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Article ; Online: Evaluation of dual p16/Ki-67 immunostaining on anal cytology specimens.

Smithgall, Marie C / Towne, William S / Gonzalez, Abel A / Cimic, Adela

2024

Abstract: Introduction: Dual immunostaining for p16/Ki67 is FDA-approved for use on liquid-based cervical cytology specimens; however, the utility of dual staining in anal cytology especially for ASCUS risk stratification is not well established.: Methods: We ... ...

Abstract	Introduction: Dual immunostaining for p16/Ki67 is FDA-approved for use on liquid-based cervical cytology specimens; however, the utility of dual staining in anal cytology especially for ASCUS risk stratification is not well established. Methods: We investigated dual staining performance on anal cytology specimens and correlated with subsequent cytologic interpretation, high-risk HPV status, and anal biopsy results. Dual staining for p16/Ki-67 was performed on all liquid-based anal cytology specimens from December 2021 to June 2022 (n = 43). Results: Three patients had high grade squamous intraepithelial lesion (HSIL/AIN2-3) on biopsy; dual staining was positive in all three cases. All HR-HPV negative cases were negative for dual staining. Among the 12 ASCUS samples with subsequent anal biopsy results all also had HR-HPV testing. Due to small sample size of cases with squamous intraepithelial lesion (SIL) diagnosed on biopsy, the sensitivity and positive predictive value was not calculated. However, the specificity and negative predictive value of p16/Ki-67 dual staining for SIL of any grade on biopsy were 1 (95% CI: 0.66-1) and 0.9 (95% CI: 0.65-0.97) respectively, whereas the specificity and negative predictive value of HR-HPV testing for SIL of any grade on biopsy were 0.44 (95% CI: 0.14-0.79) and 0.8 (95% CI: 0.41-0.96) respectively. Conclusion: Dual p16/Ki-67 staining indicates transforming HPV infection and could help serve as an ancillary test for risk stratification for atypical anal cytology specimens. Among ASCUS samples, dual staining was specific for SIL of any grade with a high negative predictive value and therefore could be useful in clinical practices with limited availability for follow-up care.
Language	English
Publishing date	2024-04-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	632710-2
ISSN	1097-0339 ; 8755-1039
ISSN (online)	1097-0339
ISSN	8755-1039
DOI	10.1002/dc.25332
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Zs.A 2117: Show issues

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Article ; Online: Case of lung fine needle aspiration showing mucinous cells and extracellular mucin.

Saliba, Maelle / Smithgall, Marie C / Saqi, Anjali / Crapanzano, John P / Sung, Simon

Diagnostic cytopathology

2024

Abstract: Mucinous neoplasm with extracellular mucin can be challenging to interpret on fine needle aspiration and core biopsies. Determining the biologic origin of the mucin/mucinous cells, that is, benign/incidental versus neoplasm, invasive versus in situ, and ... ...

Abstract	Mucinous neoplasm with extracellular mucin can be challenging to interpret on fine needle aspiration and core biopsies. Determining the biologic origin of the mucin/mucinous cells, that is, benign/incidental versus neoplasm, invasive versus in situ, and primary versus metastatic tumors, requires a thorough multidisciplinary evaluation. The work up of these lesions includes morphologic analysis with ancillary immunohistochemical and/or molecular studies and correlation with clinical and imaging studies. This review outlines a practical approach to the diagnosis of mucinous lesions in the lung with comprehensive review of literature.
Language	English
Publishing date	2024-02-26
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	632710-2
ISSN	1097-0339 ; 8755-1039
ISSN (online)	1097-0339
ISSN	8755-1039
DOI	10.1002/dc.25294
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Zs.A 2117: Show issues

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Article ; Online: Diagnostic utility of PRAME immunohistochemistry in PEComa family of tumors and morphologic mimics with emphasis on the gynecologic tract.

Smithgall, Marie C / Liu-Jarin, Xiaolin / Chen, Xiaowei / Singh, Kamaljeet / Quddus, Mohammad Ruhul / Cimic, Adela

Human pathology

2023 Volume 138, Page(s) 12–17

Abstract: Perivascular epithelioid cell tumors (PEComas), rare mesenchymal tumors with myomelanocytic differentiation, can be a diagnostic challenge, often requiring a panel of immunohistochemical markers. Preferentially expressed antigen in melanoma (PRAME) is a ... ...

Abstract	Perivascular epithelioid cell tumors (PEComas), rare mesenchymal tumors with myomelanocytic differentiation, can be a diagnostic challenge, often requiring a panel of immunohistochemical markers. Preferentially expressed antigen in melanoma (PRAME) is a relatively new antigen with utility in diagnosing melanomas. This study aimed to survey PRAME expression patterns in the PEComa family of tumors and morphologic mimics. Twenty cases of PEComas and 27 non-PEComas (10 leiomyosarcomas, 3 smooth muscle tumors of uncertain malignant potential [STUMPs], 11 leiomyomas, 1 uterine inflammatory myofibroblastic tumor [IMT], and 2 low-grade endometrial stromal sarcomas [LGESSs]) were stained with PRAME and compared to previously performed HMB45 and Melan-A stains, when available. Tumors showing no or barely perceptible PRAME staining at 10× were considered negative. Tumors were considered positive if there was full nuclear staining evident at 10× in at least one 10× field. Diffuse staining was defined as positivity in at least 80% of tumor nuclei. Overall, PRAME was expressed in 70% of PEComas, with diffuse positivity in 60%. However, PRAME was not specific for PEComas, with immunopositivity in the majority (70%) of uterine leiomyosarcoma cases, though negative in STUMP, leiomyoma, IMT, and LGESS cases. PRAME sensitivity was 70% and specificity was 74%, while HMB45 was more sensitive (90%) and specific (100%), but only 15% of PEComas showed diffuse staining. Melan-A staining was less common than HMB45 or PRAME, with only 18.8% sensitivity but 100% specificity. Among gynecologic PEComas, PRAME was expressed in 75% overall and enriched among malignant cases (85.7% positive). As part of an immunohistochemical panel, PRAME could be useful in the workup of PEComa cases. In the future, PRAME-specific immunotherapies may be beneficial in treating patients with malignant PEComas.
Language	English
Publishing date	2023-05-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	207657-3
ISSN	1532-8392 ; 0046-8177
ISSN (online)	1532-8392
ISSN	0046-8177
DOI	10.1016/j.humpath.2023.05.006
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Zs.A 722: Show issues

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Article ; Online: Accuracy of automated analyzers for the estimation of CSF cell counts: A systematic review and meta-analysis.

Waldrop, Greer E / Cocuzzo, Kaitlyn / Schneider, Colleen L / Kim, Carla Y / Goetz, Teddy G / Chomba, Mashina S / Delaurentis, Clare E / Smithgall, Marie C / Francis, Richard O / Thakur, Kiran T

International journal of laboratory hematology

2024 Volume 46, Issue 2, Page(s) 234–242

Abstract: This systematic review evaluates the evidence for accuracy of automated analyzers that estimate cerebrospinal fluid (CSF) white blood cell counts (WBC) compared to manual microscopy. Inclusion criteria of original research articles included human ... ...

Abstract	This systematic review evaluates the evidence for accuracy of automated analyzers that estimate cerebrospinal fluid (CSF) white blood cell counts (WBC) compared to manual microscopy. Inclusion criteria of original research articles included human subjects, English language, and manual microscopy comparator. PUBMED, EMBASE and Cochrane Review databases were searched through 2019 and QUADAS-2 Tool was used for assessment of bias. Data were pooled and analyzed by comparison method, using random effects estimation. Among 652 titles, 554 abstracts screened, 104 full-text review, 111 comparisons from 41 studies were included. Pooled estimates of sensitivity and specificity (n = 7) were 95% (95%-CI 93%-97%) and 84% (95%-CI: 64%-96%), respectively. Pooled R
Language	English
Publishing date	2024-02-07
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2268590-X
ISSN	1751-553X ; 1751-5521 ; 0141-9854
ISSN (online)	1751-553X
ISSN	1751-5521 ; 0141-9854
DOI	10.1111/ijlh.14236
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Zs.A 1499: Show issues

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Article ; Online: HER2/ ERBB2 Immunohistochemical Expression and Copy Number Status in Ovarian Mucinous Tumors.

Smithgall, Marie C / Yemelyanova, Anna / Mathew, Susan / Gogineni, Swarna / He, Bing / Zhang, Taotao / Robinson, Brian D / Tu, Jiangling J

International journal of gynecological pathology : official journal of the International Society of Gynecological Pathologists

2023 Volume 43, Issue 2, Page(s) 134–139

Abstract: Primary mucinous ovarian carcinoma (MOC) is a rare ovarian epithelial cancer, which is often refractory to chemotherapy. HER2-targeting therapy is being increasingly considered in gynecologic malignancies. Although there have been limited studies ... ...

Abstract	Primary mucinous ovarian carcinoma (MOC) is a rare ovarian epithelial cancer, which is often refractory to chemotherapy. HER2-targeting therapy is being increasingly considered in gynecologic malignancies. Although there have been limited studies examining the HER2 status of such tumors, the criteria for HER2 expression scoring have not been standardized for MOC as it has for other sites. This study aimed to survey immunohistochemical HER2 expression patterns in MOC and its precursor, mucinous borderline tumor in correlation with fluorescence in situ hybridization (FISH). Immunohistochemistry (IHC) for HER2 was performed on 12 cases of MOC and 15 mucinous borderline tumors, including 7 with intraepithelial carcinoma. HER2 expression was quantified using the gastric/gastroesophageal carcinoma protocol. Cases were considered 3+ if the tumor cells displayed strong complete or basolateral/lateral membranous staining in ≥10% of tumor cells. Cases (2+) had weak to moderate staining in ≥10% of tumor cells. Cases (1+) had faint staining in ≥10% of tumor cells. Cases considered 0 had no staining or faint staining in <10% of tumor cells. HER2 expression was also quantified with the endometrial serous carcinoma protocol, which uses a 30% tumor cell positivity cutoff. FISH for HER2 was performed on all 3+ and 2+ and a subset of 1+ cases. Of the MOC cases, 25% were 3+ and 1 mucinous borderline tumor with intraepithelial carcinoma had 3+ staining. All 3+ IHC MOC cases had >30% basolateral membranous staining. HER2 amplification was confirmed by FISH on all 3+ IHC cases and in one 2+ IHC case of MOC. Up to 25% of mucinous ovarian tumors showed HER2 IHC overexpression with an excellent correlation between IHC and FISH using the HER2 scoring protocol for either gastric/gastroesophageal carcinoma or uterine serous carcinoma.
MeSH term(s)	Female ; Humans ; In Situ Hybridization, Fluorescence ; DNA Copy Number Variations ; Gene Amplification ; Receptor, ErbB-2/genetics ; Receptor, ErbB-2/metabolism ; Ovarian Neoplasms/genetics ; Ovarian Neoplasms/pathology ; Carcinoma, Ovarian Epithelial ; Neoplasms, Cystic, Mucinous, and Serous ; Adenocarcinoma, Mucinous/genetics ; Endometrial Neoplasms ; Cystadenocarcinoma, Serous ; Carcinoma in Situ ; Biomarkers, Tumor/genetics
Chemical Substances	Receptor, ErbB-2 (EC 2.7.10.1) ; Biomarkers, Tumor ; ERBB2 protein, human (EC 2.7.10.1)
Language	English
Publishing date	2023-06-30
Publishing country	United States
Document type	Journal Article
ZDB-ID	604859-6
ISSN	1538-7151 ; 0277-1691
ISSN (online)	1538-7151
ISSN	0277-1691
DOI	10.1097/PGP.0000000000000966
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Zs.A 1814: Show issues

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Article ; Online: Placental pathology in women vaccinated and unvaccinated against SARS-CoV-2.

Smithgall, Marie C / Murphy, Elisabeth A / Schatz-Siemers, Nina / Matrai, Cathleen / Tu, Jiangling / Baergen, Rebecca N / Yang, Yawei J

American journal of obstetrics and gynecology

2022 Volume 227, Issue 5, Page(s) 782–784

Language	English
Publishing date	2022-06-28
Publishing country	United States
Document type	Letter
ZDB-ID	80016-8
ISSN	1097-6868 ; 0002-9378
ISSN (online)	1097-6868
ISSN	0002-9378
DOI	10.1016/j.ajog.2022.06.039
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Article ; Online: Comparison of Cepheid Xpert Xpress and Abbott ID Now to Roche cobas for the Rapid Detection of SARS-CoV-2.

Smithgall, Marie C / Scherberkova, Ioana / Whittier, Susan / Green, Daniel A

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

2020 Volume 128, Page(s) 104428

Abstract: Background: The SARS-CoV-2 pandemic has created an urgent and unprecedented need for rapid large-scale diagnostic testing to inform timely patient management. However, robust data are lacking on the relative performance of available rapid molecular ... ...

Abstract	Background: The SARS-CoV-2 pandemic has created an urgent and unprecedented need for rapid large-scale diagnostic testing to inform timely patient management. However, robust data are lacking on the relative performance of available rapid molecular tests across a full range of viral concentrations. Objective: This study aimed to compare two recently-authorized rapid tests, Cepheid Xpert Xpress SARS-CoV-2 and Abbott ID Now SARS-CoV-2, to the Roche cobas SARS-CoV-2 assay for samples with low, medium, and high viral concentrations. Study design: A total of 113 nasopharyngeal swabs from remnant patient samples were tested, including 88 positives spanning the full range of observed Ct values on the cobas assay. Results: Compared to cobas, the overall positive agreement was 73.9% with ID Now and 98.9% with Xpert. Negative agreement was 100% and 92.0% for ID Now and Xpert, respectively. Both ID Now and Xpert showed 100% positive agreement for medium and high viral concentrations (Ct value <30). However, for Ct values >30, positive agreement was 34.3% for ID Now and 97.1% for Xpert. Conclusions: While Xpert showed high agreement with cobas across a wide range of viral concentrations, this study highlights an important limitation of ID Now for specimens collected in viral or universal transport media with low viral concentrations. Further studies are needed to evaluate the performance of ID Now for direct swabs.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Betacoronavirus/genetics ; Betacoronavirus/isolation & purification ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Techniques/methods ; Coronavirus Infections/diagnosis ; Coronavirus Infections/virology ; Humans ; Infant, Newborn ; Middle Aged ; Molecular Diagnostic Techniques ; Pandemics ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/virology ; Point-of-Care Testing ; Reagent Kits, Diagnostic ; SARS-CoV-2 ; Young Adult
Chemical Substances	Reagent Kits, Diagnostic
Keywords	covid19
Language	English
Publishing date	2020-05-13
Publishing country	Netherlands
Document type	Comparative Study ; Evaluation Study ; Journal Article
ZDB-ID	1446080-4
ISSN	1873-5967 ; 1386-6532
ISSN (online)	1873-5967
ISSN	1386-6532
DOI	10.1016/j.jcv.2020.104428
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Zs.A 3790: Show issues

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Article ; Online: Laboratory Testing of SARS CoV-2: A New York Institutional Experience

Smithgall, Marie C. / Whittier, Susan / Fernandes, Helen

Keywords	covid19
Publisher	Elsevier; PMC
Document type	Article ; Online
DOI	10.1016/j.yamp.2020.07.002
Database	COVID19

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Article ; Online: Value of additional sections: Tissue handling of small biopsies in detecting squamous dysplasia of the uterine cervix.

Cimic, Adela / Smithgall, Marie C / Khoury-Collado, Fady / Liu-Jarin, Xiaolin / Vranic, Semir

Annals of diagnostic pathology

2021 Volume 56, Page(s) 151872

Abstract: Cervical cancer screening is currently based on high-risk human papillomavirus (HR-HPV) molecular testing, Pap cytology testing, and histologic evaluation of cervical biopsies. As primary HPV screening for cervical cancer becomes widely used, some of the ...

Abstract	Cervical cancer screening is currently based on high-risk human papillomavirus (HR-HPV) molecular testing, Pap cytology testing, and histologic evaluation of cervical biopsies. As primary HPV screening for cervical cancer becomes widely used, some of the recommended screening guidelines propose colposcopy and biopsies following positivity for HPV16/18 without cytologic triage. In such instances, a biopsy would be the only tissue sample available for informing further management. The use of additional histologic levels on cervical biopsies is commonly employed to achieve a diagnosis, although no set criteria for when to obtain additional levels exist. In this study, we evaluated the value of additional sections in cervical biopsy and endocervical curetting, as well as clinical and histologic features that should be considered when ordering additional levels. Additional levels were obtained for the following scenarios: benign mucosa with Pap discrepancy (HSIL or ASC-H interpretation), size discrepancy with the gross description, suspicious atypia for a high-grade lesion, and long-standing high-risk HPV infection. A change in diagnosis was observed in 21.4% of the cases, with an upgrade to a high-grade squamous intraepithelial lesion (CIN2-3) in 12.1% of cases. An initial impression of atypia significantly correlated with both a change in diagnosis and an upgrade to CIN2-3. In the era of primary HPV screening, when evaluating tissue samples following positive HPV test, small, atypical foci should be followed by additional levels. We recommend six (6) initial levels on all cervical biopsies, particularly if there is no loss of tissue between the levels, to ensure an accurate interpretation. This will be crucial in the timely and accurate identification of HPV-related intraepithelial lesions and proper subsequent management.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Biopsy ; Cervical Intraepithelial Neoplasia/diagnosis ; Cervical Intraepithelial Neoplasia/pathology ; Cervix Uteri/pathology ; Early Detection of Cancer ; Female ; Humans ; Middle Aged ; Specimen Handling ; Squamous Intraepithelial Lesions of the Cervix/diagnosis ; Squamous Intraepithelial Lesions of the Cervix/pathology ; Uterine Cervical Dysplasia/diagnosis ; Uterine Cervical Dysplasia/pathology ; Vaginal Smears ; Young Adult
Language	English
Publishing date	2021-12-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	1440011-x
ISSN	1532-8198 ; 1092-9134
ISSN (online)	1532-8198
ISSN	1092-9134
DOI	10.1016/j.anndiagpath.2021.151872
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Zs.A 5463: Show issues

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Article ; Online: Investigation of discrepant mismatch repair immunohistochemistry and microsatellite instability polymerase chain reaction test results for gynecologic cancers using next-generation sequencing.

Smithgall, Marie C / Remotti, Helen / Hsiao, Susan J / Mansukhani, Mahesh / Liu-Jarin, Xiaolin / Fernandes, Helen

Human pathology

2021 Volume 119, Page(s) 41–50

Abstract: Gynecologic cancers are routinely screened for DNA mismatch repair (MMR) gene mutations using immunohistochemistry (IHC) and/or polymerase chain reaction (PCR) for microsatellite instability (MSI) to enable selection of immune checkpoint inhibitor ... ...

Abstract	Gynecologic cancers are routinely screened for DNA mismatch repair (MMR) gene mutations using immunohistochemistry (IHC) and/or polymerase chain reaction (PCR) for microsatellite instability (MSI) to enable selection of immune checkpoint inhibitor therapy and screen for Lynch syndrome. The limited data that compare IHC and MSI in endometrial tumors have shown discordance rates of 5-10%. We reviewed MMR/MSI results in gynecologic cancers and used next-generation sequencing (NGS) to interrogate discrepancies. Of the 328 cases with both IHC and MSI results, 256 (78.0%) were microsatellite stable (MSS) with preserved MMR (pMMR), 64 (19.5%) cases were MSI-High (MSI-H) with MMR deficient (dMMR), 2 cases showed subclonal loss of MLH1 and PMS2 with MSI-H, and 6 cases were discordant. Overall, there was a 98.2% (322/328) IHC/MSI concordance. Discordant cases were retested and/or subject to NGS. Of the six discrepant cases, five showed dMMR with MSS and one showed pMMR with MSI-H. One dMMR/MSI-L case showed loss of PMS2 with a germline pathogenic mutation. The pMMR/MSI-H case was found to harbor pathogenic variants in MLH1 and MSH6. One of the two cases with subclonal populations demonstrated MSI-H in the dMMR area and MSS in the pMMR area. These results emphasize the importance of selecting the appropriate tumor tissue for both IHC and molecular testing and demonstrate that NGS can help resolve discrepant MMR and MSI results.
MeSH term(s)	Adult ; Aged ; Biomarkers, Tumor/analysis ; Biomarkers, Tumor/genetics ; DNA Mismatch Repair ; DNA Mutational Analysis ; DNA-Binding Proteins/antagonists & inhibitors ; DNA-Binding Proteins/genetics ; Databases, Factual ; Female ; Genital Neoplasms, Female/diagnosis ; Genital Neoplasms, Female/enzymology ; Genital Neoplasms, Female/genetics ; Genital Neoplasms, Female/pathology ; High-Throughput Nucleotide Sequencing ; Humans ; Immunohistochemistry ; Microsatellite Instability ; Middle Aged ; Mismatch Repair Endonuclease PMS2/analysis ; Mismatch Repair Endonuclease PMS2/genetics ; MutL Protein Homolog 1/analysis ; MutL Protein Homolog 1/genetics ; Mutation ; Polymerase Chain Reaction ; Predictive Value of Tests ; Reproducibility of Results ; Retrospective Studies
Chemical Substances	Biomarkers, Tumor ; DNA-Binding Proteins ; G-T mismatch-binding protein ; MLH1 protein, human ; PMS2 protein, human (EC 3.6.1.-) ; Mismatch Repair Endonuclease PMS2 (EC 3.6.1.3) ; MutL Protein Homolog 1 (EC 3.6.1.3)
Language	English
Publishing date	2021-10-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	207657-3
ISSN	1532-8392 ; 0046-8177
ISSN (online)	1532-8392
ISSN	0046-8177
DOI	10.1016/j.humpath.2021.10.004
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