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

Not yet recruiting

• Conditions: HIV Seropositivity; Blood Disease; Cancer
• Interventions: Diagnostic Test: HIV Ag +Ab Assay Kit (Sysmex)

• Registration Number: NCT05983536
• Lead Sponsor: Qianfoshan Hospital

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.

Study Timeline

• Study First Submitted: 2023-07-18
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Study First Posted: 2023-08-09
• Last Update Posted: 2023-08-09
• Study Start: 2023-09-20
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

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

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with blood diseases	HIV Ag +Ab Assay Kit (Sysmex)	Bone marrow aspiration and biopsy confirmed the blood disease
Cancer patients	HIV Ag +Ab Assay Kit (Sysmex)	Cancer patints that confirmed by pathological examination

Primary Outcome Measures

Name	Time	Method
The HIV Ab/Ag results	through study completion, an average of 1.5 year	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.