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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

CareStart G6PD RDT screening kit with results interpretation.Results of kit labelled with NORMAL and DEFICIENT interpretation.
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pone.0125796.g003: CareStart G6PD RDT screening kit with results interpretation.Results of kit labelled with NORMAL and DEFICIENT interpretation.

Mentions: Using CareStart G6PD deficiency screening test: The CareStart G6PD deficiency RDT format test, which is a qualitative enzyme chromatographic test is based on the reduction of colourless nitro blue tetrazolium dye to dark coloured formazan. The test kit requires minimal training and no special expertise or additional equipment for use. Two microliters (2μl) of blood added into the sample well with two drops of buffer into the buffer well gave the G6PD deficiency status of an individual in 10 minutes. Samples with normal G6PD activity produce a distinct purple colour background in the result window while no colour change was observed for samples with deficient G6PD activity (Fig 3). Samples that produced a pale purple colour giving ambiguous CareStart test results were for safety reasons called deficient, which would be the norm in a clinical setting. This could result in a decrease in specificity. The performance of CareStart G6PD deficiency RDT screening kit was stable in a temperature of 20°C to 32°C (was verified over a two-day period with Libero Ti1 digital thermometer. Data not shown) (Table 1).


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)

CareStart G6PD RDT screening kit with results interpretation.Results of kit labelled with NORMAL and DEFICIENT interpretation.
© Copyright Policy
Related In: Results  -  Collection

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

pone.0125796.g003: CareStart G6PD RDT screening kit with results interpretation.Results of kit labelled with NORMAL and DEFICIENT interpretation.
Mentions: Using CareStart G6PD deficiency screening test: The CareStart G6PD deficiency RDT format test, which is a qualitative enzyme chromatographic test is based on the reduction of colourless nitro blue tetrazolium dye to dark coloured formazan. The test kit requires minimal training and no special expertise or additional equipment for use. Two microliters (2μl) of blood added into the sample well with two drops of buffer into the buffer well gave the G6PD deficiency status of an individual in 10 minutes. Samples with normal G6PD activity produce a distinct purple colour background in the result window while no colour change was observed for samples with deficient G6PD activity (Fig 3). Samples that produced a pale purple colour giving ambiguous CareStart test results were for safety reasons called deficient, which would be the norm in a clinical setting. This could result in a decrease in specificity. The performance of CareStart G6PD deficiency RDT screening kit was stable in a temperature of 20°C to 32°C (was verified over a two-day period with Libero Ti1 digital thermometer. Data not shown) (Table 1).

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