Specimens collected in DNA/RNA Shield™ are extracted manually or with the automated KingFisher™ Flex Purification System (ThermoFisher Scientific)
Samples are analyzed using the CFX96 Touch Real-Time PCR Detection System (Bio-Rad).
Data Analysis & Interpretation
|Component||Volume per Reaction|
|CV Mix (1 or 2) Template RNA||10µl
Select HEX channel for the detection of SARS-CoV-2 targets (CV Mix 1) and Quasar 670 for the detection of human target (CV Mix 2).
Interpret the results based on Ct values
|Host Target||Viral Target||Results|
*A positive result using the Quick SARS-CoV-2 rRT-PCR Kit is considered presumptive for SARS-CoV-2 because it may result from infection by another Sarbecovirus, such as SARS-CoV. Follow-up testing may be performed if differentiation between targets is desired.
PPA: 30/30 = 100% (95% CI: 88.7% - 100%)
NPA: 30/30 = 100% (95% CI: 88.7% - 100%)
100% accurate detection as low as 15 GEC/rxn
Quick SARS-CoV-2 rRT-PCR Specifications
The Quick SARS-CoV-2 rRT-PCR Kit is a real-time reverse transcription PCR (rRT-PCR) test designed to detect three RNA regions from nucleocapsid (N) gene of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is responsible for the coronavirus disease (COVID-19). The test also detects one host-specific region (human RNase P gene) to assess sample quality. To control for the quality of the rRT-PCR run, the kit includes a CV Positive Control and No Template Control.
The input material for the Quick SARS-CoV-2 rRT-PCR kit is pure RNA from clinical sources such as swabs, saliva, sputum, and respiratory fluids.
The Quick SARS-CoV-2 rRT-PCR Kit has a Limit of Detection of 15 viral genomic copies/reaction, a ready-to-use master mix and a simple 3-step workflow with < 7 minutes hands-on.
The kit is compatible with Real-Time PCR instruments able to detect the fluorescent dyes HEX™ and Quasar® 670/Cy® 5.
If you need assistance setting up or interpreting data, technical support is available to answer your questions.
This test has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Detection of SARS-CoV-2 RNA may be affected by sample collection methods, patient factors, and/or stage of infection.