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Validation of Rectal Swab Specimens for Sensitive and Specific Carbapenemase Gene Detection in Pediatric Patients
Majie C Foster1, Kailee Cummings1, Shannon L Morris1
1New York State Department of Health, Wadsworth Center, Albany, NY, United States.
Insights
The Cepheid Xpert® Carba-R Assay is accurate for detecting carbapenem-resistant bacteria in pediatric patients. This validation ensures reliable surveillance for carbapenemase-producing organisms in younger populations.
Area of Science:
- Clinical Microbiology
- Infectious Diseases
- Molecular Diagnostics
Background:
- Carbapenem-resistant gram-negative bacteria (CRGNB) pose a significant public health threat.
- The Centers for Disease Control and Prevention (CDC) recommends surveillance for CRGNB using the Cepheid Xpert® Carba-R Assay.
- A limitation of the current assay is the lack of validation data for pediatric patients (<21 years).
Purpose of the Study:
- To validate the Cepheid Xpert® Carba-R Assay for detecting carbapenemase-producing organisms (CPOs) in pediatric patients.
- To address the gap in surveillance data for CRGNB in individuals under 21 years of age.
Main Methods:
- In-house validation using pediatric stool specimens from patients aged <1 to 21 years.
- Specimens were spiked with common CRGNB harboring various carbapenemase mechanisms (e.g., KPC, NDM, OXA-48, VIM, IMP).
- Validation involved molecular and culture analysis of 747 pediatric clinical specimens and pooled stool samples.
Main Results:
- The Cepheid Xpert® Carba-R Assay demonstrated 100% accuracy and excellent precision when using pediatric stool-spiked rectal swabs.
- Clinical surveillance data from over 24,000 rectal specimens (2018-2024) showed significantly lower carbapenemase detection rates in pediatric patients (0-20 years) compared to adults (>21 years).
- No significant age-related differences were found in the ability to isolate detected carbapenemase mechanisms from patient specimens.
Conclusions:
- The Cepheid Copan Dual Swab Collection Device and Xpert® Carba-R Assay are validated for rapid (<1 hour) screening of CPOs in pediatric patients.
- This assay provides a reliable tool for carbapenemase surveillance in the pediatric population.
- The findings support the use of this assay for reducing the spread of CRGNB in younger individuals.
Background:
To reduce the spread of carbapenem-resistant gram-negative bacteria, the Centers for Disease Control recommends rectal and perirectal swab surveillance using the Cepheid Xpert® Carba-R Assay. An expressed limitation of the assay is lack of validation data for patients <21 years. To address this limitation, an in-house validation was performed using pediatric stool specimens from patients <21 years.
Methods:
Pediatric validation of the Cepheid Copan Dual Swab Collection Device and Xpert® Carba-R Assay was performed using pooled stool specimens from 17 patients ages <1 to 21 years, spiked with Escherichia coli, Acinetobacter baumannii, Klebsiella pneumoniae, Enterobacter cloacae, and Pseudomonas aeruginosa harboring β-lactamase mechanisms (Klebsiella pneumoniae carbapenemase, New Delhi metallo-β-lactamase, oxacillinase-48-like carbapenemase, Verona integron-encoded metallo-β-lactamase, and imipenemase). Validation was supported by molecular and culture analysis of 747 pediatric clinical specimens.
Results:
Pediatric stool-spiked rectal swabs produced Cepheid Carba-R results with 100% accuracy (SD < 1; CV < 4%) and excellent precision (SD < 1, CV < 4%). Clinical carbapenemase surveillance of >24 000 rectal specimens screened by the Carba-R assay (2018-2024) showed lower carbapenemase-detected percent positivity in patients ages 0 to 20 years (3.0%-4.2%) compared with adults ages 21 to >65 (7.8%-12.7%) (χ2, P < 0.00001). No significant age-group differences were observed in the ability to isolate detected β-lactamase mechanisms from patient specimens.
Conclusion:
The Cepheid Copan Dual Swab Collection Device with the Xpert® Carba-R Assay is a valid method for rapid (<1 h) screening of carbapenemase-producing organisms (β-lactamase mechanisms: Klebsiella pneumoniae carbapenemase, New Delhi metallo-β-lactamase, oxacillinase-48-like carbapenemase, Verona integron-encoded metallo-β-lactamase, and imipenemase) in pediatric patients.
