The sensitivity and specificity of loop-mediated isothermal amplification (LAMP) assay for tuberculosis diagnosis in adults with chronic cough in Malawi

Marriott Nliwasa, Peter MacPherson, Palesa Chisala, Mercy Kamdolozi, McEwen Khundi, Kruger Kaswaswa, Mphatso Mwapasa, Chisomo Msefula, Hojoon Sohn, Clare Flach, Elizabeth L. Corbett

Research output: Contribution to journalArticle

Abstract

Background: 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. Objective: 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. Methods: 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. Results: 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). Conclusion: 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.

Original languageEnglish (US)
Article numbere0155101
JournalPloS one
Volume11
Issue number5
DOIs
StatePublished - May 1 2016
Externally publishedYes

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Diagnostic Reagent Kits
middle-aged adults
Nucleic Acid Amplification Techniques
Malawi
cough
HIV infections
young adults
chronic diseases
Fluorescence Microscopy
Cough
tuberculosis
HIV Infections
fluorescence microscopy
Young Adult
Tuberculosis
Chronic Disease
Sensitivity and Specificity
assays
HIV
Costs and Cost Analysis

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

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The sensitivity and specificity of loop-mediated isothermal amplification (LAMP) assay for tuberculosis diagnosis in adults with chronic cough in Malawi. / Nliwasa, Marriott; MacPherson, Peter; Chisala, Palesa; Kamdolozi, Mercy; Khundi, McEwen; Kaswaswa, Kruger; Mwapasa, Mphatso; Msefula, Chisomo; Sohn, Hojoon; Flach, Clare; Corbett, Elizabeth L.

In: PloS one, Vol. 11, No. 5, e0155101, 01.05.2016.

Research output: Contribution to journalArticle

Nliwasa, M, MacPherson, P, Chisala, P, Kamdolozi, M, Khundi, M, Kaswaswa, K, Mwapasa, M, Msefula, C, Sohn, H, Flach, C & Corbett, EL 2016, 'The sensitivity and specificity of loop-mediated isothermal amplification (LAMP) assay for tuberculosis diagnosis in adults with chronic cough in Malawi', PloS one, vol. 11, no. 5, e0155101. https://doi.org/10.1371/journal.pone.0155101
Nliwasa, Marriott ; MacPherson, Peter ; Chisala, Palesa ; Kamdolozi, Mercy ; Khundi, McEwen ; Kaswaswa, Kruger ; Mwapasa, Mphatso ; Msefula, Chisomo ; Sohn, Hojoon ; Flach, Clare ; Corbett, Elizabeth L. / The sensitivity and specificity of loop-mediated isothermal amplification (LAMP) assay for tuberculosis diagnosis in adults with chronic cough in Malawi. In: PloS one. 2016 ; Vol. 11, No. 5.
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abstract = "Background: 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. Objective: 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{\circledR} MTB/RIF, fluorescence smear microscopy. Methods: 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{\circledR} MTB/RIF and fluorescence smear microscopy. Sensitivity and specificity (with culture as reference standard), and costs were estimated. Results: 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{\circledR} 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{\circledR} MTB/RIF (US$ 13.38) but higher than fluorescence smear microscopy (US$ 0.65). Conclusion: The sensitivity of LAMP was similar to Xpert{\circledR} 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{\circledR} MTB/RIF prioritised for people living with HIV, already found to be smear-negative, or being considered for retreatment of tuberculosis.",
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AU - Chisala, Palesa

AU - Kamdolozi, Mercy

AU - Khundi, McEwen

AU - Kaswaswa, Kruger

AU - Mwapasa, Mphatso

AU - Msefula, Chisomo

AU - Sohn, Hojoon

AU - Flach, Clare

AU - Corbett, Elizabeth L.

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N2 - Background: 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. Objective: 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. Methods: 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. Results: 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). Conclusion: 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.

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