Adults 18 to 65, any sex, with G6PD Deficiency. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient IndividualsPrimary· All samples were collected on study day 1
For the purposes of this study, an individual was considered G6PD deficient if they tested positive in the Pointe Scientific assay. A true positive was defined as a participant with ≤ 30% of normal G6PD activity in circulating venous blood determined by the Pointe Scientific test.
Diagnostic sensitivity of the SD Biosensor G6PD test is defined as the percentage of participants who tested positive for G6PD deficiency on the reference test who were identified by the test assay as positive, calculated as:
Number of participants who were both test and true positive / (Number of participants who
Venous Blood
Group
Value
95% CI
G6PD Diagnostic Testing
100.0
59.0 – 100.0
Capillary Blood
Group
Value
95% CI
G6PD Diagnostic Testing
100.0
59.0 – 100.0
Sensitivity of SD Biosensor POC G6PD Test for Identifying Women With Intermediate G6PD ActivityPrimary· All samples were collected on study day 1
To investigate the performance of the SD Biosensor G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, assay sensitivity was determined at a G6PD activity threshold of 70%. A true positive for intermediate G6PD activity in females was defined as G6PD activity between 30 and 70% of normal in circulating venous blood as determined by the Pointe Scientific test.
Sensitivity of the SD Biosensor POC G6PD test is the percentage of women who tested positive for intermediate G6PD activity on the reference test who were identified by the test assay as po
Venous Blood
Group
Value
95% CI
G6PD Diagnostic Testing
100.0
39.8 – 100.0
Capillary Blood
Group
Value
95% CI
G6PD Diagnostic Testing
75.0
19.4 – 99.4
Specificity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient IndividualsPrimary· All samples were collected on study day 1
For the purposes of this study, an individual was considered G6PD deficient if they tested positive by the Pointe Scientific assay. A true negative was defined as \> 30% of normal G6PD activity in circulating venous blood as determined by the Pointe Scientific test.
Specificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as:
Number of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were te
Venous Blood
Group
Value
95% CI
G6PD Diagnostic Testing
94.9
90.8 – 97.5
Capillary Blood
Group
Value
95% CI
G6PD Diagnostic Testing
98.5
95.8 – 99.7
Specificity of SD Biosensor G6PD Test for Identifying Women With Intermediate G6PD ActivityPrimary· All samples were collected on study day 1
To investigate the performance of the SD Biosensor G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, the specificity was determined at a G6PD activity threshold of 70%. A true negative for intermediate G6PD activity in females was defined as G6PD activity \> 70% of normal in circulating venous blood as determined by the Pointe Scientific test.
Specificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as:
Number of participants wh
Venous Blood
Group
Value
95% CI
G6PD Diagnostic Testing
83.7
76.2 – 89.6
Capillary Blood
Group
Value
95% CI
G6PD Diagnostic Testing
92.4
86.4 – 96.3
Accuracy Between the SD Biosensor POC G6PD Test Assay and the Pointe Scientific Test KitSecondary· All samples were collected on study day 1
Accuracy between the SD Biosensor POC G6PD test assay and the Pointe Scientific G6PD reference assay was calculated as the percent agreement between both G6PD tests, ie, the percentage of participants with the same diagnosis according to both tests (either deficient, intermediate, or normal G6PD levels).
Accuracy of the SD Biosensor G6PD test was calculated from both venous and capillary blood samples.
Venous blood
Group
Value
95% CI
G6PD Diagnostic Testing
85.7
80.1 – 90.2
Capillary blood
Group
Value
95% CI
G6PD Diagnostic Testing
93.9
89.7 – 96.7
Accuracy Between the SD Biosensor POC G6PD Test Measure of Hemoglobin and the Reference Hemoglobin TestSecondary· All samples were collected on study day 1
Accuracy between the SD Biosensor POC G6PD test measure of hemoglobin and the hemoglobin reference assay was calculated as the percentage agreement between both tests, ie, the percentage of participants with the same diagnosis according to both tests (either non/mild anemia, moderate anemia or severe anemia).
Venous blood
Group
Value
95% CI
G6PD Diagnostic Testing
97.5
94.3 – 99.1
Capillary blood
Group
Value
95% CI
G6PD Diagnostic Testing
89.6
84.7 – 93.4
Median G6PD Values Measured by the SD Biosensor G6PD Test for Venous and Capillary Blood SamplesSecondary· All samples were collected on study day 1
Venous blood
Group
Value
95% CI
G6PD Diagnostic Testing
7.6
6.8 – 8.5
Capillary blood
Group
Value
95% CI
G6PD Diagnostic Testing
6.8
6.1 – 7.5
Sponsor's own description
The primary objective of this study is to assess the accuracy of the SD Biosensor STANDARD G6PD Analyzer in measuring G6PD activity when used by trained health care workers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PATH
Last refreshed: 10 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04010695.