Concordance of molecular microbiology and conventional culture techniques for infected diabetic foot ulcer management
Authors' conclusion
M16S detected a broader microbial spectrum, including fastidious anaerobes, but its low concordance with C&S and lack of antibiotic sensitivity data, challenge its suitability as a replacement for C&S in mild or moderate DFU infections. It may offer advantages in infections where increased sensitivity is beneficial, particularly where extended culture approaches are recommended to detect fastidious or low-abundance organisms. For mild to moderate DFU infections, our findings support continued reliance on conventional C&S testing.
Study context
- Population
- Participants with diabetic foot ulcers (DFUs) with suspected mild or moderate infections
- Participants
- 145 participants
- Comparison
- Metagenomic 16S rRNA gene sequencing (M16S) vs conventional culture and sensitivity (C&S)
- Outcome
- Concordance between molecular and C&S methods in identifying bacteria from infected DFUs
Methodological detailsconducted alongside CODIFI2 Phase III randomised controlled trial, tissue and swab samples
- Conducted alongside CODIFI2 Phase III randomised controlled trial
- Tissue and swab samples
Performance
As reported in the abstract
Microorganisms identified and agreement between C&S and M16S
| Test or model | Value | Genera | Anaerobic genera | No bacterial growth | Anaerobes | Samples with at least one organism |
|---|---|---|---|---|---|---|
| C&S | 248 microorganisms | 25 | eight | 25.5% (95% CI: 18.0%-32.3%) | ||
| M16S | 455 microorganisms | 40 | 15 | 173 | all samples |
Value
C&S248 microorganisms
M16S455 microorganisms
Genera
C&S25
M16S40
Anaerobic genera
C&Seight
M16S15
No bacterial growth
C&S25.5% (95% CI: 18.0%-32.3%)
M16S— not stated in the abstract
Anaerobes
C&S— not stated in the abstract
M16S173
Samples with at least one organism
C&S— not stated in the abstract
M16Sall samples
- Observed agreement between methods
- 75%
- Cohen's Kappa: low concordance overall, except Pseudomonas spp. and Streptococcus spp.
- Kappa ≥ 0.5
Original publication
Concordance of molecular microbiology and conventional culture techniques for infected diabetic foot ulcer management. Diabet Med. Published 9 July 2025. doi:10.
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