Dataset Information

The diagnostic accuracy of pericardial and urinary lipoarabinomannan (LAM) assays in patients with suspected tuberculous pericarditis.

ABSTRACT: We evaluated the diagnostic accuracy of urinary and pericardial fluid (PF) lipoarabinomannan (LAM) assays in tuberculous pericarditis (TBP). From October 2009 through September 2012, 151 patients with TBP were enrolled. Mycobacterium tuberculosis culture and/or pericardial histology were the reference standard for definite TBP. 49% (74/151), 33.1% (50/151) and 17.9% (27/151) of patients had definite-, probable-, and non-TB respectively; 69.5% (105/151) were HIV positive. LAM ELISA had the following sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value and negative predictive values (95% confidence interval): urinary - 17.4% (9.1-30.7), 93.8% (71.7-98.9), 2.8 (0.1-63.3), 0.9 (0.8-0.9), 88.9% (56.5-98.0), and 28.3% (17.9-41.6); PF - 11.6% (6.0-21.3), 88% (70.0-95.8), 0.9 (0.08-12.0), 1.0 (0.9-1.1), 72.7% (43.4-90.1), and 26.6% (18.2-36.9). Sensitivity increased with a CD4 ≤ 100 cells/mm(3) from 3.5% to 50% (p < 0.001) for urinary LAM ELISA; for urinary LAM strip test, grade 1 and 2 cut-points performed similarly, irrespective of HIV status or CD4 count. For PF LAM strip tests, switching cut-points from grade 1 to 2 significantly reduced test sensitivity (54.5% versus 19.7%; p < 0.001). Urinary and PF LAM assays have low sensitivity but high specificity for diagnosis of TBP. The sensitivity of urinary LAM is increased in HIV-infected patients with a CD4 ≤ 100 cells/mm(3).

SUBMITTER: Pandie S

PROVIDER: S-EPMC5025647 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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The diagnostic accuracy of pericardial and urinary lipoarabinomannan (LAM) assays in patients with suspected tuberculous pericarditis.

Pandie Shaheen S Peter Jonathan G JG Kerbelker Zita S ZS Meldau Richard R Theron Grant G Govender Ureshnie U Ntsekhe Mpiko M Dheda Keertan K Mayosi Bongani M BM

Scientific reports 20160916

We evaluated the diagnostic accuracy of urinary and pericardial fluid (PF) lipoarabinomannan (LAM) assays in tuberculous pericarditis (TBP). From October 2009 through September 2012, 151 patients with TBP were enrolled. Mycobacterium tuberculosis culture and/or pericardial histology were the reference standard for definite TBP. 49% (74/151), 33.1% (50/151) and 17.9% (27/151) of patients had definite-, probable-, and non-TB respectively; 69.5% (105/151) were HIV positive. LAM ELISA had the follow ...[more]

PMID: 27633798

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Project description:BACKGROUND:This study aimed to assess the diagnostic performance of Xpert MTB/RIF for tuberculous pericarditis (TBP) using pericardial tissues. METHODS:The study involved 30 patients admitted with suspected TBP from January-December 2016; three patients were later excluded. The interferon-γ release assay (T-SPOT.TB) and the Xpert MTB/RIF test were performed using peripheral blood and pericardial tissues, respectively. TBP was confirmed using pericardial histopathology and a composite reference standard (CRS). We analyzed the sensitivity, specificity, predictive value (PV), likelihood ratio (LR), and area under curve (AUC) of both assays. RESULTS:Fourteen patients were confirmed as TBP, 10 as non-TBP, and 3 as probable TBP. The sensitivity, specificity, positive PV (PPV), negative PV (NPV), PLR, NLR, and AUC (95% confidence interval [CI]) of the Xpert MTB/RIF assay were 78.6% (49.2-95.3%) and 70.6% (44.0-89.7%); 92.3% (64.0-99.8%) and 100% (69.2-100%); 91.7% (61.5-99.8%) and 100% (73.5-100%); 80.0% (51.9-95.7%) and 66.7% (38.4-88.2%); 10.21 (1.52-68.49) and the PLR value was undefined with CRS as the reference; 0.23 (0.08-0.64) and 0.29(0.14-0.61); and 0.854 (0.666-0.959) and 0.853 (0.664-0.959), against histopathology and CRS, respectively. The sensitivity, specificity, PPV, NPV, PLR, NLR, and AUC values (95% CI) of T-SPOT.TB were 92.9% (66.1-99.8%) and 94.1% (71.3-99.9%); 15.4% (1.9-45.5%) and 20.0% (2.5-55.6%); 54.2% (32.8-74.5%) and 66.7% (44.7-84.4%); 66.7% (9.4-99.2%) and 66.7% (9.4-99.2%); 1.10 (0.83-1.44) and 1.18 (0.84-1.6); 0.46 (0.05-4.53) and 0.29 (0.03-2.85); and 0.541(0.340-0.733) and 0.571(0.367-0.758), against histopathology and CRS, respectively. The differences in sensitivity, PPV, and AUC of Xpert MTB/RIF and T-SPOT.TB were not statistically significant (P > 0.05), compared to those of histopathology and CRS. However, the differences in specificity and NPV of the two assays were significant (P < 0.05), compared to those of histopathology and CRS. CONCLUSIONS:Xpert MTB/RIF test is a valid diagnostic technique for TBP with higher sensitivity and specificity than T-SPOT.TB.

Project description:BACKGROUNDInadequate tuberculosis (TB) diagnostics are a major hurdle in the reduction of disease burden, and accurate point-of-care tests (POCTs) are urgently needed. We assessed the diagnostic accuracy of Fujifilm SILVAMP TB lipoarabinomannan (FujiLAM) POCT for TB diagnosis in HIV-negative outpatients and compared it with Alere Determine TB LAM Ag (AlereLAM) POCT and a laboratory-based ultrasensitive electrochemiluminescence LAM research assay (EclLAM).METHODSIn this multicenter diagnostic test accuracy study, we recruited HIV-negative adults with symptoms suggestive of pulmonary TB presenting to outpatient health care centers in Peru and South Africa. Urine samples were tested using FujiLAM, AlereLAM, and EclLAM, and the diagnostic accuracy was assessed against a microbiological reference standard (MRS) and a composite reference standard.RESULTSThree hundred seventy-two HIV-negative participants were included and the prevalence of microbiologically confirmed TB was 30%. Compared with the MRS, the sensitivities of AlereLAM, FujiLAM, and EclLAM were 10.8% (95% confidence interval [CI] 6.3%-18.0%), 53.2% (95% CI 43.9%-62.1%), and 66.7% (95% CI 57.5%-74.7%), respectively. The specificities of AlereLAM, FujiLAM, and EclLAM were 92.3% (95% CI 88.5%-95.0%), 98.9% (95% CI 96.7%-99.6%), and 98.1% (95% CI 95.6%-99.2%), respectively. Positive likelihood ratios of AlereLAM, FujiLAM, and EclLAM were 1.4, 46.2, and 34.8, respectively, and positive predictive values were 37.5%, 95.2%, and 93.7%, respectively.CONCLUSIONCompared with AlereLAM, FujiLAM detected 5 times more patients with TB in HIV-negative participants, had a high positive predictive value, and has the potential to improve rapid diagnosis of TB at the point-of-care. EclLAM demonstrated that additional sensitivity gains are possible, which highlights LAM's potential as a biomarker. Additional research is required to assess FujiLAM's performance in prospective cohorts, its cost-effectiveness, and its impact in real-world clinical settings.FUNDINGGlobal Health Innovative Technology Fund, the UK Department for International Development, the Dutch Ministry of Foreign Affairs, the Bill and Melinda Gates Foundation, the Australian Department of Foreign Affairs and Trade, the German Federal Ministry of Education and Research through Kreditanstalt für Wiederaufbau, and the NIH and National Institute of Allergy and Infectious Diseases.

Dataset Information

The diagnostic accuracy of pericardial and urinary lipoarabinomannan (LAM) assays in patients with suspected tuberculous pericarditis.

Publications

The diagnostic accuracy of pericardial and urinary lipoarabinomannan (LAM) assays in patients with suspected tuberculous pericarditis.

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