Comparison of three screening test kits for G6PD enzyme deficiency

Implications for its use in the radical cure of vivax malaria in remote and resource-poor areas in the philippines

F Espino, JA Bibit, JB Sornillo, A Tan, Lorenz von Seidlein,, Benedikt Ley

    Research output: Contribution to journalArticleResearchpeer-review

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    Abstract

    Objective: We evaluated a battery of Glucose-6-Phosphate Dehydrogenase diagnostic point-of-care tests (PoC) to assess the most suitable product in terms of performance and operational characteristics for remote areas.

    Methods: Samples were collected in Puerto Princesa City, Palawan, Philippines and tested for G6PD deficiency with a fluorescent spot test (FST; Procedure 203, Trinity Biotech, Ireland), the semiquantitative WST8/1-methoxy PMS (WST; Dojindo, Japan) and the Carestart G6PD Rapid Diagnostic Test (CSG; AccessBio, USA). Results were compared to spectrophotometry (Procedure 345, Trinity Biotech, Ireland). Sensitivity and specificity were calculated for each test with cut-off activities of 10%, 20%, 30% and 60% of the adjusted male median.

    Results: The adjusted male median was 270.5 IU/1012 RBC. FST and WST were tested on 621 capillary blood samples, the CSG was tested on venous and capillary blood on 302 samples. At 30% G6PD activity, sensitivity for the FST was between 87.7% (95%CI: 76.8% to 93.9%) and 96.5% (95%CI: 87.9% to 99.5%) depending on definition of intermediate results; the WST was 84.2% (95%CI: 72.1% to 92.5%); and the CSG was between 68.8% (95%CI: 41.3% to 89.0%) and 93.8% (95%CI: 69.8% to 99.8%) when the test was performed on capillary or venous blood respectively. Sensitivity of FST and CSG (tested with venous blood) were comparable (p>0.05). The analysis of venous blood samples by the CSG yielded significantly higher results than FST and CSG performed on capillary blood (p<0.05). Sensitivity of the CSG varied depending on source of blood used (p<0.05).

    Conclusion:
    The operational characteristics of the CSG were superior to all other test formats. Performance and operational characteristics of the CSG performed on venous blood suggest the test to be a good alternative to the FST.
    Original languageEnglish
    Article numbere014817
    Pages (from-to)1-12
    Number of pages12
    JournalPLoS One
    Volume11
    Issue number2
    DOIs
    Publication statusPublished - 2016

    Fingerprint

    enzyme deficiencies
    Vivax Malaria
    Glucosephosphate Dehydrogenase Deficiency
    Philippines
    analytical kits
    glucose-6-phosphate 1-dehydrogenase
    malaria
    Screening
    Blood
    blood capillaries
    screening
    Enzymes
    blood
    Ireland
    testing
    sampling
    hematologic tests
    Point-of-Care Systems
    diagnostic techniques
    spectroscopy

    Cite this

    @article{83e96ae4356b4c7ba9c2baea317711bc,
    title = "Comparison of three screening test kits for G6PD enzyme deficiency: Implications for its use in the radical cure of vivax malaria in remote and resource-poor areas in the philippines",
    abstract = "Objective: We evaluated a battery of Glucose-6-Phosphate Dehydrogenase diagnostic point-of-care tests (PoC) to assess the most suitable product in terms of performance and operational characteristics for remote areas. Methods: Samples were collected in Puerto Princesa City, Palawan, Philippines and tested for G6PD deficiency with a fluorescent spot test (FST; Procedure 203, Trinity Biotech, Ireland), the semiquantitative WST8/1-methoxy PMS (WST; Dojindo, Japan) and the Carestart G6PD Rapid Diagnostic Test (CSG; AccessBio, USA). Results were compared to spectrophotometry (Procedure 345, Trinity Biotech, Ireland). Sensitivity and specificity were calculated for each test with cut-off activities of 10{\%}, 20{\%}, 30{\%} and 60{\%} of the adjusted male median. Results: The adjusted male median was 270.5 IU/1012 RBC. FST and WST were tested on 621 capillary blood samples, the CSG was tested on venous and capillary blood on 302 samples. At 30{\%} G6PD activity, sensitivity for the FST was between 87.7{\%} (95{\%}CI: 76.8{\%} to 93.9{\%}) and 96.5{\%} (95{\%}CI: 87.9{\%} to 99.5{\%}) depending on definition of intermediate results; the WST was 84.2{\%} (95{\%}CI: 72.1{\%} to 92.5{\%}); and the CSG was between 68.8{\%} (95{\%}CI: 41.3{\%} to 89.0{\%}) and 93.8{\%} (95{\%}CI: 69.8{\%} to 99.8{\%}) when the test was performed on capillary or venous blood respectively. Sensitivity of FST and CSG (tested with venous blood) were comparable (p>0.05). The analysis of venous blood samples by the CSG yielded significantly higher results than FST and CSG performed on capillary blood (p<0.05). Sensitivity of the CSG varied depending on source of blood used (p<0.05). Conclusion: The operational characteristics of the CSG were superior to all other test formats. Performance and operational characteristics of the CSG performed on venous blood suggest the test to be a good alternative to the FST.",
    author = "F Espino and JA Bibit and JB Sornillo and A Tan and {von Seidlein,}, Lorenz and Benedikt Ley",
    year = "2016",
    doi = "10.1371/journal.pone.0148172",
    language = "English",
    volume = "11",
    pages = "1--12",
    journal = "PLoS One",
    issn = "1932-6203",
    publisher = "Public Library of Science (PLoS)",
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    }

    Comparison of three screening test kits for G6PD enzyme deficiency : Implications for its use in the radical cure of vivax malaria in remote and resource-poor areas in the philippines. / Espino, F; Bibit, JA; Sornillo, JB; Tan, A; von Seidlein, Lorenz; Ley, Benedikt.

    In: PLoS One, Vol. 11, No. 2, e014817, 2016, p. 1-12.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Comparison of three screening test kits for G6PD enzyme deficiency

    T2 - Implications for its use in the radical cure of vivax malaria in remote and resource-poor areas in the philippines

    AU - Espino, F

    AU - Bibit, JA

    AU - Sornillo, JB

    AU - Tan, A

    AU - von Seidlein,, Lorenz

    AU - Ley, Benedikt

    PY - 2016

    Y1 - 2016

    N2 - Objective: We evaluated a battery of Glucose-6-Phosphate Dehydrogenase diagnostic point-of-care tests (PoC) to assess the most suitable product in terms of performance and operational characteristics for remote areas. Methods: Samples were collected in Puerto Princesa City, Palawan, Philippines and tested for G6PD deficiency with a fluorescent spot test (FST; Procedure 203, Trinity Biotech, Ireland), the semiquantitative WST8/1-methoxy PMS (WST; Dojindo, Japan) and the Carestart G6PD Rapid Diagnostic Test (CSG; AccessBio, USA). Results were compared to spectrophotometry (Procedure 345, Trinity Biotech, Ireland). Sensitivity and specificity were calculated for each test with cut-off activities of 10%, 20%, 30% and 60% of the adjusted male median. Results: The adjusted male median was 270.5 IU/1012 RBC. FST and WST were tested on 621 capillary blood samples, the CSG was tested on venous and capillary blood on 302 samples. At 30% G6PD activity, sensitivity for the FST was between 87.7% (95%CI: 76.8% to 93.9%) and 96.5% (95%CI: 87.9% to 99.5%) depending on definition of intermediate results; the WST was 84.2% (95%CI: 72.1% to 92.5%); and the CSG was between 68.8% (95%CI: 41.3% to 89.0%) and 93.8% (95%CI: 69.8% to 99.8%) when the test was performed on capillary or venous blood respectively. Sensitivity of FST and CSG (tested with venous blood) were comparable (p>0.05). The analysis of venous blood samples by the CSG yielded significantly higher results than FST and CSG performed on capillary blood (p<0.05). Sensitivity of the CSG varied depending on source of blood used (p<0.05). Conclusion: The operational characteristics of the CSG were superior to all other test formats. Performance and operational characteristics of the CSG performed on venous blood suggest the test to be a good alternative to the FST.

    AB - Objective: We evaluated a battery of Glucose-6-Phosphate Dehydrogenase diagnostic point-of-care tests (PoC) to assess the most suitable product in terms of performance and operational characteristics for remote areas. Methods: Samples were collected in Puerto Princesa City, Palawan, Philippines and tested for G6PD deficiency with a fluorescent spot test (FST; Procedure 203, Trinity Biotech, Ireland), the semiquantitative WST8/1-methoxy PMS (WST; Dojindo, Japan) and the Carestart G6PD Rapid Diagnostic Test (CSG; AccessBio, USA). Results were compared to spectrophotometry (Procedure 345, Trinity Biotech, Ireland). Sensitivity and specificity were calculated for each test with cut-off activities of 10%, 20%, 30% and 60% of the adjusted male median. Results: The adjusted male median was 270.5 IU/1012 RBC. FST and WST were tested on 621 capillary blood samples, the CSG was tested on venous and capillary blood on 302 samples. At 30% G6PD activity, sensitivity for the FST was between 87.7% (95%CI: 76.8% to 93.9%) and 96.5% (95%CI: 87.9% to 99.5%) depending on definition of intermediate results; the WST was 84.2% (95%CI: 72.1% to 92.5%); and the CSG was between 68.8% (95%CI: 41.3% to 89.0%) and 93.8% (95%CI: 69.8% to 99.8%) when the test was performed on capillary or venous blood respectively. Sensitivity of FST and CSG (tested with venous blood) were comparable (p>0.05). The analysis of venous blood samples by the CSG yielded significantly higher results than FST and CSG performed on capillary blood (p<0.05). Sensitivity of the CSG varied depending on source of blood used (p<0.05). Conclusion: The operational characteristics of the CSG were superior to all other test formats. Performance and operational characteristics of the CSG performed on venous blood suggest the test to be a good alternative to the FST.

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