Abstract
Background and study aim: The use of LPA is still new in Nigeria and only available in TB reference laboratories. In this study, the performance of LPA version 2.0 was evaluated for the detection of resistant to first-line anti-TB drugs. Patients and Methods: We evaluated the performance of LPA version 2.0 for the detection of rifampicin (RIF) and isoniazid (INH) resistance. Sputum samples from 223 participants were subjected to phenotypic drug susceptibility testing (PDST) and LPA. Statistical analyses included calculation of sensitivity, specificity, positive and negative predictive values. Cross tabulation was done along the kappa test to measure the degree of agreement between PDST and LPA. P-Value > 0.05 was considered significant. Results: The overall sensitivity and specificity of 89.6% (95% C.I 82.5-94.5%) and 65.4% (95% C.I 44.3-82.7%) for detection of RIF resistance; for INH they were 76.6 (95% C.I 67.5-84.5%) and 76.7% (95% C.I 49.5-82.6%); and for MDR-TB, they were 67.0% (95% C.I 56.4-76.5%) and 72.0% (95% C.I 57.6-83.7%). The kappa values were 0.53 (0.001), 0.38 (p = 0.000) and 0.36 (p = 0.000) for the detection of RIF, INH and MDR-TB. There was moderate agreement between PDST and LPA for detection of RIF (κ = 0.57; P = 0.0001), INH (κ = 0.44; P = 0.0001), MDR-TB (κ = 0.43; P = 0.001). Conclusion: The Line probe assay has good sensitivity and specificity for detecting rifampicin and isoniazid. However, the overall performance is moderate; this should be considered when interpreting the assay’s results.
Highlights
Tuberculosis is a significant public health challenge
This study evaluates the performance of the line probe assay version 2.0 to detect rifampicin and isoniazid by using conventional 1% phenotypic drug susceptibility testing as the reference standard in Nigeria
Line Probe Assay (LPA) had 14 (6.0%) invalid results, 68 (30.5%) specimens with valid LPA results were excluded from the study analyses because they do not have the corresponding result for phenotypic drug susceptibility testing on Lowenstein Jensen (LJ) slant
Summary
Tuberculosis is a significant public health challenge. The world health organization (WHO) reported that over 10.4 million cases and 1.7 million deaths occur globally on an annual basis due to tuberculosis [1]. Nigeria and five other countries account for 60% of the global tuberculosis burden [2]. The incidence of tuberculosis cases in Nigeria was estimated at 345000 – 890000, with a potential of zoonotic tuberculosis grossly under-reported [3]. The EndTB program's significant challenges include rapid and accurate diagnosis of tuberculosis, development of drug resistance, and timely detection of drug-resistant tuberculosis. The use of LPA is still new in Nigeria and only available in TB reference laboratories. The performance of LPA version 2.0 was evaluated for the detection of resistant to first-line anti-TB drugs
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