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PLoS One. 2011 Jan 21;6(1):e16425. doi: 10.1371/journal.pone.0016425.

Validation of the ALS assay in adult patients with culture confirmed pulmonary tuberculosis.

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1
International Centre for Diarrhoeal Diseases Research, Bangladesh, Dhaka, Bangladesh.

Abstract

BACKGROUND:

We have earlier shown that Bacille Calmette-Guérin (BCG) vaccine-specific IgG Antibodies in Lymphocyte Supernatant (ALS) can be used for diagnosis of active tuberculosis (TB) in adults and children.

METHODOLOGY/PRINCIPAL FINDINGS:

The ALS method was validated in a larger cohort (n = 212) of patients with suspicion of pulmonary TB using multiple antigens (BCG, LAM, TB15.3, TB51A, CFP10-ESAT6-A, CFP, CW) from Mycobacterium tuberculosis. The sensitivity and specificity of the ALS assay was calculated using non-TB patients as controls. The sensitivity and the specificity were highest with BCG vaccine (90% and 88% respectively) followed by LAM (89% and 87% respectively). Simultaneous assessment of multiple antigen-specific antibodies increased sensitivity (91%) and specificity (88%). Using higher lymphocyte count in smaller volume of culture media increased detection and reduced the assay duration to ∼30 hrs. Twenty one patients with clinical findings strongly suggestive of TB finally diagnosed as non-TB patients were positive by the ALS assay, of which 9 (43%) were positive for 7 antigens and 19 (90%) for at least 3 antigens.

CONCLUSIONS/SIGNIFICANCE:

Our findings show that simultaneous detection of antigens improves the diagnostic potential of the ALS assay; the modified method increases sensitivity and can provide results in <48 hours, and enable detection of some cases of pulmonary TB that are not detectable by standard methods.

PMID:
21283655
PMCID:
PMC3025031
DOI:
10.1371/journal.pone.0016425
[Indexed for MEDLINE]
Free PMC Article
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