TY - JOUR
T1 - Performance of quantitative point-of-care tests to measure G6PD activity
T2 - An individual participant data meta-analysis
AU - Sadhewa, Arkasha
AU - Satyagraha, Ari Winasti
AU - Alam, Mohammad Shafiul
AU - Adissu, Wondimagegn
AU - Anvikar, Anup
AU - Bancone, Germana
AU - Bharti, Praveen K.
AU - Bhutani, Vinod K.
AU - Das, Santasabuj
AU - Hamid, Muzamil Mahdi Abdel
AU - Hossain, Mohammad Sharif
AU - Nitika, Nitika
AU - Okech, Bernard A.
AU - Panggalo, Lydia Visita
AU - Talukdar, Arunansu
AU - von Fricken, Michael E.
AU - Wong, Ronald J.
AU - Yilma, Daniel
AU - Price, Ric N.
AU - Thriemer, Kamala
AU - Ley, Benedikt
N1 - Publisher Copyright:
: © 2025 Sadhewa et al.
PY - 2025/3
Y1 - 2025/3
N2 - 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 spectropho-tometry. 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 thresh-olds. 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% thresh-olds, 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 thresh-olds. 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.
AB - 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 spectropho-tometry. 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 thresh-olds. 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% thresh-olds, 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 thresh-olds. 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.
UR - http://www.scopus.com/inward/record.url?scp=105002105455&partnerID=8YFLogxK
U2 - 10.1371/journal.pntd.0012864
DO - 10.1371/journal.pntd.0012864
M3 - Article
C2 - 40132008
AN - SCOPUS:105002105455
SN - 1935-2727
VL - 19
JO - PLoS Neglected Tropical Diseases
JF - PLoS Neglected Tropical Diseases
IS - 3
M1 - e0012864
ER -