The use of Fionet technology for external quality control of malaria rapid diagnostic tests and monitoring health workers’ performance in rural military health facilities in Tanzania

Abstract

IntroductionInternal and external quality control (QC) of rapid diagnostic tests (RDTs) is important to increase reliability of RDTs currently used to diagnose malaria. However, cross-checking of used RDTs as part of quality assurance can rarely be done by off-site personnel because there is no guarantee of retaining visible test lines after manufacturers’ recommended reading time. Therefore, this study examined the potential of using Fionet™ technology for remote RDT quality monitoring at seven clinics, identifying reasons for making RDT processing and interpretation errors, and taking corrective actions for improvement of diagnosis and consequently improved management of febrile patientsMethodsThe study was conducted at seven military health facilities in Mainland Tanzania and utilized RDTs capable of detecting Plasmodium falciparum specific Histidine-rich protein 2 (Pf-HRP2) and the genus specific Plasmodium lactate dehydrogenase (pLDH) for other species of plasmodium (P. vivax, P. malariae or P. ovale; pan-pLDH). Patients’ data and images of processed RDTs from seven clinics were uploaded on a Fionet web portal and reviewed regularly to monitor preparation procedures and visual interpretation of test results compared to automated analysis using the Deki reader of RDT. Problems detected were rapidly communicated to remote laboratory personnel at the clinic for corrective action and follow-up of patients who were falsely diagnosed as negative and missed treatment. Factors contributing to making errors in visual interpretation of RDT results were analyzed during visits to the health facilities.ResultsA total of 1,367 (1.6%) out of 83,294 RDT test images uploaded to the Fionet portal had discordant test results of which 822 (60.1%) and 545 (39.9%) were falsely reported as negative and positive, respectively. False negative and false positive test results were common for a single test line in 515 (62.7%) and 741 (54.2%) tests, respectively. Out of 1,367 RDT images assessed, 98 (7.2%) had quality problems related to preparation procedures of which 95(96.9%) errors were due to putting too much blood on the sample well or insufficient buffer in the respective wells. The reasons for discrepant results included, false reporting of none existent lines in 526 (38.5%) tests, missing a faint positive line in 493 (36.1%), missing a strong positive line in 248(18.1%) and errors caused by poorly processed RDTs in 96 (7.2%) tests. Among the false negative tests (n = 822), 669 (48.9%) patients were eligible for follow–up and only 339 (48.5%) were reached and 291 (85.8%) received appropriate anti-malaria therapy.ConclusionFionet technology enabled remote monitoring of RDT quality issues, identifying reasons contributing to laboratory personnel making errors and provided a rapid method to implement corrective actions at remote sites to improve malaria diagnosis and consequently improved health care management of febrile patients infected with malaria.

Continuous quality monitoring in the field: an evaluation of the performance of the Fio Deki Reader™ for rapid HIV testing in South Africa

“…The artefact could also be linked to imperfect processing, which would indicate a need for HCW retraining; review of RDTs centrally (as is not currently possible) would allow this to be detected rapidly. The processing error rate (9.5%) was slightly higher than that reported by Kalinga and colleagues (2018) for malaria RDTs [24], but was notably linked to the RDT not being assessed in the allowable time period. This did highlight HCW retraining, but was also found to relate to a drawer not closing; once the drawer was replaced, this error decreased.…”

“…2 The pens used to write patient initials on the RDT absorbed into the RDT cassette plastic between the initial RDT image capture and the result capture (after processing time), causing the Deki Reader v100 to reject the RDT as a different specimen settings, ranging from true remote POC through to urban clinics. A central database allows all sites and RDT testers to be monitored in real-time, meaning that anomalies in the system, such as RDT batch errors and decreased staff proficiency, can be detected early [24]. The readily available real-time data allows for effective monitoring and surveillance of the program and remote management of HCWs, including targeted identification for retraining, which was one of the areas identified by Johnson et al (2017) [1], and the centralised storage of countrywide HIV screening results allows data to be instantly available for HIV prevalence monitoring.…”

“…Recent evaluation of the Deki Reader v100 to monitor malaria RDTs showed a 97% decrease in processing errors when using the device and applying quality monitoring through the Fionet™ portal [24]. Identification of these audit indicators (and their rate of monitoring: daily, weekly, monthly) and the responsibility of monitoring and reporting need to be defined within the laboratory and clinical interface ecosystem and responsibilities assigned, especially in large HIV programs.…”

“…Results, together with captured images of the RDT, are uploaded through a proprietary web portal, Fionet™, which allows data to be centralised and monitored on a continuous basis [24]. The Deki Reader has been evaluated for assessment of malaria RDTs and was shown to be comparable with visual RDT analysis [25][26][27][28][29][30][31], and the Fionet™ portal was recently shown to improve malaria diagnosis by enabling improved quality monitoring [24]. A recent study in Sierra Leone linking febrile illness to HIV used the Deki Reader to capture and upload the HIV RDT results [32].…”

Implementation of external quality assessment of microscopy for improved parasite detection and confirmatory diagnosis of malaria in Tanzanian Military health facilities

“…The reason behind this is the average performance in the final score of the facility being pulled down by low performers among introduced new laboratory staff with less experience in microscopy in the reporting quarters compared to the previous ones when only trained experienced staffs performed well. This was confirmed when newly introduced laboratory staff were re-trained and started to improve their individual scores, which ultimately raised the overall performance of the respective facility [ 14 ].…”