Diagnostic Assay for Respiratory Infections

(NES ABCR Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: DiaSorin Molecular LLC

Disqualifiers: Incorrect swab, Incorrect media, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The DiaSorin Molecular LIAISON® NES FLU A/B, RSV \& COVID-19 real-time polymerase chain reaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B, RSV and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors. 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 SARS-CoV-2 infection in a professional laboratory setting. Negative results do not preclude influenza A, influenza B, RSV or SARS-CoV-2, infection and should not be used as the sole basis for patient management decisions. The assay is not intended to detect the presence of the influenza C virus.

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 data supports the effectiveness of the treatment LIAISON NES FLU A/B, RSV & COVID-19 Assay?

The effectiveness of similar RT-PCR assays for detecting respiratory viruses like influenza, RSV, and SARS-CoV-2 is supported by studies showing high sensitivity and specificity, meaning they are good at correctly identifying both the presence and absence of these viruses. For example, one study showed a sensitivity of 98.2% for RSV and 96.5% for influenza, indicating these tests are reliable for diagnosing these infections. ^{1 2 3 4 5}

How does the diagnostic assay for respiratory infections differ from other treatments?

This diagnostic assay is unique because it can rapidly detect and differentiate between multiple respiratory viruses, including SARS-CoV-2, influenza A/B, and RSV, in a single test, which is a significant advancement over traditional methods that typically test for one virus at a time. ^{1 3 4 5 6}

Research Team

Eligibility Criteria

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

Specimen has undergone more than two freeze/thaw cycles

Incorrect swab type

Incorrect transport media

Trial Timeline

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

Treatment Details

Interventions

• LIAISON NES FLU A/B, RSV & COVID-19 (Virus Therapy)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

PAS Research - Henderson Henderson, NV

PAS Research - Pittsburgh Pittsburgh, PA

PAS Research - McAllen McAllen, TX

Who Is Running the Clinical Trial?

DiaSorin Molecular LLC

Lead Sponsor

Trials

3

Patients Recruited

2,200+

Findings from Research

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Two Automated Multiplex RT-PCR Tests for Rapid Detection of Influenza and Respiratory Syncytial Viruses. [2021]

2. England 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. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Performance Evaluation of the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of the Cepheid respiratory syncytial virus and influenza virus A/B real-time PCR analyte specific reagent. [2021]

5. Netherlands 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. [2023]

6. New Zealand 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. [2022]