Diagnostic accuracy of the Point-of-Care Standard G6PD test™ (SD Biosensor) for Glucose-6-phosphate dehydrogenase deficiency: a systematic review of the literature
Notice bibliographique
Résumé
Abstract Glucose-6-Phosphate Dehydrogenase deficiency (G6PDd) is a common genetic enzymopathy that can induce hemolysis triggered by various factors, including some anti-malarial drugs. Although many Point-of-Care (PoC) tests, such as STANDARD G6PD TM manufactured by SD biosensor (StandG6PD-BS), are available to detect G6PDd, its pooled diagnostic test accuracy (DTA) remains unknown. To estimate the DTA of StandG6PD-BS at various thresholds of G6PDd, we conducted a systematic review with a DTA meta-analysis, searching EMBASE, MEDLINE, and SciELO databases up to June 30, 2023. We included studies measuring G6PD activity using StandG6PD-BS (reference test) and spectrophotometry (gold standard) in patients suspected of having G6PDd. We assessed the risk of bias (RoB) of the studies using the QUADAS-2 tool and the certainty of evidence (CoE) with the GRADE approach. Our approach included the estimation of within-study DTA, a random-effect bivariate meta-analysis to determine the pooled sensitivity and specificity for 30%, 70%, and 80% enzyme levels’ thresholds, and a graphical analysis of the heterogeneity using crosshair and Confidence Regions on receiver operating characteristic (ROC) space plots. After screening 2,407 reports, we included four studies with 7,864 participants covering all thresholds. Two studies had high RoB in QUADAS-2 domains 2 and 3, and the others had low RoB. We also found low, moderate, and high heterogeneity at the 30%, 70%, and 80% thresholds, respectively. The pooled sensitivity was 99.1% (95%CI 96.9-99.7%, CoE: high), 95.7% (92.0-97.0%, high), and 90% (78.0-96.5%, low) for 30%, 70%, and 80% thresholds, respectively. The pooled specificity was 97.4% (95%CI 95.0; 98.4%, high); 92.9% (85.0-96.4%, high); and 89.0% (76.0-96.0%, moderate) for 30%, 70%, and 80% thresholds, respectively. In conclusion, StandG6PD-BS is a PoC test with high sensitivity and specificity to detect G6PDd at different thresholds. Author summary Glucose-6-Phosphate Dehydrogenase deficiency (G6PDd) is a common genetic disease that can induce the destruction of red blood cells leading to anemia triggered by various factors, including some drugs used for malaria treatment. After a literature search in different databases up to January 31, 2023, we pooled diagnostic test accuracy of the Point-of-Care (PoC) STANDARD G6PDTM test manufactured by SD biosensor (StandG6PD-BS) used to identify the G6PDd. Although two of the four studies included showed a high Risk of Bias related to the index test and the reference standard domains of the QUADAS-2 tool, the pooled sensitivity and specificity for 30%, 70%, and 80% enzyme levels’ thresholds were around 90%, with better sensitivity and specificity values for the 30% threshold (99.1% and 97.4%) compared with 70% (95.7% and 92.9%) and 80% (90% and 89%) threshold. We found low, moderate, and high heterogeneity at the 30%, 70%, and 80% thresholds. In conclusion, StandG6PD-BS is a PoC test with high sensitivity and specificity to detect G6PDd at different thresholds.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,017 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,002 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».