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Meta-Analysis
. 2025 Mar 25;19(3):e0012864.
doi: 10.1371/journal.pntd.0012864. eCollection 2025 Mar.

Performance of quantitative point-of-care tests to measure G6PD activity: An individual participant data meta-analysis

Arkasha Sadhewa  1 , Ari Winasti Satyagraha  2 , Mohammad Shafiul Alam  3 , Wondimagegn Adissu  4   5 , Anup Anvikar  6 , Germana Bancone  7   8 , Praveen K Bharti  6 , Vinod K Bhutani  9 , Santasabuj Das  10 , Muzamil Mahdi Abdel Hamid  11 , Mohammad Sharif Hossain  5 , Nitika Nitika  6 , Bernard A Okech  12 , Lydia Visita Panggalo  13 , Arunansu Talukdar  14 , Michael E von Fricken  15   16 , Ronald J Wong  9 , Daniel Yilma  4   17 , Ric N Price  1   8   18 , Kamala Thriemer  1 , Benedikt Ley  1   19
Affiliations
Meta-Analysis

Performance of quantitative point-of-care tests to measure G6PD activity: An individual participant data meta-analysis

Arkasha Sadhewa et al. PLoS Negl Trop Dis. .

Abstract

Background: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the main risk factor for severe haemolysis following treatment with 8-aminoquinolines (8AQ). The World Health Organization recommends G6PD testing prior to 8AQ-based hypnozoitocidal treatment.

Methods: We undertook an individual level meta-analysis of the performance of commercially available quantitative point-of-care diagnostics (PoCs) compared with reference spectrophotometry. A systematic literature search (PROSPERO: CRD42022330733) identified 595 articles of which 16 (2.7%) fulfilled pre-defined inclusion criteria and were included in the analysis, plus an additional 4 datasets. In total there were 12,678 paired measurements analyzed, 10,446 (82.4%) by STANDARD G6PD Test (SD Biosensor, RoK, [SDB]), 2,042 (16.1%) by CareStart G6PD Biosensor (AccessBio, USA, [CSA]), 150 (1.2%) by CareStart Biosensor (WellsBio, RoK [CSW]), and 40 (0.3%) by FINDER (Baebies, USA, [FBA]).

Findings: The pooled sensitivities of the SDB when measuring G6PD activity <30% of normal were 0.82 (95% confidence interval [CI]: 0.72-0.89) for capillary and 0.93 (95% CI: 0.75-0.99) for venous blood samples. The corresponding values for measuring <70% G6PD activity were 0.93 (95% CI: 0.67-0.99) and 0.89 (95% CI: 0.73-0.96), respectively. The pooled specificity of the SDB was high (>96%) for all blood samples and G6PD activity thresholds. Irrespective of the blood samples and thresholds applied, sensitivity of the CSA did not exceed 62%, although specificity remained high at both 30% and 70% thresholds (>88%). Only one study each for CSW and FBA was included. Sensitivities of the CSW were 0.04 (95% CI: 0.01-0.14) and 0.81 (95% CI: 0.71-0.89) at the 30% and 70% thresholds, respectively (venous blood samples). Sensitivities of the FBA were 1.00 (95% CI: 0.29-1.00) and 0.75 (95% CI: 0.19-0.99) at the 30% and 70% thresholds (venous blood samples). Specificities of the CSW and FBA were consistently high (>90%) at both thresholds. Accuracy of the SDB was higher in females at the 30% cut-off (OR: 3.49, p=0.002) and lower in malaria patients at the 70% cut-off (OR: 0.59, p = 0.005).

Conclusions: The SDB performed better than other PoCs. More evidence was available for the performance of the SDB compared to other PoCs, giving higher confidence in its utility in diagnosing G6PD deficiency.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flow chart on the systematic search and screening for articles to be included in this meta-analysis.
Fig 2
Fig 2. Forest plots of the performance of the SDB at the 30% threshold.
The plots were stratified by blood source: sensitivity (top left) and specificity (top right) for studies using capillary blood samples, and sensitivity (bottom left) and specificity (bottom right) for studies using venous blood samples. StudyId identified the first author, country, and year of publication. The sensitivity of the venous blood samples from Sadhewa et al [42] were excluded as no G6PD-deficient participants (positive results) were detected by the reference method.
Fig 3
Fig 3. Forest plots of the performance of the SDB at the 70% threshold.
The plots were stratified by blood source: sensitivity (top left) and specificity (top right) for studies using capillary blood samples, and sensitivity (bottom left) and specificity (bottom right) for studies using venous blood samples. StudyId identified the first author, country, and year of publication.
Fig 4
Fig 4. Bland-Altman plot of G6PD activity readings from SDB against reference spectrophotometry.
From studies using capillary (left) and venous (right) blood samples. Black dashed line indicates mean difference, grey shaded area indicates 95% limits of agreement (LoA).
Fig 5
Fig 5. Bland-Altman plot of G6PD activity readings from CSA against reference spectrophotometry.
From studies using capillary (left) and venous (right) blood samples. Black dashed line indicates mean difference, grey shaded area indicates 95% limits of agreement (LoA).
Fig 6
Fig 6. Bland-Altman plot of G6PD activity readings from CSW and FBA against reference spectrophotometry.
From studies evaluating the CSW (left) and FBA (right). Black dashed line indicates mean difference, grey shaded area indicates 95% limits of agreement (LoA).
Fig 7
Fig 7. Qualitative assessment of articles and datasets included [
–,,–37,41,42] in this meta-analysis. Modified from the QUADAS-2 (quality assessment tool for diagnostic accuracy studies) tool [26].
See this image and copyright information in PMC

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