Rapid antibody tests for the detection of human immunodeficiency virus (HIV) offer an effective means of providing a timely result of HIV serostatus to individuals. The increased use of rapid HIV antibody tests outside the laboratory has highlighted the need for new, cost-effective quality assurance methods to be developed for use in nonlaboratory-based and resource-limited settings. Photographed rapid HIV test results were used in a modified external quality assessment scheme to assess the interpretation proficiency and, therefore, to assess the feasibility of using this method as a basis for a quality assessment program for nonlaboratory-based testing. Participants (n ‫؍‬ 148), both experienced and inexperienced in the performance and interpretation of rapid HIV testing, interpreted the photographed results of five rapid HIV assays. These were scored according to the degree of technical discordance. Error scores were grouped according to each participant's technical experience. The accuracy of interpretation for four of the five assays was between 80 and 97%, indicating that the photographed results of samples, including those difficult to read or borderline difficult to read, can be used to assess the proficiency of test operators in interpreting results. Participants had greater difficulty in interpreting samples of weak reactivity; this was consistent across the five assays. Experience played an important role in accurate interpretation, with experienced laboratory participants exhibiting greater proficiency (P < 0.05) in interpreting the results of three of the five rapid HIV assays. It was established that photographed results of rapid HIV assays could be interpreted with accuracy and demonstrated that prior experience resulted in a more accurate interpretation performance.

HIV rapid diagnostic tests (RDTs) are now used widely in non-laboratory settings by non-laboratory-trained operators. Quality assurance programmes are essential in ensuring the quality of HIV RDT outcomes. However, there is no cost-effective means of supplying the many operators of RDTs with suitable quality assurance schemes. Therefore, it was examined whether photograph-based RDT results could be used and correctly interpreted in the non-laboratory setting. Further it was investigated if a single training session improved the interpretation skills of RDT operators. The photographs were interpreted, a 10-minute tutorial given and then a second interpretation session was held. It was established that the results could be read with accuracy. The participants (n = 75) with a range of skills interpreted results (>80% concordance with reference results) from a panel of 10 samples (three negative and seven positive) using four RDTs. Differences in accuracy of interpretation before and after the tutorial were marked in some cases. Training was more effective for improving the accurate interpretation of more complex results, e.g. results with faint test lines or for multiple test lines, and especially for improving interpretation skills of inexperienced participants. It was demonstrated that interpretation of RDTs was improved using photographed results allied to a 10-minute training session. It is anticipated that this method could be used for training but also for quality assessment of RDT operators without access to conventional quality assurance or training schemes requiring wet samples.

This paper presents the design and development of a smartphone-based urinalysis device that has the ability for chronic kidney disease (CKD) patients themselves to conduct rapid and reliable quantitative urinalysis of human serum albumin (HSA) using an aggregation-induced emission (AIE) nanomaterial bioprobe with their own smartphones. The focus of this paper is a novel solution to the device agnosticism issue as a wide diversity of smartphones co-exist in the market. The solution comprises: a) custom-design and fabrication of an imaging housing that provides a consistent imaging condition regardless of the physical dimensions and the camera position of the smartphone used, b) orchestration of an image processing and analysis process that produces consistent image colour intensity values regardless of the camera sensor and imaging software used by the smartphone, and c) special design and development of an intuitive cross-platform mobile application that is scalable to growth, adaptable to changes, resilient to loss of data, and has an extremely low requirement for smartphone hardware. Preliminary evaluation of the device has confirmed the effectiveness of the proposed solution and the viability of such a smartphone-based device for people who have already developed or are prone to CKD to regularly perform point-of-care (POC) urine testing in order to self monitor their own health conditions without the burden of frequent visits to their doctors.

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Analysis of test results of an external QC sample can be used as a statistical process control through ongoing measurement of imprecision. When laboratories test the same QC sample in the same assay and submit test results to a single database, the results can be compared and a measure of bias can be calculated. The resulting QC programme can offer detection of unexpected variation in the testing processes and the source of variation investigated.