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Clinical trial of human immunodeficiency virus antigen and antibody detection kit (chemiluminescence method)

Clinical trial of human immunodeficiency virus antigen and antibody detection kit (chemiluminescence method)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000033312
Enrollment
Unknown
Registered
2020-05-27
Start date
2020-06-15
Completion date
Unknown
Last updated
2020-06-01

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

Conditions

Human Immunodeficiency Virus

Interventions

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Western blotting
HIV nucleic acid testing.
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Sponsors

Beijing You'an Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Normal Group (those who meet the following two criteria): (1) The HIV antigen and antibody of the samples tested with the marketed reagent were negative. (2) Population without the interference type shown in table 1 in clinical protocol. 2.Interference Group (those who meet the following two criteria at the same time) : (1) The HIV antigen and antibody of the samples tested with the marketed reagent were negative. (2) The intervention population was included in combination with clinical diagnosis or test results. 3. Positive Group (HIV infection group): Patients clinically diagnosed as AIDS or HIV infection, or with HIV antibody confirmation test report.

Exclusion criteria

Exclusion criteria: 1. Turbid samples, samples with obvious microbial pollution; 2. The collection, processing and storage of samples do not meet the requirements of standard laboratory operation and product specification; 3. The sample size is not enough to complete the test.

Design outcomes

Primary

MeasureTime frame
HIV;Consistency;

Countries

China

Contacts

Public ContactChuanmin Tao

West China Hospital of Sichuan University

taochuanmin@sina.com+86 18980601661

Outcome results

None listed

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