Point-of-care CD4 technology invalid result rates in public health care settings across five countries

Abstract

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.

Performance Evaluation of the Novel Portable PIMA Point-Of-Care CD4 Analyzer in Comparison with Conventional Flow Cytometer Instruments in Cameroon

“…In respectful of the quality assurance procedures, the introduction of a new plate form needs an evaluation in terms of performance comparison and correlation with other plate forms present in the country. This will signi cantly improve patient management instead of care, treatment and clinical decision making [15]. The PIMA POC technology was for resources limited setting, to improve the quality of patient care, to increase the level of access to the diagnosis lab, the antiretroviral treatment in laboratory infrastructure, to facilitate HIV prevention through early detection and treatment, to decentralize the access [16].…”

Performance evaluation of the novel portable PIMA point-of-care CD4 analyzer in comparison with conventional flow cytometer instruments in Cameroon

“…In respectful of the quality assurance procedures, the introduction of a new plate form needs an evaluation in terms of performance comparison and correlation with other plate forms present in the country. This will significantly improve patient management instead of care, treatment and clinical decision making [15]. The PIMA POC technology was for resources limited setting, to improve the quality of patient care, to increase the level of access to the diagnosis lab, the antiretroviral treatment in laboratory infrastructure, to facilitate HIV prevention through early detection and treatment, to decentralize the access [16].…”