First clinical assessment of a prototype assay to detect the enzymatic activity of β-lactamase as a marker for pulmonary tuberculosis
The objective was to evaluate the sensitivity and specificity of a novel prototype test, TB REaD™, a reporter enzyme fluorescence-based assay, for pulmonary tuberculosis and to determine the optimal threshold for test positivity. This blinded, prospective study enrolled 250 patients, of which 23.2%...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article (Journal) |
| Language: | English |
| Published: |
19 February 2020
|
| In: |
Diagnostic microbiology and infectious disease
Year: 2020, Volume: 97, Issue: 2, Pages: 1-6 |
| ISSN: | 1879-0070 |
| DOI: | 10.1016/j.diagmicrobio.2020.115026 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://dx.doi.org/10.1016/j.diagmicrobio.2020.115026 Verlag, lizenzpflichtig, Volltext: http://www.sciencedirect.com/science/article/pii/S0732889319308181 
|
| Author Notes: | Pamela Nabeta, Pratibha Seshadri, Joshua Havumaki, Silindile Mbhele, Layla Hendricks, Mark D. Perkins, Mark P. Nicol, Claudia M. Denkinger |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1733303758 | ||
| 003 | DE-627 | ||
| 005 | 20231220105318.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 200918s2020 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.diagmicrobio.2020.115026 |2 doi | |
| 035 | |a (DE-627)1733303758 | ||
| 035 | |a (DE-599)KXP1733303758 | ||
| 035 | |a (OCoLC)1341360601 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Nabeta, Pamela |e VerfasserIn |0 (DE-588)1217867716 |0 (DE-627)1733305041 |4 aut | |
| 245 | 1 | 0 | |a First clinical assessment of a prototype assay to detect the enzymatic activity of β-lactamase as a marker for pulmonary tuberculosis |c Pamela Nabeta, Pratibha Seshadri, Joshua Havumaki, Silindile Mbhele, Layla Hendricks, Mark D. Perkins, Mark P. Nicol, Claudia M. Denkinger |
| 264 | 1 | |c 19 February 2020 | |
| 300 | |a 6 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Gesehen am 18.09.2020 | ||
| 520 | |a The objective was to evaluate the sensitivity and specificity of a novel prototype test, TB REaD™, a reporter enzyme fluorescence-based assay, for pulmonary tuberculosis and to determine the optimal threshold for test positivity. This blinded, prospective study enrolled 250 patients, of which 23.2% were Mycobacterium tuberculosis complex (MTB) culture-positive. At the manufacturer-set threshold, sensitivity of the assay was 93.1% (95% confidence interval [CI] 83.3-98.1) and specificity was 8.9% (95% CI 5.2-13.8). The highest accuracy was seen at a higher threshold: sensitivity 58.6% (95% CI 44.9-71.4), specificity 59.4% (95% CI 52.1%-66.4%), with sensitivity by smear status being 40.0% (95% CI 21.1-61.3) for smear-negative and 72.7% (95% CI 54.5-86.7) for smear-positive. This study demonstrated limited accuracy of the TB REaD™ prototype for detection of pulmonary TB. Further improvements are necessary, potentially exploring probes that are more specific to MTB. | ||
| 650 | 4 | |a Diagnosis | |
| 650 | 4 | |a TB REaD™ | |
| 650 | 4 | |a Tuberculosis | |
| 650 | 4 | |a β-Lactamase | |
| 700 | 1 | |a Seshadri, Pratibha |e VerfasserIn |4 aut | |
| 700 | 1 | |a Havumaki, Joshua |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mbhele, Silindile |e VerfasserIn |4 aut | |
| 700 | 1 | |a Hendricks, Layla |e VerfasserIn |4 aut | |
| 700 | 1 | |a Perkins, Mark D. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Nicol, Mark P. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Denkinger, Claudia M. |d 1978- |e VerfasserIn |0 (DE-588)131597701 |0 (DE-627)511279469 |0 (DE-576)298613727 |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Diagnostic microbiology and infectious disease |d Amsterdam [u.a.] : Elsevier Science, 1983 |g 97(2020), 2, Artikel-ID 115026, Seite 1-6 |h Online-Ressource |w (DE-627)32360479X |w (DE-600)2026024-6 |w (DE-576)264424107 |x 1879-0070 |7 nnas |a First clinical assessment of a prototype assay to detect the enzymatic activity of β-lactamase as a marker for pulmonary tuberculosis |
| 773 | 1 | 8 | |g volume:97 |g year:2020 |g number:2 |g elocationid:115026 |g pages:1-6 |g extent:6 |a First clinical assessment of a prototype assay to detect the enzymatic activity of β-lactamase as a marker for pulmonary tuberculosis |
| 856 | 4 | 0 | |u https://dx.doi.org/10.1016/j.diagmicrobio.2020.115026 |x Verlag |x Resolving-System |z lizenzpflichtig |3 Volltext |
| 856 | 4 | 0 | |u http://www.sciencedirect.com/science/article/pii/S0732889319308181 |x Verlag |z lizenzpflichtig |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20200918 | ||
| 993 | |a Article | ||
| 994 | |a 2020 | ||
| 998 | |g 131597701 |a Denkinger, Claudia M. |m 131597701:Denkinger, Claudia M. |d 910000 |d 911700 |e 910000PD131597701 |e 911700PD131597701 |k 0/910000/ |k 1/910000/911700/ |p 8 |y j | ||
| 999 | |a KXP-PPN1733303758 |e 3758548195 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"language":["eng"],"type":{"bibl":"article-journal","media":"Online-Ressource"},"name":{"displayForm":["Pamela Nabeta, Pratibha Seshadri, Joshua Havumaki, Silindile Mbhele, Layla Hendricks, Mark D. Perkins, Mark P. Nicol, Claudia M. Denkinger"]},"title":[{"title":"First clinical assessment of a prototype assay to detect the enzymatic activity of β-lactamase as a marker for pulmonary tuberculosis","title_sort":"First clinical assessment of a prototype assay to detect the enzymatic activity of β-lactamase as a marker for pulmonary tuberculosis"}],"recId":"1733303758","relHost":[{"physDesc":[{"extent":"Online-Ressource"}],"note":["Gesehen am 04.02.20"],"origin":[{"publisherPlace":"Amsterdam [u.a.]","dateIssuedDisp":"1983-","dateIssuedKey":"1983","publisher":"Elsevier Science"}],"id":{"eki":["32360479X"],"issn":["1879-0070"],"zdb":["2026024-6"]},"recId":"32360479X","disp":"First clinical assessment of a prototype assay to detect the enzymatic activity of β-lactamase as a marker for pulmonary tuberculosisDiagnostic microbiology and infectious disease","title":[{"title":"Diagnostic microbiology and infectious disease","title_sort":"Diagnostic microbiology and infectious disease"}],"part":{"extent":"6","issue":"2","volume":"97","year":"2020","pages":"1-6","text":"97(2020), 2, Artikel-ID 115026, Seite 1-6"},"type":{"bibl":"periodical","media":"Online-Ressource"},"language":["eng"],"pubHistory":["1.1983 -"]}],"id":{"doi":["10.1016/j.diagmicrobio.2020.115026"],"eki":["1733303758"]},"origin":[{"dateIssuedKey":"2020","dateIssuedDisp":"19 February 2020"}],"note":["Gesehen am 18.09.2020"],"person":[{"given":"Pamela","display":"Nabeta, Pamela","role":"aut","family":"Nabeta","roleDisplay":"VerfasserIn"},{"family":"Seshadri","roleDisplay":"VerfasserIn","role":"aut","display":"Seshadri, Pratibha","given":"Pratibha"},{"family":"Havumaki","roleDisplay":"VerfasserIn","role":"aut","display":"Havumaki, Joshua","given":"Joshua"},{"given":"Silindile","role":"aut","display":"Mbhele, Silindile","roleDisplay":"VerfasserIn","family":"Mbhele"},{"role":"aut","display":"Hendricks, Layla","given":"Layla","roleDisplay":"VerfasserIn","family":"Hendricks"},{"given":"Mark D.","role":"aut","display":"Perkins, Mark D.","roleDisplay":"VerfasserIn","family":"Perkins"},{"roleDisplay":"VerfasserIn","family":"Nicol","display":"Nicol, Mark P.","role":"aut","given":"Mark P."},{"family":"Denkinger","roleDisplay":"VerfasserIn","given":"Claudia M.","display":"Denkinger, Claudia M.","role":"aut"}],"physDesc":[{"extent":"6 S."}]} | ||
| SRT | |a NABETAPAMEFIRSTCLINI1920 | ||