Evaluation of a Diagnostic to Identify Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Brazil

NCT04033640 | Completed Results

• 1 other identifier: G6PD Brazil
• Study Type: interventional
• Target: 1,754
• Locations: 1 country
• Sites: 2

Brief Summary

Th objectives of this study are:

• 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

Conditions

G6PD Deficiency

Keywords

G6PD deficiency

Outcome Measures

Primary Outcomes (4)

• 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.

  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

Secondary Outcomes (6)

• Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit

  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

  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

  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

  Day 1

Study Arms (2)

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).

Diagnostic Test: SD Biosensor STANDARD G6PD Test; Diagnostic Test: Pointe Scientific Test Kit; Diagnostic Test: HemoCue System; Diagnostic Test: Complete blood count (CBC)

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.

Interventions

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.

G6PD Diagnostic Testing

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.

G6PD Diagnostic Testing

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.

G6PD Diagnostic Testing

Complete blood count (CBC) DIAGNOSTIC_TEST

In Manaus, hemoglobin concentration was determined by CBC using an automated hematology analyzer (Sysmex KX-21N).

G6PD Diagnostic Testing

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Febrile patients seeking care at the Manaus or Porto Velho clinics
• years age or older
• Willing to provide informed consent

You may not qualify if:

• Younger than 2 years of age
• Participants who received a blood transfusion in the last 3 months, self report
• Unwilling to provide informed consent
• Participants with known G6PD status
• Included in previous G6PD surveys and provided consent to be contacted again
• years of age or older
• Willing to provide informed consent or assent
• 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
• Health workers
• 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

Sponsors & Collaborators

• PATH: lead
• Fundação de Medicina Tropical Dr. Heitor Vieira Dourado: collaborator

Study Sites (2)

Tropical Medicine Foundation Doctor Heitor Vieira Dourado

Manaus, Amazonas, Brazil

Location

Centro de Pesquisa em Medicina Tropical de Rondônia

Porto Velho, Rondônia, Brazil

Location

Related Publications (2)

• 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.

  PMID: 34383774 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.

  PMID: 34238299 DERIVED

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase Deficiency

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Pooja Bansil
• Organization: PATH

pbansil@path.org

206 302 4920

Study Officials

• Marcus Lacerda, MD, PhD

  FMT/HVD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 26, 2019
• Study Start: June 27, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 11, 2021
• Results First Posted: November 11, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)