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Modification of clearview tuberculosis (TB) enzyme-linked immunosorbent assay for TB patients not infected with HIV.

ABSTRACT: Diagnosis of active tuberculosis by detection of urinary lipoarabinomannan (uLAM) from Mycobacterium tuberculosis is an attractive approach. Concentrating urine 100-fold allowed quantitation of uLAM at levels equal to picograms/ml of nonconcentrated urine. The approach of concentrating urine 100-fold improved the clinical sensitivity of the Clearview TB enzyme-linked immunosorbent assay (ELISA) from 7% to 57% yet impaired its specificity from 97% to 89%. (This study has been registered at University Hospital of Turku under registration no. 47/180/2009, Helsinki University Central Hospital under 149/2010, University Hospital of Kuopio under 105/2010, and China Medical University Hospital, Taichung, under DMR-99-IRB-075-2.).

SUBMITTER: Savolainen L

PROVIDER: S-EPMC3889579 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Modification of clearview tuberculosis (TB) enzyme-linked immunosorbent assay for TB patients not infected with HIV.

Savolainen Laura L Kantele Anu A Sandboge Bettina B Sirén Marita M Valleala Heikki H Tuompo Riitta R Pusa Liana L Erkinjuntti-Pekkanen Riitta R Knuuttila Aija A Ku Cheng-Lung CL Chi Chih-Yu CY Vasankari Tuula T Tuuminen Tamara T

Clinical and vaccine immunology : CVI 20130703 9

Diagnosis of active tuberculosis by detection of urinary lipoarabinomannan (uLAM) from Mycobacterium tuberculosis is an attractive approach. Concentrating urine 100-fold allowed quantitation of uLAM at levels equal to picograms/ml of nonconcentrated urine. The approach of concentrating urine 100-fold improved the clinical sensitivity of the Clearview TB enzyme-linked immunosorbent assay (ELISA) from 7% to 57% yet impaired its specificity from 97% to 89%. (This study has been registered at Univer ...[more]

PMID: 23825194

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Project description:The laboratory diagnosis of latent tuberculosis infection (LTBI) is mainly performed with interferon gamma release assays (IGRAs). We compared the performance of a new enzyme-linked immunosorbent assay (ELISA)-based IGRA, the Standard E TB-Feron ELISA (TBF; SD Biosensor, Gyeonggi-do, Republic of Korea), with that of a widely used assay, the QuantiFERON-TB Gold In-Tube assay (QFT-GIT; Qiagen, Hilden, Germany), in a population of 425 health care workers (HCWs). All HCWs were screened by both assays per the manufacturers' protocols and in a cross-manner, where tube sets from one assay were used with the alternative ELISA. The results were compared both qualitatively and quantitatively. TBF and QFT-GIT identified 11.3% (48/425) and 12.9% (55/425) of the positive samples, respectively. TBF demonstrated 81.6% positive and 97.4% negative percent agreement with QFT-GIT, with a Cohen's kappa value of 0.78 (strong agreement). Discordant results were detected in 20 subjects (4.3%): 13 samples (65.0%) were TBF negative and QFT-GIT positive, 6 samples (30.0%) were TBF positive and QFT-GIT negative, and 1 sample provided TBF and QFT-GIT indeterminate/negative results. We observed a statistically significant degree of correlation between the interferon gamma reactivity between the two assays (Spearman's rho [rs ] value = 0.551, P < 0.01) and between standard assays and cross-manner tests (rs value range, 0.449 to 0.816; P < 0.01 for all combinations). Cross-manner tests also revealed that the ELISA kit of TBF provided higher values for the tube containing the tuberculosis (TB) antigen and the negative-control tube than the ELISA of QFT-GIT under the same conditions (P < 0.01), although these differences disappeared when the value for the negative-control tube was subtracted from that for the TB antigen tube. TBF showed a comparable and acceptable clinical performance in detecting LTBI compared to QFT-GIT. TBF represents a useful alternative tool as an ELISA-based IGRA, especially for large-scale screening for LTBI in HCWs.

Dataset Information

Modification of clearview tuberculosis (TB) enzyme-linked immunosorbent assay for TB patients not infected with HIV.

Publications

Modification of clearview tuberculosis (TB) enzyme-linked immunosorbent assay for TB patients not infected with HIV.

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