Table 1.
Summary of demographics.
Fig 1.
Site-specific variation in G6PD activity among normal males on fresh capillary and venous specimens on A) the reference assay, and B) the STANDARD G6PD Test*.
* The UK study, which included newborns and samples with blood disorders, and the Thailand study, which was conducted on frozen samples, are not included in Figure 1.
Table 2.
Adjusted G6PD normal male median (AMM) and analytical population male medians on the reference assay at the Porto Velho, Brazil, and Kolkata, India, sites, by P. vivax malaria status.
Table 3.
Summary diagnostic performance of the STANDARD G6PD Test for identifying G6PD deficient males and females and females with intermediate G6PD activity, by specimen type, in all study participants and in P. vivax cases only.
Fig 2.
G6PD activity classification of the STANDARD G6PD and reference assay for A) males and B) females.
G6PD status classification measured by the STANDARD G6PD Test is shown on the X-axis, for capillary (grey) and venous (black) specimens, respectively. Results are plotted by the reference G6PD percent activity (Y-axis). Shaded areas correspond to true G6PD normal (green), intermediate (yellow), and deficient (red) status classifications on the reference assay.
Table 4.
2 x 2 and 3 x 3 tables for males and female G6PD classifications respectively by the reference assay (columns) and by the STANDARD G6PD test (rows).
30% and 70% normal G6PD activity thresholds were used to classify G6PD deficient and intermediate status, respectively, with the reference spectrophotometric assay. Manufacturer thresholds on the STANDARD G6PD test were used to classify G6PD deficient and intermediate status.
Table 5.
Performance indicators applying the 6.0 U/g Hb threshold on the STANDARD G6PD Test for deficient and intermediate females with G6PD activity levels between 0% and 40%, 50%, 60%, 65%, and 70% for capillary specimens.
Fig 3.
Participant eligibility and outcomes for radical cure treatment options based on the results of the STANDARD G6PD Test on capillary specimens.
Panels A and B represent eligibility and outcomes for daily primaquine regimen. Panels C and D represent eligibility and outcomes for tafenoquine and daily primaquine, with those who are considered ineligible for tafenoquine then considered for primaquine eligibility. Abbreviations: G6PD, glucose-6-phosphate-dehydrogenase; PQ, Primaquine; Hb, Hemoglobin; TQ, Tafenoquine. * No other treatment eligibility criteria (e.g., age, anemia status, pregnancy status) were considered as part of the calculation.