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

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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

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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",
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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.

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DO - 10.1371/journal.pone.0206331

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JF - PLoS One

SN - 1932-6203

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