Evidence map›Paper›PMID 34015523›Full record

SynthesisInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2021

Real-world clinical performance of commercial SARS-CoV-2 rapid antigen tests in suspected COVID-19: A systematic meta-analysis of available data as of November 20, 2020.

Johannes Hayer, Dusanka Kasapic, Claudia Zemmrich

Open access · goldAbstract readMeta-AnalysisReview
In one paragraph

Synthesis in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

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  6. Analytical sensitivity of six lateral flow antigen test kits for variant strains of SARS-CoV-2.Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2023
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  16. Clinical assessment of SARS-CoV-2 antigen rapid detection compared with RT-PCR assay for emerging variants at a high-throughput community testing site in Taiwan.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 3 countries.

Johannes HayerRoche Diagnostics GmbH, Mannheim, Germany. Electronic address: johannes.hayer@roche.com.
Dusanka KasapicRoche Diagnostics International Ltd., Rotkreuz, Switzerland. Electronic address: dusanka.kasapic@roche.com.
Claudia ZemmrichRoche Diagnostics International Ltd., Rotkreuz, Switzerland; Institute for Pharmacology and Preventive Medicine, Menzelstrasse 21, 15831 Mahlow, Germany. Electronic address: claudia.zemmrich@ippmed.de.
Roche (Switzerland) · CHRoche (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesRapid antigen tests, or RATs, are a type of lateral flow chromatographic immunoassay utilized to aid the diagnosis of SARS-CoV-2 infection. We performed a systematic meta-analysis to compare the real-world performance of commercially available RATs.

methodsWe searched several databases and websites for manufacturer-independent prospective clinical performance studies comparing SARS-CoV-2 RATs and RT-PCR. Only studies on RATs that did not need a separate reader for result retrieval and that reported data on viral load, patients' symptom status, sample type, and PCR assay used were included.

results19 studies utilizing 11,109 samples with 2,509 RT-PCR-positives were included. RAT sensitivity varied between 28.9% (95% CI 16.4-44.3) and 98.3% (95% CI 91.1-99.7), likely dependent upon population characteristics, viral load, and symptom status. RAT specificity varied between 92.4% (95% CI 87.4-95.9) and 100% (95% CI 99.7-100) with one outlier. The RATs by Roche Diagnostics/SD Biosensor and Abbott had the highest pooled sensitivity (82.4% [95% CI 74.2-88.4] and 76.9% [95% CI 72.1-81.2], respectively). Sensitivity in high-viral-load samples (cycle threshold ≤25) showed heterogeneity among the different RATs.

conclusionThe RATs offered by Roche Diagnostics/SD Biosensor and Abbott provide sufficient manufacturer-independent, real-world performance data to support their use to detect current SARS-CoV-2 infection, particularly in high-viral-load populations.

Indexed as

COVID-19SARS-CoV-2HumansProspective StudiesSensitivity and SpecificitySerologic TestsCOVID-19ImmunoassayLateral flowPoint-of-care testingRapid antigen testSARS-CoV-2

Identifiers

PMID34015523
PMCPMC8127520
OpenAlexW3162399607

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.