False positive results in severe acute respiratory coronavirus 2 (SARS-CoV-2) rapid antigen tests for inpatients

Itoh, Kazuhiro; Kawamitsu, Toru; Osaka, Yoko; Sato, Kosei; Suzuki, Yusuke; Kiriba, Chiyo; Saito, Yumi; Hirose, Ryo; Ichihara, Hiroshi; Saito, Mitsugu; Mitsuke, Yasuhiko; Kuzumi, Kenichi; Miyashita, Hirofumi; Tsutani, Hiroshi

doi:10.1016/j.jiac.2021.03.011

Cited by 13 publications

(15 citation statements)

References 7 publications

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“…False-positive results that indicate the presence of COVID-19 cause substantial harm in clinical practice [14] and the emergence of false-positive results has been repeatedly reported in Japan [15][16][17]. In the current study, the increased sensitivity when using the DIA device was negatively associated with the decrease of specificity.…”

Section: Resultsmentioning

confidence: 54%

Diagnostic performance of a novel digital immunoassay (RapidTesta SARS-CoV-2): a prospective observational study with 1,127 nasopharyngeal samples

Suzuki

Akashi

Ueda

et al. 2021

Preprint

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Introduction: Digital immunoassays are generally regarded as superior tests for the detection of infectious disease pathogens, but there have been insufficient data concerning SARS-CoV-2 immunoassays. Methods: We prospectively evaluated a novel digital immunoassay (RapidTesta SARS-CoV-2). Two nasopharyngeal samples were simultaneously collected for antigen tests and RT-PCR. Real-time RT-PCR for SARS-CoV-2, using a method developed by the National Institute of Infectious Diseases, Japan, served as the reference RT-PCR method. Results: During the study period, 1,127 nasopharyngeal samples (symptomatic patients: 802, asymptomatic patients: 325) were evaluated. For digital immunoassay antigen tests, the sensitivity was 78.3% (95% CI: 67.3%-87.1%) and the specificity was 97.6% (95% CI: 96.5%-98.5%). When technicians visually analyzed the antigen test results, the sensitivity was 71.6% (95% CI: 59.9%-81.5%) and the specificity was 99.2% (95% CI: 98.5%-99.7%). Among symptomatic patients, the sensitivity was 89.4% (95% CI; 76.9%-96.5%) with digital immunoassay antigen tests, and 85.1% (95% CI; 71.7%-93.8%) with visually analyzed the antigen test, respectively. Conclusions: The findings indicated that RapidTesta SARS-CoV-2 analysis with the DIA device had sufficient analytical performance for the detection of SARS-CoV-2 in nasopharyngeal samples. When positive DIA results are recorded without a visually recognizable red line at the positive line location on the test cassette, additional RT-PCR evaluation should be performed.

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Section: Resultsmentioning

confidence: 54%

Diagnostic performance of a novel digital immunoassay (RapidTesta SARS-CoV-2): a prospective observational study with 1,127 nasopharyngeal samples

Suzuki

Akashi

Ueda

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…There were two false-positive samples for which RT-PCR could not be repeated due to lack of sample adequacy. In a highly viscous samples false-positive can occur although the degree of viscosity cannot be accurately defined [ 18 ]. The risks of cross-contamination when testing multiple patient specimens remains high and cannot be ruled out, although samples were tested with recommended precautions.…”

Section: Discussionmentioning

confidence: 99%

Rapid antigen detection kit for the diagnosis of SARS-CoV-2 - are we missing asymptomatic patients?

Kanaujia

Ghosh

Mohindra

et al. 2021

Indian Journal of Medical Microbiology

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Purpose To determine the utility, diagnostic accuracy, sensitivity, specificity, and negative predictive value of the laboratory based Covid-19 antigen detection test (Coris Bio- Concept, Gembloux, Belgium) for the diagnosis of SARS-CoV-2 in a tertiary care hospital among symptomatic and asymptomatic patients. Methods The nasopharyngeal swab samples were collected from the symptomatic patients and their contacts. The diagnostic accuracy of this antigen kit was determined in comparison to SARS-CoV-2 real-time reverse transcriptase (RT-PCR). Results A total of 825 patients fulfilling the inclusion criteria were included in the study; RT-PCR and antigen detection was performed simultaneously for 484 samples to determine the sensitivity and specificity of the test. The overall specificity and sensitivity was 99.32% and 71.96% respectively. Also, 3.7% of the asymptomatic patients who were negative by RAT were detected positive by RT-PCR. Conclusion This rapid antigen test (RAT) was sensitive in the symptomatic patients presenting during the initial phase of the illness. Since, majority of the SARS-CoV-2 patients are asymptomatic and considering the huge population, the testing strategy formulated by Indian Council of Medical Research (ICMR) at the national level was cost effective. Thus, Ag-RDTs could play a pivotal role in early diagnosis, policy making and surveillance of the SARS-CoV-2.

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Section: Introductionmentioning

confidence: 99%

“…While they are convenient, false-positive results with RATs have been reported [4][5][6]. False-positive RATs results cause unnecessary isolation and increase in the burden of medical staff in facilities [4,5]. Several cases of false-positive RATs based on immunochromatography have been reported with detailed clinical information [4,5]; however, false-positive cases for the quantitative antigen test are rare.…”

Section: Introductionmentioning

confidence: 99%

“…False-positive RATs results cause unnecessary isolation and increase in the burden of medical staff in facilities [4,5]. Several cases of false-positive RATs based on immunochromatography have been reported with detailed clinical information [4,5]; however, false-positive cases for the quantitative antigen test are rare. Only one false-positive case has been reported with patient information in the literature [6].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Potential for false-positive results with quantitative antigen tests for SARS-CoV-2: A case of a child with acute respiratory infection

Hase

Kurita

Mito

et al. 2022

Journal of Infection and Chemotherapy

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False positive results in severe acute respiratory coronavirus 2 (SARS-CoV-2) rapid antigen tests for inpatients

Cited by 13 publications

References 7 publications

Diagnostic performance of a novel digital immunoassay (RapidTesta SARS-CoV-2): a prospective observational study with 1,127 nasopharyngeal samples

Diagnostic performance of a novel digital immunoassay (RapidTesta SARS-CoV-2): a prospective observational study with 1,127 nasopharyngeal samples

Rapid antigen detection kit for the diagnosis of SARS-CoV-2 - are we missing asymptomatic patients?

Potential for false-positive results with quantitative antigen tests for SARS-CoV-2: A case of a child with acute respiratory infection

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