Field evaluation of quantitative point of care diagnostics to measure glucose-6-phosphate dehydrogenase activity

M. S. Alam, M. G. Kibria, N. Jahan, K. Thriemer, M. S. Hossain, N. M. Douglas, C. S. Phru, W. A. Khan, R. N. Price, B. Ley

    Research output: Contribution to journalArticleResearchpeer-review

    12 Downloads (Pure)

    Abstract

    Background: Glucose-6-Phosphate dehydrogenase (G6PD) deficiency is the most common enzymopathy worldwide, no reliable bedside diagnostic tests to quantify G6PD activity exist. This study evaluated two novel quantitative G6PD diagnostics.


    Methods: Participants with known G6PD activity were enrolled in Bangladesh. G6PD activity was measured by spectrophotometry, Biosensor (BS; AccessBio/CareStart, USA) and STANDARD G6PD (SG; SDBiosensor, ROK). G6PD activity was measured repeatedly in a subset of samples stored at room temperature and 4°C.


    Results: 158 participants were enrolled, 152 samples tested by BS, 108 samples by SG and 102 samples were tested by all three methods. In comparison to spectrophotometry BS had sensitivity and specificity of 72% (95%CI: 53–86) and 100% (95%CI: 97–100) at 30% cut off respectively, while SG had a sensitivity of 100% (95%CI: 88–100) and specificity of 97% (95%CI: 91–99) at the same cut off. The sensitivity and specificity at 70% cut off activity were 71% (95%CI: 59–82) and 98% (95%CI, 92–100) respectively for BS and 89% (95%CI: 77–96) and 93% (95%CI: 83–98) respectively for SG. When an optimal cut-off was applied the sensitivity of the BS at 70 cut off rose to 91% [95%CI: 80–96] and specificity to 82% [95%CI: 83–89]; a diagnostic accuracy comparable to that of the SG (p = 0.879). G6PD activity dropped significantly (-0.31U/gHb, 95%CI: -0.61 to -0.01, p = 0.022) within 24 hours in samples stored at room temperature, but did not fall below 90% of baseline activity until day 13 (-0.87U/gHb, 95%CI: (-1.11 to -0.62), p<0.001).


    Conclusion: BS and SG are the first quantitative diagnostics to measure G6PD activity reliably at the bedside and represent suitable alternatives to spectrophotometry in resource poor settings. If samples are stored at 4°C, G6PD activity can be measured reliably for at least 7 days after sample collection.

    Original languageEnglish
    Article numbere0206331
    Pages (from-to)1-13
    Number of pages13
    JournalPLoS One
    Volume13
    Issue number11
    DOIs
    Publication statusPublished - 2 Nov 2018

    Fingerprint

    Point-of-Care Systems
    Glucosephosphate Dehydrogenase
    glucose-6-phosphate 1-dehydrogenase
    Spectrophotometry
    spectroscopy
    sampling
    Glucosephosphate Dehydrogenase Deficiency
    Sensitivity and Specificity
    Biosensing Techniques
    biosensors
    Routine Diagnostic Tests
    Biosensors
    diagnostic techniques
    Rosa

    Cite this

    Alam, M. S. ; Kibria, M. G. ; Jahan, N. ; Thriemer, K. ; Hossain, M. S. ; Douglas, N. M. ; Phru, C. S. ; Khan, W. A. ; Price, R. N. ; Ley, B. / Field evaluation of quantitative point of care diagnostics to measure glucose-6-phosphate dehydrogenase activity. In: PLoS One. 2018 ; Vol. 13, No. 11. pp. 1-13.
    @article{7abb34c64e94481eb2395ca1d7b3e4fd,
    title = "Field evaluation of quantitative point of care diagnostics to measure glucose-6-phosphate dehydrogenase activity",
    abstract = "Background: Glucose-6-Phosphate dehydrogenase (G6PD) deficiency is the most common enzymopathy worldwide, no reliable bedside diagnostic tests to quantify G6PD activity exist. This study evaluated two novel quantitative G6PD diagnostics. Methods: Participants with known G6PD activity were enrolled in Bangladesh. G6PD activity was measured by spectrophotometry, Biosensor (BS; AccessBio/CareStart, USA) and STANDARD G6PD (SG; SDBiosensor, ROK). G6PD activity was measured repeatedly in a subset of samples stored at room temperature and 4°C. Results: 158 participants were enrolled, 152 samples tested by BS, 108 samples by SG and 102 samples were tested by all three methods. In comparison to spectrophotometry BS had sensitivity and specificity of 72{\%} (95{\%}CI: 53–86) and 100{\%} (95{\%}CI: 97–100) at 30{\%} cut off respectively, while SG had a sensitivity of 100{\%} (95{\%}CI: 88–100) and specificity of 97{\%} (95{\%}CI: 91–99) at the same cut off. The sensitivity and specificity at 70{\%} cut off activity were 71{\%} (95{\%}CI: 59–82) and 98{\%} (95{\%}CI, 92–100) respectively for BS and 89{\%} (95{\%}CI: 77–96) and 93{\%} (95{\%}CI: 83–98) respectively for SG. When an optimal cut-off was applied the sensitivity of the BS at 70 cut off rose to 91{\%} [95{\%}CI: 80–96] and specificity to 82{\%} [95{\%}CI: 83–89]; a diagnostic accuracy comparable to that of the SG (p = 0.879). G6PD activity dropped significantly (-0.31U/gHb, 95{\%}CI: -0.61 to -0.01, p = 0.022) within 24 hours in samples stored at room temperature, but did not fall below 90{\%} of baseline activity until day 13 (-0.87U/gHb, 95{\%}CI: (-1.11 to -0.62), p<0.001). Conclusion: BS and SG are the first quantitative diagnostics to measure G6PD activity reliably at the bedside and represent suitable alternatives to spectrophotometry in resource poor settings. If samples are stored at 4°C, G6PD activity can be measured reliably for at least 7 days after sample collection.",
    author = "Alam, {M. S.} and Kibria, {M. G.} and N. Jahan and K. Thriemer and Hossain, {M. S.} and Douglas, {N. M.} and Phru, {C. S.} and Khan, {W. A.} and Price, {R. N.} and B. Ley",
    year = "2018",
    month = "11",
    day = "2",
    doi = "10.1371/journal.pone.0206331",
    language = "English",
    volume = "13",
    pages = "1--13",
    journal = "PLoS One",
    issn = "1932-6203",
    publisher = "Public Library of Science (PLoS)",
    number = "11",

    }

    Field evaluation of quantitative point of care diagnostics to measure glucose-6-phosphate dehydrogenase activity. / Alam, M. S.; Kibria, M. G.; Jahan, N.; Thriemer, K.; Hossain, M. S.; Douglas, N. M.; Phru, C. S.; Khan, W. A.; Price, R. N.; Ley, B.

    In: PLoS One, Vol. 13, No. 11, e0206331, 02.11.2018, p. 1-13.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Field evaluation of quantitative point of care diagnostics to measure glucose-6-phosphate dehydrogenase activity

    AU - Alam, M. S.

    AU - Kibria, M. G.

    AU - Jahan, N.

    AU - Thriemer, K.

    AU - Hossain, M. S.

    AU - Douglas, N. M.

    AU - Phru, C. S.

    AU - Khan, W. A.

    AU - Price, R. N.

    AU - Ley, B.

    PY - 2018/11/2

    Y1 - 2018/11/2

    N2 - Background: Glucose-6-Phosphate dehydrogenase (G6PD) deficiency is the most common enzymopathy worldwide, no reliable bedside diagnostic tests to quantify G6PD activity exist. This study evaluated two novel quantitative G6PD diagnostics. Methods: Participants with known G6PD activity were enrolled in Bangladesh. G6PD activity was measured by spectrophotometry, Biosensor (BS; AccessBio/CareStart, USA) and STANDARD G6PD (SG; SDBiosensor, ROK). G6PD activity was measured repeatedly in a subset of samples stored at room temperature and 4°C. Results: 158 participants were enrolled, 152 samples tested by BS, 108 samples by SG and 102 samples were tested by all three methods. In comparison to spectrophotometry BS had sensitivity and specificity of 72% (95%CI: 53–86) and 100% (95%CI: 97–100) at 30% cut off respectively, while SG had a sensitivity of 100% (95%CI: 88–100) and specificity of 97% (95%CI: 91–99) at the same cut off. The sensitivity and specificity at 70% cut off activity were 71% (95%CI: 59–82) and 98% (95%CI, 92–100) respectively for BS and 89% (95%CI: 77–96) and 93% (95%CI: 83–98) respectively for SG. When an optimal cut-off was applied the sensitivity of the BS at 70 cut off rose to 91% [95%CI: 80–96] and specificity to 82% [95%CI: 83–89]; a diagnostic accuracy comparable to that of the SG (p = 0.879). G6PD activity dropped significantly (-0.31U/gHb, 95%CI: -0.61 to -0.01, p = 0.022) within 24 hours in samples stored at room temperature, but did not fall below 90% of baseline activity until day 13 (-0.87U/gHb, 95%CI: (-1.11 to -0.62), p<0.001). Conclusion: BS and SG are the first quantitative diagnostics to measure G6PD activity reliably at the bedside and represent suitable alternatives to spectrophotometry in resource poor settings. If samples are stored at 4°C, G6PD activity can be measured reliably for at least 7 days after sample collection.

    AB - Background: Glucose-6-Phosphate dehydrogenase (G6PD) deficiency is the most common enzymopathy worldwide, no reliable bedside diagnostic tests to quantify G6PD activity exist. This study evaluated two novel quantitative G6PD diagnostics. Methods: Participants with known G6PD activity were enrolled in Bangladesh. G6PD activity was measured by spectrophotometry, Biosensor (BS; AccessBio/CareStart, USA) and STANDARD G6PD (SG; SDBiosensor, ROK). G6PD activity was measured repeatedly in a subset of samples stored at room temperature and 4°C. Results: 158 participants were enrolled, 152 samples tested by BS, 108 samples by SG and 102 samples were tested by all three methods. In comparison to spectrophotometry BS had sensitivity and specificity of 72% (95%CI: 53–86) and 100% (95%CI: 97–100) at 30% cut off respectively, while SG had a sensitivity of 100% (95%CI: 88–100) and specificity of 97% (95%CI: 91–99) at the same cut off. The sensitivity and specificity at 70% cut off activity were 71% (95%CI: 59–82) and 98% (95%CI, 92–100) respectively for BS and 89% (95%CI: 77–96) and 93% (95%CI: 83–98) respectively for SG. When an optimal cut-off was applied the sensitivity of the BS at 70 cut off rose to 91% [95%CI: 80–96] and specificity to 82% [95%CI: 83–89]; a diagnostic accuracy comparable to that of the SG (p = 0.879). G6PD activity dropped significantly (-0.31U/gHb, 95%CI: -0.61 to -0.01, p = 0.022) within 24 hours in samples stored at room temperature, but did not fall below 90% of baseline activity until day 13 (-0.87U/gHb, 95%CI: (-1.11 to -0.62), p<0.001). Conclusion: BS and SG are the first quantitative diagnostics to measure G6PD activity reliably at the bedside and represent suitable alternatives to spectrophotometry in resource poor settings. If samples are stored at 4°C, G6PD activity can be measured reliably for at least 7 days after sample collection.

    UR - http://www.scopus.com/inward/record.url?scp=85056072631&partnerID=8YFLogxK

    U2 - 10.1371/journal.pone.0206331

    DO - 10.1371/journal.pone.0206331

    M3 - Article

    VL - 13

    SP - 1

    EP - 13

    JO - PLoS One

    JF - PLoS One

    SN - 1932-6203

    IS - 11

    M1 - e0206331

    ER -