Intended use

The Applied Biosystems TaqPath COVID‑19, Flu A, Flu B, RSV Select Panel is a multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) in vitro diagnostic test for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab and anterior nasal (AN) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. This test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and RSV A/B (undifferentiated) infections in humans and is not intended to detect influenza C virus infections.

Nucleic acids from the viral organisms identified by this test are generally detectable in NP and AN swab specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings.

 

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out coinfection with other organisms. The organism(s) detected by the TaqPath COVID‑19, Flu A, Flu B, RSV Select Panel may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections.

 

The TaqPath COVID‑19, Flu A, Flu B, RSV Select Panel 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.


Target genes

SARS-CoV-2

Influenza A

Influenza B

RSV

Human sample collection control

Orf1a

Orf1b

N

PB1

M

M

NS

NP

M

L

RNase P


Kit components

The TaqPath COVID‑19, Flu A, Flu B, RSV Select Panel kit comes with the following components, to be stored at –30°C to –10°C.

  • TaqPath COVID‑19, Flu A, Flu B, RSV Select Assay
  • TaqPath COVID‑19, Flu A, Flu B, RSV Select Positive Control
  • TaqPath COVID‑19, Flu A, Flu B, RSV Select Negative Control
  • TaqPath 1-Step Select Master Mix (No ROX)

About the Dx Instrumentation

QuantStudio 5 Dx Real-Time PCR System

The Applied Biosystems QuantStudio 5 Dx Real-Time PCR System is designed to streamline workflows and minimize training needs, helping you get clinical answers quickly by integrating into your established workflow.

KingFisher Apex Dx Purification system

The Apex Dx system is designed to be part of a streamlined modular workflow that can provide precise results, easy data management, and robust security features.


About Diomni Software

Applied Biosystems Diomni Software is an on-premise workflow solution that connects the steps in your real-time PCR (qPCR) test development and routine testing workflows in a single ecosystem.

 

One connection

One interface

One workflow

Diomni Software combines instruments, assays, and consumables to streamline your workflow from samples to clinical results and lets you optimize the utilization of your QuantStudio instrument with the scalability to expand your test menu at any time.

Flexible, multimode workspaces enable labs to use a single, intuitive user interface no matter the task, from performing routine testing to using test development tools. The assay definition file (ADF) workflow offers a consistent user experience, and laboratory information system (LIS) integration may reduce time-to-results.

Extraction, assay selection, testing, analysis, quality control (QC), and interpretive reporting are all integrated in an end-to-end workflow that helps improve efficiency while reducing the potential for human error from manual steps, reducing turnaround time with results in approximately three hours.

Ordering information


For In Vitro Diagnostic Use.