The Sensitivity and Specificity of Loop-Mediated Isothermal Amplification (LAMP) Assay for Tuberculosis Diagnosis in Adults with Chronic Cough in Malawi

Autor: Clare Flach, Chisomo L. Msefula, Marriott Nliwasa, Kruger Kaswaswa, Mercy Kamdolozi, Mphatso Mwapasa, Peter MacPherson, Hojoon Sohn, McEwen Khundi, Elizabeth L. Corbett, Palesa Chisala
Rok vydání: 2016
Předmět:
Male
Bacterial Diseases
RNA viruses
0301 basic medicine
Malawi
Physiology
Human immunodeficiency virus (HIV)
lcsh:Medicine
wc_503
HIV Infections
Pathology and Laboratory Medicine
medicine.disease_cause
Gastroenterology
Fluorescence Microscopy
0302 clinical medicine
Immunodeficiency Viruses
Medicine and Health Sciences
Public and Occupational Health
030212 general & internal medicine
lcsh:Science
Microscopy
Multidisciplinary
biology
Light Microscopy
HIV diagnosis and management
Middle Aged
Vaccination and Immunization
Body Fluids
3. Good health
Actinobacteria
Chronic cough
Infectious Diseases
Medical Microbiology
Viral Pathogens
Viruses
Tuberculosis Diagnosis and Management
Female
wf_200
wb_141
Pathogens
Anatomy
medicine.symptom
Nucleic Acid Amplification Techniques
Research Article
Adult
medicine.medical_specialty
Tuberculosis
Adolescent
Immunology
wc_503_5
Loop-mediated isothermal amplification
Antiretroviral Therapy
wa_395
Research and Analysis Methods
Sensitivity and Specificity
Microbiology
Mycobacterium tuberculosis
Young Adult
03 medical and health sciences
Antiviral Therapy
Tuberculosis diagnosis
Diagnostic Medicine
Internal medicine
Retroviruses
medicine
Humans
Microbial Pathogens
Bacteria
business.industry
lcsh:R
Lentivirus
Organisms
Sputum
Biology and Life Sciences
HIV
Nucleic acid amplification technique
Tropical Diseases
biology.organism_classification
medicine.disease
Mucus
030104 developmental biology
Cough
Chronic Disease
wf_220
lcsh:Q
Reagent Kits
Diagnostic
Preventive Medicine
business
Mycobacterium Tuberculosis
Zdroj: PLoS ONE
Nliwasa, M, MacPherson, P, Chisala, P, Kamdolozi, M, Khundi, M, Kaswaswa, K, Mwapasa, M, Msefula, C, Sohn, H, Flach, C & Corbett, E L 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, pp. e0155101 . https://doi.org/10.1371/journal.pone.0155101
PLoS ONE, Vol 11, Iss 5, p e0155101 (2016)
PLOS ONE
ISSN: 1932-6203
Popis: Background\ud 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.\ud \ud Objective\ud 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.\ud \ud Methods\ud 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.\ud \ud Results\ud 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).\ud \ud Conclusion\ud 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.
Databáze: OpenAIRE
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