Rapid differential diagnosis of SARS-CoV-2, influenza A/B and respiratory syncytial viruses: Validation of a novel RT-PCR assay

Domnich, Alexander; Bruzzone, Bianca; Trombetta, Carlo-Simone; Pace, Vanessa De; Ricucci, Valentina; Varesano, Serena; Garzillo, Giada; Ogliastro, Matilde; Orsi, Andrea; Icardi, Giancarlo

doi:10.1016/j.jcv.2023.105402

Cited by 11 publications

(12 citation statements)

References 26 publications

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“…In the field of NoV and SARS-CoV-2 detection methodology, many multiple-qPCR methods have been established, and these methods have good sensitivity and specificity. For example, simultaneous detection of SARS-CoV-2, influenza A/B and respiratory syncytial viruses (RSV) ( Domnich et al, 2023 ), detection of SARS-CoV-2 and influenza A/B ( Ni et al, 2021 ), detection of NoV and Rotavirus A ( Dung et al, 2013 ) and so on. However, to the authors’ knowledge, no multiplex RT-PCR assays have been reported for simultaneous detection of NoV and SARS-CoV-2.…”

Section: Discussionmentioning

confidence: 99%

Simultaneous detection of human norovirus GI, GII and SARS-CoV-2 by a quantitative one-step triplex RT-qPCR

Yi,

Wang,

Tan

et al. 2024

Front. Microbiol.

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BackgroundThere are many similarities in the clinical manifestations of human norovirus and SARS-CoV-2 infections, and nucleic acid detection is the gold standard for diagnosing both diseases. In order to expedite the identification of norovirus and SARS-CoV-2, a quantitative one-step triplex reverse transcription PCR (RT-qPCR) method was designed in this paper.MethodsA one-step triplex RT-qPCR assay was developed for simultaneous detection and differentiation of human norovirus GI (NoV-GI), GII (NoV-GII) and SARS-CoV-2 from fecal specimens.ResultsThe triplex RT-qPCR assay had high detection reproducibility (CV < 1%) and sensitivity. The lower limits of detection (LLOD95) of the triplex RT-qPCR assay for each target site were 128.5–172.8 copies/mL, and LLOD95 of the singleplex RT-qPCR assay were 110.3–142.0 copies/mL. Meanwhile, among the detection of clinical oropharyngeal swabs and fecal specimens, the results of the singleplex and triplex RT-qPCR assay showed high agreement.ConclusionThe triplex RT-qPCR assay for simultaneous detection of NoV-GI, NoV-GII and SARS-CoV-2 from fecal specimens has high clinical application value.

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Section: Discussionmentioning

confidence: 99%

Simultaneous detection of human norovirus GI, GII and SARS-CoV-2 by a quantitative one-step triplex RT-qPCR

Yi,

Wang,

Tan

et al. 2024

Front. Microbiol.

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“…Multiplex testing allows for the simultaneous on-site detection of different analytes using a single specimen, which could mean saving time and resources [ 58 ]. By reducing incorrect or incomplete diagnosis of infectious diseases that have shared symptoms and clinical features [ 162 , 163 , 164 ], multiplex testing might help critical patients access much-needed treatment on time [ 32 , 139 ]. There are two main types of rapid multiplex tests currently available for ARIs: molecular and antigen [ 57 , 61 ].…”

Section: Overview Of Rapid Testing Optionsmentioning

confidence: 99%

The Role and Value of Professional Rapid Testing of Acute Respiratory Infections (ARIs) in Europe: A Special Focus on the Czech Republic, Poland, and Romania

Drevinek,

Flisiak,

Nemes

et al. 2024

Diagnostics

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This review aims to explore the role of professional diagnostic rapid testing of acute respiratory infections (ARIs), especially COVID-19 and influenza, ensuring proper disease management and treatment in Europe, and particularly in Czech Republic, Poland, and Romania. The paper was constructed based on a review of scientific evidence and national and international policies and recommendations, as well as a process of validation by four experts. The development of new testing technologies, treatment options, and increased awareness of the negative multidimensional impact of ARI profiles transformed differential diagnosis into a tangible and desirable reality. This review covers the following topics: (1) the multidimensional impact of ARIs, (2) ARI rapid diagnostic testing platforms and their value, (3) the policy landscape, (4) challenges and barriers to implementation, and (5) a set of recommendations illustrating a path forward. The findings indicate that rapid diagnostic testing, including at the point of care (POC), can have a positive impact on case management, antimicrobial and antibiotic stewardship, epidemiological surveillance, and decision making. Integrating this strategy will require the commitment of governments and the international and academic communities, especially as we identified room for improvement in the access and expansion of POC rapid testing in the focus countries and the inclusion of rapid testing in relevant policies.

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“…It simultaneously detects the M gene for IAV, NS1 gene for IBV, M gene for RSV, and two gene targets (ORF1ab and N) for SARS-CoV-2. For SARS-CoV-2, the detection of at least one target signifies SARS-CoV-2 infection [7]. Once the sample was vortexed for about 10 seconds, 300 µL was added directly to the cartridge for RT-PCR in the STANDARD M10 analyser according to the manufacturer's instructions.…”

Section: Index Testmentioning

confidence: 99%

“…Once the sample was vortexed for about 10 seconds, 300 µL was added directly to the cartridge for RT-PCR in the STANDARD M10 analyser according to the manufacturer's instructions. The limit of detection (LoD) of this assay is 200 copies/ml for the SARS-CoV-2 ORF1ab gene, 400 copies/ml for IAV/IBV, and 800 copies/ml for both RSV and SARS-CoV-2 N genes [7].…”

Section: Index Testmentioning

confidence: 99%

Evaluation of Standard M10 Assay for Rapid Molecular Diagnosis of SARS-CoV-2, Influenza A/B virus and Respiratory Syncytial Virus (RSV)

Abdullah,

Sam,

Ong

et al. 2023

Preprint

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SARS-CoV-2, influenza A/B virus (IAV/IBV) and respiratory syncytial virus (RSV) are among the common viruses causing acute respiratory infections. Clinical diagnosis to differentiate these viruses is challenging due to similar clinical presentations, thus laboratory-based real-time RT PCR is the gold standard for diagnosis. The study aimed to evaluate the diagnostic performance of STANDARD M10 Flu/RSV/SARS-CoV-2 (SD Biosensor Inc, Seoul, Korea). This retrospective study was conducted with archived respiratory samples positive and negative for SARS-CoV-2, IAV, IBV or RSV. The evaluation study involved a total of 322 respiratory samples comprising 215 positive samples (49 SARS-CoV-2, 48 IAV, 53 IBV, 65 RSV) and 107 negative samples. All samples were tested with both STANDARD M10 and either Xpert Xpress SARS-CoV-2 or Xpert Xpress Flu/RSV (Cepheid, USA). The sensitivity, specificity, positive predictive value and negative predictive value rates of STANDARD M10 were very similar to Xpert Xpress SARS-CoV-2 or Xpert Xpress Flu/RSV ranges for each virus (98-100%). The overall agreement was 99.4% with 99.1% agreement for positive samples and 100% agreement for negative samples. In conclusion, the STANDARD M10 point-of-care test is suitable for rapid simultaneous detection of SARS-CoV-2, IAV, IBV and RSV.

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Rapid differential diagnosis of SARS-CoV-2, influenza A/B and respiratory syncytial viruses: Validation of a novel RT-PCR assay

Cited by 11 publications

References 26 publications

Simultaneous detection of human norovirus GI, GII and SARS-CoV-2 by a quantitative one-step triplex RT-qPCR

Simultaneous detection of human norovirus GI, GII and SARS-CoV-2 by a quantitative one-step triplex RT-qPCR

The Role and Value of Professional Rapid Testing of Acute Respiratory Infections (ARIs) in Europe: A Special Focus on the Czech Republic, Poland, and Romania

Evaluation of Standard M10 Assay for Rapid Molecular Diagnosis of SARS-CoV-2, Influenza A/B virus and Respiratory Syncytial Virus (RSV)

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