Evidence map›Paper›PMID 35188408›Full record

ReviewBioanalysis2022

China's NMPA perspective on the clinical performance of SARS-CoV-2 antigen test reagents.

Yunfeng Lv, Yu Gao, Jingyun He, Chao Xu, Rongzhi Liu, Shengwei Zheng, Li Fang, Congyin Han, Ran Li

Abstract readReview
In one paragraph

Review in Bioanalysis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Article
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

9 authors.

Yunfeng LvCenter for Medical Device Evaluation, NMPA, Beijing, 100081, PR China.ORCID 0000-0002-8134-0415
Yu GaoCenter for Medical Device Evaluation, NMPA, Beijing, 100081, PR China.
Jingyun HeCenter for Medical Device Evaluation, NMPA, Beijing, 100081, PR China.
Chao XuCenter for Medical Device Evaluation, NMPA, Beijing, 100081, PR China.
Rongzhi LiuCenter for Medical Device Evaluation, NMPA, Beijing, 100081, PR China.
Shengwei ZhengCenter for Medical Device Evaluation, NMPA, Beijing, 100081, PR China.
Li FangCenter for Medical Device Evaluation, NMPA, Beijing, 100081, PR China.
Congyin HanCenter for Medical Device Evaluation, NMPA, Beijing, 100081, PR China.
Ran LiCenter for Medical Device Evaluation, NMPA, Beijing, 100081, PR China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The COVID-19 pandemic continues to spread all over the world. In the process of emergency use authorization, the Center for Medical Device Evaluation of the China National Medical Products Administration issued 'Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents' as the guidance of registration of antigen and antibody test reagents for the industry. In this document, clinical evaluation requirements of antigen detection reagents are elaborated. Based on the Key Points document and the authors' review practice, this article explains the evaluation methods and requirements of clinical performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests, then analyzes the application scenarios and intended use of antigen detection reagents.

Indexed as

Antigens, ViralChinaClinical Trials as TopicCOVID-19 Nucleic Acid TestingCOVID-19 Serological TestingHumansIndicators and ReagentsReagent Kits, DiagnosticSARS-CoV-2Specimen HandlingAntigens, ViralIndicators and ReagentsReagent Kits, DiagnosticAg-RDTsantigen testclinical evaluationCOVID-19SARS-CoV-2

Identifiers

PMID35188408
PMCPMC8860178

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.