The Applied Biosystems TaqPath COVID-19 RNase P Combo Kit 2.0 is for the real-time PCR detection of SARS-CoV-2 viral RNA. The RT-PCR assay detects SARS-CoV-2 with multiple target regions while compensating for emerging variants and mutations. The assay includes an RNase P control and can be used in combination with the included RNA control and control dilution buffer, as well as a master mix for RT-PCR detection (not included).
Features of the TaqPath COVID-19 RNase P Combo Kit 2.0 include:
• Human sample confirmation—the RNase P gene serves as endogenous control
• Multi-target assay design—multiple targets on orf1a, orf1b, and N genes compensate for emerging SARS-CoV-2 mutations
• Sensitive detection—PCR-based test with <250 GCE/mL limit of detection
• Scalable—add to your existing COVID-19 test menu
TaqPath COVID-19 RNase P Combo Kit 2.0 can be used to evaluate up to 94 or 382 samples. The assay can detect nucleic acid from SARS-CoV-2 in upper respiratory specimens, such as nasopharyngeal and anterior nasal swab samples from individuals suspected of SARS-CoV-2 coronavirus infection.
The assay can be used on the QuantStudio 5 (96 well, 0.2 mL) or QuantStudio 7 Flex (384-well) real time PCR instruments. The assay results are analyzed using Applied Biosystems Pathogen Interpretive Software. Contact your local support team (instructions below) for assistance obtaining the software.
1. Go to thermofisher.com/contactus
2. Select 'Instrument Service' category
3. Enter instrument name and select your country
4. Call the local number displayed on the screen
The TaqPath COVID-19 RNase P Combo Kit 2.0 (1000 reactions) includes the multiplex assay with primer/probe sets specific for different SARS-CoV-2 genomic regions and an RNase P control for confirmation of a human sample.
The following components are included in the multiplex kit:
• TaqPath COVID-19 RNase P Kit 2.0—the multiplex assay
• TaqPath COVID-19 Plus Control—an RNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assay
• TaqPath COVID-19 Control Dilution Buffer—a dilution buffer for the RNA control
The TaqPath 1-Step RT-qPCR Master Mix (No ROX) can be ordered separately. Access the Instructions for Use approved for your country › Intended use
The Applied Biosystems TaqPath COVID-19 RNase P Combo Kit 2.0 contains the assays and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (nasopharyngeal and nasal swabs) from individuals suspected of COVID-19.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meets 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 nasopharyngeal and anterior nares 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.
The TaqPath COVID-19 RNase P Combo Kit 2.0 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.
The TaqPath COVID-19 RNase P Combo Kit 2.0 is only for use under the Food and Drug Administration’s Emergency Use Authorization.
For Emergency Use Authorization (EUA) only. For prescription use only. For in vitro diagnostic use.