Novel coronavirus infection (COVID-19) IgM detection kit (magnetic particle chemiluminescence) clinical trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000031427

Enrollment

Unknown

Registered

2020-03-31

Start date

2020-03-25

Completion date

Unknown

Last updated

2020-04-06

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:PCR Nucleic acid detection

Index test:2019-nCov IgM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Novel coronavirus 2019-nCoV suspected cases, confirmed cases, excluded cases and clinical cases with negative detection of nucleic acid

Exclusion criteria

Exclusion criteria: (1) The time of sample collection or case information is not clear; (2) Sample size less than 200 uL; (3) Samples with severe hemolysis, lipemia and jaundice; (4) The researchers believe that the sample does not meet the test requirements.

Design outcomes

Primary

Measure	Time frame
SPE, SEN, ACC, AUC of ROC;	—

Secondary

Measure	Time frame
2019-nCov IgM;	—

Countries

China

Contacts

Public ContactXiang Changgang

the First People's Hospital of Jiangxia District

18971327286@163.com+86 18971327286

Outcome results

None listed

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