Clinical study on the detection of allergen specific IgE by Indirect chemiluminescent enzyme Immunoassay

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500105794

Enrollment

Unknown

Registered

2025-07-10

Start date

2025-07-10

Completion date

Unknown

Last updated

2025-07-14

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

Conditions

allergic diseases

Interventions

Gold Standard:Phadia ImmunoCAP fluorescence immunoassay method

Index test:indirect chemiluminescent enzyme immunoassay

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Positive for inhaled allergens?Positive for food allergens;

Exclusion criteria

Exclusion criteria: 1.Infection, autoimmune diseases;

Design outcomes

Primary

Measure	Time frame
limit of detection ( LOD) ;accuracy;precision;linear;stability;	—

Secondary

Measure	Time frame
allergens specific IgE (sIgE);	—

Countries

China

Contacts

Public ContactCui Yubao

Wuxi people’s Hospital

6801609@163.com+86 515 8535 0368

Outcome results

None listed

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