Abstract
In order to investigate the diagnostic performance characteristics of four phenotypic assays in detecting carbapenem-resistant Enterobacteriaceae (CRE), we collected the CRE strains from infected patients. The results of carbapenemase gene detection, bla KPC-2, bla OXA-23, bla NDM-1, bla NDM-4, bla NDM-5, bla IMP-4, and bla IMP-8, were used as a standard to evaluate the performances of combined disk test (CDT), modified carbapenem inactivation method(mCIM)/EDTA-modified carbapenem inactivation method(eCIM), NG-Test CARBA 5 (CARBA), and color developing immunoassay (CDI). The compliance of phenotype results based on CDT, mCIM/eCIM, CARBA, and CDI with genetic detection results was 94% (231/247), 95% (235/247), 98% (242/247), and 99% (246/247), respectively. CDT demonstrated a low specificity for carbapenemase detection, low negative predictive value (NPV), and low sensitivity for metallo-β-lactamase (79%, 55%, and 88%, respectively); it also failed to accurately detect IMP. The mCIM/eCIM assay had serious problems in detecting OXA-23-like carbapenemases. The sensitivity and specificity of CARBA and CDI were higher than those of the first two methods. However, CARBA did not cover the detection of OXA-23, while CDI cannot detect IMP-8, resulting in low NPVs (70% and 88%, respectively). In conclusion, CARBA and CDI assays are highly accurate except individual rare genes and allow direct genotype detections. CDT and mCIM/eCIM assays are moderately accurate and can only distinguish serine-β-lactamases from metallo-β-lactamases. Laboratories should choose the appropriate method that meets their needs based on its characteristic.
Highlights
Results observation: If the inhibition zones around disk #2 and #4 increased in diameter by ≥5 mm compared to those around disk #1, the strain was considered to be positive for class A or class C serine-b-lactamase production
Six Enterobacter cloacae strains and two K. pneumoniae strains were found positive for bla IMP, all of which were blaIMP-4, except for strain 323, which had blaIMP-8. blaOXA-23 was detected in two Serratia marcescens strains, one Enterobacter aerogenes strain, one E. coli strains, and one K. pneumoniae strain
This led to a reduction in the specificity for carbapenemase detection to 79%
Summary
Our aim was to provide informative references for laboratories to carry out carbapenemase assays
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