Background::The elimination of Plasmodium vivax malaria requires 8-aminoquinolines,which are contraindicated in patients with glucose-6-phosphate dehydrogenase(G6PD)deficiency due to the risk of acute haemolytic anaem...Background::The elimination of Plasmodium vivax malaria requires 8-aminoquinolines,which are contraindicated in patients with glucose-6-phosphate dehydrogenase(G6PD)deficiency due to the risk of acute haemolytic anaemia.Several point-of-care devices have been developed to detect G6PD deficiency.The objective of the present study was to evaluate the performance of two of these devices against G6PD genotypes in Mauritania.Methods::Outpatients were screened for G6PD deficiency using CareStart?rapid diagnostic test(RDT)and CareStart?G6PD biosensor in Nouakchott,Mauritania,in 2019-2020.African-type and Mediterranean-type G6PD genotypes commonly observed in Africa were determined by polymerase chain reaction-restriction fragment length polymorphism and sequencing.Qualitative variables were compared using Fisher’s exact test.Results::Of 323 patients(74 males and 249 females),5 males and 2 homozygous females had the African-type A-genotype:A-(202)in 3 males and 2 females and G6PD A-(968)in 2 males.Among heterozygous females,13 carried G6PD A-(202),12 G6PD A-(968),and 3 G6PD A-(542)variants.None had the Mediterranean-type G6PD genotype.Eight had a positive G6PD RDT result,including all 7 hemizygous males and homozygous females with A-or A-A-(0.12 to 2.34 IU/g haemoglobin,according to G6PD biosensor),but RDT performed poorly(sensitivity,11.1%at the cutoff level of<30%)and yielded many false negative tests.Thirty-seven(50.0%)males and 141(56.6%)females were anaemic.The adjusted median values of G6PD activity were 5.72 and 5.34 IU/g haemoglobin in non-anaemic males(n=35)and non-anaemic males and females(n=130)with normal G6PD genotypes using G6PD biosensor,respectively.Based on the adjusted median of 5.34 IU/g haemoglobin,the performance of G6PD biosensor against genotyping was as follows:at 30%cut-off,the sensitivity and specificity were 85.7%and 91.7%,respectively,and at 80%cut-off,the sensitivity was 100%while the specificity was 64.9%.Conclusions::Although this pilot study supports the utility of biosensor to screen for G6PD deficiency in patients,further investigation in parallel with spectrophotometry is required to promote and validate a more extensive use of this point-of-care device in areas where P.vivax is highly prevalent in Mauritania.展开更多
文摘Background::The elimination of Plasmodium vivax malaria requires 8-aminoquinolines,which are contraindicated in patients with glucose-6-phosphate dehydrogenase(G6PD)deficiency due to the risk of acute haemolytic anaemia.Several point-of-care devices have been developed to detect G6PD deficiency.The objective of the present study was to evaluate the performance of two of these devices against G6PD genotypes in Mauritania.Methods::Outpatients were screened for G6PD deficiency using CareStart?rapid diagnostic test(RDT)and CareStart?G6PD biosensor in Nouakchott,Mauritania,in 2019-2020.African-type and Mediterranean-type G6PD genotypes commonly observed in Africa were determined by polymerase chain reaction-restriction fragment length polymorphism and sequencing.Qualitative variables were compared using Fisher’s exact test.Results::Of 323 patients(74 males and 249 females),5 males and 2 homozygous females had the African-type A-genotype:A-(202)in 3 males and 2 females and G6PD A-(968)in 2 males.Among heterozygous females,13 carried G6PD A-(202),12 G6PD A-(968),and 3 G6PD A-(542)variants.None had the Mediterranean-type G6PD genotype.Eight had a positive G6PD RDT result,including all 7 hemizygous males and homozygous females with A-or A-A-(0.12 to 2.34 IU/g haemoglobin,according to G6PD biosensor),but RDT performed poorly(sensitivity,11.1%at the cutoff level of<30%)and yielded many false negative tests.Thirty-seven(50.0%)males and 141(56.6%)females were anaemic.The adjusted median values of G6PD activity were 5.72 and 5.34 IU/g haemoglobin in non-anaemic males(n=35)and non-anaemic males and females(n=130)with normal G6PD genotypes using G6PD biosensor,respectively.Based on the adjusted median of 5.34 IU/g haemoglobin,the performance of G6PD biosensor against genotyping was as follows:at 30%cut-off,the sensitivity and specificity were 85.7%and 91.7%,respectively,and at 80%cut-off,the sensitivity was 100%while the specificity was 64.9%.Conclusions::Although this pilot study supports the utility of biosensor to screen for G6PD deficiency in patients,further investigation in parallel with spectrophotometry is required to promote and validate a more extensive use of this point-of-care device in areas where P.vivax is highly prevalent in Mauritania.
