Non-actionable results, accuracy and effect of the first- and second-line line probe assays for diagnosing drug resistant tuberculosis, including on smear-negative specimens, in a high-volume laboratory (Record no. 486)
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042 ## - AUTHENTICATION CODE | |
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Authentication code | dc |
100 10 - MAIN ENTRY--PERSONAL NAME | |
Personal name | Pillay, S |
Relator term | author |
9 (RLIN) | 2949 |
245 00 - TITLE STATEMENT | |
Title | Non-actionable results, accuracy and effect of the first- and second-line line probe assays for diagnosing drug resistant tuberculosis, including on smear-negative specimens, in a high-volume laboratory |
260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
Date of publication, distribution, etc. | 2022-07-05. |
500 ## - GENERAL NOTE | |
General note | /pmc/articles/PMC7614164/ |
500 ## - GENERAL NOTE | |
General note | /pubmed/35788278 |
520 ## - SUMMARY, ETC. | |
Summary, etc. | BACKGROUND: Rapid drug susceptibility testing (DST) is crucial to confirm eligibility for new tuberculosis (TB) regimens. Genotype MTBDRsl is a widely-deployed World Health Organization (WHO)-endorsed assay yet programmatic performance data, including non-actionable results from smear-negative sputum, are scarce. METHODS: Sputa from Xpert MTB/RIF-rifampicin resistant individuals (n=951) were tested by Genotype MTBDRplus and MTBDRsl (both v2) in a routine laboratory. Phenotypic DST was the second-line drug reference standard. Discrepant results underwent Sanger sequencing. FINDINGS: 89% (849/951) individuals were culture-positive [56% (476/849) smear-negative]. MTBDRplus had at least one non-actionable result (control and/or TB-detection bands absent or invalid, precluding resistance reporting) in 19% (92/476) of smear-negatives and, for MTBDRsl, 40% (171/427) were non-actionable [28% (120/427) false-negative TB, 17% (51/427) indeterminate]. In smear-negatives, MTBDRsl sensitivity for fluoroquinolones was 84% (95% CI 67-93), 81% (54-95) for second-line injectables, and 57% (28-82) for both. Specificities were 93% (89-98), 88% (81-93), and 97% (91-99), respectively. 23% (172/746) of Xpert rifampicin-resistant specimens were MTBDRplus isoniazid-susceptible. Days-to-second-line-susceptibility reporting with the programmatic advent of MTBDRsl improved [6 (5-7) vs. 37 (35-46); p<0.001]. CONCLUSION: MTBDRsl did not generate a result in almost half of smear-negative individuals (4/10 failed), resulting in substantial missed resistance. However, if MTBDRsl generates an actionable result, that result is accurate in ruling-in second-line resistance. Isoniazid susceptibility testing remains crucial. This study provides, in the context of WHO guidance, real-world direct second-line susceptibility testing performance data on non-actionable results (which, if unaccounted for, result in an overestimation of test utility), accuracy, and care cascade impact. |
540 ## - TERMS GOVERNING USE AND REPRODUCTION NOTE | |
Terms governing use and reproduction | |
546 ## - LANGUAGE NOTE | |
Language note | en |
690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
Topical term or geographic name as entry element | Article |
655 7# - INDEX TERM--GENRE/FORM | |
Genre/form data or focus term | Text |
Source of term | local |
700 10 - ADDED ENTRY--PERSONAL NAME | |
Personal name | de Vos, M |
Relator term | author |
9 (RLIN) | 2950 |
700 10 - ADDED ENTRY--PERSONAL NAME | |
Personal name | Derendinger, B |
Relator term | author |
9 (RLIN) | 2951 |
700 10 - ADDED ENTRY--PERSONAL NAME | |
Personal name | Streicher, E |
Relator term | author |
9 (RLIN) | 2952 |
700 10 - ADDED ENTRY--PERSONAL NAME | |
Personal name | Dolby, T |
Relator term | author |
9 (RLIN) | 2953 |
700 10 - ADDED ENTRY--PERSONAL NAME | |
Personal name | Scott, LA |
Relator term | author |
9 (RLIN) | 2954 |
700 10 - ADDED ENTRY--PERSONAL NAME | |
Personal name | Steinhobel, AD |
Relator term | author |
9 (RLIN) | 2955 |
700 10 - ADDED ENTRY--PERSONAL NAME | |
Personal name | Warren, RM |
Relator term | author |
9 (RLIN) | 2956 |
700 10 - ADDED ENTRY--PERSONAL NAME | |
Personal name | Theron, G |
Relator term | author |
9 (RLIN) | 2957 |
786 0# - DATA SOURCE ENTRY | |
Note | Clin Infect Dis |
856 41 - ELECTRONIC LOCATION AND ACCESS | |
Uniform Resource Identifier | <a href="http://dx.doi.org/10.1093/cid/ciac556">http://dx.doi.org/10.1093/cid/ciac556</a> |
Public note | Connect to this object online. |
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