Clinical Microbiology Costs for Methods of Active Surveillance for <i>Klebsiella pneumoniae</i> Carbapenemase–Producing Enterobacteriaceae

Mathers, Amy J; Poulter, Melinda D.; Dirks, Dawn; Carroll, Joanne; Sifri, Costi D.; Hazen, Kevin C.

doi:10.1086/675603

Cited by 40 publications

(43 citation statements)

References 14 publications

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“…Similarly, during an outbreak of NDM-producing CRE in a Colorado hospital, a total of 90 h of technologist time was dedicated to working up growth of 135 Enterobacteriaceae isolates that were ultimately found to be carbapenem susceptible among 560 CRE surveillance cultures performed (17). Despite the additional effort, the CDC method has been found to be less sensitive than other methods, including those that employ chromogenic media (18,19). However, the chromogenic media available for CRE, including ChromID Carba (bioMérieux, Durham NC), HardyChrom CRE (Hardy Diagnostics, Santa Maria, CA), and Brilliance CRE agar (Remel, Lenexa KS), are marked as research use only (RUO) at this time, limiting their utility for clinical practice.…”

mentioning

confidence: 99%

Commentary: Continuing Challenges for the Clinical Laboratory for Detection of Carbapenem-Resistant Enterobacteriaceae

Humphries

McKinnell

2015

J Clin Microbiol

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Over the last decade, carbapenem-resistant Enterobacteriaceae (CRE) have become an urgent threat to health in the United States and elsewhere in the world (1, 2). The Centers for Disease Control and Prevention (CDC) have reported a steady increase in the burden of disease from CRE, particularly, carbapenem-resistant Klebsiella pneumoniae, in the United States (3, 4). Surveillance data from Chicago showed that 30% of residents of long-termacute-care hospitals (LTACHs) and 3.3% of patients in hospital intensive care units (ICUs) were CRE carriers, suggesting that CRE infections are now endemic in parts of the United States (5). The spread of CRE in the U.S. health care system comes at a great cost because there are limited available treatment options and high attributable mortality from CRE (6, 7).Spread of CRE in the United States appears to be driven by movement of patients though the health care system (8, 9). For instance, the CDC epicenters program demonstrated that patient transfers led to regional spread of CRE across 26 health care facilities in four counties (8). The transfer of CRE-colonized patients not only moves these organisms between institutions but also accelerates the epidemic through subsequent patient transmission events at each institution as the incidence of CRE increases (10) (11). To this point, a study of New York hospitals found that the odds of a patient acquiring CRE increased by 15% for each 1% increase in overall patient colonization at the facility (12).Recent research has shown some promising findings for curbing the spread of CRE. Hayden and colleagues demonstrated that the use of an infection prevention bundle that included chlorhexidine bathing and strict isolation practices in a high-CRE-burden LTACH was able to significantly reduce the rates of both new CRE acquisitions and bacteremia cases (13). Computer model estimates suggest that a coordinated regional response, compared to individual hospital actions, has the potential to reduce or even eliminate CRE transmission (10, 11).Such interventions require an understanding of the prevalence of CRE at the institutional level. However, the true burden of CRE at the local, regional, or national level remains poorly understood. Our limited understanding of CRE burden is due in part to challenges faced by the clinical laboratory at identifying CRE-in both clinical and surveillance cultures. In 2010, the Clinical and Laboratory Standards Institute (CLSI) revised the carbapenem breakpoints for the Enterobacteriaceae, and the U.S. Food and Drug Administration (FDA) followed suit by revising the drug product labeling to include these revised breakpoints. However, no manufacturer of commercial automated antimicrobial susceptibility test (AST) systems has obtained FDA clearance for these new standards, despite over 5 years having passed since their approval. Almost all laboratories in the United States rely on these systems for routine AST, and few have the resources to conduct the studies required to establish the performance of these syste...

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confidence: 99%

Commentary: Continuing Challenges for the Clinical Laboratory for Detection of Carbapenem-Resistant Enterobacteriaceae

Humphries

McKinnell

2015

J Clin Microbiol

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“…Nonetheless, the improved turnaround time and improved accuracy of NAATs and direct carbapenemase detection assays may result in limiting the unnecessary prolonged isolation of newly admitted patients, thus decreasing costs to the infection control program. Nevertheless, molecular tests with high sensitivity have a cost that is difficult to offset and can be prohibitive for many clinical microbiology laboratories (136). We must choose wisely.…”

Section: Discussionmentioning

confidence: 99%

“…As shown, the cost, labor intensity, and turnaround time vary by assay. Mathers et al reported that the annual costs of a surveillance program for a hospital containing 708 acute-care beds and 40 long-term beds with weekly screening and a CPE prevalence of 2.7% were about $225,000 for a qPCR (quantitative real-time PCR) assay and $23,000 for the CDC screening culture method (136). Although Mathers et al accounted for the cost of decreased specificity, the cost of decreased sensitivity is much more difficult to calculate.…”

Section: Screening Methods To Detect Fecal Carriage Of Cposmentioning

confidence: 99%

Intestinal Carriage of Carbapenemase-Producing Organisms: Current Status of Surveillance Methods

et al. 2016

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SUMMARYCarbapenemases have become a significant mechanism for broad-spectrum β-lactam resistance inEnterobacteriaceaeand other Gram-negative bacteria such asPseudomonasandAcinetobacterspp. Intestinal carriage of carbapenemase-producing organisms (CPOs) is an important source of transmission. Isolation of carriers is one strategy that can be used to limit the spread of these bacteria. In this review, we critically examine the clinical performance, advantages, and disadvantages of methods available for the detection of intestinal carriage of CPOs. Culture-based methods (Centers for Disease Control and Prevention [CDC] protocols, chromogenic media, specialized agars, and double-disk synergy tests) for detecting carriage of CPOs are convenient due to their ready availability and low cost, but their limited sensitivity and long turnaround time may not always be optimal for infection control practices. Contemporary nucleic acid amplification techniques (NAATs) such as real-time PCR, hybridization assays, loop-mediated isothermal amplification (LAMP), or a combined culture and NAAT approach may provide fast results and/or added sensitivity and specificity compared with culture-based methods. Infection control practitioners and clinical microbiologists should be aware of the strengths and limitations of available methods to determine the most suitable approach for their medical facility to fit their infection control needs.

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“…In comparison to the costs associated with culture ($3 to $8 for a negative sample and ϳ$14 to ϳ18 for a positive sample [33]), the cost for Check-Direct CPE was ϳ$24 (including extraction for both positive and negative samples). In an attempt to minimize costs, we evaluated the effect of pooling specimens into groups of three or five.…”

Section: Discussionmentioning

confidence: 99%

Clinical Performance of Check-Direct CPE, a Multiplex PCR for Direct Detection of bla _KPC , bla _NDM and/or bla _VIM , and bla _OXA-48 from Perirectal Swabs

et al. 2015

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We evaluated the clinical performance of Check-Direct CPE for carbapenemase detection directly from 301 perirectal swabs (258 patients) in a nonoutbreak setting. Culture of a PCR-confirmed, carbapenemase-containing organism, or history of colonization with such organism within the previous 2 weeks, was used as the reference standard. Check-Direct CPE demonstrated a sensitivity value, specificity value, positive predictive value (PPV), and negative predictive value (NPV) of 100% (all bla KPC ), 88%, 21%, and 100%, respectively. False positives accounted for 79% (n ‫؍‬ 34) of samples for which a cycle threshold (C T ) value was reached. Simulated studies to evaluate specimen pooling as an approach to minimize costs showed no difference in C T values for pooled groups of three or five that each contained a single specimen spiked with ϳ1,500 CFU bla KPC Klebsiella pneumoniae; however, the detection rate dropped to 60% at a seeded concentration of ϳ150 CFU. When data were pooled, C T values for bla KPC were higher for heavy-feces-containing than for light-feces-containing liquid-suspended specimens. Furthermore, C T values for liquid-suspended specimens were 4 to 5 C T values lower (i.e., represented greater sensitivity) than those seen in direct swab analysis. Culture was equivalent to or better than Check-Direct CPE for 13/15 (87%) isolates tested in a limit-of-detection analysis. Detection of a carbapenemase gene at a C T cutoff value of <35 was culture confirmed in 23/24 (96%) of cases; however, C T values of >35 overlapped broadly between culture-positive (n ‫؍‬ 21) and culture-negative (n ‫؍‬ 36) specimens. Check-Direct CPE will likely prove most useful in high-prevalence areas or in outbreak settings where rapid carbapenemase detection is critical for infection control management. C arbapenemase-producing organism (CPO) infections are now globally epidemic, causing rising concern as they demonstrate easy transmissibility between patients and the environment, with increasing numbers of reported outbreaks (1-4). The morbidity and mortality associated with CPO infections are high, and effective therapeutic options are limited. Recent data show that bla KPC , bla NDM , and bla OXA-48 are the most common carbapenemases worldwide (5). Carbapenemase detection, however, can be complicated, and detection methods are not standardized among laboratories. Because gastrointestinal colonization with a CPO is a reservoir for transmission (6), routine CPO surveillance via collection of rectal/perirectal swabs or stool samples is increasingly being utilized in many infection control programs (7) and is recommended by public health agencies such as the Centers for Disease Control and Prevention (CDC) (8).Current methods for CPO surveillance generally rely on culture using selective media. The Clinical and Laboratory Standards Institute (CLSI) recommends performing carbapenemase testing on Enterobacteriaceae isolates (i) with imipenem or meropenem MICs of 2 to 4 g/ml or an ertapenem MIC of 2 g/ml (if using the 2010 M100-S20 brea...

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Clinical Microbiology Costs for Methods of Active Surveillance for Klebsiella pneumoniae Carbapenemase–Producing Enterobacteriaceae

Cited by 40 publications

References 14 publications

Commentary: Continuing Challenges for the Clinical Laboratory for Detection of Carbapenem-Resistant Enterobacteriaceae

Commentary: Continuing Challenges for the Clinical Laboratory for Detection of Carbapenem-Resistant Enterobacteriaceae

Intestinal Carriage of Carbapenemase-Producing Organisms: Current Status of Surveillance Methods

Clinical Performance of Check-Direct CPE, a Multiplex PCR for Direct Detection of bla _KPC , bla _NDM and/or bla _VIM , and bla _OXA-48 from Perirectal Swabs

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Clinical Microbiology Costs for Methods of Active Surveillance for Klebsiella pneumoniae Carbapenemase–Producing Enterobacteriaceae

Cited by 40 publications

References 14 publications

Commentary: Continuing Challenges for the Clinical Laboratory for Detection of Carbapenem-Resistant Enterobacteriaceae

Commentary: Continuing Challenges for the Clinical Laboratory for Detection of Carbapenem-Resistant Enterobacteriaceae

Intestinal Carriage of Carbapenemase-Producing Organisms: Current Status of Surveillance Methods

Clinical Performance of Check-Direct CPE, a Multiplex PCR for Direct Detection of bla KPC , bla NDM and/or bla VIM , and bla OXA-48 from Perirectal Swabs

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Clinical Performance of Check-Direct CPE, a Multiplex PCR for Direct Detection of bla _KPC , bla _NDM and/or bla _VIM , and bla _OXA-48 from Perirectal Swabs