Clinical performance evaluation of the Randox Respiratory-fleX qPCR
Detection and discrimination of causative pathogens of respiratory infections.
An observational clinical performance study will be conducted to demonstrate that, under routine use conditions and following device instructions for use, the Respiratory-fleX device family will meet intended use and labelling claims. The study will retrospectively test nucleic acids from a stored library collected over a period greater than or equal to 12 months, and on freshly collected sample nucleic acids during a concurrent testing window (approximately 6 months) with the Randox Evidence Investigator Respiratory Multiplex Array II Assay (EV3947A/B) as a comparator. Nucleic acids will be isolated from an oral-nasal swab or sputum sample for the purposes of routine respiratory testing using the predicate assay (EV3947A/B). The Respiratory-fleX device will detect and distinguish between nucleic acids from various respiratory pathogens including: Influenza (Subtypes A and B), Respiratory Syncytial Virus, Parainfluenza Virus, human Metapneumovirus, Bordetella pertussis, Rhinovirus/Enterovirus, Adenovirus, human coronaviruses (229E/NL63 and OC43/HKU1), Streptococcus pneumoniae, Moraxella catarrhalis, Haemophilus influenzae, Chlamydophila pneumoniae and Mycoplasma pneumoniae. Results of the Respiratory-fleX device will be compared to that of the reference method (EV3947A/B). Any discrepant positive or negative results between the assays will be initially re-tested using the Respiratory-fleX device to control for nucleic acid degradation. Resolution of the discrepant result will be completed using a third commercial assay to determine concordance of the result between the Respiratory-fleX and predicate devices.
1. Persons who are suspected of having a respiratory infection, at an increased risk of respiratory infection, or believed to have a previous exposure to a respiratory pathogen and require screening. 2. Individuals aged 18 or over. 3. Samples with appropriate consent for use for performance evaluation testing.
1. Contamination and/or deterioration of the specimen or nucleic acid isolate from a specimen that, in the investigator's professional opinion, may impact the handling of the specimen or analysis of the test result.