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To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the detection of HIV antigens and antibodies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer patients | Cancer patints that confirmed by pathological examination |
| |
| Patients with blood diseases | Bone marrow aspiration and biopsy confirmed the blood disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Cancer patients and blood disease patients with age over 18 and have an HIV test in that very day.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanxiang Chen, Ph.D. | Contact | 0531-89269678 | okayhensen@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xia Zhao, Master | Qianfoshan Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35512447 | Background | 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. | |
| 33441741 |
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The planed will be shared after the clinical trial is completed and the patent protection is obtained
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006425 | Hemic and Lymphatic Diseases |