Technical evaluation and usability of a quantitative G6PD POC test in cord blood: a mixed-methods study in a low-resource setting.
molecular biology
neonatology
paediatrics
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
13 12 2022
13 12 2022
Historique:
entrez:
16
12
2022
pubmed:
17
12
2022
medline:
20
12
2022
Statut:
epublish
Résumé
New point-of-care (POC) quantitative G6PD testing devices developed to provide safe radical cure for We conducted a mixed-methods study analysing technical performance and usability of the 'STANDARD G6PD' Biosensor when used by trained midwives on cord blood samples at two rural clinics on the Thailand-Myanmar border. In 307 cord blood samples, the Biosensor had a sensitivity of 1.000 (95% CI: 0.859 to 1.000) and a specificity of 0.993 (95% CI: 0.971 to 0.999) as compared with gold-standard spectrophotometry to diagnose G6PD-deficient newborns using a receiver operating characteristic (ROC) analysis-derived threshold of ≤4.8 IU/gHb. The Biosensor had a sensitivity of 0.727 (95% CI: 0.498 to 0.893) and specificity of 0.933 (95% CI: 0.876 to 0.969) for 30%-70% activity range in girls using ROC analysis-derived range of 4.9-9.9 IU/gHb. These thresholds allowed identification of all G6PD-deficient neonates and 80% of female neonates with intermediate phenotypes.Need of phototherapy treatment for neonatal hyperbilirubinaemia was higher in neonates with deficient and intermediate phenotypes as diagnosed by either reference spectrophotometry or Biosensor.Focus group discussions found high levels of learnability, willingness, satisfaction and suitability for the Biosensor in this setting. The staff valued the capacity of the Biosensor to identify newborns with G6PD deficiency early ('We can know that early, we can counsel the parents about the chances of their children getting jaundice') and at the POC, including in more rural settings ('Because we can know the right result of the G6PD deficiency in a short time, especially for the clinic which does not have a lab'). The Biosensor is a suitable tool in this resource-constrained setting to identify newborns with abnormal G6PD phenotypes at increased risk of neonatal hyperbilirubinaemia.
Identifiants
pubmed: 36523222
pii: bmjopen-2022-066529
doi: 10.1136/bmjopen-2022-066529
pmc: PMC9748916
doi:
Substances chimiques
Sodium Oxybate
7G33012534
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e066529Subventions
Organisme : Wellcome Trust
ID : 220211
Pays : United Kingdom
Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Am J Trop Med Hyg. 2019 Jan;100(1):213-221
pubmed: 30350771
Pediatr Res. 2013 Dec;74 Suppl 1:86-100
pubmed: 24366465
J Pediatr. 2014 Jun;164(6):1416-20
pubmed: 24679610
J Pediatr. 2001 Jul;139(1):137-40
pubmed: 11445808
Nature. 1956 Jan 28;177(4500):190-1
pubmed: 13297010
J Perinatol. 2010 Oct;30 Suppl:S6-15
pubmed: 20877410
Wellcome Open Res. 2020 Feb 7;5:21
pubmed: 32766454
Lancet. 2008 Jan 5;371(9606):64-74
pubmed: 18177777
PLoS Med. 2012;9(11):e1001339
pubmed: 23152723
PLoS Negl Trop Dis. 2021 Aug 12;15(8):e0009649
pubmed: 34383774
J Perinatol. 2013 Jul;33(7):499-504
pubmed: 23429543
Semin Perinatol. 2021 Feb;45(1):151356
pubmed: 33293060
Malar J. 2021 May 12;20(1):217
pubmed: 33980257
PLoS One. 2018 Nov 2;13(11):e0206331
pubmed: 30388146
Pediatrics. 1992 Sep;90(3):401-5
pubmed: 1518696
Lancet. 1986 Feb 8;1(8476):307-10
pubmed: 2868172
Neonatal Netw. 2020 Aug 1;39(5):270-282
pubmed: 32879043
J Proteome Res. 2017 Apr 7;16(4):1492-1505
pubmed: 28166632
Implement Sci. 2012 Jan 23;7:5
pubmed: 22269037
Wellcome Open Res. 2018 Jan 2;3:1
pubmed: 29552643
Clin Pediatr (Phila). 2015 Jun;54(6):575-8
pubmed: 25385930
Indian Pediatr. 2011 Apr;48(4):277-87
pubmed: 21532099
Malar J. 2021 Jul 8;20(1):307
pubmed: 34238299
J Matern Fetal Neonatal Med. 2022 Dec;35(25):5745-5753
pubmed: 33627013
Lancet Child Adolesc Health. 2018 Aug;2(8):610-620
pubmed: 30119720
PLoS One. 2021 Sep 20;16(9):e0257560
pubmed: 34543346
PLoS One. 2021 Oct 7;16(10):e0258127
pubmed: 34618852
Pediatr Rev. 2011 Aug;32(8):341-9
pubmed: 21807875
Pediatr Hematol Oncol. 2014 Feb;31(1):95-100
pubmed: 24483842
Wellcome Open Res. 2017 Nov 2;2:72
pubmed: 29181452
BMJ Paediatr Open. 2020 Sep 24;4(1):e000750
pubmed: 33024835
Bull World Health Organ. 1989;67(6):601-11
pubmed: 2633878
PLoS One. 2014 Dec 23;9(12):e116063
pubmed: 25536053
Br J Haematol. 1983 Feb;53(2):241-6
pubmed: 6821654
PLoS One. 2013 Aug 22;8(8):e72721
pubmed: 23991145
PLoS One. 2016 Mar 24;11(3):e0151898
pubmed: 27010542
Scand J Clin Lab Invest. 2014 Apr;74(3):259-63
pubmed: 24460025