Applied Biosystems™ TaqPath™ COVID-19 Fast PCR Combo Kit 2.0 (EUA)

Description

• The Applied Biosystems TaqPath COVID-19 Fast PCR Combo Kit 2.0 multigene SARS-CoV-2 assays target eight target sequences in three different viral genomic regions, reducing the risk of failure when new viral strains arise
• The human RNase P assay run in the same well helps assess sample quality, indicates the presence of human nucleic acid, and serves as an internal process control
• The kit is designed to provide reliable and sensitive results from raw saliva samples subjected directly to PCR, bypassing nucleic acid extraction
• Features of the TaqPath COVID-19 Fast PCR Combo Kit 2.0 include: Multi-target design —compensates for current and future SARS-CoV-2 mutations, helping provide confidence in results Fast —helps increase speed from sample collection to results, enabling high-throughput testing Cost effective —minimizes infrastructure, supplies, reagents, and personnel costs across workflow Easy to use —simplifies workflow from raw saliva collection direct to PCR, with no RNA extraction step The TaqPath COVID-19 Fast PCR Combo Kit 2.0 is a single high-throughput (1,000 reaction) kit and is approved for the use on the QuantStudio 5 Real Time PCR System (96-well, 0.2 mL block) and the QuantStudio 7 Flex Real-Time PCR System (384-well) and associated Pathogen Interpretive Software v1.1.0
• The TaqPath COVID-19 Fast PCR Combo Kit 2.0 includes the following components: TaqPath COVID-19 Fast PCR Assay 2.0 —multiplexed assays that contain primer and probe sets specific to three SARS-CoV-2 viral gene targets (ORF 1a, ORF 1b, and N genes) TaqPath COVID-19 Plus Control —internal RNA control that contains one in-vitro transcribed (IVT) RNA targeting three SARS-CoV-2 viral genomic regions (N, Orf1a, and Orf1b genes) and one IVT RNA targeting human RNaseP gene TaqPath COVID-19 Control Dilution Buffer —for dilution of the TaqPath COVID-19 Fast PCR Control to a working concentration SalivaReady Solution —lysis buffer used to disrupt virus particles and prepare saliva samples for direct PCR TaqPath 1-Step Multiplex Master Mix (no ROX) is required but not included in the kit
• It is a fast, single-tube, 4X RT-qPCR mix that provides up to four different RNA/DNA targets in a single multiplex reaction
• Particularly useful for diagnostics, virus detection, and high-throughput gene-expression workflows, the mix includes thermostable MMLV reverse transcriptase, dNTPs, UNG, and thermostable Fast DNA polymerase all in a single tube
• The kit can be used for medium- to large-scale testing to quickly run 96 or 384 reactions with a fast turnaround time (∼53 min PCR run time per plate)
• Intended use The TaqPath COVID-19 Fast PCR Combo Kit 2.0 is a real‐time reverse transcription polymerase chain reaction (RT‐PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container under the supervision of a healthcare provider in a health care setting from individuals suspected of COVID-19 by their healthcare provider
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C
• §263a, that meet requirements to perform high complexity tests
• Results are for the identification of SARS-CoV-2 RNA
• The SARS-CoV-2 RNA is generally detectable in saliva specimens 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
• Laboratories within the United States and its territories are required to report all test results to the appropriate public health authorities
• 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 for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type, if clinically indicated
• The TaqPath COVID-19 Fast PCR Combo Kit 2.0 is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real‐time PCR and in vitro diagnostic procedures
• The TaqPath COVID-19 Fast PCR Combo Kit 2.0 is only for use under the Food and Drug Administration’s Emergency Use Authorization
• Pathogen Interpretive Software v1.1.0 Applied Biosystems Pathogen Interpretive Software helps your lab decrease analysis and interpretation time and reduce risk of user interpretation error
• Automatically interpret genetic analysis results from the TaqPath COVID-19 Fast PCR Combo Kit 2.0 Following instrument data analysis, the software performs a QC check against all controls on the plate The software generates a report for each specimen Pathogen Interpretive Software is available for download upon kit purchase.