Performance of loop-mediated isothermal amplification assay in the diagnosis of pulmonary tuberculosis in a high prevalence TB/HIV rural setting in Uganda

Lydia Nakiyingi, Prossy Nakanwagi, Jessica Briggs, Tifu Agaba, Frank Mubiru, Mark Mugenyi, Willy Ssengooba, Moses L. Joloba, Yukari C Manabe

Research output: Contribution to journalArticle

Abstract

Background: Smear microscopy lacks sensitivity especially in HIV co-infection, resulting in undiagnosed tuberculosis (TB) and high mortality. The loop-mediated isothermal amplification (TB-LAMP) assay can be staged with minimal infrastructure, is rapid, low cost and detection can be with the naked eye. We assessed feasibility and performance of Eiken TB-LAMP test at point-of-need in TB diagnosis in a high prevalence TB/HIV rural setting in Uganda. Methods: From October 2013-February 2014, TB-LAMP testing was performed on sputum specimens from outpatient presumptive TB adults at a district hospital and two low-level health centers in Kiboga District where smear microscopy is the available routine diagnostic option. TB-LAMP was performed by a technician after a week of training in the district hospital. The technician had no prior experience in the technology. Samples from the low-level health centers were transported to the district hospital for TB-LAMP. Results: Of the 233 presumptive TB (126 at hospital); 113 (48.5%) were HIV-infected; 129 (55%) male, median age 40 (IQR 30-53). Compared to MTB culture, overall sensitivity and specificity of TB-LAMP were 55.4% (95 CI 44.1-66.3) and 98.0% (95 CI 94.3-99.6) respectively. Among HIV-infected participants, TB-LAMP sensitivity and specificity were 52.3% (95 CI 36.7-67.5%) and 97.1% (95 CI 89.9-99.6) respectively; and 24.4% (95% CI 12.9-39.5) and 98.6% (95% CI 95.1-99.8) respectively among smear-negatives. TB-LAMP sensitivity and specificity were 62.2% (95% CI 44.8-77.5) and 97.8% (95% CI 92.1-99.7) in the hospital setting where central testing occurred compared to 50.0% (95% CI 34.9-65.1) and 98.4% (95% CI 91.2-100) respectively in low-level health centers where specimens were transported centrally. Conclusions: In this high prevalence TB/HIV rural setting, TB-LAMP performs better than conventional smear microscopy in diagnosis of MTB among presumptive TB patients although the sensitivity is lower than that reported by the World Health Organization. TB-LAMP can easily be performed following a short training period and in absence of sophisticated infrastructure and expertise.

Original languageEnglish (US)
Article number87
JournalBMC Infectious Diseases
Volume18
Issue number1
DOIs
StatePublished - Feb 21 2018

Fingerprint

Uganda
Pulmonary Tuberculosis
Tuberculosis
HIV
District Hospitals
Health Status
Microscopy
Sensitivity and Specificity

Keywords

  • Diagnostic
  • LAMP
  • Microscopy
  • Rural
  • Tuberculosis
  • Uganda

ASJC Scopus subject areas

  • Infectious Diseases

Cite this

Performance of loop-mediated isothermal amplification assay in the diagnosis of pulmonary tuberculosis in a high prevalence TB/HIV rural setting in Uganda. / Nakiyingi, Lydia; Nakanwagi, Prossy; Briggs, Jessica; Agaba, Tifu; Mubiru, Frank; Mugenyi, Mark; Ssengooba, Willy; Joloba, Moses L.; Manabe, Yukari C.

In: BMC Infectious Diseases, Vol. 18, No. 1, 87, 21.02.2018.

Research output: Contribution to journalArticle

Nakiyingi, Lydia ; Nakanwagi, Prossy ; Briggs, Jessica ; Agaba, Tifu ; Mubiru, Frank ; Mugenyi, Mark ; Ssengooba, Willy ; Joloba, Moses L. ; Manabe, Yukari C. / Performance of loop-mediated isothermal amplification assay in the diagnosis of pulmonary tuberculosis in a high prevalence TB/HIV rural setting in Uganda. In: BMC Infectious Diseases. 2018 ; Vol. 18, No. 1.
@article{b751439b816247c1a0d3e9f6e95df09a,
title = "Performance of loop-mediated isothermal amplification assay in the diagnosis of pulmonary tuberculosis in a high prevalence TB/HIV rural setting in Uganda",
abstract = "Background: Smear microscopy lacks sensitivity especially in HIV co-infection, resulting in undiagnosed tuberculosis (TB) and high mortality. The loop-mediated isothermal amplification (TB-LAMP) assay can be staged with minimal infrastructure, is rapid, low cost and detection can be with the naked eye. We assessed feasibility and performance of Eiken TB-LAMP test at point-of-need in TB diagnosis in a high prevalence TB/HIV rural setting in Uganda. Methods: From October 2013-February 2014, TB-LAMP testing was performed on sputum specimens from outpatient presumptive TB adults at a district hospital and two low-level health centers in Kiboga District where smear microscopy is the available routine diagnostic option. TB-LAMP was performed by a technician after a week of training in the district hospital. The technician had no prior experience in the technology. Samples from the low-level health centers were transported to the district hospital for TB-LAMP. Results: Of the 233 presumptive TB (126 at hospital); 113 (48.5{\%}) were HIV-infected; 129 (55{\%}) male, median age 40 (IQR 30-53). Compared to MTB culture, overall sensitivity and specificity of TB-LAMP were 55.4{\%} (95 CI 44.1-66.3) and 98.0{\%} (95 CI 94.3-99.6) respectively. Among HIV-infected participants, TB-LAMP sensitivity and specificity were 52.3{\%} (95 CI 36.7-67.5{\%}) and 97.1{\%} (95 CI 89.9-99.6) respectively; and 24.4{\%} (95{\%} CI 12.9-39.5) and 98.6{\%} (95{\%} CI 95.1-99.8) respectively among smear-negatives. TB-LAMP sensitivity and specificity were 62.2{\%} (95{\%} CI 44.8-77.5) and 97.8{\%} (95{\%} CI 92.1-99.7) in the hospital setting where central testing occurred compared to 50.0{\%} (95{\%} CI 34.9-65.1) and 98.4{\%} (95{\%} CI 91.2-100) respectively in low-level health centers where specimens were transported centrally. Conclusions: In this high prevalence TB/HIV rural setting, TB-LAMP performs better than conventional smear microscopy in diagnosis of MTB among presumptive TB patients although the sensitivity is lower than that reported by the World Health Organization. TB-LAMP can easily be performed following a short training period and in absence of sophisticated infrastructure and expertise.",
keywords = "Diagnostic, LAMP, Microscopy, Rural, Tuberculosis, Uganda",
author = "Lydia Nakiyingi and Prossy Nakanwagi and Jessica Briggs and Tifu Agaba and Frank Mubiru and Mark Mugenyi and Willy Ssengooba and Joloba, {Moses L.} and Manabe, {Yukari C}",
year = "2018",
month = "2",
day = "21",
doi = "10.1186/s12879-018-2992-1",
language = "English (US)",
volume = "18",
journal = "BMC Infectious Diseases",
issn = "1471-2334",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Performance of loop-mediated isothermal amplification assay in the diagnosis of pulmonary tuberculosis in a high prevalence TB/HIV rural setting in Uganda

AU - Nakiyingi, Lydia

AU - Nakanwagi, Prossy

AU - Briggs, Jessica

AU - Agaba, Tifu

AU - Mubiru, Frank

AU - Mugenyi, Mark

AU - Ssengooba, Willy

AU - Joloba, Moses L.

AU - Manabe, Yukari C

PY - 2018/2/21

Y1 - 2018/2/21

N2 - Background: Smear microscopy lacks sensitivity especially in HIV co-infection, resulting in undiagnosed tuberculosis (TB) and high mortality. The loop-mediated isothermal amplification (TB-LAMP) assay can be staged with minimal infrastructure, is rapid, low cost and detection can be with the naked eye. We assessed feasibility and performance of Eiken TB-LAMP test at point-of-need in TB diagnosis in a high prevalence TB/HIV rural setting in Uganda. Methods: From October 2013-February 2014, TB-LAMP testing was performed on sputum specimens from outpatient presumptive TB adults at a district hospital and two low-level health centers in Kiboga District where smear microscopy is the available routine diagnostic option. TB-LAMP was performed by a technician after a week of training in the district hospital. The technician had no prior experience in the technology. Samples from the low-level health centers were transported to the district hospital for TB-LAMP. Results: Of the 233 presumptive TB (126 at hospital); 113 (48.5%) were HIV-infected; 129 (55%) male, median age 40 (IQR 30-53). Compared to MTB culture, overall sensitivity and specificity of TB-LAMP were 55.4% (95 CI 44.1-66.3) and 98.0% (95 CI 94.3-99.6) respectively. Among HIV-infected participants, TB-LAMP sensitivity and specificity were 52.3% (95 CI 36.7-67.5%) and 97.1% (95 CI 89.9-99.6) respectively; and 24.4% (95% CI 12.9-39.5) and 98.6% (95% CI 95.1-99.8) respectively among smear-negatives. TB-LAMP sensitivity and specificity were 62.2% (95% CI 44.8-77.5) and 97.8% (95% CI 92.1-99.7) in the hospital setting where central testing occurred compared to 50.0% (95% CI 34.9-65.1) and 98.4% (95% CI 91.2-100) respectively in low-level health centers where specimens were transported centrally. Conclusions: In this high prevalence TB/HIV rural setting, TB-LAMP performs better than conventional smear microscopy in diagnosis of MTB among presumptive TB patients although the sensitivity is lower than that reported by the World Health Organization. TB-LAMP can easily be performed following a short training period and in absence of sophisticated infrastructure and expertise.

AB - Background: Smear microscopy lacks sensitivity especially in HIV co-infection, resulting in undiagnosed tuberculosis (TB) and high mortality. The loop-mediated isothermal amplification (TB-LAMP) assay can be staged with minimal infrastructure, is rapid, low cost and detection can be with the naked eye. We assessed feasibility and performance of Eiken TB-LAMP test at point-of-need in TB diagnosis in a high prevalence TB/HIV rural setting in Uganda. Methods: From October 2013-February 2014, TB-LAMP testing was performed on sputum specimens from outpatient presumptive TB adults at a district hospital and two low-level health centers in Kiboga District where smear microscopy is the available routine diagnostic option. TB-LAMP was performed by a technician after a week of training in the district hospital. The technician had no prior experience in the technology. Samples from the low-level health centers were transported to the district hospital for TB-LAMP. Results: Of the 233 presumptive TB (126 at hospital); 113 (48.5%) were HIV-infected; 129 (55%) male, median age 40 (IQR 30-53). Compared to MTB culture, overall sensitivity and specificity of TB-LAMP were 55.4% (95 CI 44.1-66.3) and 98.0% (95 CI 94.3-99.6) respectively. Among HIV-infected participants, TB-LAMP sensitivity and specificity were 52.3% (95 CI 36.7-67.5%) and 97.1% (95 CI 89.9-99.6) respectively; and 24.4% (95% CI 12.9-39.5) and 98.6% (95% CI 95.1-99.8) respectively among smear-negatives. TB-LAMP sensitivity and specificity were 62.2% (95% CI 44.8-77.5) and 97.8% (95% CI 92.1-99.7) in the hospital setting where central testing occurred compared to 50.0% (95% CI 34.9-65.1) and 98.4% (95% CI 91.2-100) respectively in low-level health centers where specimens were transported centrally. Conclusions: In this high prevalence TB/HIV rural setting, TB-LAMP performs better than conventional smear microscopy in diagnosis of MTB among presumptive TB patients although the sensitivity is lower than that reported by the World Health Organization. TB-LAMP can easily be performed following a short training period and in absence of sophisticated infrastructure and expertise.

KW - Diagnostic

KW - LAMP

KW - Microscopy

KW - Rural

KW - Tuberculosis

KW - Uganda

UR - http://www.scopus.com/inward/record.url?scp=85042460163&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85042460163&partnerID=8YFLogxK

U2 - 10.1186/s12879-018-2992-1

DO - 10.1186/s12879-018-2992-1

M3 - Article

C2 - 29466946

AN - SCOPUS:85042460163

VL - 18

JO - BMC Infectious Diseases

JF - BMC Infectious Diseases

SN - 1471-2334

IS - 1

M1 - 87

ER -