Skip to content

The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)

The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05983536
Enrollment
1200
Registered
2023-08-09
Start date
2023-09-20
Completion date
2025-07-31
Last updated
2023-08-09

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

Conditions

Blood Disease, Cancer, HIV Seropositivity

Brief summary

To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the detection of HIV antigens and antibodies.

Detailed description

First,HIV Ag +Ab Assay Kit (Sysmex)Assay Kit (Sysmex) was used to detect HIV antigens and antibodies in the serum of patients with tumor and blood diseases, and then confirmed by using the gold standard for HIV diagnosis,human immunodeficiency virus (HIV type 1+2) antibody assay kit (immunoimprinting). The specificity of HIV Ag +Ab Assay Kit (Sysmex) for HIV assay in patients with tumor and hematological diseases was calculated.

Interventions

DIAGNOSTIC_TESTHIV Ag +Ab Assay Kit (Sysmex)

Using the HIV Ag +Ab Assay Kit (Sysmex) to detect the HIV antigen and antibody in serum, then verified by Human Immunodeficiency Virus (HIV 1+2) Antibody Test Kit (Immunoimprinting). The specificity of the HIV Ag +Ab Assay Kit (Sysmex) is calculated according to the specificity calculation formula.

Sponsors

Qianfoshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of tumor Disease or blood disease * Blood samples must meet the test requirements

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
The HIV Ab/Ag resultsthrough study completion, an average of 1.5 yearThe HIV Ab/Ag results generated using HIV Ag +Ab Assay Kit (Sysmex) and the gold standard method for HIV test. The results will be recoreded seperately.

Contacts

Primary ContactHanxiang Chen, Ph.D.
okayhensen@163.com0531-89269678

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026