Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity

Döhla, Manuel; Boesecke, Christoph; Schulte, Bianca; Diegmann, Christin; Sib, Esther; Richter, Enrico; Eschbach-Bludau, Monika; Aldabbagh, Souhaib; Marx, Benjamin; Eis‐Hübinger, Anna Maria; Schmithausen, Ricarda Maria; Streeck, Hendrik

doi:10.1016/j.puhe.2020.04.009

“…In total, 4696 records based on screening of titles or abstracts and 235 after full text review were excluded. Forty studies totalling 73 study arms15161718192021222324252627282930313233343536373839404142434445464748495051525354 met the inclusion criteria. Table 1 summarises the studies by test method; the sum of the number of studies exceeds 40 because some evaluated more than one method.…”

Section: Resultsmentioning

confidence: 99%

“…Table 1 summarises the studies by test method; the sum of the number of studies exceeds 40 because some evaluated more than one method. Seventy per cent (28/40) of the studies were from China,16171819202122232425262728293031323334353839404145464748 8% (3/40) from Italy,153643 and the remainder from the United States (3/40),425052 Denmark (1/40),51 Spain (1/40),37 Sweden (1/40),53 Japan (1/40),44 the United Kingdom (1/40),49 and Germany (1/40) 5433…”

Section: Resultsmentioning

confidence: 99%

Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

Bastos

¹

,

Tavaziva

²

,

Abidi

³

et al. 2020

BMJ

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AbstractObjectiveTo determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19).DesignSystematic review and meta-analysis.Data sourcesMedline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19.Eligibility criteria and data analysisEligible studies measured sensitivity or specificity, or both of a covid-19 serological test compared with a reference standard of viral culture or reverse transcriptase polymerase chain reaction. Studies were excluded with fewer than five participants or samples. Risk of bias was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using random effects bivariate meta-analyses.Main outcome measuresThe primary outcome was overall sensitivity and specificity, stratified by method of serological testing (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), or chemiluminescent immunoassays (CLIAs)) and immunoglobulin class (IgG, IgM, or both). Secondary outcomes were stratum specific sensitivity and specificity within subgroups defined by study or participant characteristics, including time since symptom onset.Results5016 references were identified and 40 studies included. 49 risk of bias assessments were carried out (one for each population and method evaluated). High risk of patient selection bias was found in 98% (48/49) of assessments and high or unclear risk of bias from performance or interpretation of the serological test in 73% (36/49). Only 10% (4/40) of studies included outpatients. Only two studies evaluated tests at the point of care. For each method of testing, pooled sensitivity and specificity were not associated with the immunoglobulin class measured. The pooled sensitivity of ELISAs measuring IgG or IgM was 84.3% (95% confidence interval 75.6% to 90.9%), of LFIAs was 66.0% (49.3% to 79.3%), and of CLIAs was 97.8% (46.2% to 100%). In all analyses, pooled sensitivity was lower for LFIAs, the potential point-of-care method. Pooled specificities ranged from 96.6% to 99.7%. Of the samples used for estimating specificity, 83% (10 465/12 547) were from populations tested before the epidemic or not suspected of having covid-19. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).ConclusionHigher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed. Currently, available evidence does not support the continued use of existing point-of-care serological tests.Study registrationPROSPERO CRD42020179452.

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“…Therefore, there is a critical demand for alternative assays, especially rapid diagnostic tests (RDTs), which are timely, easy to perform, and can serve for point-of-care testing (POCT) or community-based testing (8). RDTs for antibody detection have been developed, but due to the delay in humoral immune response, they have limited use for early diagnosis and low sensitivity for community-based screening (9, 10). Antigen detection tests, on the other hand, have the advantage of detecting the presence of the virus itself and might therefore be a better tool for early cases, but require sufficient viral loads and high-quality sampling (11).…”

Section: Introductionmentioning

confidence: 99%

Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples

Weitzel

¹

,

Legarraga²,

Iruretagoyena³

et al. 2020

Preprint

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21In the context of the Covid-19 pandemic, the development and validation of rapid and easy-to-22 perform diagnostic methods are of high priority. We compared the performance of four rapid 23 antigen detection tests for SARS-CoV-2 in respiratory samples. Immunochromatographic SARS-24CoV-2 assays from RapiGEN, Liming bio, Savant, and Bioeasy were evaluated using universal 25 transport medium containing naso-oropharyngeal swabs from suspected Covid-19 cases. The 26 diagnostic accuracy was determined in comparison to SARS-CoV-2 RT-PCR. A total of 111 27 samples were included; 80 were RT-PCR positive. Median patients' age was 40 years, 55% were 28 female, and 88% presented within the first week after symptom onset. The evaluation of the 29Liming bio assay was discontinued due to insufficient performance. The overall sensitivity 30 values of RapiGEN, Liming bio, and Bioeasy tests were 62.0% (CI95% 51.0-71.9), 16.7% 31 (CI95% 10.0-26.5), and 85.0% (CI95% 75.6-91.2), respectively, with specificities of 100%. 32Sensitivity was significantly higher in samples with high viral loads (RapiGEN, 84.9%; Bioeasy, 33 100%). The study highlighted the significant heterogeneity of test performance among evaluated 34 assays, which might have been influenced by the use of a non-validated sample material. The 35 high sensitivity of some tests demonstrated that rapid antigen detection has the potential to serve 36 as an alternative diagnostic method, especially in patients presenting with high viral loads in 37 early phases of infection. This is particularly important in situations with limited access to PCR or prolonged turnaround time. Further comparative evaluations are necessary to select 39 products with high performance among the growing market of diagnostic tests for SARS-CoV-2. 40 41

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“… 23 A small study of 39 randomly selected patients from a high-prevalence area screening centre (German Red Cross), compared an LFA to NAT with a sensitivity of 36.4% and specificity of 88.9%. 24 The slight superiority in sensitivity of the combined IgG-IgM antibody test over individual IgG or IgM antibody test was seen in a previous study. 23 …”

Section: Discussionmentioning

confidence: 72%

Clinical evaluation of SARS-CoV-2 point-of-care antibody tests

Robosa

¹

,

Sandaradura

²

,

Dwyer

³

et al. 2020

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The aim of this study was to assess the analytic and clinical performance of four rapid lateral flow point-of-care tests (POCTs) for identifying SARS-CoV-2-specific antibodies. A retrospective study was conducted between 22 January and 30 March 2020 on 132 serum samples for SARS-CoV-2-specific antibody detection referred to a tertiary referral hospital laboratory in New South Wales. Multiple sera were tested from 20 confirmed or suspected COVID-19 patients with SARS-CoV-2-specific antibodies detected by immunofluorescence (IFA) or neutralisation, and 71 SARS-CoV-2 uninfected individuals. We measured the sensitivity and specificity for detection of SARS-CoV-2 IgM and IgG antibodies for each POCT in comparison to positive SARS-CoV-2-specific IFA and viral neutralisation, our current laboratory benchmark tests. All POCTs were found to have a low analytic sensitivity for SARS-CoV-2 antibodies, ranging from 27.3% to 58.2%, with a specificity between 88.3% and 100%, and a low clinical sensitivity from 45% to 65%, with a clinical specificity between 87.3% and 100%. All POCTs had an increased sensitivity when specimens were collected more than 14 days from onset of symptoms. The detection using POCT of SARS-CoV-2-specific antibodies after disease onset lagged behind IFA by a range of 2–9 days. POCTs promise the benefit of providing quick easy testing for SARS-CoV-2-specific antibodies. However, their poor sensitivity and delayed antibody detection make them unsuitable as a diagnostic or screening tool alone.

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Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity

Cited by 188 publications

References 8 publications

Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples

Clinical evaluation of SARS-CoV-2 point-of-care antibody tests

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