AbbottRT SARS-CoV-2 AmplReagKit, pack/96

General description: The Abbott RealTime 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 onto the m2000sp instrument from patients who are suspected of COVID-19 by their healthcare provider.

Technical specifications:
Intended use:
• For the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs from patients suspected of COVID-19.
• 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 Abbott RealTime SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Manufacturer product reference: 09N77-090

Items supplied with:
Abbott RealTime SARS-CoV-2 Amplification Reagent Kit contains;
Abbott RealTime SARS-CoV-2 Internal Control (4 vials, 1.2ml per vial)
Abbott RealTime SARS-CoV-2 Amplification Reagent Pack (4 packs, 24 tests/pack)

Storage & transportation condition:
It must be stored at –25 to –15°C and shipped on dry ice.