Quick SARS-CoV-2 rRT-PCR Kit

(For COVID-19 Detection)

FDA EUA and CE-IVD Quick SARS-CoV-2 rRT-PCR Kit product photo
The Quick SARS-CoV-2 rRT-PCR Kit is a molecular diagnostic test for SARS-CoV-2 (coronavirus detection) that provides high-quality results to healthcare professionals. It is used to identify COVID-19 patients and to personalize their clinical management. In addition, the prompt identification of COVID-19 patients to reduce the risk of SARS-CoV-2 spread among the population.

Reliable, Affordable Testing Solutions for COVID-19

The Quick SARS-CoV-2 rRT-PCR Kit is for use under the FDA’s Emergency Use Authorization (EUA) in conjunction with Zymo Research’s sample collection and viral RNA purification systems. The kit is also CE-IVD certified for countries requiring this mark. In addition, Zymo Research has a secure, reliable supply of the Quick SARS-CoV-2 rRT-PCR Kit and COVID-19 testing reagents.

Sensitivity

Extremely sensitive, with 100% viral detection at 15 GEC/reaction (250 GEC/ml of sample).

Specificity

Simultaneous detection of three conserved viral regions specific for SARS-CoV-2 and Sarbecoviruses.

Controls

Robust control system that minimizes false negative results.

Simplicity

Ready-to-use reagents for simple set-up and minimal hands-on time and results generated in less than 1.5 hours.

Competitive Pricing

Affordable solution with flexible pricing.

Flexibility

Compatible with Real-Time PCR instrumentation capable of detecting HEX/VIC and Quasar670/Cy5 fluorophores.

Intended Use

Quick SARS-CoV-2 rRT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in upper respiratory specimens (such as nasal, nasopharyngeal, mid-turbinate or oropharyngeal swabs), and lower respiratory specimens (such as sputum, tracheal aspirates, and bronchoalveolar lavage) from patients 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, to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper and lower respiratory 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 positive 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 Quick SARS-CoV-2 rRT-PCR Kit is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time RT-PCR assays. The Quick SARS-CoV-2 rRT-PCR Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Quick SARS-CoV-2 rRT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in upper respiratory specimens (such as nasal, nasopharyngeal, mid-turbinate or oropharyngeal swabs), and lower respiratory specimens (such as sputum, tracheal aspirates, and bronchoalveolar lavage) from patients suspected of COVID-19 by medical personnel. Testing is limited to diagnostic laboratories certified by health authorities to perform high complexity tests.

The test is intended for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper and lower respiratory specimens during the acute phase of infection.

Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical observations, patient history and other diagnostic information are 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.

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 Quick SARS-CoV-2 rRT-PCR Kit should be used by laboratory personnel trained in the techniques of real-time RT-PCR assays.

Learn more about Zymo Research’s COVID-19 FDA EUA Workflow:

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.

Customer Feedback

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.