A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients

Обзор

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.

Вмешательства

• Диагностический тест LIAISON NES FLU A/B, RSV & COVID-19
  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 witho

Первичные конечные точки

• Diagnostic Accuracy [Срок оценки: Samples will be tested on LIAISON NES within two hours of collection.]

Вторичные конечные точки (1)

• Clinical Performance [Срок оценки: Samples will be tested on LIAISON NES within one hour of collection.]

Критерии участия

Критерии включения

• 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).
• 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.
• The specimen is from a human patient with active signs and symptoms of respiratory tract infection at time of collection
• 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.
• 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
• The specimen was received in good condition (no leakage or drying of the specimen).

Критерии исключения

• Incorrect swab type
• Incorrect transport media
• Incorrect specimen handling (e.g. specimens not stored at recommended temperature)
• The specimen has undergone more than two freeze/thaw cycles
• Specimens collected with calcium alginate or organic swabs

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 3 центра

• PAS Research - Henderson — Henderson
• PAS Research - Pittsburgh — Pittsburgh
• PAS Research - McAllen — McAllen

Идентификаторы

NCT: NCT06672692 · DSM-PROT-005198

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗