Tricore Reference Laboratories
Tricore Reference Laboratories
Young S.,TriCore Reference Laboratories |
Illescas P.,TriCore Reference Laboratories |
Nicasio J.,TriCore Reference Laboratories |
Sickler J.J.,Roche Molecular Systems
Journal of Clinical Virology | Year: 2017
Background Accurate detection of influenza requires diagnostic testing; however, methods such as RADTs and central laboratory-based tests are limited by low sensitivity and time constraints, respectively. Objective To compare the performances of the cobas® Liat® Influenza A/B and Alere™ i Influenza A&B point-of-care (POC) assays for detecting influenza A and B viruses using fresh nasopharyngeal specimens with the GenMark Dx® Respiratory Viral Panel as the reference method, a FDA cleared IVD PCR test. Study design A total of 87 samples collected in viral transport medium from adults ≥18 years of age were re-tested on both POC assays (based on the reference PCR method, 29 were influenza A and 18 were influenza B virus positive). Results The overall sensitivity and specificity of the cobas Influenza A/B for the detection of influenza A and B relative to reference PCR was 97.9% (95% confidence interval [CI] 88.9%, 99.6%) and 97.5% (95% CI: 87.1%, 99.6%), respectively, while the sensitivity of the Alere i Influenza A&B assay relative to the reference PCR method was 63.8% (95% CI: 49.5%, 76.0%) and the specificity was 97.5% (95% CI: 87.1%, 99.6%). The individual sensitivities and specificities of the cobas Influenza A/B assay for influenza A alone and influenza B alone were comparable to those of the reference PCR method (influenza A: sensitivity of 100% [95% CI: 88.3%, 100.0%] and specificity of 98.3% [95% CI: 90.9%, 99.7%]; influenza B: sensitivity of 94.4% [95% CI: 74.2%, 99.0%] and specificity of 100% [95% CI: 94.7%, 100.0%]). For the Alere i Influenza A&B assay, the individual specificities for influenza A and B were comparable to those of the reference PCR method (98.3% [95% CI: 90.9%, 99.7%] and 97.1% [95% CI: 90.0%, 99.2%], respectively), while the individual sensitivities were low relative to reference PCR (55.2% [95% CI: 37.5%, 71.6%] and 72.2% [95% CI: 49.1%, 87.5%], respectively). Conclusion The cobas Influenza A/B assay demonstrated performance equivalent to laboratory-based PCR, and could replace rapid antigen tests. © 2017 Elsevier B.V.
Krinsky C.S.,University of New Mexico |
Lathrop S.L.,University of New Mexico |
Crossey M.,TriCore Reference Laboratories |
Baker G.,Scientific Laboratory Division |
Zumwalt R.,University of New Mexico
American Journal of Forensic Medicine and Pathology | Year: 2011
Since its approval in the United States, fentanyl has become increasingly popular for the medical management of pain and as a substance of abuse. Fentanyl is unique among the opioids in its widespread use with a transdermal delivery system, which contributes to its unique pharmacokinetics and abuse potential. We examined the demographics of deaths with fentanyl identified on toxicologic analysis and reviewed specific challenges in the laboratory detection of postmortem fentanyl levels. The New Mexico Office of the Medical Investigator database was searched for all cases from January 1986 through December 2007 with fentanyl reported as present or quantified. Those deaths with a cause of death identified as drug overdose were then analyzed separately. From 1986 to 2007, 154 cases were identified with fentanyl present in postmortem samples, with 96 of the cases identified as fentanyl-related drug overdoses. The number of fentanyl-related deaths has increased over the past 20 years, corresponding to both statewide increases in the medical use of fentanyl and the abuse of prescription opioids. The demographics of these fentanyl-related overdoses showed that subjects were more likely to be female, white non-Hispanic, and older than those in previously described overdose deaths. Several cases were identified with central and peripheral blood samples and antemortem and postmortem samples available for fentanyl quantification. Given the uncharacteristic demographics of fentanyl-related deaths and the complexity of the laboratory analysis of fentanyl, forensic scientists must use caution in both the detection and interpretation of fentanyl concentrations. Copyright © 2011 by Lippincott Williams & Wilkins.
Rao A.,Scott and White Healthcare |
Young S.,TriCore Reference Laboratories |
Erlich H.,Hoffmann-La Roche |
Boyle S.,Hoffmann-La Roche |
And 4 more authors.
Journal of Clinical Microbiology | Year: 2013
The cobas human papillomavirus (HPV) test, approved by the FDA in April 2011, is a fully automated assay for the detection of 14 high-risk (hr) HPV genotypes from cervical specimens collected in liquid-based cytology medium using real-time PCR amplification of the L1 gene and TaqMan probes. Results are simultaneously reported as positive or negative for the pooled 12 oncogenic HPV types (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68) from channel 1, with HPV16 and HPV18 genotypes read individually from channels 2 and 3. A fourth channel detects the human β-globin gene as a control for sample adequacy and assay inhibition. To optimize clinical sensitivity and specificity, cutoff values (cycle thresholds [CT]) were established for each channel based on the detection of cervical intraepithelial neoplasia grade 2 (CIN2) or greater (≥CIN2). For women aged≥21 years with cytology results indicating atypical squamous cells of undetermined significance (ASC-US), CT values provided a sensitivity of 90% (95% confidence interval [CI], 81.5% to 94.8%) for the detection of≥CIN2 and a specificity of 70.5% (95% CI, 68.1% to 72.7%). The analytic sensitivity (limit of detection) ranged from 150 to 2,400 copies/ml, depending on genotype. The analytic specificity, evaluated by comparing the HPV result with a combined comparator of Sanger sequencing and the Qiagen digene HC2 high-risk HPV DNA test (hc2), demonstrated overall positive agreement of 96.3% for 14 hrHPV types in women with ASC-US cytology results who were aged≥21 years and 86.1% in women with NLIM (negative for intraepithelial neoplasia or malignancy) cytology who were aged≥30 years. These and other performance validation studies demonstrate that the cobas HPV test is a fully automated and clinically validated robust test. Copyright © 2013, American Society for Microbiology.
News Article | November 15, 2016
LEXINGTON, MA and ALBUQUERQUE, NM--(Marketwired - November 14, 2016) - iSpecimen®, a trusted source of customized human biospecimen collections, and TriCore Reference Laboratories (TriCore), New Mexico's largest commercial reference lab, today announced an agreement through which iSpecimen will serve as a TriCore channel partner for making patient biospecimens and associated data available for research. iSpecimen's cloud-based technology will be used to tap into the flow of patients, specimens, and data running through the TriCore organization, matching researchers with a variety of annotated, de-identified samples to fuel their studies. With the surge of precision medicine, scientists are increasingly in need of human biospecimens that match specific patient and specimen criteria, across variables such as laboratory results, demographics, disease states, and treatment histories. Further, researchers have specific study protocols that dictate whether they can use clinical remnants, samples stored in biobanks, or those collected prospectively and specifically for research. TriCore presents a unique opportunity to identify and collect a wide variety of specimen types with its on-site biorepository and over 50 patient collection sites where patients may consent to participate in prospective research collections. "TriCore has been a long-time supporter of the advancement of biomedical research," shared Eric Carbonneau, MS, MT (ASCP), Director Core Lab Operations & Research Institute at TriCore. "The new agreement with iSpecimen will allow us to expand our reach across the scientific community, providing specimens directly for the discovery of new diagnostics and therapeutics. The increased visibility for TriCore with researchers throughout the country will also allow us to participate in more translational research and clinical trials which in turn, will bring more jobs and growth from outside New Mexico." "Collaborating with TriCore is a milestone achievement for us," said Christopher Ianelli, MD, PhD, CEO, at iSpecimen. "Their specimen volume and diversity will be appealing for many different types of research and their reputation as a testing powerhouse speaks to the quality and efficiency of their practices. We are really excited to begin technology implementation and start matching researchers with the specimens they need with the characteristics they want." TriCore Reference Laboratories was established in 1998 through a joint partnership with Presbyterian Healthcare Services (PHS) and University of New Mexico Health Sciences Center (UNMHSC). Synergies were created that continue to exist today with these three organizations sharing the common goals of improving quality of care, improving the health of the populations we serve, increasing efficiencies and reducing costs. TriCore also provides investigational services including FDA-regulated clinical trials, IRB-approved studies, device and diagnostic instrument testing, serving global biotech firms as well as academic clients. Visit www.tricore.org for more information. Privately held and headquartered in Lexington, Massachusetts, iSpecimen is a trusted, one-stop source of customized human biospecimen collections. Compliantly sourced from our diverse partner network of hospitals, labs, biorepositories, blood centers, and other organizations, our solid tissue, biofluids, and cells are delivered directly into the hands of researchers using unique, turnkey technology. Scientists gain access to a ready supply of the high-quality, richly-annotated biospecimens they need from the patients they want. Supply partners gain an opportunity to further contribute to biomedical discovery as well as their bottom line. And ultimately, healthcare advances for all. For more information about iSpecimen, please visit www.ispecimen.com.
News Article | November 14, 2016
LEXINGTON, Mass. and ALBUQUERQUE, N.M., Nov. 14, 2016 /PRNewswire/ -- iSpecimen®, a trusted source of customized human biospecimen collections, and TriCore Reference Laboratories (TriCore), New Mexico's largest commercial reference lab, today announced an agreement through which iSpecimen...
Reichard K.K.,University of New Mexico |
Kang H.,University of New Mexico |
Robinett S.,TriCore Reference Laboratories
Modern Pathology | Year: 2011
B-lymphoblastic leukemia (a.k.a. precursor B-cell acute lymphoblastic leukemia) is a heterogeneous disease at the clinical, morphologic, immunophenotypic and genetic levels. Recurrent genetic abnormalities in B-lymphoblastic leukemia with prognostic significance are well known and specifically delineated in the WHO 2008 classification (eg hyperdiploidy, t(9;22)(q34;q11.2); BCR-ABL1, t(12;21)(p13;q22); ETV6-RUNX1). In recent years, a subgroup of B-lymphoblastic leukemia with the recurring genetic alteration of RUNX1 amplification has emerged. This subgroup has a low incidence (2%) and an increased risk of relapse and overall worse outcome. Given these apparently distinctive clinicopathologic features, we evaluated eight cases of pediatric B-lymphoblastic leukemia with RUNX1 amplification treated on Children's Oncology Group protocols from 2000-2009. Compared with 25 consecutive B-lymphoblastic leukemia cases without RUNX1 amplification, we identified a trend toward male predominance (P-value=0.082) and low white blood cell count at presentation (P-value=0.081) in B-lymphoblastic leukemia with RUNX1 amplification. Older age at presentation was significant (median age 9.5 years, P-value=0.006). There was no significant difference in the presence of central nervous system disease, CD20 or myeloid antigen positivity on the blasts or percent circulating blasts in B-lymphoblastic leukemia with RUNX1 amplification versus other B-lymphoblastic leukemia types. Seven of eight patients (88%) are alive and free of disease at the time of last checkup (mean 50 months, range 14-116 months). Although we see a relatively good outcome in our small cohort of patients, recent findings from the Children's Oncology Group on a large set of patients suggests otherwise that these patients may have an inferior outcome compared with patients with B-lymphoblastic leukemia without RUNX1 amplification. Long-term follow-up in larger cohorts including minimal residual disease correlation is required. © 2011 USCAP, Inc. All rights reserved.
Insuasti-Beltran G.,University of Arkansas for Medical Sciences |
Gale J.M.,TriCore Reference Laboratories |
Wilson C.S.,University of New Mexico |
Foucar K.,University of New Mexico |
Czuchlewski D.R.,University of New Mexico
Archives of Pathology and Laboratory Medicine | Year: 2015
Context.-Lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) are welldefined clinicopathologic entities. However, distinguishing LPL from MZL and from atypical cases of CLL can sometimes be difficult because of overlapping features. Recent studies have identified a recurrent L265P mutation in the MYD88 gene in most cases of LPL. Although this represents a promising diagnostic marker for LPL, the mutation is also reported in rare cases of MZL and CLL (as well as other types of B-cell lymphoma). Detection rates for this mutation have varied depending on the analytic methodology. Objective.-To assess the diagnostic utility of MYD88 L265P mutation in diagnosing low-grade B-cell lymphomas. Design.-We developed a novel pyrosequencing assay for the MYD88 L265P mutation and assessed its diagnostic utility in 317 cases of low-grade B-cell lymphoma (45 LPL [14%], 53 MZL [17%], and 219 CLL [69%]). We incorporated formal clinical and pathologic review of selected cases to ensure the most accurate diagnosis and subclassification. Results.-The MYD88 L265P mutation was identified in 43 cases of LPL (96%), including 3 nonimmunoglobulin-M LPL cases. In contrast, the mutation was present in only 2 cases of MZL (4%), and 5 cases of CLL (2%). Thus, pyrosequencing for the MYD88 L265P mutation demonstrates a high clinical sensitivity and specificity to distinguish LPL from MZL and CLL. Conclusions.-This study confirms the strong association of the MYD88 L265P mutation with LPL, as well as the existence of rare cases of small B-cell lymphoma that complicate this association.
Crookston K.P.,University of New Mexico |
Crookston K.P.,TriCore Reference Laboratories |
Richter D.M.,University of New Mexico
Journal of Clinical Apheresis | Year: 2010
Apheresis Medicine has evolved markedly due to an explosion of knowledge and technology, whereas the time available for training has shrunk as curricula have become increasingly overloaded. Apheresis teaching has inherited a strong clinical context where real patient problems are used in a hands-on environment. To optimize instruction, those involved in the education of apheresis professionals need to have (1) knowledge of how clinical laboratory medicine education has developed as a field, (2) an understanding of what is known from theory and research about how people learn, and (3) the skills to design teaching/learning activities in ways consistent with literature-based principles of adult education. These developments in education provide a context for curriculum projects currently underway by the American Society for Apheresis. Teachers must determine which competencies are central to the essence of a trained professional. Specific, robust, learning objectives targeted toward the development of higher levels of thinking, professional attitudes, and requisite skills are formulated to guide the learner toward mastering those competencies. Curriculum is developed for each objective, consisting of content and the best teaching/learning methods to help learners attain the objective. Appropriate assessment strategies are identified to determine whether the objective is being achieved. The integration of objectives, curriculum, and assessment creates The Bermuda Triangle of Education (Richter, The Circle of Learning and Bermuda Triangle in Education, University of New Mexico School of Medicine, 2004). When educators do not effectively navigate The Bermuda Triangle of Education, learning may disappear into the murky depths of confusion and apathy. When successfully navigated, the result will be a significant learning experience that leads to transformation through education. © 2010 Wiley-Liss, Inc.
Pitchford C.W.,University of New Mexico |
Hettinga A.C.,Tricore Reference Laboratories |
Reichard K.K.,University of New Mexico |
Reichard K.K.,Tricore Reference Laboratories
American Journal of Clinical Pathology | Year: 2010
Multiple studies, with differing results, have compared the added sensitivity of fluorescence in situ hybridization (FISH) with conventional cytogenetics (CC) to detect genetic abnormalities in myelodysplastic syndrome (MDS). We hypothesized that in the setting of an adequate CC study, FISH would correlate with microscopic genetic abnormalities involving chromosomes 5, 7, 8, and 20. We performed FISH for -5/5q, -7/7q, +8, and del(20q) on 102 MDS cases with normal CC (≥20 consecutive metaphases) and on 35 MDS cases with abnormal CC. Of the 102 MDS cases with normal CC, only 1 was discrepant between FISH (showing +8) and CC (<1% of total cases). Of the 35 MDS cases with abnormal CC, 1 showed a minor discrepancy (-5 by CC vs del(5q) by FISH). FISH for MDS abnormalities (-5/5q, -7/7q, +8, and del(20q)) correlates with an adequate karyotypic result without increased sensitivity. Consequently, we recommend that FISH not be performed in MDS cases with an adequate karyotype. © American Society for Clinical Pathology.
Culbreath K.,University of North Carolina at Chapel Hill |
Culbreath K.,Tricore Reference Laboratories |
Ager E.,University of North Carolina at Chapel Hill |
Ager E.,Landstuhl Regional Medical Center |
And 3 more authors.
Journal of Clinical Microbiology | Year: 2012
We present the evolution of testing algorithms at our institution in which the C. Diff Quik Chek Complete immunochromatographic cartridge assay determines the presence of both glutamate dehydrogenase and Clostridium difficile toxins A and B as a primary screen for C. difficile infection and indeterminate results (glutamate dehydrogenase positive, toxin A and B negative) are confirmed by the GeneXpert C. difficile PCR assay. This two-step algorithm is a cost-effective method for highly sensitive detection of toxigenic C. difficile. Copyright © 2012 American Society for Microbiology. All Rights Reserved.