ArticleThorax2020
Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 seroprevalence survey.
Article in Thorax, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
73 citing papers in PubMed, 4 syntheses or guidelines pooled it, 157 citations in OpenAlex.
- Dynamics of SARS-CoV-2 seroassay sensitivity: a systematic review and modelling study.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2023Pooled it
- Antibody tests for identification of current and past infection with SARS-CoV-2.The Cochrane database of systematic reviews · 2022Pooled it
- Clinical applications of detecting IgG, IgM or IgA antibody for the diagnosis of COVID-19: A meta-analysis and systematic review.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021Pooled it
- Pooled it
- User experience of home-based AbC-19 SARS-CoV-2 antibody rapid lateral flow immunoassay test.Scientific reports · 2022Trial
- Article
- Current and future opportunities for lateral flow immunoassay strips based on tunable plasmonic properties of gold nanoparticles.Mikrochimica acta · 2025Review
- Article
- Cognition and Memory after Covid-19 in a Large Community Sample.The New England journal of medicine · 2024Article
- Design and Implementation of a National Program to Monitor the Prevalence of SARS-CoV-2 IgG Antibodies in England Using Self-Testing: The REACT-2 Study.American journal of public health · 2023Article
- Microgel-based etalon immunoassay for IgG detection.Analytical and bioanalytical chemistry · 2023Article
- SARS CoV-2 IgG seropositivity post-vaccination among dental professionals: a prospective study.BMC infectious diseases · 2023Article
- Seroprevalence of COVID-19 in Oran: Cross-Sectional Study.Microbiology spectrum · 2023Article
- Recent Advances in Quantum Dot-Based Lateral Flow Immunoassays for the Rapid, Point-of-Care Diagnosis of COVID-19.Biosensors · 2023Review
- Advancements in SARS-CoV-2 Testing: Enhancing Accessibility through Machine Learning-Enhanced Biosensors.Micromachines · 2023Review
- Spray-On Colorimetric Sensors for Distinguishing the Presence of Lead Ions.Chemosensors (Basel, Switzerland) · 2023Article
- Article
- Rapid quantitation of SARS-CoV-2 antibodies in clinical samples with an electrochemical sensor.Biosensors & bioelectronics · 2023Article
- Evaluation of eight lateral flow tests for the detection of anti-SARS-CoV-2 antibodies in a vaccinated population.BMC infectious diseases · 2023Article
- Article
13 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
38 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundAccurate antibody tests are essential to monitor the SARS-CoV-2 pandemic. Lateral flow immunoassays (LFIAs) can deliver testing at scale. However, reported performance varies, and sensitivity analyses have generally been conducted on serum from hospitalised patients. For use in community testing, evaluation of finger-prick self-tests, in non-hospitalised individuals, is required.
methodsSensitivity analysis was conducted on 276 non-hospitalised participants. All had tested positive for SARS-CoV-2 by reverse transcription PCR and were ≥21 days from symptom onset. In phase I, we evaluated five LFIAs in clinic (with finger prick) and laboratory (with blood and sera) in comparison to (1) PCR-confirmed infection and (2) presence of SARS-CoV-2 antibodies on two 'in-house' ELISAs. Specificity analysis was performed on 500 prepandemic sera. In phase II, six additional LFIAs were assessed with serum.
findings95% (95% CI 92.2% to 97.3%) of the infected cohort had detectable antibodies on at least one ELISA. LFIA sensitivity was variable, but significantly inferior to ELISA in 8 out of 11 assessed. Of LFIAs assessed in both clinic and laboratory, finger-prick self-test sensitivity varied from 21% to 92% versus PCR-confirmed cases and from 22% to 96% versus composite ELISA positives. Concordance between finger-prick and serum testing was at best moderate (kappa 0.56) and, at worst, slight (kappa 0.13). All LFIAs had high specificity (97.2%-99.8%).
interpretationLFIA sensitivity and sample concordance is variable, highlighting the importance of evaluations in setting of intended use. This rigorous approach to LFIA evaluation identified a test with high specificity (98.6% (95%CI 97.1% to 99.4%)), moderate sensitivity (84.4% with finger prick (95% CI 70.5% to 93.5%)) and moderate concordance, suitable for seroprevalence surveys.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.