G6PD Deficiency Clinical Trial
Official title:
Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase Deficiency: Diagnostic Accuracy and Repeatability in Capillary Samples
Verified date | August 2021 |
Source | PATH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the study is to assess the accuracy of the SD Biosensor STANDARD™ point-of-care (POC) G6PD test in measuring G6PD activity and classifying results compared to a reference assay and across repeated measurements in capillary samples.
Status | Completed |
Enrollment | 229 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Must communicate an understanding of the study protocol. - Must be able to provide written consent to undergo screening and provide medical history. - Participants must be afebrile and in general good health in the opinion of the investigator as determined by vital signs, medical history, and physical examination. - Black/African-American, by self-report. Exclusion Criteria: - Blood transfusion in the past 3 months by self-report |
Country | Name | City | State |
---|---|---|---|
United States | BSC corporation | Reading | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
PATH |
United States,
Pal S, Myburgh J, Bansil P, Hann A, Robertson L, Gerth-Guyette E, Ambler G, Bizilj G, Kahn M, Zobrist S, Manis MR, Styke NA, Allan V, Ansbro R, Akingbade T, Bryan A, Murphy SC, Kublin JG, Layton M, Domingo GJ. Reference and point-of-care testing for G6PD deficiency: Blood disorder interference, contrived specimens, and fingerstick equivalence and precision. PLoS One. 2021 Sep 20;16(9):e0257560. doi: 10.1371/journal.pone.0257560. eCollection 2021. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals | 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 STANDARD 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 were test and true positive + Number of participants who were test negative but true positive [ie false negative]) * 100%. Sensitivity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples. |
All samples were collected on study day 1 | |
Primary | Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity | To investigate the performance of the SD Biosensor STANDARD 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 STANDARD 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 positive, calculated as: Number of women who were both test and true positive / (Number of women who were test and true positive + Number of women who were test negative but true positive [ie false negative]) * 100%. Sensitivity of the SD Biosensor STANDARD G6PD test for identifying females with intermediate G6PD activity was calculated from both venous and capillary blood samples. |
All samples were collected on study day 1 | |
Primary | Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals | 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 test positive but true negative [ie false positive]) * 100%. Specificity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples. |
All samples were collected on study day 1 | |
Primary | Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity | To investigate the performance of the SD Biosensor STANDARD 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 who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative [ie false positive]) * 100%. Specificity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples. |
All samples were collected on study day 1 | |
Secondary | Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit | Accuracy between the SD Biosensor STANDARD 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 STANDARD G6PD test was calculated from both venous and capillary blood samples. |
All samples were collected on study day 1 | |
Secondary | Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference Hemoglobin Test | Accuracy between the SD Biosensor STANDARD 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). | All samples were collected on study day 1 | |
Secondary | Repeatability Substudy: G6PD Levels in Capillary Blood Samples Measured Using the SD Biosensor G6PD Test, by Operator and Analyzer | Capillary blood samples were collected in duplicate from four different fingers on the participants hands, for a total of eight samples. Within each duplicate, a sample was tested on 1 of 2 SD Biosensor G6PD instruments by 1 of 2 operators. Overall there were 3 instruments used in the testing and 3 operators. | All samples were collected on study day 1 and tested immediately | |
Secondary | Repeatability Substudy: Hemoglobin Levels in Capillary Blood Samples Measured Using the SD Biosensor STANDARD Hemoglobin Test, by Operator and Analyzer | Capillary blood samples were collected in duplicate from four different fingers on the participants hands, for a total of eight samples. Within each duplicate, a sample was tested on 1 of 2 SD Biosensor instruments by 1 of 2 operators. Overall there were 3 instruments used in the testing and 3 operators. | All samples were collected on study day 1 and tested immediately | |
Secondary | Sample Stability Substudy: G6PD Levels Measured Over Time After Storage at Room Temperature | Each participant in the sample stability substudy underwent an additional blood draw in 3 different anti-coagulants which were stored at room temperature (15-30°C/59-86°F). The freshly collected venous whole blood samples were tested at the clinic site lab using the SD Biosensor STANDARD G6PD test within 1 hour of collection for baseline (0 hour) and at 4 additional time points, up to 2 days (48 hours) after collection. The anti-coagulants included:
ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood heparin-anti-coagulated blood acid citrate dextrose (ACD)-anti-coagulated blood |
Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection. | |
Secondary | Sample Stability Substudy: G6PD Levels Measured Over Time After Refrigerated Storage | Each participant in the sample stability substudy underwent an additional blood draw in 3 different anti-coagulants which were stored in a refrigerator (2-8°C/25-46°F). The freshly collected venous whole blood samples were tested at the clinic site lab using the SD Biosensor STANDARD G6PD test within 1 hour of collection for baseline (0 hour) and at 5 additional time points, up to 7 days (168 hours) after collection. The anti-coagulants included:
ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood heparin-anti-coagulated blood acid citrate dextrose (ACD)-anti-coagulated blood |
Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 24, 48, 72, 96, and 168 hours after collection. | |
Secondary | Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Storage at Room Temperature | Each participant in the sample stability substudy underwent a blood draw in 3 different anti-coagulants which were stored at room temperature (15-30°C/59-86°F). Hemoglobin levels were measured from the freshly collected venous whole blood samples at the clinic site lab using the SD Biosensor STANDARD hemoglobin test within 1 hour of collection for baseline (0 hour) and at 4 additional time points, up to 24 hours after collection. The anti-coagulants included:
ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood heparin-anti-coagulated blood acid citrate dextrose (ACD)-anti-coagulated blood |
Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 2, 4, 6, and 24 hours after collection. | |
Secondary | Sample Stability Substudy: Hemoglobin Levels Measured Over Time After Refrigerated Storage | Each participant in the sample stability substudy underwent an additional blood draw in 3 different anti-coagulants which were stored in a refrigerator (2-8°C/25-46°F). Hemoglobin levels were measured from the freshly collected venous whole blood samples at the clinic site lab using the SD Biosensor STANDARD hemoglobin test within 1 hour of collection for baseline (0 hour) and at 5 additional time points, up to 7 days (168 hours) after collection. The anti-coagulants included:
ethylenediaminetetraacetic acid (EDTA)-anti-coagulated blood heparin-anti-coagulated blood acid citrate dextrose (ACD)-anti-coagulated blood |
Blood samples were collected on day 1. Samples were tested immediately (< 1 hour) and at 24, 48, 72, 96, and 168 hours after collection. |
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