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Tuberculosis (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients. Urine based detection of lipoarabinomannan (LAM) provides promising methods for quick diagnosis of TB in HIV-infected patients. However, the sensitivity and specificity of TB-LAM is still not well established, especially in area where non-tuberculosis mycobacterium is also prevalence. Here we aimed to evaluate the clinical utility of TB-LAM in diagnosis of active TB in hospitalized HIV-infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnosis arm | Experimental | Urine TB-LAM, sputum smear, Gene Xpert, mycobacterial culture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alere TB-LAM | Diagnostic Test | Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity against microbiological reference standard | Number of TB-LAM positive/Number of positive by culture or Gene Xpert | 2 months |
| Specificity against microbiological reference standard | 1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity against composite reference standard | Number of TB-LAM positive/Number of active TB diagnosed clinically | 2 months |
| Specificity against composite reference standard | 1-Number of TB-LAM negative/Number of TB excluded |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Chen, M.D | Contact | +86-21-37990333 | 3222 | qtchenjun@163.com |
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Participant data without individual identification can be provided upon request.
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| 2 months |
| 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 |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |