Comparison of nucleic acid sequence-based amplification and loop-mediated isothermal amplification for diagnosis of human African trypanosomiasis.
Diagnosis of human African trypanosomiasis (HAT) using molecular tests should ideally achieve high sensitivity without compromising specificity. This study compared 2 simplified tests, nucleic acid sequence-based amplification (NASBA) combined with oligochromatography (OC) and loop-mediated isothermal amplification (LAMP), executed on 181 blood samples from 65 Trypanosoma brucei gambiense HAT patients, 86 controls, and 30 serological suspects from Uganda. Basing on the composite reference standard, the diagnostic sensitivity and specificity of NASBA were 93.9% (95% confidence interval [CI] = 84.9-98.3%) and 100% (95% CI = 94.9-100%), respectively. The same parameters for LAMP were 76.9% (95% CI = 64.8-86.5%) and 100% (95% CI = 91.6-100%), respectively. The level of agreement between LAMP and microscopy was good with a kappa (κ) value of 79.2% (95% CI = 69.4-88.9%), while that of NASBA-OC/microscopy was very good (κ value 94.6%; 95% CI = 89.3-99.8%). The sensitivity of NASBA-OC was significantly higher than that of LAMP (Z = 2.723; P = 0.007). These tests have potential application to HAT surveillance.
School of Biosecurity Biotechnical Laboratory Sciences, College of Veterinary Medicine, Animal Resources and Biosecurity (COVAB), Makerere University Kampala, Uganda.
Claire M
CM
Mugasa
School of Biosecurity Biotechnical Laboratory Sciences, College of Veterinary Medicine, Animal Resources and Biosecurity (COVAB), Makerere University Kampala, Uganda.
Diana
D
Katiti
School of Biosecurity Biotechnical Laboratory Sciences, College of Veterinary Medicine, Animal Resources and Biosecurity (COVAB), Makerere University Kampala, Uganda.
Alex
A
Boobo
School of Biosecurity Biotechnical Laboratory Sciences, College of Veterinary Medicine, Animal Resources and Biosecurity (COVAB), Makerere University Kampala, Uganda.
George W
GW
Lubega
Koninklijk Instituut voor de Tropen (KIT)/Royal Tropical Institute, KIT Biomedical Research, Department of Parasitology, Amsterdam, The Netherlands.
Henk D F H
HD
Schallig
School of Biosecurity Biotechnical Laboratory Sciences, College of Veterinary Medicine, Animal Resources and Biosecurity (COVAB), Makerere University Kampala, Uganda. Electronic address: matovue@vetmed.mak.ac.ug.
Enock
E
Matovu
D016022:Case-Control Studies; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014345:Trypanosoma / Q000145:classification* / Q000235:genetics*; D014347:Trypanosoma brucei gambiense / Q000235:genetics; D014353:Trypanosomiasis, African / Q000175:diagnosis*
Human African Trypanosomiasis (HAT); LAMP; Molecular Diagnostics; NASBA