostate tissue. Because the antibody does not react with tumors of non-prostatic origin, the antibody is useful for determining if an isolated metastasis is of prostatic origin.
Identifies a tumor suppressor gene which functions as a negative regulator of the cell cycle by interacting with transcription factors. Because it may act by regulating transcription, loss of its function leads to uncontrolled cell growth. Aberrations of the RB gene are involved in cancers of the breast, colon, prostate, kidney, nasopharynx, and leukemia.
Identifies a proto-oncogene highly expressed in a variety of tumor cells. Rearrangement of the ROS1 gene results in the production of constitutively active fusion proteins that have been reported in non-small cell lung cancers. ROS1 gene rearrangements are reported in 1% and 2% of lung adenocarcinomas and are associated with a response to the multi-targeted tyrosine kinase inhibitor crizotinib. Data suggests that ROS1-rearragned cancers respond to ALK inhibitors and the performance characteristics of this antibody justify its use as an alternative to, or in conjunction with, ROS1 FISH for the identification of lung adenocarcinomas harboring ROS1 gene translocations.
In normal kidney, renal cell carcinoma is localized along the brush border of the proximal tube, while in other normal tissues, RCC is also localized along the luminal surfaces of breast lobules and ducts, the luminal surface of the epididymal tubular epithelium, within the cytoplasm of parathyroid parenchymal cells and focally within the colloid of thyroid follicles. Other normal tissues do not express similar or cross-reacting antigens and RCC is expressed by most primary and metastatic renal cell carcinomas.
Identifies a nuclear and cytoplasmic marker of a wide subset of tumors. The antibody to S100 protein stains Schwannomas, ependymomas, astrogliomas, almost all benign melanocytic lesions, melanomas, and their metastases.. The protein is also expressed in the Langerhans cells in the skin and interdigitating reticulum cells in the paracortex of lymph nodes.
Identifies a member of the S100 family, of which expression is increased in a number of tumors, including pancreas, lung, breast, and ovary carcinomas. S100P can be seen in many pancreatic ductal carcinomas, and it displays no staining in the benign pancreatic ducts and acinar glands.
Detects antibodies against nucleocapsid protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), indicating recent or prior infection.
Acts as a marker for colorectal/appendiceal carcinomas, tumors showing osteoblastic differentiation such as osteosarcoma, and renal/urothelial tumors. It stains colonic and osteogenic cells and their neoplasms and is a useful marker for the workup of carcionoma of unknown primary.
SF1 is expressed in all steroidogenic tissues, including the adrenal cortex, testicular Sertoli cells, and Leydig cells, ovarian theca, hypothalamus, and anterior pituitary. Nuclear localization of SF1 can be used to distinguish sex cord-stromal tumors (SCST) from non-sex cord-stromal tumors. It is a valuable marker to determine adrenocortical origin and should be run in a panel with other sex cord-stromal tumor markers, such as inhibin and calretinin.
Loss of expression identifies pancreatic ductal adenocarcinoma as well as some tumors of the ampulla and colon, and SMAD4 is a useful marker for the workup of carcinoma of unknown primary.
A highly specific and sensitive nuclear transcription factor found in nerve sheath tumors and melanomas, including conventional, spindled, and desmoplastic subtypes. It has also been expressed in salivary gland as well as soft tissue tumors showing myoepithelial differentiation, and is diffusely expressed in schwannoma, neurofibroma, and granular cell tumor. It was not identified in any other mesenchymal and epithelial tumors except for myoepitheliomas and diffuse astrocytomas. SOX10 is also far more specific than S100.
Identifies a transcription factor expressed in almost all cases of mantle cell lymphoma (MCL) including cyclin D1-negative MCL. Routine use of anti-SOX11 in cases of suspected CD5+ diffuse large B cell lymphoma might help identify additional cases of cyclin D1-negative blastoid MCL. It is not expressed in potential MCL mimics such as atypical chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, and marginal zone lymphoma.
Identifies transcription factor proteins that are normally located in the cytoplasm in latent form and migrate to the nucleus on cytokine exposure and subsequent phosphorylation. Recurrent fusions between NAB2 and STAT6 in chromosome 12q13 have been present in the majority of solitary fibrous tumors/hemangiopericyomas. Nuclear STAT6 immunoreactivity has been reported as a surrogate marker for the NAB2-STAT6 gene fusion, and is used to identify solitary fibrous tumor as it is the defining driver of mutation for these tumors
Identifies a zinc-finger transcriptional factor that is required for the maintenance of embryonic cell pluripotency by modulating OCT4. It is a very sensitive marker for germ cell tumors, including seminoma, embryonal carcinoma, yolk sac tumor, and choriocarcinoma. It also shows high specificity for germ cell tumors, although it is positive in a subset of gastric carcinomas.
Identifies a peptide marker of intestinal neuroendocrine cells and carcinoid tumors.
Binds to smooth muscle cells and myoepithelial cells and stains the muscularis propria and muscularis mucosae of the GI tract, the uterine myometrium, medial layer of blood vessels, myoepithelial cells of salivary glands, and other organs. It does not stain skeletal and cardiac muscle, endothelium, connective tissue, epithelium, or nerve. It identifies leiomyomas, leiomyosarcomas, and mesenchymal tumors manifesting myofibroblastic differentiation.
Identifies a component of smooth muscle myosin, a protein expressed in cells and tumors showing smooth muscle or myoepithelial differentiation. This antibody reacts with human visceral and vascular smooth muscle cells and myoepithelial cells and is useful in distinguishing between benign sclerosing breast leasons and infiltrating carcinomas because it strongly stains the myoepithelial layer in the benign lesions while being negative in the infiltrating carcinomas.
A novel cytoskeletal protein that reacts with proteins exclusively found in smooth muscle cells. Because it only reacts with smoothelin, which is exclusively found in smooth muscle cells, it aids in differentiating from cells with smooth muscle cell-like characteristics, such as myofibroblasts and myoepithelial cells, as well as skeletal and cardiac muscle cells. It could be used to differentiate muscularis propria from muscularis mucosa.
Identifies the receptor for somatostatins-14 and -28 and has great value in the assessment of sst2A status in human neuroendocrine tumors, as overexpression of SSTR2 in neuroendocrine tumors is diagnostically helpful and may have therapeutic implications.
ClearLLab 10C Standard Leukemia/Lymphoma Panel – 27 markers; Available as global and tech-only. Markers are CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b, CD13, CD14, CD15, CD16, CD19, CD20, CD33, CD34, CD38, CD45, CD56, CD64, CD117, CD123, CD200, HLA-DR, Kappa, Lambda, TCR-γδ.
CLINICAL SIGNIFICANCE: Useful to aid in diagnosis of leukemia and lymphoma, and for post-treatment follow-up.
Flow cytometry, also known as flow immunophenotyping or fluorescence activated cell count (FACS) is a technology that can rapidly count, sort, and analyze different cell types by creating a fluid suspension of cells with labeled targets to pass through an electronic detection system. This technique is widely used in diagnostics, biomarker detection, evaluating gene expression, and measuring both new and total synthesized DNA, allowing for simultaneous analysis of multiple physical and biochemical properties with one sample.
Our 10-color flow cytometry technique provides a precise characterization of various cell populations, improves detection of low-level abnormalities, and increases success with smaller specimens, delivering more specific and meaningful results for you and your patients.
For the standard leukemia / lymphoma panel we use the ClearLLab 10C system which is an integrated FDA cleared and CE-marked IVD leukemia and lymphoma (L&L) immunophenotyping solution for lymphoid and myeloid lineages using the dry DURA Innovations technology. ClearLLab Control Cells are the first application specific control cells for L&L immunophenotyping.
Our hematopathologist and Chief Medical Officer, Dr. Adrian Padurean Palmer, was one of the four principal investigators instrumental in Beckman Coulter’s ClearLLab 10C system application and FDA approval. *
*Hedley BD, Cheng G, Keeney M, Kern W,Padurean A, Luider J, Chin-Yee I, Lowes LE, Rohrbach J, Ortega R, Smit A, Lo K, Magari R, Tejidor L. A Multi-center Study Evaluation of the ClearLLab 10C Panels. Cytometry B Clin Cytom. 2021 Mar;100(2):225-234. (https://pubmed.ncbi.nlm.nih.gov/32667744/ )
Identifies neural and neuroendocrine cells and tumors as well as epithelial type neoplasms. It shows superior sensitivity to chromogranin A in the context of high grade neuroendocrine carcinomas. It is also expressed in PNET/ES and other tumors showing neural differentiation.
Identifies a protein present in both the cytoplasm and nucleus of immature normal T cells, T cell prolymphocytic leukemia, a variety of B cell lymphoproliferative disorders including CLL/SLL, and blastic plasmacytoid dendritic cell neoplasms. This antibody is used to distinguish B cell lymphomas from T cell lymphomas, CD30+ anaplastic large cell lymphomas, multiple myeloma, and marginal zone B cell lymphoma.
Identifies the alpha/beta chain of the T cell receptor, present on normal T lymphocytes and most T cell neoplasms. It is expressed by thymocytes and a majority of peripheral (alpha/beta TCR-bearing) T cells. It is negative on normal B cells, B cell neoplasms, anaplastic large cell lymphoma, and NK/T cell neoplasms.
Identifies a specialized DNA polymerase expressed in immature, pre-B, pre-T lymphoid cells, and also the majority of precursor B- and T- lymphoblastic leukemias/lymphomas. It is a valuable marker for differentiating between lymphoblastic lymphoma and Burkitt lymphoma. It is also aberrantly expressed in a small subset of acute myeloid leukemias.
Identifies a member of the helix-loop-helix family of transcription factors, which is a sensitive and specific marker of Xp11 translocation in renal cell carcinomas. It is also expressed in alveolar soft part sarcoma, which is a chromosomal rearrangement at 17q25 and Xp11.2.
Identifies a cytoplasmic protein expressed in a coarse granular pattern in both cytotoxic T cells and NK cells, and on neoplasms arising from these cell types, including the majority of anaplastic large cell lymphomas. It also reacts with most granular lymphocytic leukemias, hepatosplenic T cell lymphomas, intestinal T cell lymphomas, NK-like T cell lymphomas, NK-cell lymphomas, nasal T/NK-cell lymphomas, subcutaneous T cell lymphomas, and pulmonary angiocentric lymphomas of T or NK phenotype. All B cell lymphomas, Hodgkin, and lymphoblastic leukemias are negative for TIA1.
Identifies a transducing-like receptor (TLE) gene, a family of genes whose expression correlated with immature epithelial cells that are progressing toward a terminally differentiated state. This antibody is an excellent discriminator of synovial sarcoma from other sarcomas, including histologically similar tumors such as malignant peripheral nerve sheath tumor.
Bi-directional sequencing of TP53 exons 4-9.
The TP53 gene encodes the tumor suppressor p53. TP53 mutations are detected in at least 50% of all adult tumors and are generally associated with a poor prognosis. For patients with chronic lymphocytic leukemia (CLL), TP53 sequencing, in addition to FISH for 17p deletion, aids in prognosis and/or therapy selection. Germline mutations in TP53 are the cause of Li-Fraumeni Syndrome.
Identifies a pituitary hormone that stimulates thyroid growth and the production of thyroid hormones. The antibody labels thyrotropic cells of the pituitary and is used in the classification of pituitary adenomas and the differential identification of primary and metastatic tumors of the pituitary. It is also used for the differential diagnosis of primary hypothyroidism from secondary hypothyroidism and hyperthyroidism.
Identifies a nuclear transcription factor found predominantly in lung and thyroid neoplasms. In lung carcinomas, it is expressed in both non-neuroendocrine as well as endocrine neoplasms, but only rarely in lung squamous cell carcinomas. It is expressed in all variants of thyroid carcinoma with the exception of anaplastic carcinoma. It can also be more uncommonly expressed in other carcinomas, including those primary to the colorectum and breast. The utility of this antibody becomes apparent in the differential diagnosis of primary versus metastatic carcinomas, especially in the lung.
This antibody recognizes the Thymidylate Synthase protein, which is a targed for the fluoropyrimidine group of antineoplastic drugs used to treat solid tumors. Expression of TS is associated with response to 5-FU in human breast, colorectal, gastric, head, and neck carcinomas.
Labels a dimeric protein produced by and used within the thyroid gland. This antibody is useful in positive identification of metastatic thyroid carcinomas of the papillary and follicular types, but technical issues with these antibodies often producing nonspecific signal make the combination of TTF-1 and PAX-8 expression a better marker for these tumors.
Identifies Toxoplasma Gondii organisms, crescent shaped sporozoans that live as intracellular parasites in various tissues of vertebrates and complete their life cycles in a single host.
Identifies a serum protein produced by the liver and choroid plexus that forms the basis of one subtype of amyloid. This protein can serve as a marker of choroid plexus tumors.
Identifies the spirochete bacterium which causes syphilis. Treponema palladium also cross-reacts with Borrelia burgdorferi (Lyme disease).
Identifies the most abundant secreatory granule derived serine proteinase used to label a mast cell tryptase. It will also show reactivity to basophils, but to a lesser degree.
Identifies a copper-staining rate limiting enzyme for controlling the production of melanin and marks melanocytic cells and tumors. Mutations of this gene occur in various forms of albinism and it is one of the targets for cytotoxic T-cell recognition in melanoma patients. Staining of melanomas with this antibody showed tyrosinase in melanotic as well as amelanotic variants.
Identifies a transmembrane protein that is a specific differentiation product of urothelial cellsand is a specific marker of transitional cell epithelium and tumors. In non-neoplastic urothelium, UPIII is expressed in the luminal surface plasmalemma of superficial cells. It detects half of urothelial carcinomas, whereas many non-urothelial carcinomas are negative. Because UP expression was found to be absent after malignant transformation in normal urothelium and bladder cancer specimens, UP expression might reflect the malignant potential of urothelial cancer cells as well as being cytodifferential markers of urothelial cells. While highly specific, UPIII is a marker of low sensitivity for urothelial carcinomas.
Used to detect VIPoma in patients with chronic diarrheal diseases.
Identifies cells infected with varicella zoster virus, a member of the human herpes family, which causes two distinct clinical manifestations: chickenpox and shingles. Primary VZV infection results in chickenpox (varicella), which may result in complications including encephalitis or pneumonia.
Identifies villin, an actin binding protein found in human renal epithelial cells and is a marker of carcinomas of GI tract origin. Villin, along with CDX2, is a highly specific and fairly sensitive marker of colorectal as well as noncolorectal GI tract (pancreatobiliary tract) derived carcinomas. In the latter tumors, a brush border pattern is characteristic. A subset of lung adenocarcinomas are also villin positive.
Identifies the major intermediate filament in a variety of mesenchymal cells, including endothelial cells, all fibroblastic cells, macrophages, Sertoli cells, melanocytes, lymphocytes, and ovarian granulosa cells. Vimentin is found in all types of sarcomas and lymphomas, and it is co-expressed with cytokeratin in a subset of carcinomas (the use of TTF-1, PAX-8, etc. are preferred in this setting). Positive staining for vimentin is seen in most cells of fibrosarcomas, liposarcomas, malignant fibrous histocytomas, angiosarcomas, chondrosarcomas, and lymphomas. All melanomas and Schwannomas are strongly vimentin-positive.
Identifies the Wilms tumor gene product, a marker of ovarian serous carcinoma and mesothelioma. It can be employed as part of a panel to distinguish mesothelioma from adenocarcinoma in tissue sections of pleural tumors, and in the subclassification of ovarian carcinomas.
Identifies spirochete (Treponema pallidum), the causative agent of syphilis.
Identifies a cytoplasmic protein ubiquitously expressed in T cells and NK cells, and in neoplasms derived from these cells. It is not expressed by most normal B cells, but is expressed in a variety of B cell non-Hodgkin lymphomas. Expression of ZAP-70 in chronic lymphocytic leukemia/small lymphocytic lymphoma strongly correlates with a lack in immunoglobulin gene mutation, and has been associated with an adverse prognosis.
Identifies a protein found in prostatic adenocarcinoma but not in benign prostatic tissue. It has also been found to stain premalignant lesions of the prostate, high-grade prostatic intraepithelial neoplasia (PIN) and atypical adenomatous hyperplasia. Stains the majority of prostate cancers and numerous other tumors types, such as hepatoma, breast carcinoma, pancreatic islet tumor, and desmoplastic small round cell tumor.