Severe acute respiratory syndrome-associated coronavirus IVDs

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Saadav alates:

Vela Diagnostics Australia Pty Ltd

Klass:

Class 3

Valmistatud:

Vela Operations Singapore Pte Ltd #05-07 The Kendall, 50 Science Park Road, Science Park II, 117406 Singapore

Terapeutiline ala:

CT772 - Severe acute respiratory syndrome-associated coronavirus IVDs

Näidustused:

The ViroKey? SARS-CoV-2 RT-PCR Test v2.0 is a real-time RT-PCR based in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider. The ViroKey? SARS-CoV-2 RT-PCR Test v2.0 is configured for use on the Sentosa? SX101 instrument, with the ViroKey? SX Virus Total Nucleic Acid Kit or the Sentosa? SX Virus Total Nucleic Acid Kit v2.0, in conjunction with Sentosa? SA201 Real-Time PCR system or the Applied Biosystems? 7500 Fast Dx Real-Time PCR system. 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. The agent detected may not be the definite cause of disease. 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.

Volitamisolek:

A

Loa andmise kuupäev:

2020-08-26