Nliwasa, Marriott, MacPherson, Peter 
ORCID: 0000-0002-0329-9613, Chisala, Palesa, Kamdolozi, Mercy, Khundi, McEwen, Kaswaswa, Kruger, Mwapasa, Mphatso, Msefula, Chisomo, Sohn, Hojoon, Flach, Clare et al (show 1 more authors)
(2016)
The Sensitivity and Specificity of Loop-Mediated Isothermal Amplification (LAMP) Assay for Tuberculosis Diagnosis in Adults with Chronic Cough in Malawi.
PLOS ONE, 11 (5).
e0155101-.
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Abstract
<h4>Background</h4>Current tuberculosis diagnostics lack sensitivity, and are expensive. Highly accurate, rapid and cheaper diagnostic tests are required for point of care use in low resource settings with high HIV prevalence.<h4>Objective</h4>To investigate the sensitivity and specificity, and cost of loop-mediated isothermal amplification (LAMP) assay for tuberculosis diagnosis in adults with chronic cough compared to Xpert® MTB/RIF, fluorescence smear microscopy.<h4>Methods</h4>Between October 2013 and March 2014, consecutive adults at a primary care clinic were screened for cough, offered HIV testing and assessed for tuberculosis using LAMP, Xpert® MTB/RIF and fluorescence smear microscopy. Sensitivity and specificity (with culture as reference standard), and costs were estimated.<h4>Results</h4>Of 273 adults recruited, 44.3% (121/273) were HIV-positive and 19.4% (53/273) had bacteriogically confirmed tuberculosis. The sensitivity of LAMP compared to culture was 65.0% (95% CI: 48.3% to 79.4%) with 100% (95% CI: 98.0% to 100%) specificity. The sensitivity of Xpert® MTB/RIF (77.5%, 95% CI: 61.5% to 89.2%) was similar to that of LAMP, p = 0.132. The sensitivity of concentrated fluorescence smear microscopy with routine double reading (87.5%, 95% CI: 73.2% to 95.8%) was higher than that of LAMP, p = 0.020. All three tests had high specificity. The lowest cost per test of LAMP was at batch size of 14 samples (US$ 9.98); this was lower than Xpert® MTB/RIF (US$ 13.38) but higher than fluorescence smear microscopy (US$ 0.65).<h4>Conclusion</h4>The sensitivity of LAMP was similar to Xpert® MTB/RIF but lower than fluorescence smear microscopy; all three tests had high specificity. These findings support the Malawi policy that recommends a combination of fluorescence smear microscopy and Xpert® MTB/RIF prioritised for people living with HIV, already found to be smear-negative, or being considered for retreatment of tuberculosis.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Humans, Tuberculosis, HIV Infections, Cough, Chronic Disease, Reagent Kits, Diagnostic, Sensitivity and Specificity, Nucleic Acid Amplification Techniques, Adolescent, Adult, Middle Aged, Malawi, Female, Male, Young Adult |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 13 May 2016 12:47 |
| Last Modified: | 19 Jan 2023 07:36 |
| DOI: | 10.1371/journal.pone.0155101 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3001228 |
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