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Trial Title:
The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)
NCT ID:
NCT05983536
Condition:
HIV Seropositivity
Cancer
Blood Disease
Conditions: Official terms:
HIV Seropositivity
Hematologic Diseases
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
HIV Ag +Ab Assay Kit (Sysmex)
Description:
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.
Arm group label:
Cancer patients
Arm group label:
Patients with blood diseases
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.
Criteria for eligibility:
Study pop:
Cancer patients and blood disease patients with age over 18 and have an HIV test in that
very day.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Clinical diagnosis of tumor Disease or blood disease
- Blood samples must meet the test requirements
Exclusion Criteria:
- N/A
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Start date:
September 20, 2023
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Qianfoshan Hospital
Agency class:
Other
Source:
Qianfoshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05983536
