Publications by authors named "Julia Engstrom-Melnyk"

5 Publications

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Adherence to National Comprehensive Cancer Network ALK Testing Guidelines for Patients with Advanced Non-Small Cell Lung Cancer in U.S. Community Medical Centers.

Oncologist 2021 Apr 6. Epub 2021 Apr 6.

University of Mississippi Medical Center, Jackson, Mississippi, USA.

Background: National Comprehensive Cancer Network (NCCN) guidelines recommend biomarker testing as the first step in the management of patients with advanced non-small cell lung cancer (aNSCLC). We assessed anaplastic lymphoma kinase (ALK) testing rates and factors related to underuse in community medical systems between 2012 and 2019 to understand guideline adoption.

Methods: A retrospective observational study using a nationwide electronic health record (EHR)-derived deidentified database was conducted. Patients with aNSCLC diagnosed in community medical centers from January 2012 to May 2019 were included to describe the ALK testing trend. This cohort was further restricted to patients diagnosed after 2015 to understand factors associated with testing underuse using mixed-effects multivariable logistic regression models.

Results: Trends for increased ALK testing rates by year were observed in both NCCN guideline-eligible patients (59.5% in 2012 to 84.1% in 2019) and -ineligible patients (15.6% to 50.8%) in a cohort of 41,728 patients. Histology type and smoking status had the greatest impact on test use. Compared with patients with nonsquamous histology and no smoking history, patients with squamous histology and no smoking history (adjusted odds ratio [aOR], 7.6; 95% confidence interval [CI], 5.6-10.4), NSCLC histology not otherwise specified (NOS) with smoking history (aOR, 3.4; 95% CI, 2.8-4.2); NSCLC NOS/nonsmoker (aOR, 1.8; 95% CI, 1.1-3.2), and nonsquamous/smoker (aOR, 1.5; 95% CI, 1.3-1.7) were less likely to be tested. Factors related to underuse also included Eastern Cooperative Oncology Group performance status, stage at initial diagnosis, and demographics.

Conclusion: This analysis of real-world data shows increasing test use by year; however, one fifth of patients eligible for ALK testing still remain untested and potentially missing therapeutic options.

Implications For Practice: Advancement in treatment of lung cancer is accompanied by an increasing number of tests that should be run to determine potential therapy options for each patient. This study assessed adoption of testing recommendations for anaplastic lymphoma kinase rearrangements in a national database. Although test use increased over the time period studied (2012-2019), there is still room for improvement. Efforts are needed to increase test use in undertested groups, thus enabling eligible patients to benefit from novel lung cancer therapies.
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http://dx.doi.org/10.1002/onco.13779DOI Listing
April 2021

Evaluation of Contamination Risk by the cobas e 602 Serology Module Before Viral Load Testing on the cobas 6800 System.

Sex Transm Dis 2020 05;47(5S Suppl 1):S32-S34

Medical and Scientific Affairs, Roche Molecular Systems, Pleasanton, CA.

Background: Diagnosis of HCV, HBV, and HIV involves antibody screening followed by confirmation and/or treatment decision using nucleic acid tests. However, minimal data exist evaluating the risk of nucleic acid cross-contamination on serology devices upstream of molecular testing despite the potential clinical and laboratory workflow advantages of single specimen vial testing for both procedures.

Methods: We conducted a checkerboard study investigating the potential risk of HCV, HBV, and HIV nucleic acid cross-contamination on 480 negative specimens by a serology screening instrument that uses disposable tips for sample transfer, rather than a fixed needle, before molecular testing.

Results: Nucleic acid contamination was observed in 0 of 480 negative specimens when processed with alternating high-titer HCV, HBV, or HIV specimens on the serology platform.

Conclusions: This study suggests that specimens analyzed by a serology instrument using disposable tips for sample transfer may be suitable for direct primary specimen reflex testing by a sensitive nucleic acid confirmatory test.
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http://dx.doi.org/10.1097/OLQ.0000000000001125DOI Listing
May 2020

Assay Integrity of a PCR Influenza Point-of-Care Test Remains Following Artificial System Contamination.

J Appl Lab Med 2019 11 1;4(3):422-426. Epub 2019 Jul 1.

Roche Diagnostics Corporation, Indianapolis, IN.

Background: Healthcare providers who have access to tests at the point of care (POC) are increasingly requesting the same performance from the POC test as they expect from the laboratory. With the introduction of the cobas Liat instrument, highly sensitive molecular diagnostic testing can be performed closer to the patient in CLIA-waived, POC settings. As more sensitive tests become available, there is concern regarding contamination of instrumentation owing to improper handling, mistakes made when processing, or environmental contamination. Recent concerns were raised when a nurse performed environmental surveillance for flu A/B by inserting a dry swab into the cobas Liat instrument and then ran it as a sample on the instrument, generating a positive result. This finding stimulated questions about the possibility of system contamination contributing to false-positive results, ultimately leading to the possibility of providing incorrect treatment to patients.

Methods: To assess the likelihood of system contamination contributing to the generation of false-positive results, in this study we contaminated a cobas Liat System with flu A/B-positive control material. The system contamination was then assessed by swabbing exposed surfaces. Following confirmed system contamination, negative control samples were processed to determine whether system contamination had an impact on the expected negative results.

Results: Instrument contamination was confirmed, and no detectable flu A/B signal was observed for any of the negative control tubes run immediately following confirmation of system contamination.

Conclusion: Environmental contamination of the Liat instrument does not have an impact on the integrity of the result.
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http://dx.doi.org/10.1373/jalm.2018.028639DOI Listing
November 2019

Current and Emerging Multianalyte Assays with Algorithmic Analyses-Are Laboratories Ready for Clinical Adoption?

Clin Chem 2018 06 17;64(6):885-891. Epub 2018 Jan 17.

Department of Pathology and Laboratory Medicine, Women and Infants' Hospital of Rhode Island, The Warren Alpert Medical School of Brown, Providence, Rhode Island.

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http://dx.doi.org/10.1373/clinchem.2017.275677DOI Listing
June 2018

The biology of HPV infections: understanding the progression to cervical cancer.

MLO Med Lab Obs 2014 Apr;46(4):16, 20

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April 2014