Results presented at the American Society of Tropical Medicine and Hygiene’s 64th Annual Meeting highlight the feasibility and impact of introducing Fio’s integrated diagnostic and data technology into infectious disease programs.
Fio and partners are presenting the following findings this week at the American Society of Tropical Medicine and Hygiene’s 64th Annual Meeting:
Abstract 1799: In-field Assessment of Malaria Rapid Diagnostic Test Performance by Community Healthcare Workers
Under ideal conditions, the accuracy of malaria rapid diagnostic tests (RDTs) is considered equivalent to routine microscopy. However, in the field inaccurate test results may occur because of defective RDTs, human processing errors and/or errors reading test results. Data ascertained from 9 implementation studies of the Fionet system was used to evaluate the frequency of these errors during routine use of malaria RDTs by healthcare workers. In each study, healthcare workers received training on processing RDTs and integrated an automated RDT reader into their point-of-care case management. The reader features in-process quality control and automated test interpretation for malaria RDTs. In 4 of the 9 studies the workers were blinded to device results allowing an evaluation of in-field reading of test results. In these four studies, a total of 19,212 malaria RDTs were processed and had overall agreement of 91.76% (kappa=84.45%). A stronger agreement (96.39%; kappa=92.45%) was observed when the device had a positive or negative test result, consistent across all studies. The discordant results predominantly occurred when the device indicated a quality control warning and the user interpreted that RDT. All 9 studies were used to evaluate the proportion of RDTs with quality control warning. The quality control issues were categorized into 2 main groups: faulty RDTs (e.g. no control line, smearing) and human processing errors (e.g. incorrect volume or placement of solutions, delayed reading, interpreting the wrong RDT). A total of 31,705 tests conducted by 151 healthcare workers were analyzed. There were approximately twice as many (~2200) human processing errors compared to any other error type. A random-effects meta-analysis, using Freeman-Tukey transformation, was used to estimate the average proportion of errors across users and studies. The meta-analyses estimated 7.61% (95% CI: 6.57%, 8.76%) errors due to human processing across. RDT brand was associated with the proportion of defective RDTs. These errors can jeopardize the accuracy of the results. Quality assurance devices would help prevent the use of compromised test results.
Please participate in our virtual RDT reading survey to further contribute to these findings by following the links below:
Abstract LB-5247: A new approach to PAHO’s DENGUE FEVER INTEGRATED MANAGEMENT STRATEGY (DF IMS): Feasibility of an innovative system using available e-mobile technologies.
Abstract LB-5365: Introduction of an innovative system to assist malaria rapid diagnostic testing and reporting in the private sector in Wakiso District, Uganda
Abstract 843: The use of Fionet™ technology as a tool in identifying the problems with RDT quality in military health facilities of Tanzania
Over 93% of the Tanzanian population is at risk for malaria infection. In the past, malaria diagnosis in health facilities below hospital level relied on clinical diagnosis and rarely microscopy. The World Health Organization advocates the use of Rapid Diagnostic Tests (RDTs) where microscopy is not feasible. Despite the promising use of RDTs, quality control (QC) is challenging. While cross-checking malaria slides is a common external QC method, cross-checking RDTs by off-site personnel can be unreliable because RDT result lines begin degrading within hours. Fionet™ technology is a web-based workflow guidance system that addresses RDT quality control issues. The system uses the Deki Reader™ (DR) and standard mobile devices to provide step-by-step guidance for performing RDTs, and to capture and transmit digital records of each test. Web-based oversight of RDT performance is enabled through Fionet™ to provide real time reporting and case management. RDT QC through Fionet™ was implemented at selected Tanzanian military facilities in collaboration with the US Army. Images of RDTs performed at the sites were viewed through the web portal for preparation problems and discordant results between device and human interpretations. Concerns were communicated remotely with health workers at the point of service for improvement. In 2014, 2.9% (960/32655) and 0.1% (26/32655) of all uploaded images were identified to have quality problems related to interpretation of results and RDT preparations respectively. Of the false results, 56% (539/960) were false negative and 44% (421/960) were false positive. False positive interpretations were commonly found in mixed species infections (64.5%; 247/383); false negative interpretations were found more in single species infections (54.5%; 294/539). The main factors leading to errors in RDT interpretations were assumption of presence of imaginary positive line (44.5%; 150/337) and missing weak positive test lines (35.9%; 121/337).