Table 2.
Diagnostic Assay |
Detected Substances | Time Required | Cost | Specificity | Sensitivity | Accessibility | Challenge level | References |
---|---|---|---|---|---|---|---|---|
C. difficile anaerobic culture | Colony morphology and color | 1-3 days | Low | High | High | Medium accessibility, low cost of instruments, one of the gold standards | Medium challenge, time-consuming, medium personnel and operational requirements, unable to distinguish non-toxigenic strains, cannot POCT | (Zhou et al., 2024) |
CCTA | Tcd B | 1-3 days | High | High | Low | Medium accessibility, low cost of instruments, can distinguish between toxigenic and non-toxigenic strains, one of the gold standards | Medium challenge, time-consuming, medium personnel and operational requirements, cannot POCT | (Antonara and Leber, 2016) |
TC | Toxinogenic C. difficile | 3-5 days | High | High | Medium to high | Medium accessibility, low cost of instruments, one of the gold standards | Medium challenge, time-consuming, medium personnel and operational requirements, unable to distinguish non-toxigenic strains, cannot POCT | (Strachan et al., 2013) |
GDH | GDH, TcdA and TcdB | Several hours | Low | Low | High | High accessibility, short time consumption, low cost, high NPV, high reliability, often used as an initial screening test for CDI | Low challenge, unable to distinguish between toxigenic and non-toxigenic strains | (Shetty et al., 2011) |
EIA | Tcd A/TcdB | 3-5 hours | Low | High | Low | High accessibility, easy to operate, can distinguish between toxigenic and non-toxigenic strains | Low challenge, low cost, time-consuming, sensitivity fluctuates greatly, prone to false negatives. Low PPV | (Zangiabadian et al., 2023) |
NAAT | Toxin Genes | 1-3 hours | High | High | High | High accessibility, short time, quantitative analysis possible, can implement POCT | Low challenge, high cost, medium personnel and operational requirements | (Lin et al., 2022; Maestri, 2022) |
NGS | DNA sequences (tcdA, tcdB, etc.) | Several hours to one day | High | High | High | Low accessibility, high throughput, capable of metagenomic sequencing | High challenge, requires PCR amplification, high equipment cost | (Goodwin et al., 2016) |
NS | DNA sequences (tcdA, tcdB, etc.), methyltransferases (CamA, etc.) | Several hours | High | High | Relatively high | Low accessibility, long read length, no PCR required, real-time sequencing | High challenge, higher error rate, relatively high equipment and time costs | (Hargreaves et al., 2016; Koya et al., 2019) |
CRISPR-Cas | tcdA, tcdB | About 1 hour | Medium | High | High | High accessibility, short time consumption, high portable, suitable for POCT | Medium challenge, medium personnel and operational requirements | (Jiang et al., 2023b) |
UPLC-MS | Metabolic markers (lipids, amino acids, etc.) | Several hours | High | High | Medium to high | Low accessibility, can diagnose unique fecal metabolomic features | High challenge, high cost, complex operation and data processing, low throughput, and limitations to specific analytes | (Zhou et al., 2018) |
RS | Biomarkers (SlpA, TcdB, etc.) | Less than 30 minutes | Low to medium | Medium to high | High | High accessibility, short time consumption, portable, suitable for POCT | Medium challenge, medium personnel and operational requirements | (Hassanain et al., 2021) |
RTCA | TcdB | Less than 24h | High | High | High | High accessibility, effective differentiation between infection and colonisation, quantitative detection of toxins | Medium challenge, operational complexity, high cost, subject to inhibitors | (Shen et al., 2024) |