Department of Health recommends
a 2-step testing system for CDI17
Step 1.
GDH EIA (or NAAT/PCR)
If above is positive
Step 2.
Sensitive toxin EIA test (or a cytotoxin assay)*
*Note: a cytotoxin assay (the reference method) yields slower results and this needs to be taken
into account when making management and infection control decisions17
Interpretation of a 2-step C. difficile testing algorithm17
Step 3. Interpreting test results
The following actions should be taken depending on the test result:
Result of 2-test algorithm** |
Interpretation |
Include in mandatory reporting† |
GDH EIA (or NAAT) positive, toxin EIA positive |
CDI is likely to be present |
Yes |
GDH EIA (or NAAT) positive, toxin EIA negative |
C. difficile could be present, so may have transmission potential. Patient could be potential C. difficile excretor. |
No, but may be suitable for local reporting |
GDH EIA (or NAAT) negative, toxin EIA negative |
C. difficile or CDI is very unlikely to be present, so may have transmission potential. Patient could have other potential pathogens. |
No |
It must be remembered that no test or combination of tests is infallible and the clinical condition of the patient should always be taken into consideration when making management and treatment choices.17
**A cytotoxin assay may be considered as an alternative to a sensitive toxin EIA, but it yields slower results and this will need to be taken into account in making decisions about infection control.17
†Unless a repeat sample within 28 days. Please refer to the Mandatory Surveillance Protocol for full case definition and further information.17
Where there’s any doubt Suspect. test. act.
GDH, glutamate dehydrogenase; EIA, enzyme immunoassay; NAAT, nucleic acid amplification test; PCR, polymerase chain reaction test.