Effectiveness of tests to detect the presence of SARS-CoV-2 virus, and antibodies to SARS-CoV-2, to inform COVID-19 diagnosis: a rapid systematic review

Abstract

ObjectivesWe undertook a rapid systematic review with the aim of identifying evidence that could be used to answer the following research questions: (1) What is the clinical effectiveness of tests that detect the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to inform COVID-19 diagnosis? (2) What is the clinical effectiveness of tests that detect the presence of antibodies to the SARS-CoV-2 virus to inform COVID-19 diagnosis?Design and settingSystematic review and meta-analysis of studies of diagnostic test accuracy. We systematically searched for all published evidence on the effectiveness of tests for the presence of SARS-CoV-2 virus, or antibodies to SARS-CoV-2, up to 4 May 2020, and assessed relevant studies for risks of bias using the QUADAS-2 framework.Main outcome measuresMeasures of diagnostic accuracy (sensitivity, specificity, positive/negative predictive value) were the main outcomes of interest. We also included studies that reported influence of testing on subsequent patient management, and that reported virus/antibody detection rates where these facilitated comparisons of testing in different settings, different populations or using different sampling methods.Results38 studies on SARS-CoV-2 virus testing and 25 studies on SARS-CoV-2 antibody testing were identified. We identified high or unclear risks of bias in the majority of studies, most commonly as a result of unclear methods of patient selection and test conduct, or because of the use of a reference standard that may not definitively diagnose COVID-19. The majority were in hospital settings, in patients with confirmed or suspected COVID-19 infection. Pooled analysis of 16 studies (3818 patients) estimated a sensitivity of 87.8% (95% CI 81.5% to 92.2%) for an initial reverse-transcriptase PCR test. For antibody tests, 10 studies reported diagnostic accuracy outcomes: sensitivity ranged from 18.4% to 96.1% and specificity 88.9% to 100%. However, the lack of a true reference standard for SARS-CoV-2 diagnosis makes it challenging to assess the true diagnostic accuracy of these tests. Eighteen studies reporting different sampling methods suggest that for virus tests, the type of sample obtained/type of tissue sampled could influence test accuracy. Finally, we searched for, but did not identify, any evidence on how any test influences subsequent patient management.ConclusionsEvidence is rapidly emerging on the effectiveness of tests for COVID-19 diagnosis and management, but important uncertainties about their effectiveness and most appropriate application remain. Estimates of diagnostic accuracy should be interpreted bearing in mind the absence of a definitive reference standard to diagnose or rule out COVID-19 infection. More evidence is needed about the effectiveness of testing outside of hospital settings and in mild or asymptomatic cases. Implementation of public health strategies centred on COVID-19 testing provides opportunities to explore these important areas of research.

Role of 2-[18F]FDG as a Radiopharmaceutical for PET/CT in Patients with COVID-19: A Systematic Review

“…Coronavirus Disease (COVID-19) is an infectious acute respiratory syndrome caused by the virus SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) able to enter the human cells through the angiotensin-converting enzyme 2 (ACE2) receptor, like the SARS virus [1]. COVID-19 mainly affects Pharmaceuticals 2020, 13, 377 2 of 11 the lower respiratory tract and causes several flu-like symptoms.…”

“…through the angiotensin-converting enzyme 2 (ACE2) receptor, like the SARS virus [1]. COVID-19 mainly affects the lower respiratory tract and causes several flu-like symptoms.…”

Relative Sensitivity of Saliva and Upper Airway Swabs for Initial Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Ambulatory Patients

“…In spite of these weaknesses, this systematic review has several offsetting strengths. It focuses on sample sets that have been taken at the same time, thus differing from other systematic reviews, 34 , 35 , 36 , 37 , 38 as well as a release from the Norwegian Institute of Public Health. ( https://www.fhi.no/globalassets/dokumenterfiler/rapporter/2020/saliva-sample-for-testing-sars-cov-2-infection-memo-2020.pdf , last accessed 12/14/2020) The total number of samples included in the meta-analysis is substantially greater than that of any idividual study based on simultaneous sample comparison, and allows for meta-analysis based sensitivity estimates.…”

Performance of two rapid point of care SARS-COV-2 antibody assays against laboratory-based automated chemiluminescent immunoassays for SARS-COV-2 IG-G, IG-M and total antibodies

“…It is essential that the performance of newly developed POCT assays be thoroughly evaluated before use. Performance between different POCT assays varies greatly (see Supplementary Table 4 ) [ [5] , [6] , [7] , [8] , [9] , [10] , [11] , [12] ] with a range of different assay sensitivities. The meta-analysis by ML Bastos in July 2020 [ 3 ] showed that POCT assays up till April 2020 had varied sensitivities (36.4%–100%).…”