End to End workflow for COVID-19 Detection Hero Banner

End-to-End Workflow for COVID-19 Detection

Quick SARS-CoV-2 rRT-PCR Kit

Zymo Research Testing for COVID-19 Detection

The Quick SARS-CoV-2 rRT-PCR Kit from Zymo Research is intended for the qualitative detection of nucleic acids from SARS-CoV-2 in upper and lower respiratory specimens from patients suspected of COVID-19 by their health care provider. The Quick SARS-CoV-2 rRT-PCR Kit is FDA Emergency Use Authorized (EUA) and has been granted with the CE-IVD mark.

Highlights

  • No cold-chain required for specimen transportation
  • Compatible with automated and manual RNA extraction
  • Targets the SARS-CoV-2 nucleocapsid (N) gene and the human RNaseP gene
  • Limit of Detection (LoD) of 15 viral genome equivalent copies per reaction (GEC)/rxn
  • Simple and fast reaction set-up with results in < 1.5 hours after RNA extraction

Zymo Research's SARS-CoV-2 FDA EUA Authorized Testing Includes:

Sample Collection in DNA/RNA Shield™
Shield Swab and Saliva Collection

Proprietary sample collection technology

  • Store the sample at ambient temperature up to 7 days.
  • No cold-chain required for shipping.
  • Collection devices for upper and lower respiratory tract specimens.
RNA Extraction Using Quick-DNA/RNA™ Viral Magbead Kit
Direct-zol RNA Microprep Kits

Robust nucleic acid purification

  • Compatible with manual and automated procedures.
  • Automated RNA extraction in < 1 hour using the KingFisher™ Flex Purification System (ThermoFisher Scientific).
SARS-CoV 2 Detection Using the Quick SARS-CoV-2 rRt-PCR Kit
Quick SARS-CoV-2 Kit

SARS-CoV-2 detection system

  • Simple reaction set-up.
  • 100% detection at 15 GEC/rxn.
  • Results in < 1.5 hours after extraction.
  • Includes CV Mix 1 (for SARS-CoV-2 detection), CV Mix 2 (internal human control), CV Positive Control and No Template Control.

Specifications

1

Specimens collected in DNA/RNA Shield™ are extracted manually or with the automated KingFisher™ Flex Purification System (ThermoFisher Scientific)

spec 1
spec 2

2

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
10µl
Total 20µl

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).

RT-PCR Setup
Interpret the results based on Ct values
Host Target Viral Target Results
+ - SARS-CoV-2 Negative
+ + SARS-CoV-2 Positive*
- + SARS-CoV-2 Positive*
- - Invalid

*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.

3

Performance:

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

step 3 graph
Product image
Instructions for Use FDA Emergency Use Authorization Patient Fact Sheet Healthcare Provider Fact Sheet King Fisher Script
Quick SARS-CoV-2 rRT-PCR Kit
R3011
Fill out my online form.

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.