Evaluation of the Deki Reader™, an automated RDT reader and data management device, in a household survey setting in low malaria endemic southwestern Uganda

Abstract

BackgroundEarly diagnosis of suspected malaria cases with a rapid diagnostic test (RDT) has been shown to be an effective malaria control tool used in many resource-constrained settings. However, poor quality control and quality assurance hinder the accurate reporting of malaria diagnoses. Recent use of a portable, battery operated RDT reader (Deki Reader™, Fio Corporation) has shown to have high agreement with visual inspection across diverse health centre settings, however evidence of its feasibility and usability during cross sectional surveys are limited. This study aimed to evaluate the performance of the Deki Reader™ in a cross-sectional survey of children from southwestern Uganda.MethodsA two-stage, stratified cluster sampling survey was conducted between July and October 2014 in three districts of southwestern Uganda, with varying malaria transmission intensities. A total of 566 children aged 6–59 months were included in the analysis. Blood samples were collected and tested for malaria using: the SD Bioline Malaria Ag Pf/Pan RDT and microscopy. Results were compared between visual inspection of the RDT and by the Deki Reader™. Diagnostic performance of both methods were compared to gold-standard microscopy.ResultsThe sensitivity and specificity of the Deki Reader™ was 94.1% (95% CI 69.2–99.6%) and 95.6% (95% CI 93.4–97.1%), respectively. The overall percent agreement between the Deki Reader™ and visual RDT inspection was 98.9% (95% CI 93.2–99.8), with kappa statistic of 0.92 (95% CI 0.85–0.98).ConclusionsThe findings from this study suggest that the Deki Reader™ is comparable to visual inspection and performs well in detecting microscopy-positive Plasmodium falciparum cases in a household survey setting. However, the reader’s performance was highly dependent on ensuring adequate battery life and a work environment free of dirt particles.

Comparison of visual and automated Deki Reader interpretation of malaria rapid diagnostic tests in rural Tanzanian military health facilities

“…In this study, the sensitivity, specificity, PPV, NPV, and accuracy RDTs as interpreted by the automated DR (94.1, 71.8, 75.8 and 82.6%) were similar to the interpretations which were visually done by unskilled health care workers (93.5, 72.4, 76.1 and 82.1%) with no significant differences. These findings are consistent with the previous studies conducted in Colombia, Tanzania and Uganda [ 28 , 29 , 32 ] where the interpretations of RDTs by automated device were comparable to expert visual interpretation (concordance rate > 95%) for P. falciparum which is the dominant malaria species in Tanzania.…”

“…This comparative study in interpreting RDTs between unskilled cadre of health workers and automated DR for routine outpatients is the first to be done in rural military health facilities. Whereas previous studies conducted in Tanzania, Colombia and Uganda [ 28 , 29 , 32 ] employed laboratory technicians from research institutions in performing RDT testing and operating the DR, in this study unskilled health care workers who had no formal training in laboratory sciences were employed to operate the automated device and also to visually interpret RDT test results. In the current trend of expanding the use of RDTs to the community level, community health workers are becoming solely responsible for malaria testing.…”

“…The performance agreement of the DR compared to visual interpretation conducted by unskilled health care workers in interpreting RDTs does suggest that the device can be used alone or concurrently with microscopy for malaria diagnosis. The use of this DR device at the point of care not only interprets RDT results, but has the added advantage to provide stepwise procedures for RDT testing, data transfer and timely reporting as also studied in Kenya and Uganda [ 32 , 52 ]. Moreover, similar to skilled laboratory technologists, unskilled laboratory staff can be trained how to operate the DR for couple of days, assigned and use it for malaria diagnosis in remote areas, such as military camps; the DR is mostly automated in its operation and is, therefore, simple to use by any laboratory staff regardless level of education or professional training in laboratory technology.…”

Inorganic Complexes and Metal-Based Nanomaterials for Infectious Disease Diagnostics

“…Since test position and illumination can affect image analysis, many camera-based lateral flow readers include housing units for run-to-run consistency. Commercial lateral flow imaging devices include the Deki Reader (Fio), AX-2X (Axxin Inc.), SkanSmart (Skannex), and the RDS-2500 PRO (Detekt Biomedical LLC) (Figure B). − These devices have been used for quantification of malaria, − dengue, Burkholderia pseudomallei, and Y. pestis lateral flow assays, and some, such as the Deki Reader, have been tested extensively in the field. − …”

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

“…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].…”