Evaluation of adenovirus amplified detection of immunochromatographic test using tears including conjunctival exudate in patients with adenoviral keratoconjunctivitis
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We evaluated a novel silver amplification immunochromatography test for rapid detection of adenovirus (AdV) antigen equipped with an automated reader system using tears including conjunctival exudate in patients with adenoviral keratoconjunctivitis.
Two kinds of immunochromatographic (IC) kits, a conventional IC kit for conjunctival scrapings (control kit) and an IC kit using tears including conjunctival exudate collected by pressing a filter paper strip on the conjunctiva (test kit), were tested on 90 patients who attended Migita Eye Clinic with suspected adenoviral conjunctivitis. The results of the test kits were automatically obtained by a specific reader, which was based on silver amplification immunochromatography system, in 15 min. The detection of AdV was confirmed by real-time polymerase chain reaction (PCR) method, and typing was performed by direct sequencing. Comparative dilution assay was carried out with the two kits, using AdV type 3 and type 54 strains.
The sensitivity of the control kit and test kit was 89.8% and 98.3%, respectively. The specificity of both kits was 100%. A significant difference in the sensitivities of the two IC kits against PCR positivity was observed (P < 0.01). A significant correlation was found between AdV DNA copy numbers on a logarithmic scale obtained with the two tests (P < 0.01). The sensitivity of the test kit was 32–64-fold higher than that of the control kit without silver amplification for both AdV types.
These results suggest that this novel amplified AdV detection kit using tears including conjunctival exudate is useful, because it decreases patients’ discomfort from specimen collection and its sensitivity is significantly higher than that of the conventional IC kit.
KeywordsAdenovirus Immunochromatography Silver amplification Tear
The clinical strains of adenovirus type 3 and type 54 used for comparative dilution assay were kindly provided by the Kobe Institute of Health.
This work was supported by a Grant-in-Aid for Encouragement of Scientists (18K09466) from the Ministry of Education, Science, Sports and Culture of Japan.
Compliance with ethical standards
Conflict of interest
Authors Migita, Tsukahara-Kawamura, Saeki, and Uchio were provided immunochromatography tests (Quick Chaser Auto Adeno Eye (Nitten Pharmaceutical Co., Ltd., Nagoya, Japan), FUJI DRI-CHEM IMMUNO AG cartridge Adeno OPH (FUJIFILM Corp., Tokyo, Japan)) and immuno reader (Quick Chaser® Immuno Reader (Mizuho Medy Co. Ltd., Tosu, Japan), FUJI DRI-CHEM IMMUNO AG1 (FUJIFILM Corp.)) from each company. Author Ueno declares that he has no conflict of interest. Author Hanaoka declares that he has no conflict of interest. Author Fujimoto declares that he has no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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