Evidence map›Paper›PMID 35441745›Full record

ArticleJournal of clinical laboratory analysis2022

Performance evaluation of STANDARD Q COVID-19 Ag home test for the diagnosis of COVID-19 during early symptom onset.

Hyoshim Shin, Seungjun Lee, Kristin Widyasari, Jongyoun Yi, Eunsin Bae, Sunjoo Kim

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical laboratory analysis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
1.4field-weighted citation impact, top 18% 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

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
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  7. Review
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  10. Evaluation of the T cell and B cell response following the administration of COVID-19 vaccines in Korea.Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi · 2022
    Article
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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

6 authors at 4 institutions in 1 country.

Hyoshim ShinDepartment of Laboratory Medicine, Gyeongsang National University Hospital, Jinju, Korea.ORCID https://orcid.org/0000-0001-9737-2393
Seungjun LeeDepartment of Laboratory Medicine, Gyeongsang National University Changwon Hospital, Changwon, Korea.ORCID https://orcid.org/0000-0002-3377-4833
Kristin WidyasariDepartment of Laboratory Medicine, Gyeongsang National University Changwon Hospital, Changwon, Korea.ORCID https://orcid.org/0000-0002-1033-734X
Jongyoun YiDepartment of Laboratory Medicine, Pusan National University School of Medicine, Busan, Korea.ORCID https://orcid.org/0000-0001-9098-3765
Eunsin BaeSeegene Institute of Clinical Research, Seegene Inc., Seoul, Korea.ORCID https://orcid.org/0000-0002-5279-467X
Sunjoo KimDepartment of Laboratory Medicine, Gyeongsang National University Changwon Hospital, Changwon, Korea.ORCID https://orcid.org/0000-0001-8099-8891
Changwon National University · KRGyeongsang National University Hospital · KRPusan National University · KRSejong Institute · KR

Funding

the National Research Foundation (NRF) of Korea NRF-2021M3E5E3080382the National Research Foundation (NRF) of Korea NRF-2021R1I1A3044483
6 · The paper itself

Abstract

backgroundSurveillance and control of SARS-CoV-2 outbreak through gold standard detection, that is, real-time polymerase chain reaction (RT-PCR), become a great obstacle, especially in overwhelming outbreaks. In this study, we aimed to analyze the performance of rapid antigen home test (RAHT) as an alternative detection method compared with RT-PCR.

methodsIn total, 79 COVID-19-positive and 217 COVID-19-negative patients confirmed by RT-PCR were enrolled in this study. A duration from symptom onset to COVID-19 confirmation of <5 days was considered a recruiting criterion for COVID-19-positive cases. A nasal cavity specimen was collected for the RAHT, and a nasopharyngeal swab specimen was collected for RT-PCR.

resultsSensitivity of the STANDARD Q COVID-19 Ag Home Test (SD Biosensor, Korea), compared with RT-PCR, was 94.94% (75/79) (95% [confidence interval] CI, 87.54%-98.60%), and specificity was 100%. Sensitivity was significantly higher in symptomatic patients (98.00%) than in asymptomatic (89.66%) patients (p-value = 0.03). There was no difference in sensitivity according to the duration of symptom onset to confirmation (100% for 0-2 days and 96.97% for 3-5 days, respectively) (p-value = 1.00). The RAHT detected all 51 COVID-19 patients whose Ct values were ≤25 (100%), whereas sensitivity was 73.33% (11/15) among patients with Ct values >25 (p-value = 0.01).

conclusionThe RAHT showed an excellent sensitivity for COVID-19-confirmed cases, especially for those with symptoms. There was a decrease in sensitivity when the Ct value is over 25, indicating that RAHT screening may be useful during the early phase of symptom onset, when the viral numbers are higher and it is more transmissible.

Indexed as

COVID-19Antigens, ViralCOVID-19 Serological TestingHumansMass ScreeningSARS-CoV-2Sensitivity and SpecificityAntigens, ViralCOVID-19 testingdiagnosispoint of careSARS-CoV-2

Identifiers

PMID35441745
PMCPMC9110955
OpenAlexW4224246584

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.