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Evaluation of the diagnostic accuracy of CareStart G6PD deficiency Rapid Diagnostic Test (RDT) in a malaria endemic area in Ghana, Africa.

Adu-Gyasi D, Asante KP, Newton S, Dosoo D, Amoako S, Adjei G, Amoako N, Ankrah L, Tchum SK, Mahama E, Agyemang V, Kayan K, Owusu-Agyei S - PLoS ONE (2015)

Bottom Line: Data entry and analysis were done using Microsoft Access 2010 and Stata Software version 12.Kintampo Health Research Centre Institutional Ethics Committee granted ethical approval.Malaria infection status had no significant (P=0.199) change on the performance of the G6PD RDT test kit compared to the "gold standard".

View Article: PubMed Central - PubMed

Affiliation: Kintampo Health Research Centre, P O Box 200, Kintampo, Brong Ahafo, Ghana.

ABSTRACT

Background: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most widespread enzyme defect that can result in red cell breakdown under oxidative stress when exposed to certain medicines including antimalarials. We evaluated the diagnostic accuracy of CareStart G6PD deficiency Rapid Diagnostic Test (RDT) as a point-of-care tool for screening G6PD deficiency.

Methods: A cross-sectional study was conducted among 206 randomly selected and consented participants from a group with known G6PD deficiency status between February 2013 and June 2013. A maximum of 1.6ml of capillary blood samples were used for G6PD deficiency screening using CareStart G6PD RDT and Trinity qualitative with Trinity quantitative methods as the "gold standard". Samples were also screened for the presence of malaria parasites. Data entry and analysis were done using Microsoft Access 2010 and Stata Software version 12. Kintampo Health Research Centre Institutional Ethics Committee granted ethical approval.

Results: The sensitivity (SE) and specificity (SP) of CareStart G6PD deficiency RDT was 100% and 72.1% compared to Trinity quantitative method respectively and was 98.9% and 96.2% compared to Trinity qualitative method. Malaria infection status had no significant (P=0.199) change on the performance of the G6PD RDT test kit compared to the "gold standard".

Conclusions: The outcome of this study suggests that the diagnostic performance of the CareStart G6PD deficiency RDT kit was high and it is acceptable at determining the G6PD deficiency status in a high malaria endemic area in Ghana. The RDT kit presents as an attractive tool for point-of-care G6PD deficiency for rapid testing in areas with high temperatures and less expertise. The CareStart G6PD deficiency RDT kit could be used to screen malaria patients before administration of the fixed dose primaquine with artemisinin-based combination therapy.

No MeSH data available.


Related in: MedlinePlus

ROC curve of RDT performance with plotted points of considered enzyme activity.
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pone.0125796.g004: ROC curve of RDT performance with plotted points of considered enzyme activity.

Mentions: G6PD deficiency RDT and Trinity Biotech quantitative: The SE and SP of CareStart G6PD deficiency RDT method were 100% and 72.1% using Trinity Biotech quantitative method as a gold standard. The ROC was 0.86 (Table 2). Considering the performance of the kit at (0.6, 1.1, 1.7, 2.2, 3.3, 4.4, and >4.4) Ug/Hb of G6PD enzyme activity, a ROC of 0.94 was obtained as presented in Fig 4. The sensitivity of the RDT kit was excellent at G6PD enzyme activity less than 8.0 Ug/Hb.


Evaluation of the diagnostic accuracy of CareStart G6PD deficiency Rapid Diagnostic Test (RDT) in a malaria endemic area in Ghana, Africa.

Adu-Gyasi D, Asante KP, Newton S, Dosoo D, Amoako S, Adjei G, Amoako N, Ankrah L, Tchum SK, Mahama E, Agyemang V, Kayan K, Owusu-Agyei S - PLoS ONE (2015)

ROC curve of RDT performance with plotted points of considered enzyme activity.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4401677&req=5

pone.0125796.g004: ROC curve of RDT performance with plotted points of considered enzyme activity.
Mentions: G6PD deficiency RDT and Trinity Biotech quantitative: The SE and SP of CareStart G6PD deficiency RDT method were 100% and 72.1% using Trinity Biotech quantitative method as a gold standard. The ROC was 0.86 (Table 2). Considering the performance of the kit at (0.6, 1.1, 1.7, 2.2, 3.3, 4.4, and >4.4) Ug/Hb of G6PD enzyme activity, a ROC of 0.94 was obtained as presented in Fig 4. The sensitivity of the RDT kit was excellent at G6PD enzyme activity less than 8.0 Ug/Hb.

Bottom Line: Data entry and analysis were done using Microsoft Access 2010 and Stata Software version 12.Kintampo Health Research Centre Institutional Ethics Committee granted ethical approval.Malaria infection status had no significant (P=0.199) change on the performance of the G6PD RDT test kit compared to the "gold standard".

View Article: PubMed Central - PubMed

Affiliation: Kintampo Health Research Centre, P O Box 200, Kintampo, Brong Ahafo, Ghana.

ABSTRACT

Background: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most widespread enzyme defect that can result in red cell breakdown under oxidative stress when exposed to certain medicines including antimalarials. We evaluated the diagnostic accuracy of CareStart G6PD deficiency Rapid Diagnostic Test (RDT) as a point-of-care tool for screening G6PD deficiency.

Methods: A cross-sectional study was conducted among 206 randomly selected and consented participants from a group with known G6PD deficiency status between February 2013 and June 2013. A maximum of 1.6ml of capillary blood samples were used for G6PD deficiency screening using CareStart G6PD RDT and Trinity qualitative with Trinity quantitative methods as the "gold standard". Samples were also screened for the presence of malaria parasites. Data entry and analysis were done using Microsoft Access 2010 and Stata Software version 12. Kintampo Health Research Centre Institutional Ethics Committee granted ethical approval.

Results: The sensitivity (SE) and specificity (SP) of CareStart G6PD deficiency RDT was 100% and 72.1% compared to Trinity quantitative method respectively and was 98.9% and 96.2% compared to Trinity qualitative method. Malaria infection status had no significant (P=0.199) change on the performance of the G6PD RDT test kit compared to the "gold standard".

Conclusions: The outcome of this study suggests that the diagnostic performance of the CareStart G6PD deficiency RDT kit was high and it is acceptable at determining the G6PD deficiency status in a high malaria endemic area in Ghana. The RDT kit presents as an attractive tool for point-of-care G6PD deficiency for rapid testing in areas with high temperatures and less expertise. The CareStart G6PD deficiency RDT kit could be used to screen malaria patients before administration of the fixed dose primaquine with artemisinin-based combination therapy.

No MeSH data available.


Related in: MedlinePlus