Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação de Medicina Tropical Dr. Heitor Vieira Dourado | OTHER |
Not provided
Not provided
Not provided
Th objectives of this study are:
This is a cross-sectional diagnostic accuracy study that includes both participants and health worker participants.
The participant population will be recruited at clinics and through a household survey using an enriched sample of a population with known G6PD status, established through previous epidemiological studies. Clinic staff will take capillary blood samples and conduct two point of care (POC) tests: 1) HemoCue® hemoglobin test, and 2) the investigational Standard Diagnostics (SD) Biosensor STANDARD POC test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. Venous blood will be collected and transferred to a laboratory where reference assays will be performed on venous samples using the Pointe Scientific G6PD Analyzer and hemoglobin tests.
The health worker participants will include trained intended users of the G6PD tests. Trained health workers will be surveyed to assess product usability through a questionnaire to assess label and packing comprehension as well as results interpretation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G6PD Diagnostic Testing | Other | Participants provided whole blood samples as well as finger-stick capillary blood samples. At the clinic site, study staff performed the SD Biosensor STANDARD G6PD test and the POC HemoCue hemoglobin test on finger stick blood samples. At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by a complete blood count (CBC) using an automated hematology analyzer (Manaus site only). |
|
| Health Workers | No Intervention | Participants were trained on use of the SD Biosensor STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SD Biosensor STANDARD G6PD Test | Diagnostic Test | The SD Biosensor G6PD Analyzer is designed to measure the quantitative determination of total hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays in a point-of-care (POC) setting. The test is intended to aid in the identification of people with G6PD deficiency. The test is currently not licensed for use in Brazil and is considered an investigational product. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Participants with unknown G6PD status
Inclusion criteria:
Exclusion criteria
Participants with known G6PD status
Inclusion criteria:
Exclusion criteria:
Health workers
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marcus Lacerda, MD, PhD | FMT/HVD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tropical Medicine Foundation Doctor Heitor Vieira Dourado | Manaus | Amazonas | Brazil | |||
| Centro de Pesquisa em Medicina Tropical de Rondônia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34383774 | Derived | Zobrist S, Brito M, Garbin E, Monteiro WM, Clementino Freitas S, Macedo M, Soares Moura A, Advani N, Kahn M, Pal S, Gerth-Guyette E, Bansil P, Domingo GJ, Pereira D, Lacerda MV. Evaluation of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency in Brazil. PLoS Negl Trop Dis. 2021 Aug 12;15(8):e0009649. doi: 10.1371/journal.pntd.0009649. eCollection 2021 Aug. | |
| 34238299 |
Not provided
Not provided
There is no plan to share any IPD with other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
This diagnostic accuracy study was conducted at 2 centers situated in the Brazilian Amazon and included both participants and health workers. Participants were recruited at clinics and through an enriched sample in Manaus and Porto Velho, Brazil. Health worker participants included both health care providers, such as community health workers/field agents, and laboratory technicians who perform malaria rapid diagnostic tests and other malaria testing near the point of care (POC).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | G6PD Diagnostic Testing | Participants provided whole blood samples as well as finger-stick capillary blood samples. At the clinic site, study staff performed the Standard Diagnostics (SD) Biosensor STANDARD glucose-6-phosphate dehydrogenase (G6PD) test and the POC HemoCue hemoglobin test on finger stick blood samples. At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by a complete blood count (CBC) using an automated hematology analyzer (Manaus site only). |
| FG001 | Health Workers | Participants were trained on use of the STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographic information were not collected for the health worker participants in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | G6PD Diagnostic Testing | Participants provided whole blood samples as well as finger-stick capillary blood samples. At the clinic site, study staff performed SD Biosensor STANDARD G6PD test and the POC HemoCue hemoglobin test on finger stick blood samples. At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by CBC. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographic information were not collected for the health worker participants in this study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants with available data | Posted | Number | 95% Confidence Interval | percentage of participants | All samples were collected on study day 1 |
|
Approximately 30 minutes
Health worker participants were not monitored for safety and no adverse event or mortality information were collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | G6PD Diagnostic Testing | Participants provided whole blood samples as well as finger-stick capillary blood samples. At the clinic site, study staff performed SD Biosensor STANDARD G6PD test and the POC HemoCue hemoglobin test on finger stick blood samples. At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by CBC. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pooja Bansil | PATH | 206 302 4920 | pbansil@path.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2019 | Oct 13, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005955 | Glucosephosphate Dehydrogenase Deficiency |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| ID | Term |
|---|---|
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pointe Scientific Test Kit | Diagnostic Test | The Pointe Scientific test kit will serve as the reference assay to assess G6PD activity. Its intended use is for the quantitative, kinetic determination of G6PD in blood at 340 nm. |
|
| HemoCue System | Diagnostic Test | The HemoCue hemoglobin (Hb) 201+ system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 201+ Analyzer, and specially designed microcuvettes, the HemoCue Hb 201+Microcuvettes. |
|
| Complete blood count (CBC) | Diagnostic Test | In Manaus, hemoglobin concentration was determined by CBC using an automated hematology analyzer (Sysmex KX-21N). |
|
| All samples were collected on study day 1 |
| 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 |
| All samples were collected on study day 1 |
| Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference HemoCue Hemoglobin Test | Accuracy between the SD Biosensor STANDARD G6PD test measure of hemoglobin and the HemoCue 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 |
| Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Hemoglobin Measured in a Complete Blood Count | Accuracy between the SD Biosensor STANDARD G6PD test measure of hemoglobin and the hemoglobin result from the complete blood count (CBC) reference assay (using an automated hematology analyzer) 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). Complete blood counts were only conducted for participants enrolled at the site in Manaus. | All samples were collected on study day 1 |
| Median G6PD Values Measured by the SD Biosensor STANDARD G6PD Test for Venous and Capillary Blood Samples | All samples were collected on study day 1 |
| Number of Participants Who Met Acceptance Criteria for Label Comprehension | After completing training, health worker participants were asked to complete a questionnaire to assess their comprehension of the test label. The questionnaire consisted of 13 multiple-choice questions with mutually exclusive options and a single correct answer focused on aspects of the product label including key warnings, limitations, and restrictions as well as the proper test procedure. Acceptance (success) criterion for label comprehension was defined as at least 85% correct responses (11 out of 13 possible points). | Day 1 |
| Number of Participants Who Met Acceptance Criteria for Accurate Results Interpretation | After completing training, health worker participants were asked to complete a questionnaire to assess their ability to interpret the test result outputs. The questionnaire consisted of seven short-answer questions (5 valid results, 2 invalid results) focused on the participant's ability to read the results screen, record the simulated G6PD and hemoglobin quantitative results, and classify the results as normal, intermediate, deficient, or invalid. For each valid result, three points were possible: (one for G6PD result transcription, one for hemoglobin result transcription, and one for result interpretation) and for each invalid result, one point was possible, resulting in a total of 17 possible points. Acceptance (success) criterion for results interpretation was defined as at least 85% correct responses (15 out of 17 possible points). | Day 1 |
| Porto Velho |
| Rondônia |
| Brazil |
| Derived |
| Gerth-Guyette E, Adissu W, Brito M, Garbin E, Macedo M, Sharma A, Das S, Lacerda MVG, Pereira D, Talukdar A, Yilma D, Pal S, Zobrist S, Domingo GJ. Usability of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency: a multi-country assessment of test label comprehension and results interpretation. Malar J. 2021 Jul 8;20(1):307. doi: 10.1186/s12936-021-03803-1. |
| BG001 | Health Workers | Participants were trained on use of the STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Demographic information were not collected for the health worker participants in this study. | Count of Participants | Participants |
|
| Sex: Female, Male | Demographic information were not collected for the health worker participants in this study. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | G6PD Diagnostic Testing | Participants provided whole blood samples as well as finger-stick capillary blood samples. At the clinic site, study staff performed SD Biosensor STANDARD G6PD test and the POC HemoCue hemoglobin test on finger stick blood samples. At the reference laboratories, G6PD activity was measured from whole blood samples using the SD Biosensor STANDARD G6PD test and the Pointe Scientific G6PD reference assay and hemoglobin was measured using the HemoCue hemoglobin test and by CBC. |
|
|
| 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. | Female participants with available data | Posted | Number | 95% Confidence Interval | percentage of participants | 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. | Participants with available data | Posted | Number | 95% Confidence Interval | percentage of participants | 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. | Female participants with available data | Posted | Number | 95% Confidence Interval | percentage of participants | 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. | Participants with available data | Posted | Number | 95% Confidence Interval | percentage of participants | All samples were collected on study day 1 |
|
|
|
| Secondary | Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference HemoCue Hemoglobin Test | Accuracy between the SD Biosensor STANDARD G6PD test measure of hemoglobin and the HemoCue 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). | Participants with available data | Posted | Number | 95% Confidence Interval | percentage of participants | All samples were collected on study day 1 |
|
|
|
| Secondary | Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Hemoglobin Measured in a Complete Blood Count | Accuracy between the SD Biosensor STANDARD G6PD test measure of hemoglobin and the hemoglobin result from the complete blood count (CBC) reference assay (using an automated hematology analyzer) 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). Complete blood counts were only conducted for participants enrolled at the site in Manaus. | Participants enrolled at the site in Manaus with available data | Posted | Number | 95% Confidence Interval | percentage of participants | All samples were collected on study day 1 |
|
|
|
| Secondary | Median G6PD Values Measured by the SD Biosensor STANDARD G6PD Test for Venous and Capillary Blood Samples | Participants with available data | Posted | Median | 95% Confidence Interval | units / gram of hemoglobin | All samples were collected on study day 1 |
|
|
|
|
| Secondary | Number of Participants Who Met Acceptance Criteria for Label Comprehension | After completing training, health worker participants were asked to complete a questionnaire to assess their comprehension of the test label. The questionnaire consisted of 13 multiple-choice questions with mutually exclusive options and a single correct answer focused on aspects of the product label including key warnings, limitations, and restrictions as well as the proper test procedure. Acceptance (success) criterion for label comprehension was defined as at least 85% correct responses (11 out of 13 possible points). | Health worker participants | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Number of Participants Who Met Acceptance Criteria for Accurate Results Interpretation | After completing training, health worker participants were asked to complete a questionnaire to assess their ability to interpret the test result outputs. The questionnaire consisted of seven short-answer questions (5 valid results, 2 invalid results) focused on the participant's ability to read the results screen, record the simulated G6PD and hemoglobin quantitative results, and classify the results as normal, intermediate, deficient, or invalid. For each valid result, three points were possible: (one for G6PD result transcription, one for hemoglobin result transcription, and one for result interpretation) and for each invalid result, one point was possible, resulting in a total of 17 possible points. Acceptance (success) criterion for results interpretation was defined as at least 85% correct responses (15 out of 17 possible points). | Health worker participants | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 1,736 |
| 0 |
| 1,736 |
| 0 |
| 1,736 |
| EG001 | Health Workers | Participants were trained on use of the STANDARD G6PD test by members of the study team with extensive experience with G6PD diagnostics and the STANDARD G6PD test. Health worker participants were surveyed to assess label and packing comprehension as well as results interpretation. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| 16-64 years |
|
| 65+ years |
|
|
|
|
|
|
|
|