Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT06672692
Status:
RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants are not provided investigational results and will only be provided with routine standard of care diagnostics results.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-01', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-11-01', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Accuracy', 'timeFrame': 'Samples will be tested on LIAISON NES within two hours of collection.', 'description': 'Estimates of Sensitivity/percent positive agreement (PPA) and Specificity/percent negative agreement (NPA) will be calculated based on a two-by-two table (comparator method result vs. result from LIAISON® NES FLU A/B, RSV \\& COVID-19 assay or LIAISON PLEX® RSP Flex assay) for each target. In addition, 95% two-sided confidence intervals will be provided. A separate Sensitivity/PPA and Specificity/NPA for each target, to include those specimens excluded due to a discrepancy between the standard-of-care and molecular comparator result, will be presented in a separate 2 x 2 table.'}], 'secondaryOutcomes': [{'measure': 'Clinical Performance', 'timeFrame': 'Samples will be tested on LIAISON NES within one hour of collection.', 'description': 'The secondary objective is to compare the clinical performance of the LIAISON NES FLU A/B, RSV \\& COVID-19 assay per clinical site, target patient sub-population (e.g. age group, patient location) and specimen collection method (e.g. professionally collected, patient self-collected).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza a', 'Influenza B', 'RSV', 'COVID 19']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nNegative 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The specimen is a NPS or NS from a patient collected and preserved in 3 mL Universal Transport Media (UTM), BD Universal Viral Transport (UVT), or MicroTest M4RT transport media, or 1 mL Copan Eswab (Liquid Amies).\n* The specimen is from a patient who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.\n* The specimen is from a human patient with active signs and symptoms of respiratory tract infection at time of collection\n* Specimen stored at 2-8°C for up to 72 hours from collection. If there is a delay in testing, store specimen at ≤-70 °C.\n* The total volume of the leftover specimen received is ≥1.5 mL, except for specimens collected in Liquid Amies which requires a total leftover volume of ≥0.5 mL\n* The specimen was received in good condition (no leakage or drying of the specimen).\n\nExclusion Criteria:\n\n* Incorrect swab type\n* Incorrect transport media\n* Incorrect specimen handling (e.g. specimens not stored at recommended temperature)\n* The specimen has undergone more than two freeze/thaw cycles\n* Specimens collected with calcium alginate or organic swabs'}, 'identificationModule': {'nctId': 'NCT06672692', 'acronym': 'NES ABCR', 'briefTitle': 'A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'DiaSorin Molecular LLC'}, 'officialTitle': 'A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients', 'orgStudyIdInfo': {'id': 'DSM-PROT-005198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Blinded, Prospective Arm', 'description': '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.\n\nWhere 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.\n\nNasopharyngeal (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.', 'interventionNames': ['Diagnostic Test: LIAISON NES FLU A/B, RSV & COVID-19']}], 'interventions': [{'name': 'LIAISON NES FLU A/B, RSV & COVID-19', 'type': 'DIAGNOSTIC_TEST', 'description': 'The LIAISON® NES FLU A/B, RSV \\& COVID-19 assay used on the LIAISON® NES instrument is a real-time PCR system that enables the direct amplification, detection and differentiation of Flu A viral RNA, Flu B viral RNA RSV viral RNA, and SARS-CoV-2 RNA from dry nasal swabs. Nasal Swabs can be professionally collected by a Healthcare Provider or self-collected by the patient under the supervision of the healthcare provider. The collected nasal swab can then be directly loaded into the cartridge without nucleic acid extraction.', 'armGroupLabels': ['Blinded, Prospective Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89014', 'city': 'Henderson', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janet VP of Clinical Affairs', 'role': 'CONTACT', 'email': 'janet.farhang@diasorin.com', 'phone': '5124015472'}], 'facility': 'PAS Research - Henderson', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '15227', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janet VP of Clinical Affairs', 'role': 'CONTACT', 'email': 'janet.farhang@diasorin.com', 'phone': '5124015472'}], 'facility': 'PAS Research - Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78504', 'city': 'McAllen', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janet VP of Clinical Affairs', 'role': 'CONTACT', 'email': 'janet.farhang@diasorin.com', 'phone': '5124015472'}], 'facility': 'PAS Research - McAllen', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}], 'centralContacts': [{'name': 'Janet Farhang', 'role': 'CONTACT', 'email': 'janet.farhang@diasorin.com', 'phone': '5124015472'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DiaSorin Molecular LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}