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Clinics in Laboratory Medicine

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https://www.readbyqxmd.com/read/30115399/it-s-mass-spectrometry-s-turn-to-change-clinical-practice
#1
EDITORIAL
Geza S Bodor
No abstract text is available yet for this article.
September 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/30115398/development-of-a-25-hydroxyvitamin-d-liquid-chromatography-tandem-mass-spectrometry-assay-cleared-by-the-food-and-drug-administration-via-the-de-novo-pathway
#2
REVIEW
Nicole V Tolan
Despite great improvement in vitamin D assay standardization, inaccurate recoveries of 25(OH)D2 remain for immunoassays and many laboratory-developed LC-MS/MS methods don't separate out the 3-epimer interferents. Through the process of obtaining FDA-clearance, we learned that communication is key. Mass spectrometry-based assays raise different questions of safety and efficacy than the predicate immunoassays, with fewer risks due to increased accuracy. This process required improving our quality management system to support the development and registration of an in vitro diagnostic device...
September 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/30115397/special-considerations-for-liquid-chromatography-tandem-mass-spectrometry-method-development
#3
REVIEW
Brian A Rappold
Method development for diagnostic liquid-chromatography-tandem mass spectrometry (LC-MS/MS) assays are not broadly discussed in publications. Certain aspects of the development process are thus learned via experience. This article touches on a number of aspects that should be contemplated during method development for LC-MS/MS tests beyond sample preparation, chromatographic separation, and mass spectrometric detection. Utilization of factors intrinsic to LC-MS/MS, such as isotopically labeled internal standards and appraisal of transition ratios, engenders confidence in assay development and accelerates movement toward validation and testing...
September 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/30115396/liquid-chromatography-mass-spectrometry-education-for-clinical-laboratory-scientists
#4
REVIEW
Judith A Stone, Robert L Fitzgerald
This article describes the need for, stratifies the complexity of, and proposes detailed lists of training competencies for diagnostic laboratory personnel using quantitative liquid chromatography-tandem mass spectrometry (LC-MS/MS) for patient care. Although quantitative LC-MS/MS is evolving toward greater automation with less need for technical expertise, gaps remain in resources for training and assessment.
September 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/30115395/accreditation-and-quality-assurance-for-clinical-liquid-chromatography-mass-spectrometry-laboratories
#5
REVIEW
Kara L Lynch
For mass spectrometry (MS) testing in the clinical laboratory, postimplementation monitoring for quality is just as important as method development and validation but often receives less attention. Quality-assurance monitoring for liquid chromatography-tandem MS (LC-MS/MS) testing should be proactive rather than reactive and should monitor the entire testing process. An LC-MS/MS quality-assurance plan should cover overall batch review parameters, individual peak review parameters, system and reagent changes, and assessment of long-term accuracy...
September 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/30115394/harmonization-of-liquid-chromatography-tandem-mass-spectrometry-protein-assays
#6
REVIEW
Alan L Rockwood, Mark S Lowenthal, Cory Bystrom
Harmonization of diagnostic test results is fundamental to the effective use of laboratory testing in the diagnosis, treatment, and monitoring of disease. Formal approaches to harmonization and standardization provide a rigorous and high-quality roadmap to this end, although the formal harmonization process can be long and complex. In the meantime, more informal approaches to harmonization can provide a useful pathway to improved harmonization in the short term. Factors relevant to harmonization are discussed with particular attention to protein assays using LC-MS/MS...
September 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/30115393/proteoform-analysis-to-fulfill-unmet-clinical-needs-and-reach-global-standardization-of-protein-measurands-in-clinical-chemistry-proteomics
#7
REVIEW
Yuri E M van der Burgt, Christa M Cobbaert
In clinical testing of protein markers, structure variants of the measurand are often not taken into account. This heterogeneous character of protein measurands in immunoassays often renders test standardization impossible. Consequently, test results from different methods can lead to underdiagnosis or overdiagnosis and, thus, undertreatment or overtreatment of patients. The systematic structural analysis of protein isoforms has been coined proteoform profiling and is performed through mass spectrometry-based proteomics strategies...
September 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/30115392/matrix-assisted-laser-desorption-time-of-flight-mass-spectrometry
#8
REVIEW
Donna M Wolk, Andrew E Clark
Matrix-assisted laser desorption time of flight mass spectrometry (MALDI-TOF MS), adapted for use in clinical microbiology laboratories, challenges current standards of microbial detection and identification. This article summarizes the capabilities of MALDI-TOF MS in diagnostic clinical microbiology laboratories and describes the underpinnings of the technology, highlighting topics such as sample preparation, spectral analysis, and accuracy. The use of MALDI-TOF MS in the clinical microbiology laboratory is growing, and, when properly deployed, can accelerate diagnosis and improve patient care...
September 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/30115391/pain-management-testing-by-liquid-chromatography-tandem-mass-spectrometry
#9
REVIEW
Geza S Bodor
For appropriate pain medication monitoring, the analytical method must be sensitive enough to detect the prescribed medication and metabolites at a sufficiently low concentration to recognize compliance, even with a low-dose prescription. The method must also provide excellent selectivity to identify simultaneously present drugs even with similar chemical structures. The analytical method should uncover common illicit drugs/nonprescribed medications. Traditional immunoassays cannot satisfy these criteria, but liquid chromatography tandem mass spectrometry can...
September 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/30115390/25-hydroxyvitamin-d-testing-immunoassays-versus-tandem-mass-spectrometry
#10
REVIEW
Uttam Garg
Vitamin D has been associated with many health conditions. Because of widespread deficiency in the general population, laboratory testing of vitamin D has increased exponentially in recent years. Currently, 25-hydroxyvitamin D (25[OH]D) is considered the best marker of vitamin D status. Automated immunoassays and tandem mass spectrometry are the most widely used assays for the measurement of 25(OH)D. Because a medical decision of vitamin D deficiency and treatment are made based on specific levels, it is important that different 25(OH)D assays are harmonized...
September 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29776640/looking-good-in-your-genes-maximizing-one-s-personalized-molecular-fingerprint-for-optimal-health
#11
EDITORIAL
Martin H Bluth
No abstract text is available yet for this article.
June 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29776639/gynecologic-cancers-molecular-updates-2018
#12
REVIEW
Eman Abdulfatah, Quratulain Ahmed, Baraa Alosh, Sudeshna Bandyopadhyay, Martin H Bluth, Rouba Ali-Fehmi
Ovarian carcinoma continues to be a concern for woman and maintains significant morbidity and mortality. Emerging molecular markers are providing additional opportunities for effective diagnosis and prognosis of disease. An integrated clinicopathologic and molecular classification of gynecologic malignancies has the potential to refine the clinical risk prediction of patients with cancer and to provide more tailored treatment recommendations.
June 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29776638/breast-carcinoma-updates-in-molecular-profiling-2018
#13
REVIEW
Sudeshna Bandyopadhyay, Martin H Bluth, Rouba Ali-Fehmi
The most significant contribution of molecular subtyping of breast carcinomas has been the identification of estrogen-positive and estrogen-negative tumor subtypes. Knowledge of genetic alterations in these tumors will help clinicians identify novel therapeutic targets. Understanding the progression pathways involved in the transition of in situ carcinoma to invasive carcinoma might lead to efficient risk stratification in these patients. The Cancer Genome Analysis Network has collected genomic and epigenomic data to provide comprehensive information regarding carcinogenesis and pathway interactions...
June 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29776637/an-update-regarding-the-molecular-genetics-of-melanocytic-neoplasms-and-the-current-applications-of-molecular-genetic-technologies-in-their-diagnosis-and-treatment
#14
REVIEW
Katrin Kiavash, Martin H Bluth, Andrew David Thompson
Molecular genetic technologies are used to aid in diagnosis and treatment of borderline melanocytic tumors as an adjuvant to the gold standard histopathologic evaluation. A specific set of fluorescence in situ hybridization probes is widely used to aid in diagnosing challenging melanocytic lesions. New melanoma probe cocktails have revealed increased sensitivity and specificity in ambiguous melanocytic cases. Array comparative genomic hybridization is a more complex technology used for the work-up of diagnostically problematic Spitzoid melanocytic proliferations...
June 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29776636/molecular-diagnostics-in-the-neoplasms-of-the-pancreas-liver-gallbladder-and-extrahepatic-biliary-tract-2018-update
#15
REVIEW
Lei Zhang, Martin H Bluth, Amarpreet Bhalla
Pancreatic neoplasms, including ductal adenocarcinoma, solid pseudopapillary neoplasm, pancreatic endocrine neoplasms, acinar cell carcinoma, and pancreatoblastoma, are associated with different genetic abnormalities. Hepatic adenomas with beta-catenin exon 3 mutation are associated with a high risk of malignancy. Hepatic adenoma with arginosuccinate synthetase 1 expression or sonic hedgehog mutations are associated with a risk of bleeding. Hepatocellular carcinoma and choangiocarcinoma display heterogeneity at both morphologic and molecular levels Cholangiocellular carcinoma is most commonly associated with IDH 1/2 mutations...
June 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29776635/molecular-diagnostics-in-esophageal-and-gastric-neoplasms-2018-update
#16
REVIEW
Muhammad Zulfiqar, Martin H Bluth, Amarpreet Bhalla
Esophageal cancer (EC) is rapidly increasing in incidence in the United States. Genetic changes associated with the development of EC involve the p16, p53, and APC genes. Human epidermal growth factor 2 (HER-2) overexpression is seen in gastroesophageal junction carcinoma and a subset gastric carcinoma (GC). Interestingly, up to 50% cases of GC are related to Helicobacter pylori infection and up to 16% are related to EBV infection. Microsatellite instability is observed in up to 39% of GC and cell free nucleic acid analysis provides additional opportunities for diagnosis and prognosis of disease...
June 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29776634/molecular-diagnostics-in-the-neoplasms-of-small-intestine-and-appendix-2018-update
#17
REVIEW
Yingtao Zhang, Muhammad Zulfiqar, Martin H Bluth, Amarpreet Bhalla, Rafic Beydoun
Neoplasms of the small intestine are rare in comparison with colorectal tumors. The most common tumor types arising in the small intestine are adenocarcinomas, well-differentiated neuroendocrine tumors, gastrointestinal stromal tumors, and lymphoma. Primary appendiceal neoplasms are rare and found in less than 2% of appendectomy specimens with an incidence of approximately 1.2 cases per 100,000 people per year in the United States. This article explores molecular diagnostics in the neoplasms of small intestine and appendix...
June 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29776633/molecular-diagnostics-in-colorectal-carcinoma-advances-and-applications-for-2018
#18
REVIEW
Amarpreet Bhalla, Muhammad Zulfiqar, Martin H Bluth
The molecular pathogenesis and classification of colorectal carcinoma are based on the traditional adenomaecarcinoma sequence, serrated polyp pathway, and microsatellite instability (MSI). The genetic basis for hereditary nonpolyposis colorectal cancer is the detection of mutations in the MLH1, MSH2, MSH6, PMS2, and EPCAM genes. Genetic testing for Lynch syndrome includes MSI testing, methylator phenotype testing, BRAF mutation testing, and molecular testing for germline mutations in MMR genes. Molecular makers with predictive and prognostic implications include quantitative multigene reverse transcriptase polymerase chain reaction assay and KRAS and BRAF mutation analysis...
June 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29776632/molecular-diagnosis-of-hematopoietic-neoplasms-2018-update
#19
REVIEW
Radhakrishnan Ramchandren, Tarek Jazaerly, Martin H Bluth, Ali M Gabali
Diagnosis of hematologic malignancies have matured to encompass molecular as well as phenotypic characteristics. Cytogenetic abnormalities are considered common events in this regard. These abnormalities generally consist of structural chromosomal abnormalities or gene mutations, which often are integral to the pathogenesis and subsequent evolution of an individual malignancy. Improvements made in identifying and interpreting these molecular alterations have resulted in advances in the diagnosis, prognosis, monitoring, and therapy for cancer...
June 2018: Clinics in Laboratory Medicine
https://www.readbyqxmd.com/read/29776631/molecular-pathology-in-transfusion-medicine-new-concepts-and-applications
#20
REVIEW
Matthew B Elkins, Robertson D Davenport, Martin H Bluth
Virtually all the red blood cell and platelet antigen systems have been characterized at the molecular level. Highly reliable methods for red blood cell and platelet antigen genotyping are now available. Genotyping is a useful adjunct to traditional serology and can help resolve complex serologic problems. Although red blood cell and platelet phenotypes can be inferred from genotype, knowledge of the molecular basis is essential for accurate assignment. Genotyping of blood donors is an effective method of identifying antigen-negative and/or particularly rare donors...
June 2018: Clinics in Laboratory Medicine
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