1. Utility of the Rapid Antigen Detection Test E. histolytica Quik Chek for the Diagnosis of Entamoeba histolytica Infection in Nonendemic Situations
- Author
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Kasumi Hayasaka, Ayaka Nagata, Rieko Shimogawara, Rika Fukushima, Toshikazu Miyagawa, Taiichiro Kobayashi, Tomohiko Koibuchi, Hirotomo Nakata, Koji Watanabe, Yasuaki Yanagawa, Tomoyuki Endo, Michiko Koga, Yoshimi Kikuchi, Etsuko Tsuchihashi, Kazumi Sakai, Mami Shibuya, Hiroyuki Shingyochi, Hiroyuki Gatanaga, Shinichi Oka, Risa Otsuka, and Kenji Yagita
- Subjects
Microbiology (medical) ,medicine.medical_specialty ,Diagnostic methods ,diagnosis ,030231 tropical medicine ,Combined use ,Antigens, Protozoan ,Enzyme-Linked Immunosorbent Assay ,Gastroenterology ,Sensitivity and Specificity ,03 medical and health sciences ,Entamoeba histolytica ,Feces ,0302 clinical medicine ,fluids and secretions ,Antigen ,Japan ,Internal medicine ,parasitic diseases ,medicine ,Entamoeba histolytica Infection ,Humans ,030212 general & internal medicine ,Reference standards ,cyst ,biology ,Entamoebiasis ,business.industry ,Assay sensitivity ,biology.organism_classification ,Cross-Sectional Studies ,Parasitology ,amebiasis ,business - Abstract
Entamoeba histolytica infection is an increasingly common sexually transmitted infection in Japan. Currently, stool ova and parasite examination (O&P) is the only approved diagnostic method. Here, we assessed the utility of the commercially available rapid antigen detection test (Quik Chek) for E. histolytica. A multicenter cross-sectional study was conducted. Stool samples that had been submitted for O&P were included. The samples were subjected to both Quik Chek and PCR, and the Quik Chek results were assessed in comparison with PCR as the reference standard., Entamoeba histolytica infection is an increasingly common sexually transmitted infection in Japan. Currently, stool ova and parasite examination (O&P) is the only approved diagnostic method. Here, we assessed the utility of the commercially available rapid antigen detection test (Quik Chek) for E. histolytica. A multicenter cross-sectional study was conducted. Stool samples that had been submitted for O&P were included. The samples were subjected to both Quik Chek and PCR, and the Quik Chek results were assessed in comparison with PCR as the reference standard. E. histolytica infection was confirmed in 5.8% (38/657) of the samples and comprised 20 diarrheal and 18 nondiarrheal cases. The overall sensitivity and specificity of Quik Chek were 44.7% (95% confidence interval, 30.1 to 60.3) and 99.8% (99.1 to 100), respectively. The sensitivity of Quik Chek was higher for diarrheal cases (60.0%) than for nondiarrheal cases (27.8%). Furthermore, the combined use of Quik Chek with O&P increased the sensitivity (78.9%), especially for diarrheal cases (up to 90%). The E. histolytica burden assessed by quantitative PCR was similar between Quik Chek-positive and -negative samples. The Quik Chek assay sensitivity was lower for cyst-containing stools than for trophozoite-containing stools, although it was shown that cultured E. histolytica clinical strains from Quik Chek-negative cyst-containing stools exhibited antigenicity in vitro. The present study confirmed the high specificity of Quik Chek for E. histolytica infection. Combined use with O&P increased the sensitivity of detection, facilitating the use of Quik Chek in point-of-care settings in nonendemic situations.
- Published
- 2020