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NCT05983536 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05983536
Other study ID # 89269678
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 20, 2023
Est. completion date July 31, 2025

Study information
Verified date August 2023
Source Qianfoshan Hospital
Contact Hanxiang Chen, Ph.D.
Phone 0531-89269678
Email okayhensen@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1200
Est. completion date July 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of tumor Disease or blood disease - Blood samples must meet the test requirements Exclusion Criteria: - N/A

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• HIV 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Qianfoshan Hospital

References & Publications (2)

Alali M, Carlucci JG, Christenson J, Prather C, Skiles J. Case Series of False-Positive HIV Test Results in Pediatric Acute Lymphoblastic Leukemia Patients Following Chimeric Antigen Receptor T-Cell Therapy: Guidance on How to Avoid and Resolve Diagnostic Dilemmas. J Pediatric Infect Dis Soc. 2022 Aug 30;11(8):383-385. doi: 10.1093/jpids/piac028. — View Citation

Lu X, Zhang M, Liu W, Sheng N, Du Q, Zhang M, Guo X, Wang G, Wang Q. A method to alleviate false-positive results of the Elecsys HIV combi PT assay. Sci Rep. 2021 Jan 13;11(1):1033. doi: 10.1038/s41598-020-80047-0. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The HIV Ab/Ag results The 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. through study completion, an average of 1.5 year
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