TY - JOUR
T1 - Analysis of the reliability of rapid diagnostic tests for varicella, including breakthrough cases
AU - Higashimoto, Yuki
AU - Hattori, Fumihiko
AU - Kawamura, Yoshiki
AU - Kozawa, Kei
AU - Hamano, Aoi
AU - Kato, Mizuki
AU - Kato, Sayaka
AU - Hosokawa, Asuka
AU - Enya, Yasuko
AU - Ihira, Masaru
AU - Yoshikawa, Tetsushi
N1 - Funding Information:
The authors would like to thank Akiko Yoshikawa, Chieko Mori, and Yoko Osakabe of the Fujita Health University School of Medicine (Toyoake, Japan) for their assistance with laboratory research. We also thank the clinicians in the Nagoya VZV Study Group who collected clinical samples and patient information: Dr. Naoko Itakura, Dr. Masashi Morooka, and Dr. Hiroshi Tanaka. This work was supported by a Japan Society for the Promotion of Science (JSPS) Grant‐in‐Aid for Early‐Career Scientists (grant number JP20K16534), an Aichi Health Promotion Foundation 2020 Grant for Medical Research and Health Promotion Activities, and a 2021 grant‐in‐aid from Fujita Health University.
Funding Information:
The authors would like to thank Akiko Yoshikawa, Chieko Mori, and Yoko Osakabe of the Fujita Health University School of Medicine (Toyoake, Japan) for their assistance with laboratory research. We also thank the clinicians in the Nagoya VZV Study Group who collected clinical samples and patient information: Dr. Naoko Itakura, Dr. Masashi Morooka, and Dr. Hiroshi Tanaka. This work was supported by a Japan Society for the Promotion of Science (JSPS) Grant-in-Aid for Early-Career Scientists (grant number JP20K16534), an Aichi Health Promotion Foundation 2020 Grant for Medical Research and Health Promotion Activities, and a 2021 grant-in-aid from Fujita Health University.
Publisher Copyright:
© 2023 Wiley Periodicals LLC.
PY - 2023/2
Y1 - 2023/2
N2 - In the era of universal varicella vaccination, diagnosis of varicella is challenging, especially for breakthrough cases. We sought to clarify the reliability of direct varicella-zoster virus (VZV) loop-mediated isothermal amplification (LAMP) and DermaQuick® VZV using the immunochromatography technique as rapid diagnostic tests for varicella. In addition, the usefulness of saliva as a sample type for direct LAMP was investigated. Among the 46 enrolled patients with suspected VZV infection, 31 patients (67.3%) were positive for the nucleic acid test based on real-time PCR from skin swab samples. Direct LAMP of skin swabs was positive in 29 (63.0%) of 46 patients. DermaQuick® VZV was positive in 25 (54.3%) of 46 patients. VZV DNA was detected in only 48.4% of oral swabs with the direct LAMP method. With real-time polymerase chain reaction (PCR) as the standard for diagnosing varicella, the sensitivity and specificity of DermaQuick® VZV were 80.7% and 100%, respectively. The sensitivity and specificity of direct LAMP from skin swabs were 93.6% and 100%, respectively. The sensitivity and specificity of real-time PCR for DNA extracted from oral swabs were 74.2% and 93.3%, respectively. Thus, oral swab samples are not suitable for breakthrough varicella diagnosis. Although DermaQuick® VZV is considered the most convenient point-of-care test for varicella, its sensitivity and specificity were lower than those of direct VZV LAMP.
AB - In the era of universal varicella vaccination, diagnosis of varicella is challenging, especially for breakthrough cases. We sought to clarify the reliability of direct varicella-zoster virus (VZV) loop-mediated isothermal amplification (LAMP) and DermaQuick® VZV using the immunochromatography technique as rapid diagnostic tests for varicella. In addition, the usefulness of saliva as a sample type for direct LAMP was investigated. Among the 46 enrolled patients with suspected VZV infection, 31 patients (67.3%) were positive for the nucleic acid test based on real-time PCR from skin swab samples. Direct LAMP of skin swabs was positive in 29 (63.0%) of 46 patients. DermaQuick® VZV was positive in 25 (54.3%) of 46 patients. VZV DNA was detected in only 48.4% of oral swabs with the direct LAMP method. With real-time polymerase chain reaction (PCR) as the standard for diagnosing varicella, the sensitivity and specificity of DermaQuick® VZV were 80.7% and 100%, respectively. The sensitivity and specificity of direct LAMP from skin swabs were 93.6% and 100%, respectively. The sensitivity and specificity of real-time PCR for DNA extracted from oral swabs were 74.2% and 93.3%, respectively. Thus, oral swab samples are not suitable for breakthrough varicella diagnosis. Although DermaQuick® VZV is considered the most convenient point-of-care test for varicella, its sensitivity and specificity were lower than those of direct VZV LAMP.
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U2 - 10.1002/jmv.28569
DO - 10.1002/jmv.28569
M3 - Article
C2 - 36762573
AN - SCOPUS:85148612181
SN - 0146-6615
VL - 95
JO - Journal of Medical Virology
JF - Journal of Medical Virology
IS - 2
M1 - e28569
ER -