Point-of-care CD4 technology invalid result rates in public health care settings across five countries.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2019
2019
Historique:
received:
12
04
2019
accepted:
14
06
2019
entrez:
6
7
2019
pubmed:
6
7
2019
medline:
23
2
2020
Statut:
epublish
Résumé
Since 2010, point-of-care (POC) CD4 testing platforms have been introduced in both urban and rural settings to expand access to testing by bringing diagnostic services closer to patients. We conducted an analysis of routinely collected CD4 testing data to determine the invalid result rates associated with POC CD4 testing. We analyzed 981,152 CD4 testing records collected from Alere Pima Analyzers between January 2011 and December 2016 across five countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to determine the rate of invalid test results per month, by facility type, and by operator based on cumulative usage during the study period. In addition, frequency of invalid test types and utilization of control beads were assessed. Across the five countries, 75,530 invalid messages were returned, resulting in an overall invalid result rate of 7.7%. The invalid result rate by country ranged from 6.6% to 11.2%. Invalid result rates were consistent across facility types. Invalid result rates were inversely correlated with operator usage: low volume operators (<50 tests over study period) experienced an invalid result rate of 10.2%, while high volume operators (>500 tests over study period) experienced an invalid result rate of 5.5%. Two invalid result types (exposure position control and reagent control) accounted for nearly 50% of invalid results. Routine data showed that control beads were run on 88.3% of days that the device was used. Our analysis found that the rate of invalid results was consistent across all types of health facilities, indicating that decentralization of POC CD4 testing to lower level health facilities did not exhibit high invalid result rates or increase cartridge wastage. Additionally, invalid result rates were inversely correlated to operator usage, with high-volume operators experiencing lower invalid result rates than low-volume operators. POC CD4 testing can, therefore, be performed in decentralized national testing programs; however, adequate training, quality assurance, routine monitoring, and ongoing mentorship should also be implemented for success.
Sections du résumé
BACKGROUND
Since 2010, point-of-care (POC) CD4 testing platforms have been introduced in both urban and rural settings to expand access to testing by bringing diagnostic services closer to patients. We conducted an analysis of routinely collected CD4 testing data to determine the invalid result rates associated with POC CD4 testing.
METHODS
We analyzed 981,152 CD4 testing records collected from Alere Pima Analyzers between January 2011 and December 2016 across five countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to determine the rate of invalid test results per month, by facility type, and by operator based on cumulative usage during the study period. In addition, frequency of invalid test types and utilization of control beads were assessed.
RESULTS
Across the five countries, 75,530 invalid messages were returned, resulting in an overall invalid result rate of 7.7%. The invalid result rate by country ranged from 6.6% to 11.2%. Invalid result rates were consistent across facility types. Invalid result rates were inversely correlated with operator usage: low volume operators (<50 tests over study period) experienced an invalid result rate of 10.2%, while high volume operators (>500 tests over study period) experienced an invalid result rate of 5.5%. Two invalid result types (exposure position control and reagent control) accounted for nearly 50% of invalid results. Routine data showed that control beads were run on 88.3% of days that the device was used.
CONCLUSIONS
Our analysis found that the rate of invalid results was consistent across all types of health facilities, indicating that decentralization of POC CD4 testing to lower level health facilities did not exhibit high invalid result rates or increase cartridge wastage. Additionally, invalid result rates were inversely correlated to operator usage, with high-volume operators experiencing lower invalid result rates than low-volume operators. POC CD4 testing can, therefore, be performed in decentralized national testing programs; however, adequate training, quality assurance, routine monitoring, and ongoing mentorship should also be implemented for success.
Identifiants
pubmed: 31276477
doi: 10.1371/journal.pone.0219021
pii: PONE-D-19-10541
pmc: PMC6611583
doi:
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0219021Subventions
Organisme : NIAID NIH HHS
ID : R01 AI122991
Pays : United States
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
Références
Lancet. 2011 Oct 29;378(9802):1572-9
pubmed: 21951656
S Afr Med J. 2020 Jan 29;110(2):126-131
pubmed: 32657683
Bull World Health Organ. 2015 Sep 1;93(9):623-30
pubmed: 26478626
AIDS Res Ther. 2012 Sep 21;9(1):26
pubmed: 22998738
PLoS One. 2016 May 13;11(5):e0155256
pubmed: 27175484
Clin Infect Dis. 2018 Mar 5;66(6):893-903
pubmed: 29373672
AIDS. 2016 Jan 2;30(1):159-61
pubmed: 26731762
PLoS Med. 2016 Aug 23;13(8):e1002088
pubmed: 27551917
Clin Infect Dis. 2018 Mar 4;66(suppl_2):S126-S131
pubmed: 29514239
Afr J Lab Med. 2016 Oct 17;5(2):554
pubmed: 28879131