Premium
Clinical study of Dermatophyte Test Strip, an immunochromatographic method, to detect tinea unguium dermatophytes
Author(s) -
Tsunemi Yuichiro,
Hiruma Masataro
Publication year - 2016
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/1346-8138.13348
Subject(s) - dermatophyte , concordance , medicine , trichophyton , pcr test , dermatology , polymerase chain reaction , microbiology and biotechnology , biology , biochemistry , gene , antifungal
The Dermatophyte Test Strip visualizes mycotic antigens by immunochromatography. It allows easy and fast detection of dermatophytes. A multicenter, single‐arm, comparative clinical study was designed to evaluate the capacity of Dermatophyte Test Strip to detect dermatophytes in suspected tinea unguium specimens in comparison with direct microscopy and polymerase chain reaction ( PCR ). Signed consent was obtained from 222 subjects and all subjects completed the study. With the Dermatophyte Test Strip, dermatophytes were detected in 201 of 222 (90.5%) specimens but not in 21 of 222 (9.5%) specimens. With direct microscopy, dermatophytes were detected in 170 of 222 (76.6%) specimens but not in 52 of 222 (23.4%). Of the 45 specimens that showed inconsistent results between the two methods, PCR gave further results for 40 specimens, of which 37 (92.5%) specimens were positive and three (7.5%) were negative for dermatophytes. The positive concordance rate, negative concordance rate and overall concordance rate between the Dermatophyte Test Strip and direct microscopy were 81.1%, 66.7% and 79.7%, respectively. When inconsistent results were corrected using the results of PCR , these rates were 97.5%, 71.4% and 95.0%, respectively. When five specimens that could not be tested by PCR because no piece for the PCR test was left were excluded from analysis, these rates were 99.0%, 78.9% and 97.2%, respectively. The present results indicate good detection capacity of the Dermatophyte Test Strip. The Dermatophyte Test Strip provides a reliable, convenient and quick method to test for tinea unguium.