A systematic review of the sensitivity and specificity of lateral flow devices in the detection of SARS-CoV-2

Abstract

Background Lateral flow devices (LFDs) are viral antigen tests for the detection of SARS-CoV-2 that produce a rapid result, are inexpensive and easy to operate. They have been advocated for use by the World Health Organisation to help control outbreaks and break the chain of transmission of COVID-19 infections. There are now several studies assessing their accuracy but as yet no systematic review. Our aims were to assess the sensitivity and specificity of LFDs in a systematic review and summarise the sensitivity and specificity of these tests. Methods A targeted search of Pubmed and Medxriv, using PRISMA principles, was conducted identifying clinical studies assessing the sensitivity and specificity of LFDs as their primary outcome compared to reverse transcriptase polymerase chain reaction (RT-PCR) for the detection of SARS-CoV-2. Based on extracted data sensitivity and specificity was calculated for each study. Data was pooled based on manufacturer of LFD and split based on operator (self-swab or by trained professional) and sensitivity and specificity data were calculated. Results Twenty-four papers were identified involving over 26,000 test results. Sensitivity from individual studies ranged from 37.7% (95% CI 30.6–45.5) to 99.2% (95% CI 95.5–99.9) and specificity from 92.4% (95% CI 87.5–95.5) to 100.0% (95% CI 99.7–100.0). Operation of the test by a trained professional or by the test subject with self-swabbing produced comparable results. Conclusions This systematic review identified that the performance of lateral flow devices is heterogeneous and dependent on the manufacturer. Some perform with high specificity but a great range of sensitivities were shown (38.32–99.19%). Test performance does not appear dependent on the operator. Potentially, LFDs could support the scaling up of mass testing to aid track and trace methodology and break the chain of transmission of COVID-19 with the additional benefit of providing individuals with the results in a much shorter time frame.

A General Computational Framework for COVID-19 Modelling with Applications to Testing Varied Interventions in Education Environments

“…The authors conclude that LFD specificity ranged from 92.4% to 100%. In particular, the manufacturer Bioeasy was highlighted as the only LFD supplier with an average specificity <97% [49]. These results are in agreement with the study conducted by the UK COVID-19 Lateral Flow Oversight Team which was designed to analyse the efficacy of LFDs suppliers to the UK [50].…”

“…Furthermore, the systematic review of LFD efficacy conducted by Mistry et al [49] found that LFD sensitivities ranged from 37.7% to 99.2%, highlighting that LFD falsenegative rates are not only dependent on the manufacturer but also on the operator, and thus we consider the probability of LFD false-negative result to be variable.…”

“…We assume that the tests being used are LFDs, which are assigned to have a falsepositive probability, P f p and a false-negative probability, P f n . In a recent systematic review of LFD efficacy in SARS-CoV-2 detection, the authors summarised the results of twenty-four studies involving over 26,000 RT-PCR confirmed cases comparing the sensitivity and specificity of LFDs from global manufacturers [49]. The authors conclude that LFD specificity ranged from 92.4% to 100%.…”

population level study of SARS-CoV-2 prevalence amongst people experiencing homelessness in Wales, UK

“…Though Lateral Flow Device (LFD) testing data are available within SAIL for linkage studies, we chose not to use LFD data. Meta-analysis of LFD testing has found that it has poor sensitivity in detecting SARS-CoV-2 infection [ 19 ], and potentially provides high false positive rates when community cases rates are low [ 20 ]. Furthermore, as SARS-CoV-2 testing policy in Wales is that a positive lateral flow test be followed by a confirmatory PCR test, then people with SARS-CoV-2 identified through positive LFD tests would, in most cases, be recorded under the more reliable PCR testing process [ 21 ].…”

Comparative analyses of FDA EUA-approved rapid antigen tests and RT-PCR for COVID-19 quarantine and surveillance-based isolation

“…The accuracy of our results is dependent on the quality of data collected. Numerous factors influence the diagnostic sensitivity of RA tests relative to RT-PCR, such as the level of training of those who collect the samples, anatomical collection site, and storage conditions [72][73][74][75] . Substantial heterogeneity across RA tests exists in the assessment period of their sensitivity.…”