INTENDED USE (09N78-091)
The Alinity m SARS-CoV-2 assay is a reverse transcription polymerase chain reaction (RT-PCR) test for use with automated Alinity m System for the qualitative detection of nucleic acid from SARS-CoV-2 from patients with or without signs and symptoms of COVID-19 infection in the following specimen types:
- individual nasopharyngeal (NP) swabs and oropharyngeal (OP) swabs collected by a healthcare provider (HCP)
- individual nasal swabs self-collected under HCP supervision or collected by HCP
- individual saliva specimens collected under HCP supervision, and
- pooled samples containing aliquots of transport media from up to 5 individual nasal, NP, and OP swabs specimens.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results from pooled testing should not be treated as definitive. If patient’s clinical signs and symptoms are inconsistent with a negative result and if results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools with a positive result must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing.
The Alinity m SARS-CoV-2 assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
INTENDED USE (09N78-090)
The Alinity m SARS-CoV-2 assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs collected by a healthcare provider, from patients who are suspected of COVID-19 infection.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swabs during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Alinity m SARS-CoV-2 assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
