Essential attributes of an acceptable in vitro diagnostic test

Author(s):  
Abdel B. Halim
1999 ◽  
Vol 29 (10) ◽  
pp. 1402-1411 ◽  
Author(s):  
May ◽  
Weber ◽  
Gall ◽  
Kaufmann ◽  
Zollner

1985 ◽  
Vol 75 (1) ◽  
pp. 123 ◽  
Author(s):  
J AMEISEN ◽  
M JOSEPH ◽  
A TONNEL ◽  
E FOURNIER ◽  
B WALLAERT ◽  
...  

Antibiotics ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. 460
Author(s):  
Junsung Hong ◽  
Dayoung Kang ◽  
Dokyun Kim

The objective of this study was to evaluate the performance of the RESIST-5 O.K.N.V.I. assay for identifying these five common domestic carbapenemases among a large number of clinical isolates in South Korea. A total of 268 non-duplicated clinical isolates of gram-negative bacilli were included in this study as follows: 258 carbapenemase-producing (CP) strains (OXA-48-like, KPC, NDM, VIM, IMP, GES, OXA-23 and two or more carbapenemase producers) and 10 non-CP carbapenem-resistant Enterobacterales (non-CP CREs). Overall sensitivity and specificity were 98.4% and 100%, respectively. In addition, all non-targeted carbapenemase producers including GES and OXA-23 producers and non-CP CREs were correctly identified as negative results. There were only four discrepant cases in which three VIM carbapenemase producers and one NDM carbapenemase producer were not detected. The RESIST-5 O.K.N.V.I. assay as an in vitro diagnostic test for detecting five common carbapenemases provided rapid and accurate results in a short time, indicating that this method could provide an innovative solution for early detection, resulting in appropriate antimicrobial treatment in the clinical field.


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