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Published on: April 9, 2012
Diagnostic value of two rapid immunochromatographic tests for suspected tuberculosis diagnosis in clinical practice
Sirisak Nanta1, Patcharee Kantipong, Panita Pathipvanich
1Clinical Epidemiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Insights
The endogenous immunochromatographic test for tuberculosis (ICT-TB) showed better diagnostic value than the exogenous ICT-TB, particularly for ruling in TB cases in specific patient subgroups. This local test offers a meaningful tool for initial TB screening.
Area of Science:
- Medical Diagnostics
- Infectious Diseases
- Immunology
Background:
- Tuberculosis (TB) diagnosis relies on accurate and accessible testing methods.
- Immunochromatographic tests for tuberculosis (ICT-TB) offer rapid detection potential.
- Comparing the diagnostic utility of different ICT-TB assays is crucial for clinical implementation.
Purpose of the Study:
- To evaluate and compare the diagnostic performance of two commercial immunochromatographic tests for tuberculosis (ICT-TB) in a clinical setting.
- To assess the effectiveness of an endogenous ICT-TB versus an exogenous ICT-TB.
Main Methods:
- An extended cross-sectional study involving 401 patients with suspected active TB.
- Utilized two commercial ICT-TB serum tests: an endogenous (local) and an exogenous (imported) test.
- Followed up with all subjects for two months to ascertain diagnoses.
Main Results:
- The endogenous ICT-TB demonstrated superior diagnostic values compared to the exogenous ICT-TB, except for specificity.
- Overall sensitivity was low for both tests (endogenous: 35.6%; exogenous: 13.7%), with high and equivalent specificity (93.7%).
- Diagnostic values were higher in human immunodeficiency virus (HIV) seronegatives and in HIV-seropositive patients with CD4+ cell counts over 200 cells/microL.
Conclusions:
- The endogenous ICT-TB serves as a valuable tool for first-line testing to help rule in suspected TB cases.
- HIV-seronegative individuals and HIV-seropositive patients with CD4+ counts above 200 cells/microL are likely to benefit most from this test.
- The findings support the use of the endogenous ICT-TB in specific clinical contexts for improved TB case identification.
Objective:
To evaluate and compare the diagnostic value of two immunochromatographic tests for tuberculosis (ICT-TB) in clinical practice.
Material And Method:
The present extended cross-sectional study investigated suspected active TB patients at Maesai district hospital, and Lampang regional hospital between April 2009 and May 2010. Subjects underwent two commercial ICT-TB serum tests including: an endogenous ICT-TB, a local made test coated with 38 kD, 16 kD, and 6 kD antigens; and an exogenous ICT-TB, an imported test coated with 38 kD and lipoarabinomanan [LAM] antigens. All subjects received two months of follow up.
Results:
Of 401 patients, 146 (36.4%) had active TB, and 206 (51.4%) were HIVseropositive. An endogenous ICT-TB was superior to an exogenous ICT-TB in all diagnostic values measured except for specificity. In all patients, sensitivity was low, 35.6% (95% CI: 30.9-40.3) in an endogenous ICT-TB vs. 13.7% (95% CI: 10.3-17.1) in an exogenous ICT-TB. The specificity was high and equivalent in both tests, 93.7% (95%CI: 91.4-96.1). Higher diagnostic values were found among human immunodeficiency virus (HIV) seronegatives than in HIV seropositives when unadjusted for CD4+ cell count level. The likelihood ratios (LHR) were higher in patients with CD4+ cell count over 200 cells/microL than for the HIV seronegative group (LHR+ 7.6 vs. 4.8 in an endogenous ICT-TB, and 2.5 vs. 1.9 in an exogenous ICT-TB).
Conclusion:
For the present study setting, an endogenous ICT-TB can be a meaningful tool for first-line testing to rule in TB suspected cases. Subgroups of HIV seronegative and HIV seropositive patients with CD4+ cell count over 200 cells/microL may be expected to benefit most from the test.
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