Evidence map›Paper›PMID 33427483›Full record

ArticleBioanalysis2021

Key points of technical review for the registration of SARS-CoV-2 antigen/antibody tests.

Hongran Li, Jingyun He, Wen Bao, Peirong Wang, Yunfeng Lv, Chao Xu, Peng Hu, Yu Gao, Shengwei Zheng, Juanjuan An and 2 more

Open access · greenAbstract read
In one paragraph

Article in Bioanalysis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 44% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

12 authors at 1 institution in 1 country.

Hongran LiCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.
Jingyun HeCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.
Wen BaoCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.
Peirong WangCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.ORCID https://orcid.org/0000-0002-7736-9389
Yunfeng LvCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.ORCID https://orcid.org/0000-0002-8134-0415
Chao XuCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.
Peng HuCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.
Yu GaoCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.
Shengwei ZhengCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.
Juanjuan AnCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.
Gang DengCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.
Jinchun DongCenter for Medical Device Evaluation, NMPA, Building 1, No. 50 Qixiang Road, Haidian District, Beijing 100081, PR China.
National Medical Products Administration · CN

Funding

Ministry of Science and Technology 2020YFC0841200
6 · The paper itself

Abstract

Coronavirus disease-2019 (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread globally since its first report and become a worldwide pandemic. In response to the outbreak of COVID-19, Center for Medical Device Evaluation, NMPA (CMDE) initiated emergency review and approval procedures to accelerate the process of reviewing emergent medical products and issued the Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Tests (Key Points) to provide the requirements on the technical review of the tests. With uncontrolled spread and evolution of COVID-19 in the world, continuous prevention and measurements are necessary for fighting this pandemic and SARS-CoV-2 antigen/antibody tests are still urgently needed. This article is an attempt to expand clarification of the Key Points to wider audiences based on current understanding of SARS-CoV-2 to facilitate the development and application of SARS-CoV-2 antigen/antibody tests.

Indexed as

COVID-19 TestingAntibodies, ViralAntigen-Antibody ReactionsAntigens, ViralChinaClinical Trials as TopicCOVID-19Cross ReactionsHumansImmunoglobulin MLimit of DetectionPandemicsReference StandardsReproducibility of ResultsAntibodies, ViralAntigens, ViralImmunoglobulin MantibodyantigenregistrationSARS-CoV-2tests

Identifiers

PMID33427483
PMCPMC7814677
OpenAlexW3119511322

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.