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2. Interlaboratory Performance in Measurement of Dabigatran and Rivaroxaban: Results of the College of American Pathologists External Quality Assessment Program

Author

Volod, Oksana, Rollins-Raval, Marian, Iv, Andrew J. Goodwin, Higgins, Russell A., Long, Thomas, Chandler, Wayne L., Harris, Neil S., Pham, Huy P., Isom, James Alexander, Moser, Karen, Olson, John D., Smock, Kristi J., VanSandt, Amanda, Wool, Geoffrey, and Chen, Dong

Subjects
Rivaroxaban -- Testing, Pharmacokinetics -- Research, Pharmacology, Experimental, Chemistry, Analytic -- Quantitative, Biochemical assays -- Usage, Medical laboratories -- Standards -- Quality management, Dabigatran etexilate -- Testing, Health, College of American Pathologists -- Standards
Abstract

* Context.--Assessing direct oral anticoagulant (DOAC) drug levels by reliable laboratory assays is necessary in a number of clinical scenarios. Objective.--To evaluate the performance of DOACspecific assays for various concentrations [...]

Published
2022
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6. External Quality Assurance of Platelet Function Assays: Results of the College of American Pathologists Proficiency Testing Program

Author

Chandler, Wayne L., Brown, Alan F., Chen, Dong, Moser, Karen, Olson, John D., Pham, Huy Phu, Smock, Kristi J., Volod, Oksana, and Higgins, Russell A.

Subjects
Blood platelets -- Research, Pathologists -- Practice, Bioassay -- Usage, Collagen, Unsaturated fatty acids, EDTA, Tirofiban, Arachidonic acid, Fatty acids, ATPases, Health
Abstract

Context.--The College of American Pathologists (CAP) developed proficiency testing for platelet function assays by using blood collected by the participant added to challenge tubes containing either saline (normal) or tirofiban (abnormal). Objective.--To analyze platelet function proficiency testing for Platelet Function Analyzer PFA-100, platelet aggregation, PlateletWorks, and PlateletMapping. Design.--Proficiency testing data from 2012-2016 were analyzed. Results.--For PFA-100, a total of 1200 laboratories participated; the coefficient variation (CV) of cartridge closure times was 22% (saline); 44,952 of 45,616 survey responses (99%) provided an interpretation, and 42,934 of 44,952 (96%) were correct. For optical platelet aggregation, 190 laboratories participated; the CV was 17% (saline), 7444 of 7813 survey responses (95%) provided an interpretation, and 7015 of 7444 (94%) were correct. For PlateletWorks, 60 laboratories participated; the CV was 3% to 11% (saline); 2412 of 2454 survey responses (98%) provided an interpretation, and 1207 of 1276 (95%) were correct for adenosine diphosphate (ADP) and 936 of 1136 (82%) for collagen. For PlateletMapping, 200 laboratories participated. For ADP, 1128 of 2697 survey responses (42%) provided an interpretation, but only 927 of 1128 (82%) were correct. For arachidonic acid, 1139 of 2604 survey responses (44%) provided an interpretation and 964 of 1139 (85%) were correct. Conclusions.--CAP is the first to provide proficiency testing for platelet aggregation, PlateletWorks, and PlateletMapping. Platelet aggregation, PFA-100, and PlateletWorks using ADP as an agonist performed well with more than 90% of laboratories providing an interpretation and a similar number providing correct results. PlateletWorks using collagen and PlateletMapping showed worse interpretive accuracy than the other methods. (Arch Pathol Lab Med. 2019;143:472-482; doi: 10.5858/arpa.2017-0556-CP), Platelets perform multiple functions related to hemostasis and can be activated by multiple pathways; thus, no single platelet function test can assess all aspects of platelet function or diagnose all [...]

Published
2019
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10. List of Contributors

Author

Acharya, Suchitra S., primary, Aeschlimann, Judith, additional, Al-Huniti, Ahmad, additional, Antun, Ana G., additional, Arinsburg, Suzanne A., additional, Avecilla, Scott T., additional, Bahar, Burak, additional, Bailey, Debra Jo, additional, Batsuli, Glaivy, additional, Billett, Henny H., additional, Bloch, Evan M., additional, Briones, Michael A., additional, Bussel, James B., additional, Carden, Marcus A., additional, Chandler, Wayne L., additional, Chen, Dong, additional, Csete, Marie, additional, Cuker, Adam, additional, Cushing, Melissa M., additional, Davila, Jennifer, additional, DeSimone, Robert A., additional, Dodd, Roger Y., additional, Dunbar, Nancy M., additional, Dunn, Amy L., additional, Erdman, Patrick A., additional, Francischetti, Ivo M.B., additional, Francis, Richard O., additional, Ginzburg, Yelena Z., additional, Godbey, Elizabeth A., additional, Goel, Ruchika, additional, Gokhale, Amit, additional, Goldstein, Yitz, additional, Gorlin, Jed B., additional, Goss, Cheryl A., additional, Hamilton, Janis R., additional, Hendrickson, Jeanne E., additional, He, Rong, additional, Hillyer, Christopher D., additional, Hod, Eldad A., additional, Hsu, Yen-Michael S., additional, Hume, Heather A., additional, Jacob, Jack, additional, Jain, Shilpa, additional, Jalikis, Florencia G., additional, Jimenez, Alexandra, additional, Jobe, Shawn M., additional, Josephson, Cassandra D., additional, Karafin, Matthew S., additional, Katz, Louis M., additional, Kempton, Christine L., additional, Kessler, Debra A., additional, Kushnir, Margarita, additional, Lambert, Michele P., additional, Li, Marissa, additional, Manwani, Deepa, additional, Maramica, Irina, additional, Marschner, Susanne, additional, Frenet, Emeline Masson, additional, McGuinn, Catherine E., additional, Meeks, Shannon L., additional, Miller, Connie H., additional, Minniti, Caterina P., additional, Mitchell, William B., additional, Monis, Grace F., additional, Nester, Theresa, additional, Norris, Philip, additional, Novotny, Angela, additional, Paroder-Belenitsky, Monika, additional, Pati, Shibani, additional, Peck, Kim, additional, Pham, Huy P., additional, Pishko, Allyson, additional, Quinley, Eva D., additional, Racine-Brzostek, Sabrina, additional, Rahorst, Lynsi, additional, Rennert, Hanna, additional, Restivo, Joseph S.A., additional, Reyes Gil, Morayma, additional, Rosenbaum-Marinaro, Liz, additional, Roshal, Mikhail, additional, Rutter, Sara, additional, Sachais, Bruce S., additional, Saini, Surbhi, additional, Sarangi, Susmita N., additional, Savage, William J., additional, Scaradavou, Andromachi, additional, Schwartz, Joseph, additional, Seheult, Jansen N., additional, Senaldi, Eric, additional, Shaikh, Salima, additional, Sharathkumar, Anjali, additional, Shaz, Beth H., additional, Shi, Patricia A., additional, Simmons, Sierra C., additional, Staley, Elizabeth M., additional, Storch, Emily K., additional, Strauss, Donna, additional, Tanhehco, Yvette C., additional, Tobian, Aaron A.R., additional, Tormey, Christopher A., additional, Townsend, Mary, additional, Tran, Duc Q., additional, Van Buren, Nancy L., additional, Vege, Sunitha, additional, Velliquette, Randall, additional, Vinchi, Francesca, additional, Weinberg, Rona S., additional, Weisberg, Stuart P., additional, Westhoff, Connie M., additional, White, Michael, additional, Winkler, Anne M., additional, Wolgast, Lucia R., additional, Woods, Kalinda, additional, Dimberg, Lina Y., additional, Yazer, Mark H., additional, Young, Carolyn T., additional, Zerra, Patricia E., additional, and Zimowski, Karen L., additional

Published
2019
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20. Causes of platelet loss during extracorporeal life support.

Author

Atchison, Christie, Widdershins, Afton, and Chandler, Wayne L.

Subjects
EXTRACORPOREAL membrane oxygenation, BLOOD platelets, DISSEMINATED intravascular coagulation, BLOOD volume, BLOOD platelet transfusion, PLATELET count, VESICLES (Cytology)
Abstract

Background: Most pediatric patients show a decline in platelet counts while on extracorporeal life support (ECLS) and require multiple platelet transfusions. To better understand platelet loss during ECLS, this study estimated platelet loss rates due to diagnostic phlebotomy, platelet activation, bleeding and other causes. Methods: We collected data on 91 patients (1d‐20y, 50 M, 41F). Platelet losses were estimated based on changes in platelet count, patient+circuit blood volume, and transfused platelet volumes. Platelet extracellular vesicles were measured by flow cytometry. Results: Median platelet loss was 2.8 × 109/L/hr, more than twice the normal rate of platelet removal and equivalent to a 67 000/μl decrease in platelet count per day. While platelet loss was correlated with platelet transfusion (r2 = 0.51), transfusion underestimated platelet loss in patients with large decreases in platelet count and over‐estimated platelet loss in neonates where the circuit volume > patient blood volume. Patients with disseminated intravascular coagulation before or significant bleeding during ECLS have double the rate of platelet loss. Platelet activation accounted for ~32% of total platelet loss, bleeding ~36% and phlebotomy 4%, with the remaining one‐third due to other causes. Annexin‐negative platelet extracellular vesicle release, a measure of platelet damage, was increased 9‐fold during ECLS. Conclusion: Our study is the first to quantitate total, phlebotomy and activation related platelet loss during ECLS. Platelet activation accounts for ~32% of total platelet loss, while bleeding doubles the platelet loss rate. The etiology of the remaining platelet loss is unknown. [ABSTRACT FROM AUTHOR]

Published
2023
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21. Monitoring Direct Thrombin Inhibitors With Calibrated Diluted Thrombin Time vs Activated Partial Thromboplastin Time in Pediatric Patients.

Author

Hasan, Rida A, Pak, Jennifer, Kirk, Christa Jefferis, Friedland-Little, Joshua M, and Chandler, Wayne L

Subjects
PARTIAL thromboplastin time, ANTITHROMBINS, THROMBIN time, CHILD patients, THROMBIN, BIVALIRUDIN
Abstract

Objectives: Activated partial thromboplastin time (aPTT) is the primary test used to monitor intravenous (IV) direct thrombin inhibitors (DTIs) but has many limitations. The plasma diluted thrombin time (dTT) has shown better correlation with DTI levels than aPTT. This study compared dose-response curves for dTT and aPTT in pediatric patients receiving argatroban and bivalirudin.Methods: A retrospective review of pediatric patients treated with argatroban (n = 45) or bivalirudin (n = 14) monitored with dTT and aPTT.Results: The dTT assay was calibrated to report DTI concentrations in µg/mL for argatroban and bivalirudin with good analytic sensitivity and specificity. The dTT was fivefold more likely to show a stable dose-response slope than the aPTT (P < .0002; odds ratio, 4.9). For patients in whom both dTT and aPTT showed a significant correlation between dose and assay results, dTT had a higher average correlation factor compared with aPTT (P = .007). Argatroban dose-response slopes showed more inter- and intrapatient variation than bivalirudin (dose-response slope coefficient of variation, 132% vs 52%).Conclusions: The dTT assay was more likely to show a stable dose response and have a stronger correlation with DTI dose than aPTT. Argatroban shows more variation in dose response than bivalirudin. [ABSTRACT FROM AUTHOR]

Published
2023
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25. The Interlaboratory Performance in Measurement of Dabigatran and Rivaroxaban: Results of the College of American Pathologists External Quality Assessment Program

Author

Volod, Oksana, primary, Rollins-Raval, Marian, additional, Goodwin, Andrew J., additional, Higgins, Russell A., additional, Long, Thomas, additional, Chandler, Wayne L., additional, Harris, Neil S., additional, Pham, Huy P., additional, Isom, James Alexander, additional, Moser, Karen, additional, Olson, John D., additional, Smock, Kristi J., additional, VanSandt, Amanda, additional, Wool, Geoffrey, additional, and Chen, Dong, additional

Published
2021
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30. Contributors

Author

Abrams, Charles S., primary, Abshire, Thomas C., additional, Arinsburg, Suzanne A., additional, Avecilla, Scott T., additional, Babic, Aleksandar M., additional, Bellone, Michael, additional, Bennett, Carolyn M., additional, Briones, Michael A., additional, Bussel, James B., additional, Chandler, Wayne L., additional, Csete, Marie, additional, Cuker, Adam C., additional, Cushing, Melissa M., additional, Desormeaux, Marie-Laure, additional, Dodd, Roger Y., additional, Dunn, Amy L., additional, Francis, Richard O., additional, Garbaini, Jennifer, additional, Ginzberg, Yelena Z., additional, Goodrich, Raymond P., additional, Goss, Cheryl A., additional, Greco, Benjamin J., additional, Hendrickson, Jeanne E., additional, Hillyer, Christopher D., additional, Hod, Eldad A., additional, Hume, Heather A., additional, Jalikis, Florencia G., additional, Jobe, Shawn M., additional, Josephson, Casssandra D., additional, Karafin, Matthew S., additional, Karim, Sadiqa, additional, Katz, Louis M., additional, Kempton, Christine L., additional, Kessler, Debra A., additional, Lal, Devika, additional, Lambert, Michele P., additional, Lim, Wendy, additional, Maramica, Irina Knezevic, additional, Marschner, Susanne, additional, Mcguinn, Catherine E., additional, Meeks, Shannon L., additional, Miller, Connie H., additional, Mitchell, W. Beau, additional, Monis, Grace F., additional, Nester, Theresa, additional, Pham, Huy Phu, additional, Quinley, Eva D., additional, Rennert, Hanna, additional, Reyes, Morayma, additional, Rich, Anna-Sophie, additional, Roshal, Mikhail, additional, Ruch, Joshua M., additional, Savage, William J., additional, Scaradavou, Andromachi, additional, Schwartz, Joseph, additional, Shaz, Beth H., additional, Shi, Patricia, additional, Sood, Suman, additional, Weinberg, Rona S., additional, Westhoff, Connie M., additional, Winkler, Anne M., additional, Yan, Jiong, additional, and Zimring, James C., additional

Published
2013
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34. Effect of fondaparinux on coagulation assays: results of College of American Pathologists proficiency testing

Author

Smogorzewska, Agata, Brandt, John T., Chandler, Wayne L., Cunningham, Mark T., Hayes, Timothy E., Olson, John D., Kottke-Marchant, Kandice, and Van Cott, Elizabeth M.

Subjects
United States. Food and Drug Administration -- Standards, College of American Pathologists -- Research, Heparin -- Usage, Heparin -- Research, Thromboembolism -- Care and treatment, Thromboembolism -- Research
Published
2006

41. Prothrombotic coagulation abnormalities preceding the hemolytic-uremic syndrome

Author

Chandler, Wayne L., Jelacic, Srdjan, Boster, Daniel R., Ciol, Marcia A., Williams, Glyn D., Watkins, Sandra L., Igarashi, Takashi, and Tarr, Phillip I.

Subjects
Hemolytic-uremic syndrome -- Research, Blood clotting disorders -- Research
Abstract

The blood clotting disorder that forms a part of hemolytic-uremic syndrome appears to occur before the kidney disease and may in fact cause it. This syndrome is caused by an E. coli O157:H7 infection.

Published
2002

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