Diagnostic Assay for Respiratory Infections

(NES ABCR Trial)

Recruiting at 2 trial locations

Overseen By Janet Farhang

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: DiaSorin Molecular LLC

Disqualifiers: Incorrect swab, Incorrect media, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new diagnostic tool, the LIAISON NES FLU A/B, RSV & COVID-19 Assay, which identifies and differentiates viruses causing respiratory infections, such as the flu, RSV, and COVID-19, using nasal swabs. The goal is to enhance the speed and accuracy of diagnosing these infections in a lab setting. Suitable participants include those currently experiencing respiratory infection symptoms and are in a hospital, emergency department, outpatient clinic, or long-term care facility. As an unphased trial, this study allows participants to contribute to advancements in diagnostic technology for respiratory infections.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this assay is safe for use in diagnosing respiratory infections?

Research has shown that the LIAISON NES FLU A/B, RSV & COVID-19 test reliably identifies respiratory viruses such as the flu, RSV, and COVID-19. Various studies have used it to diagnose these infections quickly and accurately in a lab setting.

While specific safety details for this test are not provided, it typically involves taking a nasal swab. This common and safe procedure is generally well-tolerated. There have been no major reports of issues arising from the testing process itself.

The technology behind this test is designed for high accuracy, minimizing any associated risk. For those considering participation in a trial using this test, the process should be straightforward and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LIAISON NES FLU A/B, RSV & COVID-19 assay because it offers a comprehensive and rapid diagnostic approach for multiple respiratory infections, all in one go. Unlike traditional tests that usually require separate swabs and longer processing times for each virus, this assay can detect influenza A and B, respiratory syncytial virus (RSV), and COVID-19 from a single nasal swab, potentially speeding up diagnosis and treatment decisions. Additionally, the ability for up to 40% of these swabs to be self-collected under professional supervision could make the testing process more accessible and less burdensome for patients. This approach is particularly promising for quickly identifying and managing co-infections in a clinical setting.

What evidence suggests that this assay is effective for diagnosing respiratory infections?

Research has shown that the LIAISON NES FLU A/B, RSV & COVID-19 test, used by participants in this trial, effectively detects influenza A, influenza B, RSV, and COVID-19 from nasal swabs. This test employs RT-PCR, a method that accurately distinguishes these viruses, aiding doctors in making correct diagnoses. Studies have proven RT-PCR to be a reliable method for identifying viral infections, as it can detect even small amounts of viral genetic material. Although a negative result should not be the sole factor in health decisions, this test serves as a valuable tool for diagnosing respiratory infections.

Are You a Good Fit for This Trial?

This trial is for patients showing symptoms of respiratory infections, who may have COVID-19, flu types A/B, or RSV. It's important that they are in the acute phase of their illness and haven't been diagnosed yet.

Inclusion Criteria

My specimen volume is at least 1.5 mL, or 0.5 mL if in Liquid Amies.

My sample was collected and stored properly.

Specimen was received in good condition (no leakage or drying of the specimen)

Exclusion Criteria

Incorrect swab type

Incorrect transport media

Incorrect specimen handling (e.g. specimens not stored at recommended temperature)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Sample Collection

Clinical specimens are collected from patients with signs or symptoms of respiratory tract infection

1 day

1 visit (in-person)

Testing

Samples are tested on LIAISON NES within one to two hours of collection for diagnostic accuracy and clinical performance

1 day

Follow-up

Participants are monitored for any adverse events or discrepancies in test results

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LIAISON NES FLU A/B, RSV & COVID-19

Trial Overview The trial is testing the LIAISON NES FLU A/B, RSV & COVID-19 assay. This lab test uses a nasal swab to detect and differentiate between flu viruses A/B, RSV, and SARS-CoV-2 using RT-PCR technology.

How Is the Trial Designed?

Group I: Blinded, Prospective Arm Experimental Treatment 1 Intervention

Clinical specimens shall be collected prospectively from patients with signs or symptoms of respiratory tract infection. Nasal swab in Copan universal transport media (UTM) 3 milliliters for comparator testing should be collected by a healthcare professional. Where subjects are willing and able, up to 40% of nasal swab for the investigational device will be self-collected under the guidance and supervision of a healthcare professional. Nasopharyngeal (NPS) specimens (optional) should only be collected by a healthcare professional. All specimens collected from children 13 years or younger should only be collected by a trained healthcare professional. Follow the Centers for Disease Control and Prevention guidelines for collecting NPS swabs, unless otherwise specified by the sponsor.

Who Is Running the Clinical Trial?

DiaSorin Molecular LLC

Lead Sponsor

Trials

3

Recruited

2,200+

Published Research Related to This Trial

The TaqMan SARS-CoV-2, Flu A/B, RSV RT-PCR multiplex assay demonstrated high accuracy (96.38% to 100% for nasopharyngeal samples and 94.87% to 100% for saliva samples) in detecting SARS-CoV-2, Influenza A/B, and RSV, making it a reliable tool for diagnosing respiratory infections during the COVID pandemic.

This assay effectively differentiates between multiple pathogens without being affected by SARS-CoV-2 variants, including Omicron, highlighting its potential for managing co-infections and improving clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance Evaluation of TaqMan SARS-CoV-2, Flu A/B, RSV RT-PCR Multiplex Assay for the Detection of Respiratory Viruses. Neopane, P., Nypaver, J., Shrestha, R., et al.[2022]

The STANDARD M10 Flu/RSV/SARS-CoV-2 RT-PCR assay demonstrated a high overall agreement of 94.6% when compared to a reference kit, indicating its reliability in diagnosing multiple respiratory viruses.

This assay achieved 100% positive percent agreement for influenza A and B, RSV, and high negative percent agreement, making it an effective tool for rapid differential diagnosis of these viruses within one hour.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid differential diagnosis of SARS-CoV-2, influenza A/B and respiratory syncytial viruses: Validation of a novel RT-PCR assay. Domnich, A., Bruzzone, B., Trombetta, CS., et al.[2023]

The new rapid real-time RT-PCR assays for detecting respiratory syncytial virus (RSV) and influenza A and B showed high sensitivity (98.2% for RSV and 96.5% for influenza) and 100% specificity, indicating they are reliable for clinical use.

In a study involving 100 samples for RSV and 96 for influenza, the new assays demonstrated excellent performance compared to existing methods, with minimal discrepancies in results, confirming their effectiveness in accurately identifying these viruses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Cepheid respiratory syncytial virus and influenza virus A/B real-time PCR analyte specific reagent. Sails, AD., Saunders, D., Airs, S., et al.[2021]

The NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Assay demonstrated 100% sensitivity and specificity for detecting both influenza viruses and SARS-CoV-2 in a study involving 115 positive clinical samples, making it a highly reliable diagnostic tool.

For RSV, the assay showed a sensitivity of 93.47% and maintained a specificity of 100%, indicating it is effective for simultaneous detection of multiple respiratory viruses, which is crucial given the overlapping symptoms of these infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Performance Evaluation of the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay. Meletis, G., Tychala, A., Gkeka, I., et al.[2023]

The cobas Influenza A/B & RSV assay (cobas Liat) demonstrated a rapid turnaround time of 20 minutes per specimen and had a significantly lower rate of invalid results (0.4%) compared to the Simplexa assay (4.2%), making it a more efficient point-of-care test for detecting respiratory viruses.

While both tests showed high sensitivity and specificity for Flu A, Flu B, and RSV, the cobas Liat had superior performance for RSV detection, particularly with a sensitivity of 100% for RSV compared to Simplexa's 80% for RSVB, indicating its reliability in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Two Automated Multiplex RT-PCR Tests for Rapid Detection of Influenza and Respiratory Syncytial Viruses. Hur, KH., Sung, H., Kim, MN.[2021]

The cobas Liat assay effectively detected influenza A and B in 30% of samples tested in an emergency department setting, with a total of 308 positive cases out of 1027 samples.

The assay demonstrated high sensitivity (85%) and specificity (98%) for detecting influenza, indicating it is a reliable tool for diagnosing influenza in adults, with strong predictive values for both positive and negative results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the cobas Liat influenza point-of-care test into an emergency department during a high-incidence season: a retrospective evaluation following real-world implementation. Youngs, J., Iqbal, Y., Glass, S., et al.[2020]

Citations

1. reaganudall.org reaganudall.org/clinical-trial/multi-site-clinical-evaluation-liaison-nes-flu-ab-rsv-covid-19-assay-symptomatic

A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B The LIAISON® NES FLU A/B, RSV & COVID-19 assay is intended for use as an aid in thedifferential diagnosis of influenza A, influenza B, RSV and SARS-CoV-2 ...

2. trialx.com trialx.com/clinical-trials/listings/305172/a-multi-site-clinical-evaluation-of-the-liaison-nes-flu-ab-rsv-covid-19-assay-in-symptomatic-patients/

A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/ ... The LIAISON® NES FLU A/B, RSV & COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B, RSV and ...

3. us.diasorin.com us.diasorin.com/sites/default/files/press-releases/PR%20NES%20ABCR%20submission%20ENG.pdf

510( Saluggia, Italy – July 2, 2025 The LIAISON NES® system is designed to provide laboratory-quality molecular results, delivering high diagnostic accuracy with the speed and ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/K201505.pdf

K201505.pdf - accessdata.fda.gov The DiaSorin Molecular Simplexa™ Flu A/B & RSV Direct Gen II assay is intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06392451

LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial ... The LIAISON® NES FLU A/B, RSV & COVID-19 real-time (RT) PCR assay is a Point of Care (POC) system that enables the extraction, amplification, detection and ...