Multicentre clinical study of the herpes simplex virus immunochromatographic assay kit for the diagnosis of herpetic epithelial keratitis.

Background/aims The novel immunochromatographic assay (ICGA) kit was recently developed to diagnose herpes simplex virus (HSV) infection. This multicentre study aimed to evaluate the value of the ICGA kit for the diagnosis of herpetic epithelial keratitis by comparing it with immunofluorescence assay (IFA) and real-time PCR. Methods Corneal scrapings were collected from 117 patients, including 77 with herpetic keratitis as their final clinical diagnosis as well as 40 others at 21 facilities. These samples were tested by the ICGA kit, IFA and real-time PCR. Results The positive concordance between final clinical diagnosis and ICGA was 46.7% (35/75 cases) and the negative concordance was 100% (39/39). The positive and negative concordance between real-time PCR and ICGA were 57.4% (35/61 cases) and 100% (53/53), respectively. The positive and negative concordance between IFA and ICGA were 61.1% (22/36 cases) and 83.3% (55/66), respectively. In 92 cases where anti-HSV drugs were not prescribed prior to corneal scraping, the positive and negative concordance between final clinical diagnosis and ICGA were 55.0% (33/60 cases) and 100% (32/32), respectively. Conclusions The ICGA kit has moderate sensitivity and high specificity, indicating clinical utility in the diagnosis of herpetic epithelial keratitis.