The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)
Study Details
Study Description
Brief Summary
To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the detection of HIV antigens and antibodies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cancer patients Cancer patints that confirmed by pathological examination |
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.
|
| Patients with blood diseases Bone marrow aspiration and biopsy confirmed the blood disease |
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical diagnosis of tumor Disease or blood disease
-
Blood samples must meet the test requirements
Exclusion Criteria:
- N/A
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Qianfoshan Hospital
Investigators
- Principal Investigator: Xia Zhao, Master, Qianfoshan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 89269678