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Background: Lateral flow immunoassays (LFIAs) are being used worldwide for COVID-19 mass testing and antibody prevalence studies. Relatively simple to use and low cost, these tests can be self-administered at home, but rely on subjective interpretation of a test line by eye, risking false positives and false negatives. Here, we report on the development of ALFA (Automated Lateral Flow Analysis) to improve reported sensitivity and specificity. Methods: Our computational pipeline uses machine learning, computer vision techniques and signal processing algorithms to analyse images of the Fortress LFIA SARS-CoV-2 antibody self-test, and subsequently classify results as invalid, IgG negative and IgG positive. A large image library of 595,339 participant-submitted test photographs was created as part of the REACT-2 community SARS-CoV-2 antibody prevalence study in England, UK. Alongside ALFA, we developed an analysis toolkit which could also detect device blood leakage issues. Results: Automated analysis showed substantial agreement with human experts (Cohen's kappa 0.90-0.97) and performed consistently better than study participants, particularly for weak positive IgG results. Specificity (98.7-99.4%) and sensitivity (90.1-97.1%) were high compared with visual interpretation by human experts (ranges due to the varying prevalence of weak positive IgG tests in datasets). Conclusions: Given the potential for LFIAs to be used at scale in the COVID-19 response (for both antibody and antigen testing), even a small improvement in the accuracy of the algorithms could impact the lives of millions of people by reducing the risk of false-positive and false-negative result read-outs by members of the public. Our findings support the use of machine learning-enabled automated reading of at-home antibody lateral flow tests as a tool for improved accuracy for population-level community surveillance.
RESUMEN
PURPOSE: Artificial-intelligence population-based automated quantification of placental maturation and health from a rapid functional Magnetic Resonance scan. The placenta plays a crucial role for any successful human pregnancy. Deviations from the normal dynamic maturation throughout gestation are closely linked to major pregnancy complications. Antenatal assessment in-vivo using T2* relaxometry has shown great promise to inform management and possible interventions but clinical translation is hampered by time consuming manual segmentation and analysis techniques based on comparison against normative curves over gestation. METHODS: This study proposes a fully automatic pipeline to predict the biological age and health of the placenta based on a free-breathing rapid (sub-30 second) T2* scan in two steps: Automatic segmentation using a U-Net and a Gaussian process regression model to characterize placental maturation and health. These are trained and evaluated on 108 3T MRI placental data sets, the evaluation included 20 high-risk pregnancies diagnosed with pre-eclampsia and/or fetal growth restriction. An independent cohort imaged at 1.5 T is used to assess the generalization of the training and evaluation pipeline. RESULTS: Across low- and high-risk groups, automatic segmentation performs worse than inter-rater performance (mean Dice coefficients of 0.58 and 0.68, respectively) but is sufficient for estimating placental mean T2* (0.986 Pearson Correlation Coefficient). The placental health prediction achieves an excellent ability to differentiate cases of placental insufficiency between 27 and 33 weeks. High abnormality scores correlate with low birth weight, premature birth and histopathological findings. Retrospective application on a different cohort imaged at 1.5 T illustrates the ability for direct clinical translation. CONCLUSION: The presented automatic pipeline facilitates a fast, robust and reliable prediction of placental maturation. It yields human-interpretable and verifiable intermediate results and quantifies uncertainties on the cohort-level and for individual predictions. The proposed machine-learning pipeline runs in close to real-time and, deployed in clinical settings, has the potential to become a cornerstone of diagnosis and intervention of placental insufficiency. APPLAUSE generalizes to an independent cohort imaged at 1.5 T, demonstrating robustness to different operational and clinical environments.