Definitions for the level of evidence (I-IV) and grade of recommendation (A-C) are provided at the end of the "Major Recommendations" field.
Screening is recommended only for patients presenting with unusual forms of ulceration where other diagnoses have been ruled out and a suggestive travel history is obtained. Screening of asymptomatic patients attending United Kingdom (UK) genitourinary (GU) clinics is not indicated. Contacts of known cases should undergo careful examination.
Recommended Tests for Suspected Clinical Cases of Donovanosis
Examination of Stained Smears for Donovan Bodies (Evidence Level IV, Grade of Recommendation C)
This method was that originally described by Donovan in 1905 and has been the most widely used since then. Donovan bodies show up well with Giemsa, Wright's and Leishman stains. Rapi-diff is a useful quick version of the Giemsa stain. This approach to diagnosis has been recommended consistently as a simple and reliable method.
Specimen collection: surface debris from purulent ulcers should be removed gently with a cotton swab, after this the lesion may be pressed directly on to a glass slide, or material collected by rolling a swab over the lesion and then on to a slide. The slide should be air-dried and either stained immediately or, where this is not possibly, fixed in 95% ethanol for 5 minutes and stained later. This approach to diagnosis works well in patients whose lesions have plentiful Donovan bodies. Additional methods listed below are more suitable for cases with low numbers of Donovan bodies.
Biopsy (Evidence Level IV, Grade of Recommendation C)
Biopsy may be considered for smear negative lesions, large lesions with easily removed friable tissue, any lesion where malignancy is suspected and less common lesions of the mouth, anus, cervix and uterus. Examination of biopsy material is more time-consuming and may involve greater discomfort for the patient. Good results may be obtained by taking up to three 3 to 5 mm punch or snip biopsies and placing them in 10% formalin/saline solution. Smears for more rapid diagnosis may be made by smearing the inferior surface of one of the biopsy specimens on to a glass slide, avoiding re-spreading of any area and stopping when the specimen becomes dry. Biopsy tissue may be examined with the stains recommended for smears and also with silver stains or slow Giemsa.
Culture (not currently available in UK) (Evidence Level IIa, Grade of Recommendation B)
Successful culture has been reported in human peripheral blood mononuclear cells and in Hep-2 cells. So far these techniques have only been successfully utilized by two research laboratories outside the UK (Darwin and Durban). Pre-treatment of specimens with antibiotics such as vancomycin and metronidazole is necessary to remove contaminants.
PCR (polymerase chain reaction) (not currently available in the UK) (Evidence Level IIa, Grade of Recommendation B)
A PCR test has been developed in Australia and is used on a small scale in the Australian eradication programme. Testing facilities are located in Queensland and Perth.
Recommended Sites for Testing
- Base or edge of ulcerated lesions.
- Regional lymph nodes if enlarged or ulcerated especially if ulcer gives negative results.
Factors Which Alter Tests Recommended or Sites Tested
Culture and PCR only available in special centres. Use of biopsy depends whether smear diagnosis is achievable and whether biopsy is acceptable to the patient. Sites tested depend on clinical presentation.
Risk Groups
- Gay men (no alteration to standard recommendation)
- Sex workers (no alteration to standard recommendation)
- Young patients (no alteration to standard recommendation)
Other
- Pregnant women (no alteration to standard recommendation)
- Women with a history of hysterectomy (no alteration to standard recommendation)
- Patients who are known contacts of the infection (no alteration to standard recommendation)
Recommendation for Frequency of Repeat Testing in an Asymptomatic Patient
Recommendation for Test of Cure
- Clinical assessment without sampling is sufficient.
Definitions:
Levels of Evidence
Ia: Evidence obtained from meta-analysis of randomised controlled trials
Ib: Evidence obtained from at least one randomised controlled trial
IIa: Evidence obtained from at least one well designed controlled study without randomisation
IIb: Evidence obtained from at least one other type of well designed quasi-experimental study
III: Evidence obtained from well designed non-experimental descriptive studies
IV: Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities
Grading of Recommendations
- Evidence at level Ia or Ib
- Evidence at level IIa, IIb, or III
- Evidence at level IV
