Gomez peer pending
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This was a systematic review of clinical studies in peer reviewed journal articles. This study also set out to identify if there were any differences in sensitivity and specificity between different manufacturers of LFDs and between different operators of the LFD test. The primary objective was to identify the sensitivities and specificities of lateral flow devices in the detection of SARS-CoV-2 compared to reverse transcriptase polymerase chain reaction in patients with symptoms of COVID-19 or those screened as part of mass testing programmes. To date, there has yet to be a systematic review to assess the sensitivity and specificity of LFDs in the detection of SARS-CoV-2 without which a thorough evaluation of the efficacy of these tests cannot be undertaken. Many countries have pioneered the use of LFDs for surge-testing in the healthcare, community and educational setting. Lateral flow devices (LFDs) offer a potential solution as they can quickly turn around a result in less than 30 min without the need for specialist staff or laboratory capacity. Where there are national or local outbreaks, it is important to be able to expand testing in a short time frame (surge-testing) to enable effective identification of individuals infected with the virus for contact tracing and mass population testing in an endeavour to stop the chain of transmission of the virus. Furthermore, many countries possess a limited capacity to perform RT-PCR tests, hindering their ability to engage in mass-testing with RT-PCR alone as an example, the United Kingdom’s current RT-PCR capacity for the detection of SARS-CoV-2 is approximately 500,000 tests per day. This usually has a turnaround time that is variable but of at least 24 h. However, RT-PCR requires swabs to be sent off to a laboratory with specialist equipment and analysed by trained laboratory staff. For both of these tests, nasopharyngeal swabs are used to isolate the antigen. Currently, the gold standard for detection of SARS-CoV-2 is reverse transcriptase polymerase chain reaction (RT-PCR). There has been an increasing number of papers reporting on the use of LFDs in the detection of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which has caused the Coronavirus disease 2019 (COVID-19) pandemic. This antibody-antigen complex moves via capillary flow to a test area which then identifies a positive test by the presence of a coloured line. They work by binding of conjugated antibodies to a specific antigen in a sample. Lateral flow device (LFD) immunoassays are common, inexpensive, readily available testing devices that are used in the detection of a number of different medical conditions.
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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. Test performance does not appear dependent on the operator.
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Some perform with high specificity but a great range of sensitivities were shown (38.32–99.19%). This systematic review identified that the performance of lateral flow devices is heterogeneous and dependent on the manufacturer.
GOMEZ PEER PENDING PROFESSIONAL
Operation of the test by a trained professional or by the test subject with self-swabbing produced comparable results. Twenty-four papers were identified involving over 26,000 test results. 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. Based on extracted data sensitivity and specificity was calculated for each study. MethodsĪ 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. Our aims were to assess the sensitivity and specificity of LFDs in a systematic review and summarise the sensitivity and specificity of these tests. There are now several studies assessing their accuracy but as yet no systematic review. 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. 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.