Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory

Erin Elizabeth Milner; Absone Rowland; Jessica Jeanette Fasio; Lam Henry

doi:doi:10.11648/j.cmr.20180705.13

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Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory

Erin Elizabeth Milner, Absone Rowland, Jessica Jeanette Fasio, Lam Henry

Published in Clinical Medicine Research (Volume 7, Issue 5)

Received: 27 August 2018 Accepted: 13 September 2018 Published: 12 November 2018

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Abstract

Herein we report a modified Pointe Scientific method for Glucose-6-Phosphate Dehydrogenase (G6PD) testing which eliminates time-consuming and labor intensive pre-analytical steps previously required. Pre-lyse and on-board lyse Pointe Scientific methods were compared to the on-board lyse Trinity Biotech method using Abbott Architect c8000 analyzers integrated into an a3600 track system. In order to streamline the implementation of this method involving both G6PD and hemoglobin analysis, we sought to capitalize on the Instrument Manager (IM) middleware and the a3600 Abbott track system for high-throughput analysis using the Abbott Architect c8000 platform. IM rules were developed to route the whole blood specimen to the wait area of the Input Output Module (IOM) while the initial result is determined. When the initial result is intermediate or deficient, the G6PD activity per gram of hemoglobin (U/g Hgb) is determined by rerouting the specimen to the analyzer as an automated reflex test. The data associated with method comparison, precision, carryover and linearity studies completed per regulatory guidelines indicate the assay parameters reported herein are available for the immediate implementation of fully-automated G6PD testing. A viable method that includes on-board lysing and reflex testing has been implemented allowing for high-throughput G6PD testing in a clinical laboratory. Given market research yielded limited vendors with Food and Drug Administration (FDA)-cleared G6PD assays, the automation of the Pointe Scientific method will allow Department of Defense (DOD) laboratories to rapidly screen service members in order to ascertain the tolerability of a Primaquine dosing regimen.

Published in	Clinical Medicine Research (Volume 7, Issue 5)
DOI	10.11648/j.cmr.20180705.13
Page(s)	119-123
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2018. Published by Science Publishing Group

Keywords

Glucose-6-Phosphate Dehydrogenase (G6PD) Assay, Primaquine G6PD Deficiency, Pointe Scientific Automated G6PD Assay

References

[1]	Hill, D.R., Baird JK, Parise ME, Lewis LS, Ryan ET, Magill AJ, Primaquine: Report from CDC expert meeting on malaria chemoprophylaxis I. Am J Trop Med Hyg, 2006; 75(3): p. 402-415.
[2]	Primaquine Phosphate Label. Food and Drug Administration Web Site http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008316s021lbl.pdf. Published 2015. Accessed June 1, 2018.
[3]	Baird, J.K., Drug therapy: Effectiveness of antimalarial drugs. N Engl J Med, 2005; 352(15): p. 1565-1577.
[4]	Updated WHO policy recommendation: Single dose primaquine as a gametocytocide in Plasmodium falciparum malaria. World Health Organization Web Site http://www.who.int/malaria/publications/atoz/who_pq_policy_recommendation/en/.
[5]	Published October 2012. Accessed June 1, 2018.
[6]	White, N.J., Qiao LG, Qi G, Luzzatto L., Rationale for recommending a lower dose of primaquine as a Plasmodium falciparum gametocytocide in populations where G6PD deficiency is common. Malar J, 2012; 11: p. 418.
[7]	Baird, J.K., Primaquine toxicity forestalls effective therapeutic management of the endemic malarias. Int J Parasit, 2012; 42(12): p. 1049-1054.
[8]	Vale, N., R. Moreira, and P. Gomes, Primaquine revisited six decades after its discovery. Eur J Med Chem, 2009; 44(3): p. 937-953.
[9]	Pointe Scientific. Glucose-6-phosphate dehydrogenase reagent set. Package Insert. June 2017.
[10]	Pointe Scientific. Hemoglobin Reagent. Package Insert. December 2016.
[11]	Pointe Scientific. Hemoglobin Standard. Package Insert. December 2016.
[12]	Trinity Biotech. Glucose-6-phosphate dehydrogenase (G-6-PDH). Package Insert. February 2012.
[13]	Trinity Biotech. G-6-PDH Control, Normal (G6888), Intermediate (G5029), Deficient (G5888). May 2013.
[14]	BioRad. Liquichek Diabetes 172 Control Levels 1, 2 and 3. 5250B (Rev. 1). April 2014.
[15]	Ambruster, D., Alexander, D., Stredler, D., Barton, C. Sample-to-Sample Carryover on an Integrated Clinical Chemistry/Immunoassay System. American Association for Clinical Chemistry Annual Meeting. June 23-27, 2006.
[16]	Trinity Biotech. Architect c8000 Glucose-6-Phosphate Dehydrogenase Architect Application Catalog # 6GLY.
[17]	Pointe Scientific. Architect c8000 Glucose-6-Phosphate Dehydrogenase Application Catalog # G7583.
[18]	College of American Pathologists Accreditation Program. All Common Laboratory Checklist. August 21, 2017.
[19]	College of American Pathologists Accreditation Program. Chemistry and Toxicology Checklist. August 21, 2017.

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APA Style

Erin Elizabeth Milner, Absone Rowland, Jessica Jeanette Fasio, Lam Henry. (2018). Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory. Clinical Medicine Research, 7(5), 119-123. https://doi.org/10.11648/j.cmr.20180705.13

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ACS Style

Erin Elizabeth Milner; Absone Rowland; Jessica Jeanette Fasio; Lam Henry. Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory. Clin. Med. Res. 2018, 7(5), 119-123. doi: 10.11648/j.cmr.20180705.13

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AMA Style

Erin Elizabeth Milner, Absone Rowland, Jessica Jeanette Fasio, Lam Henry. Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory. Clin Med Res. 2018;7(5):119-123. doi: 10.11648/j.cmr.20180705.13

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@article{10.11648/j.cmr.20180705.13,
  author = {Erin Elizabeth Milner and Absone Rowland and Jessica Jeanette Fasio and Lam Henry},
  title = {Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory},
  journal = {Clinical Medicine Research},
  volume = {7},
  number = {5},
  pages = {119-123},
  doi = {10.11648/j.cmr.20180705.13},
  url = {https://doi.org/10.11648/j.cmr.20180705.13},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.cmr.20180705.13},
  abstract = {Herein we report a modified Pointe Scientific method for Glucose-6-Phosphate Dehydrogenase (G6PD) testing which eliminates time-consuming and labor intensive pre-analytical steps previously required. Pre-lyse and on-board lyse Pointe Scientific methods were compared to the on-board lyse Trinity Biotech method using Abbott Architect c8000 analyzers integrated into an a3600 track system. In order to streamline the implementation of this method involving both G6PD and hemoglobin analysis, we sought to capitalize on the Instrument Manager (IM) middleware and the a3600 Abbott track system for high-throughput analysis using the Abbott Architect c8000 platform. IM rules were developed to route the whole blood specimen to the wait area of the Input Output Module (IOM) while the initial result is determined. When the initial result is intermediate or deficient, the G6PD activity per gram of hemoglobin (U/g Hgb) is determined by rerouting the specimen to the analyzer as an automated reflex test. The data associated with method comparison, precision, carryover and linearity studies completed per regulatory guidelines indicate the assay parameters reported herein are available for the immediate implementation of fully-automated G6PD testing. A viable method that includes on-board lysing and reflex testing has been implemented allowing for high-throughput G6PD testing in a clinical laboratory. Given market research yielded limited vendors with Food and Drug Administration (FDA)-cleared G6PD assays, the automation of the Pointe Scientific method will allow Department of Defense (DOD) laboratories to rapidly screen service members in order to ascertain the tolerability of a Primaquine dosing regimen.},
 year = {2018}
}

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TY  - JOUR
T1  - Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory
AU  - Erin Elizabeth Milner
AU  - Absone Rowland
AU  - Jessica Jeanette Fasio
AU  - Lam Henry
Y1  - 2018/11/12
PY  - 2018
N1  - https://doi.org/10.11648/j.cmr.20180705.13
DO  - 10.11648/j.cmr.20180705.13
T2  - Clinical Medicine Research
JF  - Clinical Medicine Research
JO  - Clinical Medicine Research
SP  - 119
EP  - 123
PB  - Science Publishing Group
SN  - 2326-9057
UR  - https://doi.org/10.11648/j.cmr.20180705.13
AB  - Herein we report a modified Pointe Scientific method for Glucose-6-Phosphate Dehydrogenase (G6PD) testing which eliminates time-consuming and labor intensive pre-analytical steps previously required. Pre-lyse and on-board lyse Pointe Scientific methods were compared to the on-board lyse Trinity Biotech method using Abbott Architect c8000 analyzers integrated into an a3600 track system. In order to streamline the implementation of this method involving both G6PD and hemoglobin analysis, we sought to capitalize on the Instrument Manager (IM) middleware and the a3600 Abbott track system for high-throughput analysis using the Abbott Architect c8000 platform. IM rules were developed to route the whole blood specimen to the wait area of the Input Output Module (IOM) while the initial result is determined. When the initial result is intermediate or deficient, the G6PD activity per gram of hemoglobin (U/g Hgb) is determined by rerouting the specimen to the analyzer as an automated reflex test. The data associated with method comparison, precision, carryover and linearity studies completed per regulatory guidelines indicate the assay parameters reported herein are available for the immediate implementation of fully-automated G6PD testing. A viable method that includes on-board lysing and reflex testing has been implemented allowing for high-throughput G6PD testing in a clinical laboratory. Given market research yielded limited vendors with Food and Drug Administration (FDA)-cleared G6PD assays, the automation of the Pointe Scientific method will allow Department of Defense (DOD) laboratories to rapidly screen service members in order to ascertain the tolerability of a Primaquine dosing regimen.
VL  - 7
IS  - 5
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Author Information

Erin Elizabeth Milner

Department of Pathology, Dwight D. Eisenhower Army Medical Center, Ft Gordon, United States of America
Absone Rowland

Department of Pathology, Dwight D. Eisenhower Army Medical Center, Ft Gordon, United States of America
Jessica Jeanette Fasio

Department of Pathology, Dwight D. Eisenhower Army Medical Center, Ft Gordon, United States of America
Lam Henry

Department of Pathology, Dwight D. Eisenhower Army Medical Center, Ft Gordon, United States of America

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Plain Text BibTeX RIS

APA Style

Erin Elizabeth Milner, Absone Rowland, Jessica Jeanette Fasio, Lam Henry. (2018). Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory. Clinical Medicine Research, 7(5), 119-123. https://doi.org/10.11648/j.cmr.20180705.13

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ACS Style

Erin Elizabeth Milner; Absone Rowland; Jessica Jeanette Fasio; Lam Henry. Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory. Clin. Med. Res. 2018, 7(5), 119-123. doi: 10.11648/j.cmr.20180705.13

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AMA Style

Erin Elizabeth Milner, Absone Rowland, Jessica Jeanette Fasio, Lam Henry. Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory. Clin Med Res. 2018;7(5):119-123. doi: 10.11648/j.cmr.20180705.13

Copy | Download

@article{10.11648/j.cmr.20180705.13,
  author = {Erin Elizabeth Milner and Absone Rowland and Jessica Jeanette Fasio and Lam Henry},
  title = {Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory},
  journal = {Clinical Medicine Research},
  volume = {7},
  number = {5},
  pages = {119-123},
  doi = {10.11648/j.cmr.20180705.13},
  url = {https://doi.org/10.11648/j.cmr.20180705.13},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.cmr.20180705.13},
  abstract = {Herein we report a modified Pointe Scientific method for Glucose-6-Phosphate Dehydrogenase (G6PD) testing which eliminates time-consuming and labor intensive pre-analytical steps previously required. Pre-lyse and on-board lyse Pointe Scientific methods were compared to the on-board lyse Trinity Biotech method using Abbott Architect c8000 analyzers integrated into an a3600 track system. In order to streamline the implementation of this method involving both G6PD and hemoglobin analysis, we sought to capitalize on the Instrument Manager (IM) middleware and the a3600 Abbott track system for high-throughput analysis using the Abbott Architect c8000 platform. IM rules were developed to route the whole blood specimen to the wait area of the Input Output Module (IOM) while the initial result is determined. When the initial result is intermediate or deficient, the G6PD activity per gram of hemoglobin (U/g Hgb) is determined by rerouting the specimen to the analyzer as an automated reflex test. The data associated with method comparison, precision, carryover and linearity studies completed per regulatory guidelines indicate the assay parameters reported herein are available for the immediate implementation of fully-automated G6PD testing. A viable method that includes on-board lysing and reflex testing has been implemented allowing for high-throughput G6PD testing in a clinical laboratory. Given market research yielded limited vendors with Food and Drug Administration (FDA)-cleared G6PD assays, the automation of the Pointe Scientific method will allow Department of Defense (DOD) laboratories to rapidly screen service members in order to ascertain the tolerability of a Primaquine dosing regimen.},
 year = {2018}
}

Copy | Download

TY  - JOUR
T1  - Modification of the Pointe Scientific Automated Glucose-6-Phosphate Dehydrogenase (G6PD) Assay for High-Throughput Use in the Clinical Laboratory
AU  - Erin Elizabeth Milner
AU  - Absone Rowland
AU  - Jessica Jeanette Fasio
AU  - Lam Henry
Y1  - 2018/11/12
PY  - 2018
N1  - https://doi.org/10.11648/j.cmr.20180705.13
DO  - 10.11648/j.cmr.20180705.13
T2  - Clinical Medicine Research
JF  - Clinical Medicine Research
JO  - Clinical Medicine Research
SP  - 119
EP  - 123
PB  - Science Publishing Group
SN  - 2326-9057
UR  - https://doi.org/10.11648/j.cmr.20180705.13
AB  - Herein we report a modified Pointe Scientific method for Glucose-6-Phosphate Dehydrogenase (G6PD) testing which eliminates time-consuming and labor intensive pre-analytical steps previously required. Pre-lyse and on-board lyse Pointe Scientific methods were compared to the on-board lyse Trinity Biotech method using Abbott Architect c8000 analyzers integrated into an a3600 track system. In order to streamline the implementation of this method involving both G6PD and hemoglobin analysis, we sought to capitalize on the Instrument Manager (IM) middleware and the a3600 Abbott track system for high-throughput analysis using the Abbott Architect c8000 platform. IM rules were developed to route the whole blood specimen to the wait area of the Input Output Module (IOM) while the initial result is determined. When the initial result is intermediate or deficient, the G6PD activity per gram of hemoglobin (U/g Hgb) is determined by rerouting the specimen to the analyzer as an automated reflex test. The data associated with method comparison, precision, carryover and linearity studies completed per regulatory guidelines indicate the assay parameters reported herein are available for the immediate implementation of fully-automated G6PD testing. A viable method that includes on-board lysing and reflex testing has been implemented allowing for high-throughput G6PD testing in a clinical laboratory. Given market research yielded limited vendors with Food and Drug Administration (FDA)-cleared G6PD assays, the automation of the Pointe Scientific method will allow Department of Defense (DOD) laboratories to rapidly screen service members in order to ascertain the tolerability of a Primaquine dosing regimen.
VL  - 7
IS  - 5
ER  -

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