TY - JOUR
T1 - Repeatability and reproducibility of a handheld quantitative G6PD diagnostic
AU - Ley, Benedikt
AU - Winasti Satyagraha, Ari
AU - Kibria, Mohammad Golam
AU - Armstrong, Jillian
AU - Bancone, Germana
AU - Bei, Amy K.
AU - Bizilj, Greg
AU - Brito, Marcelo
AU - Ding, Xavier C.
AU - Domingo, Gonzalo J.
AU - von Fricken, Michael E.
AU - Gornsawun, Gornpan
AU - Lam, Brandon
AU - Menard, Didier
AU - Monteiro, Wuelton
AU - Ongarello, Stefano
AU - Pal, Sampa
AU - Panggalo, Lydia Visita
AU - Parikh, Sunil
AU - Pfeffer, Daniel A.
AU - Price, Ric N.
AU - da Silva Orfano, Alessandra
AU - Wade, Martina
AU - Wojnarski, Mariusz
AU - Worachet, Kuntawunginn
AU - Yar, Aqsa
AU - Alam, Mohammad Shafiul
AU - Howes, Rosalind E.
N1 - Funding Information:
This study was funded by a grant from the Australian government (DFAT) to the Foundation for Innovative New Diagnostics (FIND). RNP is a Wellcome Senior Fellow in Clinical Science (200909), and GB and GG are in part funded by the Wellcome Trust (220211). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Publisher Copyright:
© 2022, Public Library of Science. All rights reserved.
PY - 2022/2/1
Y1 - 2022/2/1
N2 - BACKGROUND: The introduction of novel short course treatment regimens for the radical cure of Plasmodium vivax requires reliable point-of-care diagnosis that can identify glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. While deficient males can be identified using a qualitative diagnostic test, the genetic make-up of females requires a quantitative measurement. SD Biosensor (Republic of Korea) has developed a handheld quantitative G6PD diagnostic (STANDARD G6PD test), that has approximately 90% accuracy in field studies for identifying individuals with intermediate or severe deficiency. The device can only be considered for routine care if precision of the assay is high. METHODS AND FINDINGS: Commercial lyophilised controls (ACS Analytics, USA) with high, intermediate, and low G6PD activities were assessed 20 times on 10 Biosensor devices and compared to spectrophotometry (Pointe Scientific, USA). Each device was then dispatched to one of 10 different laboratories with a standard set of the controls. Each control was tested 40 times at each laboratory by a single user and compared to spectrophotometry results. When tested at one site, the mean coefficient of variation (CV) was 0.111, 0.172 and 0.260 for high, intermediate, and low controls across all devices respectively; combined G6PD Biosensor readings correlated well with spectrophotometry (rs = 0.859, p<0.001). When tested in different laboratories, correlation was lower (rs = 0.604, p<0.001) and G6PD activity determined by Biosensor for the low and intermediate controls overlapped. The use of lyophilised human blood samples rather than fresh blood may have affected these findings. Biosensor G6PD readings between sites did not differ significantly (p = 0.436), whereas spectrophotometry readings differed markedly between sites (p<0.001). CONCLUSIONS: Repeatability and inter-laboratory reproducibility of the Biosensor were good; though the device did not reliably discriminate between intermediate and low G6PD activities of the lyophilized specimens. Clinical studies are now required to assess the devices performance in practice.
AB - BACKGROUND: The introduction of novel short course treatment regimens for the radical cure of Plasmodium vivax requires reliable point-of-care diagnosis that can identify glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. While deficient males can be identified using a qualitative diagnostic test, the genetic make-up of females requires a quantitative measurement. SD Biosensor (Republic of Korea) has developed a handheld quantitative G6PD diagnostic (STANDARD G6PD test), that has approximately 90% accuracy in field studies for identifying individuals with intermediate or severe deficiency. The device can only be considered for routine care if precision of the assay is high. METHODS AND FINDINGS: Commercial lyophilised controls (ACS Analytics, USA) with high, intermediate, and low G6PD activities were assessed 20 times on 10 Biosensor devices and compared to spectrophotometry (Pointe Scientific, USA). Each device was then dispatched to one of 10 different laboratories with a standard set of the controls. Each control was tested 40 times at each laboratory by a single user and compared to spectrophotometry results. When tested at one site, the mean coefficient of variation (CV) was 0.111, 0.172 and 0.260 for high, intermediate, and low controls across all devices respectively; combined G6PD Biosensor readings correlated well with spectrophotometry (rs = 0.859, p<0.001). When tested in different laboratories, correlation was lower (rs = 0.604, p<0.001) and G6PD activity determined by Biosensor for the low and intermediate controls overlapped. The use of lyophilised human blood samples rather than fresh blood may have affected these findings. Biosensor G6PD readings between sites did not differ significantly (p = 0.436), whereas spectrophotometry readings differed markedly between sites (p<0.001). CONCLUSIONS: Repeatability and inter-laboratory reproducibility of the Biosensor were good; though the device did not reliably discriminate between intermediate and low G6PD activities of the lyophilized specimens. Clinical studies are now required to assess the devices performance in practice.
UR - http://www.scopus.com/inward/record.url?scp=85124776598&partnerID=8YFLogxK
U2 - 10.1371/journal.pntd.0010174
DO - 10.1371/journal.pntd.0010174
M3 - Article
C2 - 35176015
AN - SCOPUS:85124776598
SN - 1935-2727
VL - 16
SP - 1
EP - 17
JO - PLoS Neglected Tropical Diseases
JF - PLoS Neglected Tropical Diseases
IS - 2
M1 - e0010174
ER -