Reference and point-of-care testing for G6PD deficiency: Blood disorder interference, contrived specimens, and fingerstick equivalence and precision.

Autor: Pal S; PATH, Seattle, Washington, United States of America., Myburgh J; Special Haematology Laboratory, Hammersmith Hospital, London, United Kingdom., Bansil P; PATH, Seattle, Washington, United States of America., Hann A; Special Haematology Laboratory, Hammersmith Hospital, London, United Kingdom., Robertson L; Special Haematology Laboratory, Hammersmith Hospital, London, United Kingdom., Gerth-Guyette E; PATH, Seattle, Washington, United States of America., Ambler G; PATH, Seattle, Washington, United States of America., Bizilj G; PATH, Seattle, Washington, United States of America., Kahn M; PATH, Seattle, Washington, United States of America., Zobrist S; PATH, Seattle, Washington, United States of America., Manis MR; Departments of Laboratory Medicine and Microbiology, University of Washington School of Medicine, Seattle, Washington, United States of America., Styke NA; Departments of Laboratory Medicine and Microbiology, University of Washington School of Medicine, Seattle, Washington, United States of America., Allan V; PATH, Seattle, Washington, United States of America., Ansbro R; Consultant, London, United Kingdom., Akingbade T; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America., Bryan A; Departments of Laboratory Medicine and Microbiology, University of Washington School of Medicine, Seattle, Washington, United States of America., Murphy SC; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, United States of America.; Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington, United States of America., Kublin JG; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America., Layton M; Special Haematology Laboratory, Hammersmith Hospital, London, United Kingdom., Domingo GJ; PATH, Seattle, Washington, United States of America.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2021 Sep 20; Vol. 16 (9), pp. e0257560. Date of Electronic Publication: 2021 Sep 20 (Print Publication: 2021).
DOI: 10.1371/journal.pone.0257560
Abstrakt: Certain clinical indications and treatments such as the use of rasburicase in cancer therapy and 8-aminoquinolines for Plasmodium vivax malaria treatment would benefit from a point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. Three studies were conducted to evaluate the performance of one such test: the STANDARD™ G6PD Test (SD BIOSENSOR, South Korea). First, biological interference on the test performance was evaluated in specimens with common blood disorders, including high white blood cell (WBC) counts. Second, the test precision on fingerstick specimens was evaluated against five individuals of each, deficient, intermediate, and normal G6PD activity status. Third, clinical performance of the test was evaluated at three point-of-care settings in the United States. The test performed equivalently to the reference assay in specimens with common blood disorders. High WBC count blood samples resulted in overestimation of G6PD activity in both the reference assay and the STANDARD G6PD Test. The STANDARD G6PD Test showed good precision on multiple fingerstick specimens from the same individual. The same G6PD threshold values (U/g Hb) were applied for a semiquantitative interpretation for fingerstick- and venous-derived results. The sensitivity/specificity values (95% confidence intervals) for the test for G6PD deficiency were 100 (92.3-100.0)/97 (95.2-98.2) and 100 (95.7-100.0)/97.4 (95.7-98.5) for venous and capillary specimens, respectively. The same values for females with intermediate (> 30% to ≤ 70%) G6PD activity were 94.1 (71.3-99.9)/88.2 (83.9-91.7) and 82.4 (56.6-96.2)/87.6(83.3-91.2) for venous and capillary specimens, respectively. The STANDARD G6PD Test enables point-of-care testing for G6PD deficiency.
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
Externí odkaz: