Solution reagent 11-612-002

salt solutionnucleic acidclinical

The Saline Solution (0.85%) is an isotonic solution, manufactured in compliance with ISO 13485:2016 standards. It is intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided, see IFU for details), to be analyzed in the laboratory with validated qRT-PCR assays. This Saline Solution (0.85%) has been validated for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans.1,2 The use of this device for other viral specimens is the responsibility of the end user including the validation thereof. SPECIFICATIONS Product Principle - Intended to aid in the process of collection and transport of human clinical specimen Ensures a non-replicating competent status of SARS-CoV-2 Is aseptic and does not contain bacteria or fungi growth-inhibition agents. Validated to be compatible with the identification of SARS-CoV-2 using qRT-PCR technology Simple Convenience - Viral specimen stored in the Saline Solution (0.85%) at room temperature (18–25 °C) for 72 hours is compatible with downstream qRT-PCR tests Compatible with approved nucleic acid extraction and qRT-PCR tests Storage - Do not store frozen. Keep away from direct light and heat exposure. Do not use expired solution. Do not use the solution if it appears to be damaged, leaking or the solution appears to be cloudy or evaporated. Specimen - Nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens