Analytical and clinical evaluation of a point-of-care molecular diagnostic system and its influenza A/B assay for rapid molecular detection of the influenza virus

Akashi, Yusaku; Suzuki, Hiromichi; Ueda, Atsuo; Hirose, Yumi; Hayashi, Daisuke; Imai, Hironori; Ishikawa, Hiroichi

doi:10.1016/j.jiac.2019.02.022

Cited by 18 publications

(13 citation statements)

References 12 publications

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“…The inconsistent case was positive on GENECUBE ® FLU A/B but negative on reference RT-PCR and the subsequent Filmarray ® assay. This case may be a false positive; however, in our previous study using fresh samples [13], the cobas Liat Influenza A/B assay (Roche Molecular Systems, Pleasanton, CA, USA) provided a positive result for influenza B virus for the discordant sample. Further data are required to evaluate the possibility of false-positive results associated with the GENECUBE ® FLU A/B.…”

Section: Discussionmentioning

confidence: 95%

“…During the COVID-19 endemic period, sample-collecting for PCR in the Tsukuba district was intensively performed with a drive-through-type method at the PCR center in Tsukuba Medical Center Hospital (TMCH) following a referral from a local public health center and 63 primary care facilities and among healthcare workers at TMCH. Due to the low prevalence rate of influenza and lack of fresh influenza virus-positive samples, we used preserved Universal Transport Medium™ (UTM™) samples that had been stored at −80 °C and used in our previous study [13].…”

Section: Methodsmentioning

confidence: 99%

“…These drawbacks can limit their accessibility and utility in the clinical setting. GENECUBE ® (TOYOBO Co., Ltd., Osaka, Japan) is a rapid, fully automated genetic analyzer that uses the Qprobe-PCR method [7] [7,10], Staphylococcus aureus (nuc and mecA) [11] and the toxin gene of Clostridiodes difficile [12].…”

Section: Introductionmentioning

confidence: 99%

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A prospective evaluation of the analytical performance of GENECUBE^® HQ SARS-CoV-2 and GENECUBE^® FLU A/B

Kiyasu

Akashi

Sugiyama

et al. 2021

Preprint

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Background: Molecular tests are the mainstay for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, their accessibility can be limited by the long examination time and inability to evaluate multiple samples at once. This study evaluated the analytical performance of the newly developed rapid molecular assays GENECUBE® HQ SARS-CoV-2 and the GENECUBE® FLU A/B. Method: This prospective study was conducted between December 14, 2020, and January 9, 2021, at a polymerase chain reaction (PCR) center. Samples were collected from the nasopharynx with flocked swabs. Molecular tests were performed with the GENECUBE® system and reference reverse transcription (RT)-PCR, and the results of the two assays were compared. Result: Among 1065 samples, 81 (7.6%) were positive for SARS-CoV-2 on the reference RT-PCR. Three showed discordance between GENECUBE® HQ SARS-CoV-2 and the reference RT-PCR; the total, positive and negative samples of concordance for the two assays were 99.7%, 100%, and 99.7%, respectively. All discordant cases were positive for GENECUBE® HQ SARS-CoV-2 and negative for the reference RT-PCR. SARS-CoV-2 was detected from all three samples by another molecular assay for SARS-CoV-2. For the GENECUBE® FLU A/B, the total, positive and negative samples of concordance for the two assays were 99.5%, 100%, and 99.1%. Conclusion: The GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B demonstrated sufficient analytical performance to detect SARS-CoV-2 and influenza virus A/B.

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Section: Discussionmentioning

confidence: 95%

Section: Methodsmentioning

confidence: 99%

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A prospective evaluation of the analytical performance of GENECUBE^® HQ SARS-CoV-2 and GENECUBE^® FLU A/B

Kiyasu

Akashi

Sugiyama

et al. 2021

Preprint

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“…The high sensitivity and specificity for influenza A, influenza B and RSV found in our study was comparable to previous findings, with better diagnostic accuracy than other routinely available point-of-care devices. [14][15][16][17][18][20][21][22][23][24][25][26][27][28][29][30] The diagnostic accuracy of POCTs for influenza has been examined in individual studies and several systematic reviews. [31][32][33] Although the impact of the cobas® Liat® POCT on clinical decision making during visits to the emergency department has been established, [34] the effect on patient-relevant clinical outcomes still has to be determined.…”

Section: Comparison With Previous Studiesmentioning

confidence: 99%

“…An rCt of Clinical and Cost effectiveness in primary CarE (ALIC 4 E)" trial, [12,13] to evaluate the cobas® Liat® POCT, selected as it is easy to use and has excellent proof-of-principle supporting data. [14][15][16][17][18] However, before uptake into routine care, it is critical that analytic performance be established using samples obtained from real patients in the setting in which the test might be marketed.…”

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confidence: 99%

Performance and ease of use of a molecular point-of-care test for influenza A/B and RSV in patients presenting to primary care

Verbakel

Matheeussen

Loens

et al. 2020

Eur J Clin Microbiol Infect Dis

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Annual influenza epidemics cause substantial morbidity and mortality, and the majority of patients with influenza-like illness present to primary care. Point-of-care influenza tests could support treatment decisions. It is critical to establish analytic performance of these platforms in real-life patient samples before uptake can be considered. We aimed to assess the analytical performance and ease of use of the cobas® Liat® PCR POCT in detecting influenza A/B and RSV in samples collected from patients with influenza-like illness in primary care. Sensitivity and specificity of the cobas® Liat® POCT are calculated in comparison with a commercial laboratory-based PCR test (Fast-Track Respiratory Pathogens 21 Plus kit (Fast-Track Diagnostics)). Samples with discordant results were analysed additionally by the RespiFinder 2Smart (PathoFinder) using an Extended Gold Standard (EGS). Acceptability was scored on a five-point Likert scale as well as a failure mode analysis of the cobas® Liat® POCT was performed. Nasal and oropharyngeal swabs were obtained from 140 children and nasopharyngeal swabs from 604 adults (744 patients). The cobas® Liat® POCT had a sensitivity and specificity of 100% (95% CI 99-100%) and 98.1% (95%CI 96.3-99%) for influenza A, 100% (95% CI 97.7-100%) and 99.7% (95%CI 98.7-99.9%) for influenza B and 100% (95% CI 87.1-100%) and 99.4% (95%CI 98.6-99.8%) for RSV, respectively. According to trained lab technicians, the cobas® Liat® POCT was considered easy-to-use, with a fast turnaround time. Cobas® Liat® POCT is a promising decentralised test platform for influenza A/B and RSV in primary care as it provides fairly rapid results with excellent analytic performance. Point-of-care influenza tests could support treatment decisions in primary care. Cobas® Liat® POCT is a promising decentralised test platform for influenza A/B and RSV in primary care as it provides fairly rapid results with excellent analytic performance. Keywords Influenza. Point-of-care. Primary care. Ease-of-use. PCR BACKGROUND Annual influenza epidemics cause substantial morbidity and mortality and the 2009 H1N1 influenza outbreak was defined as a pandemic by the World Health Organisation (WHO). [1, 2] About 50% of patients presenting to primary care with influenza-like illness (ILI) during a period of high influenza incidence, with some variation by country, usually have laboratory-confirmed influenza infection. [3] Unlike in Japan for example, [4] in European primary care, point-of-care testing for influenza is not routine practice, making it difficult for clinicians to distinguish influenza from other viral infections that cause ILI at the point of care with a high degree of certainty. [5] It is common practice throughout Europe to base treatment or advice to patients with ILI on signs and symptoms alone, given that point-of-care tests (POCTs) may neither be feasible nor perform adequately, and that antiviral Electronic supplementary material The online version of this article (

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A Prospective Evaluation of the Analytical Performance of GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B

et al. 2021

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Background Molecular tests are the mainstay of detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, their accessibility can be limited by the long examination time and inability to evaluate multiple samples at once. Objective This study evaluated the analytical performance of the newly developed rapid molecular assays GENECUBE ® HQ SARS-CoV-2 and GENECUBE ® FLU A/B. Method This prospective study was conducted between 14 December 2020 and 9 January 2021 at a polymerase chain reaction (PCR) center. Samples were collected from the nasopharynx with flocked swabs. Molecular tests were performed with the GENECUBE ® system and reference reverse transcription (RT)-PCR, and the results of the two assays were compared. Result Among 1065 samples, 81 (7.6%) were positive for SARS-CoV-2 on the reference RT-PCR. Three showed discordance between GENECUBE ® HQ SARS-CoV-2 and the reference RT-PCR; the total, positive, and negative samples of concordance for the two assays were 99.7%, 100%, and 99.7%, respectively. All discordant cases were positive with GENECUBE ® HQ SARS-CoV-2 and negative with the reference RT-PCR. SARS-CoV-2 was detected in all three samples using another molecular assay for SARS-CoV-2. For GENECUBE ® FLU A/B, the total, positive, and negative samples of concordance for the two assays were 99.5%, 100%, and 99.1%. ConclusionThe GENECUBE ® HQ SARS-CoV-2 and GENECUBE ® FLU A/B demonstrated sufficient analytical performance to detect SARS-CoV-2 and influenza virus A/B.

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Analytical and clinical evaluation of a point-of-care molecular diagnostic system and its influenza A/B assay for rapid molecular detection of the influenza virus

Cited by 18 publications

References 12 publications

A prospective evaluation of the analytical performance of GENECUBE^® HQ SARS-CoV-2 and GENECUBE^® FLU A/B

A prospective evaluation of the analytical performance of GENECUBE^® HQ SARS-CoV-2 and GENECUBE^® FLU A/B

Performance and ease of use of a molecular point-of-care test for influenza A/B and RSV in patients presenting to primary care

A Prospective Evaluation of the Analytical Performance of GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B

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Analytical and clinical evaluation of a point-of-care molecular diagnostic system and its influenza A/B assay for rapid molecular detection of the influenza virus

Cited by 18 publications

References 12 publications

A prospective evaluation of the analytical performance of GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B

A prospective evaluation of the analytical performance of GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B

Performance and ease of use of a molecular point-of-care test for influenza A/B and RSV in patients presenting to primary care

A Prospective Evaluation of the Analytical Performance of GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B

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Product

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A prospective evaluation of the analytical performance of GENECUBE^® HQ SARS-CoV-2 and GENECUBE^® FLU A/B

A prospective evaluation of the analytical performance of GENECUBE^® HQ SARS-CoV-2 and GENECUBE^® FLU A/B