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Medical records based study for the accuracy of SARS-CoV-2 IgM antibody screening for diagnosis of novel coronavirus pneumonia (COVID-19)

Accuracy analysis of SARS-CoV-2 IgM antibody screening for diagnosis of COVID-19

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030754
Enrollment
Unknown
Registered
2020-03-13
Start date
2020-03-11
Completion date
Unknown
Last updated
2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Gold Standard:2019 nCOV detection
Index test:SARS-CoV-2 IgM

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: patients with positive SARS-CoV-2 IgM antibody

Exclusion criteria

Exclusion criteria: recently diagnosed as a confirmed COVID-19 case

Design outcomes

Primary

MeasureTime frame
false positive rate of SARS-CoV-2 IgM antibody;SEN, SPE, ACC, AUC of ROC;—

Countries

China

Contacts

Public ContactZhanlian Huang

The Third Affiliated Hospital of Sun Yat-sen University

zhanlianh@163.com+86 13580584031

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026