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BACKGROUND: CYP2C19 polymorphisms contribute about 12% of the variability in the antiplatelet effect of clopidogrel, which is commonly prescribed for patients undergoing percutaneous coronary intervention. For these patients, rapid turnaround time of CYP2C19 genotyping may be critical. We validated and compared the performance of two point-of-care CYP2C19 genotype tests, Nanosphere Verigene CYP2C19 Nucleic Acid Test and Spartan RX CYP2C19 System. MATERIALS AND METHODS: Our CLIA certified Molecular Diagnostic Laboratory performed 99 Verigene tests and 108 Spartan RX CYP2C19 assays. We compared performance and genotype results between the two platforms, across runs, and among technologists. Based on our validation results, we started offering CYP2C19 genotyping using the Spartan RX CYP2C19 assay for post-percutaneous coronary intervention patients. RESULTS: Laboratory validation genotype results were consistent between both assays when the assays produced results (100% accuracy); however, the Verigene CYP2C19 had a 33% no call rate. In contrast, Spartan consistently showed accurate results. Using a newly established clinical workflow, we assayed 342 post-percutaneous coronary intervention patients with the Spartan test. Within one hour of submitting patient samples, ordering physicians were notified of any clinically significant results and provided clinical decision support. CONCLUSIONS: Every approach has its limitations, but our practice of using the Spartan RX CYP2C19 test in our acute cardiac workflow provides accurate and rapid results to guide clinical decision-making at the point-of-care. Prospective follow-up is ongoing to evaluate outcomes and effectiveness of CYP2C19 testing.

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BACKGROUND: The molecular diagnostics laboratory faces the challenge of improving test turnaround time (TAT). Low and consistent TATs are of great clinical and regulatory importance, especially for molecular virology tests. Laboratory information systems (LISs) contain all the data elements necessary to do accurate quality assurance (QA) reporting of TAT and other measures, but these reports are in most cases still performed manually: a time-consuming and error-prone task. The aim of this study was to develop a web-based real-time QA platform that would automate QA reporting in the molecular diagnostics laboratory at our institution, and minimize the time expended in preparing these reports. METHODS: Using a standard Linux, Nginx, MariaDB, PHP stack virtual machine running atop a Dell Precision 5810, we designed and built a web-based QA platform, code-named Alchemy. Data files pulled periodically from the LIS in comma-separated value format were used to autogenerate QA reports for the human immunodeficiency virus (HIV) quantitation, hepatitis C virus (HCV) quantitation, and BK virus (BKV) quantitation. Alchemy allowed the user to select a specific timeframe to be analyzed and calculated key QA statistics in real-time, including the average TAT in days, tests falling outside the expected TAT ranges, and test result ranges. RESULTS: Before implementing Alchemy, reporting QA for the HIV, HCV, and BKV quantitation assays took 45-60 min of personnel time per test every month. With Alchemy, that time has decreased to 15 min total per month. Alchemy allowed the user to select specific periods of time and analyzed the TAT data in-depth without the need of extensive manual calculations. CONCLUSIONS: Alchemy has significantly decreased the time and the human error associated with QA report generation in our molecular diagnostics laboratory. Other tests will be added to this web-based platform in future updates. This effort shows the utility of informatician-supervised resident/fellow programming projects as learning opportunities and workflow improvements in the molecular laboratory.

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BACKGROUND: In the era of personalized medicine, requests for molecular testing of specimens obtained with minimally invasive procedures such as fine-needle aspiration have been increasing. Although cell blocks (CBs) are the recommended specimens for molecular testing, their performance has not been well analyzed. The objective of this study was to assess the frequency and types of samples deemed unsatisfactory for molecular testing (quantity not sufficient [QNS]). METHODS: One year after the implementation of careful monitoring of QNS cases, cases submitted for lung cancer molecular testing were analyzed for the QNS rate. When the cases were rejected for the inadequacy of CBs of cytology specimens, air-dried, Diff-Quik (DQ)-stained smears were reviewed and used if they were adequate. The QNS rates were compared across 4 specimen categories: large resection, small biopsy, CB alone, and CB with DQ smears. RESULTS: One hundred seventy-six cases were studied, and 45 (25.6%) were unsatisfactory. Only 1 of 73 large resection specimens was rejected because of decalcification. The QNS rate for small biopsy specimens was 35.9% (28 of 78), whereas 64% (16 of 25) of cytology cases ordered on CBs were rejected. In combination with DQ smears, the QNS rate of cytology specimens was 32% (8 of 25), which was a significant improvement over CBs only (P = .024) and was not significantly different from the QNS rate for small biopsies (P = .671). CONCLUSIONS: The utilization of DQ-stained smears for molecular testing improves the adequacy of cytologic samples and provides a minimally invasive alternative to surgical biopsy when molecular analysis of tumor material is necessary.

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