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Applicability of a novel anti-lipoarabinomannan monoclonal antibody to detect Mycobacterium tuberculosis in formalin-fixed paraffin-embedded tissue

Applicability of a novel anti-lipoarabinomannan monoclonal antibody to detect Mycobacterium tuberculosis in formalin-fixed paraffin-embedded tissue

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20190906001
Enrollment
120
Registered
2019-09-06
Start date
2018-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis lipoarabinomannan immunohistochemistry AFB PCR tuberculosis

Interventions

The positive immunohistochemical image of anti&#45
lipoarabinomannan monoclonal antibody is a granular round dot. We count the dots in 1 hotspot under 40x to determine the cut&#45
off point yielding the best diagnostic ability.
Diagnostic
Tuberculosis&#44
Granuloma&#44
Lipoarabinomannan&#44
Immunohistochemistry

Sponsors

Ratchadapiseksompotch Fund, Faculty of Medicine
Lead Sponsor
Ratchadapiseksompotch Fund&#44
Collaborator
Faculty of Medicine
Collaborator

Eligibility

Sex/Gender
All
Age
0 Years to 90 Years

Inclusion criteria

Inclusion criteria: Cases with available PCR result from July 2017- December 2018

Exclusion criteria

Exclusion criteria: No paraffin block available in the department Insufficient tissue in the paraffin block No clinical information provided

Design outcomes

Primary

MeasureTime frame
Diagnostic ability of anti-lipoarabinomannan monoclonal antibody compared with culture immediately after complete staining evaluation Sensitivity, specificity, PPV, NPV—

Secondary

MeasureTime frame
Correlation between anti-lipoarabinomannan monoclonal antibody and histomorphology after complete staining evaluation ROC curve,Correlation between anti-lipoarabinomannan monoclonal antibody and immunocompromised status after complete staining evaluation ROC curve,Cut-off number of positive dots which is correlated with positive culture result after complete staining evaluation ROC curve—

Contacts

Public ContactMarisa Prasanpanich

Faculty of medicine, Chulalongkorn university

marisaprasanpanich@gmail.com+66959478015

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026