![]() ![]() Alinity m SARS-CoV-2 AMP Kit Package Insert (PI): 53-608193/R4. Up to 1080 samples in 24 hours (Number of actual samples per 24-hour period may vary based on laboratory practice and workflow)Ġ9N78-091 Recombinant Virus in Simulated Nasal Matrix and Saliva: 100 virus copies/mL CGIV* in NP and Nasal Swab: 0.009 TCID50 /mL (or 55 GE/mL) CGIV* in Saliva: 55 GE/mL 09N78-090 The lowest concentration level with observed positive rates ≥ 95% was 100 virus Copies/mL. One negative and one positive control per 48 hoursĪrmored RNA® from pumpkin gene, added to each specimen and control (Symptomatic and asymptomatic patients) 09N78-090 Nasopharyngeal and oropharyngeal swabs (Symptomatic patients)ĭepending on tube type between 0.8 mL and 1.4 mL (see package insert for details) < 115 min time to first results (12 results) 12, more results 16 min thereafter (assumption 100% efficiency)ĭual-target, single-stranded linear probeĠ9N78-091 - Nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, saliva, and pooled samples containing aliquots of transport media from up to 5 individual nasal, NP, and OP swabs. Negative results must be combined with clinical observations, patient history, and epidemiological information.ĪBBOTT ALINITY m SARS-COV-2 ASSAY SPECIFICATIONS 1-4 Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Positive results do not rule out bacterial infection or co-infection with other viruses. 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. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swabs during the acute phase of infection. Results are for the identification of SARS-CoV-2 RNA. 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. 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. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing. Specimens included in pools with a positive result must be tested individually prior to reporting a result. 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. Negative results from pooled testing should not be treated as definitive. Negative results must be combined with clinical observations, patient history, and epidemiological information. The SARS-CoV-2 RNA is generally detectable during the acute phase of infection. pooled samples containing aliquots of transport media from up to 5 individual nasal, NP, and OP swabs specimens.individual saliva specimens collected under HCP supervision, and.individual nasal swabs self-collected under HCP supervision or collected by HCP.individual nasopharyngeal (NP) swabs and oropharyngeal (OP) swabs collected by a healthcare provider (HCP).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: ![]()
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