TY - JOUR
T1 - Accuracy of Xpert MTB/RIF Ultra for the diagnosis of tuberculosis in adult patients
T2 - a retrospective cohort study
AU - Kaswala, Chintan
AU - Schmiedel, Yvonne
AU - Kundu, Debasree
AU - George, Mithun Mohan
AU - Dayanand, Divya
AU - Devasagayam, Emily
AU - S, Abi Manesh
AU - Kumar, Selwyn Selva
AU - Michael, Joy S.
AU - Ninan, Marilyn M.
AU - Chacko, Geeta
AU - Zachariah, Anand
AU - Sathyendra, Sowmya
AU - Hansdak, Samuel George
AU - Iyadurai, Ramya
AU - Christopher, Devasahayam Jesudas
AU - Gupta, Richa
AU - Karthik, Rajiv
AU - Abraham, Ooriapadickal Cherian
AU - Varghese, George M.
N1 - Publisher Copyright:
© 2022 The Author(s)
PY - 2022/9/1
Y1 - 2022/9/1
N2 - Objectives: The value of the “trace” result in Xpert Ultra for diagnosing active tuberculosis (TB) remains unclear. Our study evaluated the diagnostic accuracy of Xpert MTB/RIF Ultra (Xpert Ultra) (Cepheid, Sunnyvale, USA) over Xpert MTB/RIF (Xpert) (Cepheid, Sunnyvale, USA) and mycobacterial culture when compared with a composite reference standard (CRS). Methods: A retrospective single-center observational study was conducted in a tertiary care hospital in South India. Over three months, patients (aged ≥15 years) data on Xpert Ultra tests and mycobacterial culture of pulmonary and extrapulmonary samples were extracted from their electronic medical records. Patients were defined as TB cases based on the CRS criteria. Sensitivity, specificity, positive and negative predictive values of diagnostic tests were calculated by comparing them to the CRS. Results: Xpert Ultra was more sensitive (87.8%) than Xpert (72.1%) and culture (44.1%). The specificity of Xpert Ultra was lower (98.1%) than those of Xpert (100%) and culture (100%). The sensitivity (92%) and specificity (100%) of Xpert Ultra were highest when performed on pus samples. Conclusions: Xpert Ultra with the trace category is superior to the conventional Xpert, and mycobacterial culture in identifying TB.
AB - Objectives: The value of the “trace” result in Xpert Ultra for diagnosing active tuberculosis (TB) remains unclear. Our study evaluated the diagnostic accuracy of Xpert MTB/RIF Ultra (Xpert Ultra) (Cepheid, Sunnyvale, USA) over Xpert MTB/RIF (Xpert) (Cepheid, Sunnyvale, USA) and mycobacterial culture when compared with a composite reference standard (CRS). Methods: A retrospective single-center observational study was conducted in a tertiary care hospital in South India. Over three months, patients (aged ≥15 years) data on Xpert Ultra tests and mycobacterial culture of pulmonary and extrapulmonary samples were extracted from their electronic medical records. Patients were defined as TB cases based on the CRS criteria. Sensitivity, specificity, positive and negative predictive values of diagnostic tests were calculated by comparing them to the CRS. Results: Xpert Ultra was more sensitive (87.8%) than Xpert (72.1%) and culture (44.1%). The specificity of Xpert Ultra was lower (98.1%) than those of Xpert (100%) and culture (100%). The sensitivity (92%) and specificity (100%) of Xpert Ultra were highest when performed on pus samples. Conclusions: Xpert Ultra with the trace category is superior to the conventional Xpert, and mycobacterial culture in identifying TB.
KW - Culture
KW - Mycobacterium tuberculosis
KW - Nucleic acid amplification tests
KW - Sensitivity
KW - Xpert MTB/RIF
KW - Xpert Ultra
KW - Rifampin/pharmacology
KW - Humans
KW - Tuberculosis/diagnosis
KW - Mycobacterium tuberculosis/genetics
KW - Sensitivity and Specificity
KW - Sputum/microbiology
KW - Adult
KW - Retrospective Studies
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U2 - 10.1016/j.ijid.2022.07.016
DO - 10.1016/j.ijid.2022.07.016
M3 - Article
C2 - 35811084
AN - SCOPUS:85134666594
SN - 1201-9712
VL - 122
SP - 566
EP - 568
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
ER -
