Quantitative G6PD Deficiency Screening in Routine Malaria Diagnostic Units in the Brazilian Amazon (SAFEPRIM): An Operational Mixed-Methods Study

Abstract

Background: Glucose-6-phosphate dehydrogenase (G6PD) deficiency testing is not routinely performed before primaquine treatment in most Plasmodium vivax endemic areas, despite the risk of primaquine-associated hemolysis. This is due to the operational challenges associated with pragmatic G6PD testing and as such needs to be addressed. Methods and findings: This mixed-methods operational study was aimed at implementing the quantitative point-of-care StandardTM G6PD (SD Biosensor, Korea) screening test in malaria treatment units (MTUs) in the municipalities of Rio Preto da Eva and Mâncio Lima, in the Brazilian Amazon, between mid-January 2020 and December 2020. In total, 1286 P. vivax cases were treated based on the Standard G6PD test: 1230 had activity equal to or greater than 4.0 U/g Hb, and 56 less than 4.0 U/g Hb. No G6PD deficient (G6PDd) genotypes were found in 96 samples from the 1230, and only 21 of the 56 G6PDd cases had confirmed G6PDd genotypes. Evaluations were conducted on the proficiency of health care professionals (HCPs) training to perform the test, the reliability of testing performed in the field, and the perceptions of HCPs and patients about the implementation. Post-training proficiency was 73.4% after a 4-hour training session. This study revealed that locations with lower malaria caseloads will need regular refresher training. The test was well accepted by both HCPs and patients. Signs and symptoms of hemolysis were not always associated with malaria treatment drugs by HCPs and patients. Interpretation: Point-of-care quantitative G6PD testing can be performed at MTUs in the Brazilian Amazon to inform treatment decisions with primaquine. Limitations related to technical and cultural aspects need to be addressed further when expanding screening to larger areas.

Primaquine dose and the risk of haemolysis in patients with uncomplicated Plasmodium vivax malaria: a systematic review and individual patient data meta-analysis

“… 45 Some barriers to its implementation in remote and low-resourced locations remain, including a need for training and a high cost for the devices and test strips. 46 …”

Diagnostic accuracy of the Point-of-Care Standard G6PD test™ (SD Biosensor) for Glucose-6-phosphate dehydrogenase deficiency: a systematic review of the literature

“…However, the authors found limitations linked to technical and cultural aspects that should be addressed when expanding screening to larger areas (37).…”

“…A study on barriers and facilitators for G6PD test implementation (36) identified three main barriers: perceived low risk of hemolysis, wrong perception of P. vivax malaria as a benign condition, and the cost of routine testing as part of the healthcare attention of malaria patients. A study conducted in Brazil on the operational challenges associated with pragmatic G6PD testing (37) found that the StandG6PD-BS PoC test was well accepted by both healthcare professionals and patients and can be performed at malaria treatment units in the Brazilian Amazon to inform treatment decisions with PQ. However, the authors found limitations linked to technical and cultural aspects that should be addressed when expanding screening to larger areas (37).…”

“…A study conducted in Brazil on the operational challenges associated with pragmatic G6PD testing (37) found that the StandG6PD-BS PoC test was well accepted by both healthcare professionals and patients and can be performed at malaria treatment units in the Brazilian Amazon to inform treatment decisions with PQ. However, the authors found limitations linked to technical and cultural aspects that should be addressed when expanding screening to larger areas (37).…”

A Review of the Current Status of G6PD Deficiency Testing to Guide Radical Cure Treatment for Vivax Malaria

“…In an operational study in Brazil implementing the STANDARD G6PD, the study location with the lowest case load had the lowest assessment score at 6 months after initial training. As such, the authors suggest refresher training every 6 months in such locations [ 146 ].…”