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

NCT05983536 | Unknown DMC

• 1 other identifier: 89269678
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

HIV Seropositivity; Cancer; Blood Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cancer patients

Cancer patints that confirmed by pathological examination

Diagnostic Test: HIV Ag +Ab Assay Kit (Sysmex)

Patients with blood diseases

Bone marrow aspiration and biopsy confirmed the blood disease

Diagnostic Test: HIV Ag +Ab Assay Kit (Sysmex)

Interventions

HIV Ag +Ab Assay Kit (Sysmex) DIAGNOSTIC_TEST

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.

Cancer patients; Patients with blood diseases

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients and blood disease patients with age over 18 and have an HIV test in that very day.

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Related 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.

  PMID: 35512447 BACKGROUND

• 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.

  PMID: 33441741 BACKGROUND

MeSH Terms

Conditions

HIV Seropositivity; Neoplasms; Hematologic Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xia Zhao, Master

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanxiang Chen, Ph.D.

CONTACT

0531-89269678; okayhensen@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 9, 2023
• Study Start: September 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: August 9, 2023

Record last verified: 2023-08