Evaluation of a Diagnostic to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Brazil
NCT ID: NCT04033640
Last Updated: 2021-11-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1754 participants
INTERVENTIONAL
2019-06-27
2019-12-31
Brief Summary
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* To determine the performance of G6PD tests in detecting G6PD activity and hemoglobin (Hb) compared to a reference assay
* To assess the comprehension of the G6PD test packaging and labelling among intended users
* To assess the usability of G6PD test result outputs among intended users
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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G6PD Diagnostic Testing
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).
SD Biosensor STANDARD G6PD 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.
Pointe Scientific Test Kit
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
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)
In Manaus, hemoglobin concentration was determined by CBC using an automated hematology analyzer (Sysmex KX-21N).
Health Workers
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.
No interventions assigned to this group
Interventions
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SD Biosensor STANDARD G6PD 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.
Pointe Scientific Test Kit
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
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)
In Manaus, hemoglobin concentration was determined by CBC using an automated hematology analyzer (Sysmex KX-21N).
Eligibility Criteria
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Inclusion Criteria
* 2 years age or older
* Willing to provide informed consent
* Included in previous G6PD surveys and provided consent to be contacted again
* 2 years of age or older
* Willing to provide informed consent or assent
* Provides malaria case management at study facility or study site
* Considered an intended user of quantitative POC G6PD tests
* Trained and proficient in the use of the POC G6PD test
* Willing to provide informed consent
Exclusion Criteria
* Participants who received a blood transfusion in the last 3 months, self report
* Unwilling to provide informed consent
2. Participants with known G6PD status
* Younger than 2 years of age
* Participants who received a blood transfusion in the last 3 months, self report
* Unwilling to provide informed consent or assent or unavailable during study visit
3. Health workers
* Does not provide malaria case management at study facility or study site
* Not considered an intended user of quantitative POC G6PD tests
* Not trained or not proficient in the use of the POC G6PD test
* Unwilling to provide informed consent
2 Years
ALL
Yes
Sponsors
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Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
OTHER
PATH
OTHER
Responsible Party
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Principal Investigators
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Marcus Lacerda, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
FMT/HVD
Locations
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Tropical Medicine Foundation Doctor Heitor Vieira Dourado
Manaus, Amazonas, Brazil
Centro de Pesquisa em Medicina Tropical de Rondônia
Porto Velho, Rondônia, Brazil
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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G6PD Brazil
Identifier Type: -
Identifier Source: org_study_id