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Article ; Online: Testing For SARS-CoV-2: The Day the World Turned its Attention to the Clinical Laboratory.

Zhao, Xuemei / Markensohn, Julia F / Wollensak, David A / Laterza, Omar F

2020 Volume 13, Issue 5, Page(s) 871–876

Abstract: In the last few months, an unprecedented number of laboratory tests for coronavirus disease 2019 (COVID-19) have been developed at a remarkable speed. With the rapid adoption of these tests into clinical practice, combined with the widespread publicity ... ...

Abstract	In the last few months, an unprecedented number of laboratory tests for coronavirus disease 2019 (COVID-19) have been developed at a remarkable speed. With the rapid adoption of these tests into clinical practice, combined with the widespread publicity they received, questions arose related to the different types of tests, their utility, performance, and regulatory approval status. The aim of this publication is to provide a general landscape of laboratory testing for COVID-19 and offer a historical and regulatory perspective associated with them. Specifically, we aim to elaborate on the regulatory complexities of diagnostic testing in the United States and its implications to the present outbreak, as well as provide a synopsis of laboratory tests that have been developed for COVID-19. We will first address the detection of severe acute respiratory syndrome-coronavirus 2 directly by either nucleic acid amplification tests or by the detection of the viral protein for active infections. Subsequently, we will provide an overview of serological tests that can aid not only in diagnosis but additionally help to identify prior infections and potential immunity.
MeSH term(s)	Antibodies, Viral/immunology ; Antibodies, Viral/isolation & purification ; Antigens, Viral/immunology ; Antigens, Viral/isolation & purification ; Betacoronavirus/genetics ; Betacoronavirus/immunology ; Betacoronavirus/isolation & purification ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Services/legislation & jurisprudence ; Clinical Laboratory Services/organization & administration ; Clinical Laboratory Techniques/methods ; Coronavirus Infections/diagnosis ; Coronavirus Infections/epidemiology ; Coronavirus Infections/transmission ; Coronavirus Infections/virology ; Humans ; Pandemics ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/transmission ; Pneumonia, Viral/virology ; RNA, Viral/isolation & purification ; SARS-CoV-2 ; Serologic Tests/methods ; United States
Chemical Substances	Antibodies, Viral ; Antigens, Viral ; RNA, Viral
Keywords	covid19
Language	English
Publishing date	2020-06-29
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.12828
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Testing For SARS‐CoV‐2

Zhao, Xuemei / Markensohn, Julia F. / Wollensak, David A. / Laterza, Omar F.

Clinical and Translational Science ; ISSN 1752-8054 1752-8062

The Day the World Turned its Attention to the Clinical Laboratory

2020

Keywords	General Pharmacology, Toxicology and Pharmaceutics ; General Biochemistry, Genetics and Molecular Biology ; General Neuroscience ; General Medicine ; covid19
Language	English
Publisher	Wiley
Publishing country	us
Document type	Article ; Online
DOI	10.1111/cts.12828
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Testing For SARS‐CoV‐2

Xuemei Zhao / Julia F. Markensohn / David A. Wollensak / Omar F. Laterza

Clinical and Translational Science, Vol 13, Iss 5, Pp 871-

The Day the World Turned its Attention to the Clinical Laboratory

2020 Volume 876

Abstract: In the last few months, an unprecedented number of laboratory tests for coronavirus disease 2019 (COVID‐19) have been developed at a remarkable speed. With the rapid adoption of these tests into clinical practice, combined with the widespread publicity ... ...

Abstract	In the last few months, an unprecedented number of laboratory tests for coronavirus disease 2019 (COVID‐19) have been developed at a remarkable speed. With the rapid adoption of these tests into clinical practice, combined with the widespread publicity they received, questions arose related to the different types of tests, their utility, performance, and regulatory approval status. The aim of this publication is to provide a general landscape of laboratory testing for COVID‐19 and offer a historical and regulatory perspective associated with them. Specifically, we aim to elaborate on the regulatory complexities of diagnostic testing in the United States and its implications to the present outbreak, as well as provide a synopsis of laboratory tests that have been developed for COVID‐19. We will first address the detection of severe acute respiratory syndrome‐coronavirus 2 directly by either nucleic acid amplification tests or by the detection of the viral protein for active infections. Subsequently, we will provide an overview of serological tests that can aid not only in diagnosis but additionally help to identify prior infections and potential immunity.
Keywords	Therapeutics. Pharmacology ; RM1-950 ; Public aspects of medicine ; RA1-1270 ; covid19
Language	English
Publishing date	2020-09-01T00:00:00Z
Publisher	Wiley
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Testing For SARS-CoV-2: The Day the World Turned its Attention to the Clinical Laboratory

Zhao, Xuemei / Markensohn, Julia F / Wollensak, David A / Laterza, Omar F

Clin Transl Sci

Abstract	In the last few months, an unprecedented number of laboratory tests for coronavirus disease 2019 (COVID-19) have been developed at a remarkable speed. With the rapid adoption of these tests into clinical practice, combined with the widespread publicity they received, questions arose related to the different types of tests, their utility, performance, and regulatory approval status. The aim of this publication is to provide a general landscape of laboratory testing for COVID-19 and offer a historical and regulatory perspective associated with them. Specifically, we aim to elaborate on the regulatory complexities of diagnostic testing in the United States and its implications to the present outbreak, as well as provide a synopsis of laboratory tests that have been developed for COVID-19. We will first address the detection of severe acute respiratory syndrome-coronavirus 2 directly by either nucleic acid amplification tests or by the detection of the viral protein for active infections. Subsequently, we will provide an overview of serological tests that can aid not only in diagnosis but additionally help to identify prior infections and potential immunity.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #437063
Database	COVID19

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Article ; Online: Measuring Tumor Mutational Burden (TMB) in Plasma from mCRPC Patients Using Two Commercial NGS Assays.

Qiu, Ping / Poehlein, Christian H / Marton, Matthew J / Laterza, Omar F / Levitan, Diane

Scientific reports

2019 Volume 9, Issue 1, Page(s) 114

Abstract: Tumor tissue mutational burden (TMB) has emerged as a promising predictive biomarker for immune checkpoint therapy. Measuring TMB from circulating tumor DNA (ctDNA) found in plasma is attractive in tissue-constrained indications. We compared the ... ...

Abstract	Tumor tissue mutational burden (TMB) has emerged as a promising predictive biomarker for immune checkpoint therapy. Measuring TMB from circulating tumor DNA (ctDNA) found in plasma is attractive in tissue-constrained indications. We compared the performance of two plasma-based commercial TMB assays including the effect of two different collection methods. Our findings suggest that the two plasma based TMB assays are highly correlated and they are also both correlated with a tissue-based TMB assay for relatively high TMB samples. The two collection methods are also found to be very comparable. Plasma-based TMB assays may be mature enough to be clinically useful in mCRPC and potentially other indications.
MeSH term(s)	Biomarkers, Tumor/blood ; Circulating Tumor DNA/blood ; Humans ; Immunotherapy ; Liquid Biopsy ; Male ; Mutation ; Prostatic Neoplasms, Castration-Resistant/blood ; Prostatic Neoplasms, Castration-Resistant/genetics ; Prostatic Neoplasms, Castration-Resistant/therapy ; Tumor Burden
Chemical Substances	Biomarkers, Tumor ; Circulating Tumor DNA
Language	English
Publishing date	2019-01-14
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-018-37128-y
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: PAPP-A: a marker of plaque instability. Is it ready for prime time?

Laterza, Omar F

Future cardiology

2005 Volume 1, Issue 4, Page(s) 495–500

Abstract: Pregnancy-associated plasma protein-A (PAPP-A) is a zinc-binding metalloproteinase that was first identified circulating in the serum of pregnant women, but has recently been suggested to be a predictor of risk for cardiovascular events. Publications on ... ...

Abstract	Pregnancy-associated plasma protein-A (PAPP-A) is a zinc-binding metalloproteinase that was first identified circulating in the serum of pregnant women, but has recently been suggested to be a predictor of risk for cardiovascular events. Publications on PAPP-A, primarily from the last 4-5 years, were reviewed extensively. A special emphasis was placed on those that address the development of methods for the detection of PAPP-A in human serum/plasma and those that study the diagnostic/prognostic accuracy of PAPP-A in patients with acute coronary syndrome. This review shall focus on the possible mechanism of action of PAPP-A, clinical studies involving PAPP-A, PAPP-A assays and its molecular structure. All clinical studies to date related to the diagnostic/prognostic accuracy of PAPP-A (a total of eight studies) were included. They suggest that elevations in PAPP-A correlate with higher risk for the development of cardiovascular adverse events. However, there are conflicting data as to whether PAPP-A levels correlate with cardiac troponins or C-reactive protein. Thus, there is room for speculation as to whether PAPP-A is involved in inflammatory processes, and as to what its role is in plaque rupture and subsequent cardiac ischemic events. Furthermore, new insights into the molecular structure of PAPP-A could aid in the development of more specific assays that may help unravel the clinical utility of PAPP-A.
Language	English
Publishing date	2005-07
Publishing country	England
Document type	Journal Article
ZDB-ID	2274267-0
ISSN	1744-8298 ; 1479-6678
ISSN (online)	1744-8298
ISSN	1479-6678
DOI	10.2217/14796678.1.4.495
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Article ; Online: Measuring Tumor Mutational Burden (TMB) in Plasma from mCRPC Patients Using Two Commercial NGS Assays

Ping Qiu / Christian H. Poehlein / Matthew J. Marton / Omar F. Laterza / Diane Levitan

Scientific Reports, Vol 9, Iss 1, Pp 1-

2019 Volume 3

Abstract: Abstract Tumor tissue mutational burden (TMB) has emerged as a promising predictive biomarker for immune checkpoint therapy. Measuring TMB from circulating tumor DNA (ctDNA) found in plasma is attractive in tissue-constrained indications. We compared the ...

Abstract	Abstract Tumor tissue mutational burden (TMB) has emerged as a promising predictive biomarker for immune checkpoint therapy. Measuring TMB from circulating tumor DNA (ctDNA) found in plasma is attractive in tissue-constrained indications. We compared the performance of two plasma-based commercial TMB assays including the effect of two different collection methods. Our findings suggest that the two plasma based TMB assays are highly correlated and they are also both correlated with a tissue-based TMB assay for relatively high TMB samples. The two collection methods are also found to be very comparable. Plasma-based TMB assays may be mature enough to be clinically useful in mCRPC and potentially other indications.
Keywords	Medicine ; R ; Science ; Q
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	Nature Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Experimental Medicine Study to Measure Immune Checkpoint Receptors PD-1 and GITR Turnover Rates In Vivo in Humans.

Lassman, Michael E / Chappell, Derek L / McAvoy, Thomas / Cheng, Amy / de Alwis, Dinesh P / Pruitt, Scott K / Laterza, Omar F / Li, Claire / Stoch, Aubrey / Mayawala, Kapil

Clinical pharmacology and therapeutics

2021 Volume 109, Issue 6, Page(s) 1575–1582

Abstract: Development of monoclonal antibodies (mAbs) targeting immune-checkpoint receptors (IMRs) for the treatment of cancer is one of the most active areas of investment in the biopharmaceutical industry. A key decision in the clinical development of anti-IMR ... ...

Abstract	Development of monoclonal antibodies (mAbs) targeting immune-checkpoint receptors (IMRs) for the treatment of cancer is one of the most active areas of investment in the biopharmaceutical industry. A key decision in the clinical development of anti-IMR mAbs is dose selection. Dose selection can be challenging because the traditional oncology paradigm of administering the maximum tolerated dose is not applicable to anti-IMR mAbs. Instead, dose selection should be informed by the pharmacology of immune signaling. Engaging an IMR is a key initial step to triggering pharmacologic effects, and turnover (i.e., the rate of protein synthesis) of the IMR is a key property to determining the dose level needed to engage the IMR. Here, we applied the stable isotope labeling mass spectrometry technique using
MeSH term(s)	Algorithms ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/therapeutic use ; Glucocorticoid-Induced TNFR-Related Protein/metabolism ; Half-Life ; Healthy Volunteers ; Humans ; Immune Checkpoint Inhibitors/therapeutic use ; Immunotherapy ; Leucine/pharmacokinetics ; Mass Spectrometry ; Programmed Cell Death 1 Receptor/metabolism ; Reproducibility of Results
Chemical Substances	Antibodies, Monoclonal ; Glucocorticoid-Induced TNFR-Related Protein ; Immune Checkpoint Inhibitors ; PDCD1 protein, human ; Programmed Cell Death 1 Receptor ; TNFRSF18 protein, human ; Leucine (GMW67QNF9C)
Language	English
Publishing date	2021-02-01
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.2129
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Influence of Pre-Analytical Factors on Thymus- and Activation-Regulated Chemokine Quantitation in Plasma.

Zhao, Xuemei / Delgado, Liliana / Weiner, Russell / Laterza, Omar F

Journal of circulating biomarkers

2015 Volume 4, Page(s) 10

Abstract: Thymus- and activation-regulated chemokine (TARC) in serum/plasma associates with the disease activity of atopic dermatitis (AD), and is a promising tool for assessing the response to the treatment of the disease. TARC also exists within platelets, with ... ...

Abstract	Thymus- and activation-regulated chemokine (TARC) in serum/plasma associates with the disease activity of atopic dermatitis (AD), and is a promising tool for assessing the response to the treatment of the disease. TARC also exists within platelets, with elevated levels detectable in AD patients. We examined the effects of pre-analytical factors on the quantitation of TARC in human EDTA plasma. TARC levels in platelet-free plasma were significantly lower than those in platelet-containing plasma. After freeze-thaw, TARC levels increased in platelet-containing plasma, but remained unchanged in platelet-free plasma, suggesting TARC was released from the platelets during the freeze-thaw process. In contrast, TARC levels were stable in serum independent of freeze-thaw. These findings underscore the importance of pre-analytical factors to TARC quantitation. Plasma TARC levels should be measured in platelet-free plasma for accurate quantitation. Pre-analytical factors influence the quantitation, interpretation, and implementation of circulating TARC as a biomarker for the development of AD therapeutics.
Language	English
Publishing date	2015-10-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	2802655-X
ISSN	1849-4544 ; 1849-4544
ISSN (online)	1849-4544
ISSN	1849-4544
DOI	10.5772/61749
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: A Machine Learning Approach to Identify a Circulating MicroRNA Signature for Alzheimer Disease.

Zhao, Xuemei / Kang, John / Svetnik, Vladimir / Warden, Donald / Wilcock, Gordon / David Smith, A / Savage, Mary J / Laterza, Omar F

The journal of applied laboratory medicine

2019 Volume 5, Issue 1, Page(s) 15–28

Abstract: Background: Accurate diagnosis of Alzheimer disease (AD) involving less invasive molecular procedures and at reasonable cost is an unmet medical need. We identified a serum miRNA signature for AD that is less invasive than a measure in cerebrospinal ... ...

Abstract	Background: Accurate diagnosis of Alzheimer disease (AD) involving less invasive molecular procedures and at reasonable cost is an unmet medical need. We identified a serum miRNA signature for AD that is less invasive than a measure in cerebrospinal fluid. Methods: From the Oxford Project to Investigate Memory and Aging (OPTIMA) study, 96 serum samples were profiled by a multiplex (>500 analytes) microRNA (miRNA) reverse transcription quantitative PCR analysis, including 51 controls, 32 samples from patients with AD, and 13 samples from patients with mild cognitive impairment (MCI). Clinical diagnosis of a subset of AD and the controls was confirmed by postmortem (PM) histologic examination of brain tissue. In a machine learning approach, the AD and control samples were split 70:30 as the training and test cohorts. A multivariate random forest statistical analysis was applied to construct and test a miRNA signature for AD identification. In addition, the MCI participants were included in the test cohort to assess whether the signature can identify early AD patients. Results: A 12-miRNA signature for AD identification was constructed in the training cohort, demonstrating 76.0% accuracy in the independent test cohort with 90.0% sensitivity and 66.7% specificity. The signature, however, was not able to identify MCI participants. With a subset of AD and control participants with PM-confirmed diagnosis status, a separate 12-miRNA signature was constructed. Although sample size was limited, the PM-confirmed signature demonstrated improved accuracy of 85.7%, largely owing to improved specificity of 80.0% with comparable sensitivity of 88.9%. Conclusion: Although additional and more diverse cohorts are needed for further clinical validation of the robustness, the miRNA signature appears to be a promising blood test to diagnose AD.
MeSH term(s)	Aged ; Alzheimer Disease/blood ; Alzheimer Disease/diagnosis ; Alzheimer Disease/genetics ; Alzheimer Disease/mortality ; Autopsy/methods ; Brain/metabolism ; Brain/pathology ; Circulating MicroRNA/blood ; Cognitive Dysfunction/cerebrospinal fluid ; Cognitive Dysfunction/diagnosis ; Cognitive Dysfunction/genetics ; Early Diagnosis ; Female ; Gene Expression Profiling/methods ; Humans ; Machine Learning ; Male ; Reproducibility of Results ; Sensitivity and Specificity ; Transcriptome
Chemical Substances	Circulating MicroRNA
Language	English
Publishing date	2019-11-29
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2576-9456
ISSN	2576-9456
DOI	10.1373/jalm.2019.029595
Database	MEDical Literature Analysis and Retrieval System OnLINE

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