SARS-CoV-2 RT-qPCR Kit

WHAT IS THE SARS-CoV-2 RT-qPCR Kit?

The SARS-CoV-2 RT-qPCR Kit is a molecular test designed for the direct, qualitative detection of SARS-CoV-2, the novel coronavirus that causes COVID-19, from human respiratory samples via a nasopharyngeal and/or oropharyngeal swab. The assay is a real-time reverse transcription polymerase chain reaction (RT-qPCR), which is the gold-standard method for identifying active infections of COVID-19.

VALIDATION & ANALYTICAL SPECIFICITY

The SARS-CoV-2 Kit exhibited over 99.99% sensitivity in correctly identifying the RNA of the novel coronavirus. The SARS-CoV-2 Kit by NIPD Genetics exhibited full agreement with FDA authorized CDC 2019-nCOV, SARS-CoV-2 RT-qPCR Diagnostic Panel. The specificity of the assay was confirmed against 26 common respiratory pathogens, including but not limited to influenza viruses, respiratory syncytial virus, bordetella, legionella, MERS, and other human coronaviruses. Cross-reactivity was not detected among any of the 26 pathogens tested.

ADVANTAGES

  • Over 99.99% sensitivity
  • Low limit of detection for SARS-CoV-2 virus
  • Shorter PCR time, allowing for faster time-to-results
  • Assay validated using various RNA extraction kits
  • Exceptional sensitivity, specificity and performance
  • Compatible with a wide range of qPCR devices
  • Limited hands-on time
  • No cross-reactivity detected between 26 microorganisms

ASSAY SPECIFICATIONS

METHODOLOGY

RT-qPCR

No OF REACTIONS

96

PCR PROTOCOL TIME

1 hour and 10 minutes

STORAGE CONDITIONS

-20°C

SHELF-LIFE

6 months

SPECIMEN TYPE

Nasopharyngeal or oropharyngeal

SAMPLE STORAGE

2-8°C for up to 72 hours

PROCESS

Sample Collection
RNA extraction
RT-qPCR
Data Analysis
Reporting
SARS-CoV-2 RT-qPCR Kit

BACKGROUND INFORMATION

SARS-CoV-2 is a coronavirus that first appeared in 2019 and causes the infectious COVID-19 disease (COrona VIrus Disease 19) which is responsible for the ongoing pandemic. Coronaviruses are the largest known RNA viruses. There are six coronaviruses known to cause human diseases, which can range from mild to lethal illnesses. SARS-CoV-2 is transmitted from human-to-human through respiratory droplets via direct contact, or through indirect contact via contaminated surfaces. Symptoms of SARS-CoV-2 may appear from 2 to 14 days after exposure to the virus. The most common symptoms are fever, dry cough and fatigue. Less common symptoms include aches and pains, nasal congestion, sore throat, diarrhea, loss of smell (anosmia) or loss of taste (ageusia). Patients with immunocompromised systems, chronic or pre-existing conditions like high BMI, diabetes mellitus type or heart disorders are at higher risk of being affected more seriously and requiring hospitalization. Fast, accurate and reliable detection of SARS-CoV-2 is crucial for taking speedy containment measures to prevent the spread of the disease.

ADDITIONAL INFORMATION

The SARS-CoV-2 Kit is a CE-marked, in-vitro diagnostic RT-qPCR assay intended to be used for identification of COVID-19 viral RNA. The assay is intended for use with the extraction systems and the designated PCR platforms. The SARS-CoV-2 Kit 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.

ORDERING INFORMATION

Product Name Catalog Number Documentation
SARS-CoV-2 RT-qPCR KIT (CE-IVD) EC302-00-0096 SARS-CoV-2 RT-qPCR KIT
SARS-CoV-2 RT-qPCR KIT (RUO) EC302-RU-0096 SARS-CoV-2 RT-qPCR KIT


For assistance and inquiries, contact our team at info@nipd.com

For orders, contact our team at purchaseorders@nipd.com

NIPD Genetics - Privacy Policy

General Statement

This Privacy Policy applies only to www.nipd.com and its subdomains (hereafter collectively referred to as “Sites") that link to this policy. NIPD Genetics Sites are owned by NIPD Genetics Public Company Ltd and are operated by NIPD Genetics Public Company Ltd and on occasion by a third-party that is responsible for the technical maintenance of the Sites.

If, you do not agree with this Privacy Policy, please do not access or use any of NIPD Genetics Sites.

NIPD Genetics values your interest in NIPD Genetics, its products and its services. NIPD Genetics takes the protection of your data seriously.

Personal data for purposes of this Privacy Policy, is any information by which you can be individually identified, including, but not limited to, your name, profession, address, e-mail address, and telephone number.

You may contact NIPD Genetics Public Company Ltd at
NIPD Genetics Public Company Ltd
Neas Engomis 31
Engomi, Nicosia
2409, Cyprus

NIPD Genetics Data Protection Officer can be reached at dpo@nipd.com

This Privacy Policy applies only to the Sites as defined above and which are operated by NIPD Genetics. The NIPD Genetics Privacy Policy seeks to inform the users of its Sites of the following:

NIPD Genetics will not use or share your information with anyone, except as described in this Privacy Policy. This Privacy Policy does not apply to any information we might collect by other digital and offline means and or from other digital and offline sources. The use of information collected through our Sites shall be limited to the purposes under this Privacy Policy and our Terms of Use to customers.

This page informs you of our policies regarding the collection, use, and disclosure of personal data when you use our Sites and the choices you have associated with that data.

We use your data to provide and improve the Sites. By using the Sites, you agree to the collection and use of information in accordance with this policy. Unless otherwise defined in this Privacy Policy, terms used in this Privacy Policy have the same meanings as in our Terms and Conditions, accessible from www.nipd.com

Type of personal information NIPD Genetics may collect through its Sites

Information Collection And Use

We collect several different types of information for various purposes to provide and improve our Sites and services to you.

Personal Data

While using NIPD Genetics Sites, you may be asked to provide NIPD Genetics certain personally identifiable information that can be used to contact or identify you ("Personal Information"). Personal Information that might be used to identify you includes, but is not limited to:

If you send us a query via our Contact us form, your email address, the content and any follow up emails are retained indefinitely.

Cookies and Usage Data

Usage Data

We may also collect information how the Sites are accessed and used ("Usage Data"). This Usage Data may include information such as your computer's Internet Protocol address (e.g. IP address), browser type, browser version, the pages of our Sites that you visit, the time and date of your visit, the time spent on those pages, unique device identifiers and other diagnostic data.

Tracking & Cookies Data

We use cookies and similar tracking technologies to track the activity on our Sites and hold certain information.

Cookies are files with small amount of data which may include an anonymous unique identifier. Cookies are sent to your browser from a website and stored on your device. Tracking technologies also used are beacons, tags, and scripts to collect and track information and to improve and analyze our Sites.

You can instruct your browser to refuse all cookies or to indicate when a cookie is being sent. However, if you do not accept cookies, you may not be able to use some portions of our Sites.

Examples of Cookies we use:

Session Cookies. We use Session Cookies to operate our Sites.

Preference Cookies. We use Preference Cookies to remember your preferences and various settings.

Security Cookies. We use Security Cookies for security purposes.

Visitor behavior cookies. To understand how visitors use and navigate the Sites

Keyword cookies. To understand how visitors discover the Sites.

Use of Data

www.nipd.com uses the collected data for various purposes:

Transfer of Data

Your information, including personal data, may be transferred to — and maintained on — computers located outside of your province, country or other governmental jurisdiction where the data protection laws may differ than those from your jurisdiction.

If you are located outside Cyprus and choose to provide information to us, please note that we transfer the data, including personal data, to Cyprus and process it there.

Your consent to this Privacy Policy followed by your submission of such information represents your agreement to that transfer.

www.nipd.com will take all reasonable steps necessary to ensure that your data is treated securely and in accordance with this Privacy Policy and no transfer of your personal data will take place to an organization or a country unless there are adequate controls in place including the security of your data and other personal information.

Disclosure of Data

NIPD Genetics complies with the protection of personal data regulation and will not sale or trade your personal data.

NIPD Genetics may disclose your personal data in the good faith belief that such action is necessary to:

Security of Data

The security of your data is important to us, but remember that no method of transmission over the Internet, or method of electronic storage is 100% secure. While we strive to use commercially acceptable means to protect your Personal Data, we cannot guarantee its absolute security.

Service Providers

We may employ third party companies and individuals to facilitate, maintain or operate our Sites ("Service Providers"), to provide the SItes on our behalf, to perform service-related services or to assist us in analyzing how our Sites is used.

These third parties have access to your Personal Data only to perform these tasks on our behalf and are obligated not to disclose or use it for any other purpose.

Analytics

We may use third-party Service Providers to monitor and analyze the use of our Sites.

Google Analytics

Google Analytics is a web analytics service offered by Google that tracks and reports website traffic. Google uses the data collected to track and monitor the use of our Service. This data is shared with other Google services. Google may use the collected data to contextualize and personalize the ads of its own advertising network.

You can opt-out of having made your activity on the Service available to Google Analytics by installing the Google Analytics opt-out browser add-on. The add-on prevents the Google Analytics JavaScript (ga.js, analytics.js, and dc.js) from sharing information with Google Analytics about visits activity.

For more information on the privacy practices of Google, please visit the Google Privacy & Terms web page

Access to your personal data, correction, deletion, and Opting Out

You have the right to review, update or delete any of your personal data by sending a request at NIPD Genetics Personal Data Officer pdo@nipd.com

Links to Other Sites

Our Sites may contain links to other sites that are not operated by us. If you click on a third-party link, you will be directed to that third party's site. We strongly advise you to review the Privacy Policy of every site you visit.

We have no control over and assume no responsibility for the content, privacy policies or practices of any third-party sites or services.

Children's Privacy

Our Service does not address anyone under the age of 18 ("Children").

We do not knowingly collect personally identifiable information from anyone under the age of 18. If you are a parent or guardian and you are aware that your Children has provided us with Personal Data, please contact us. If we become aware that we have collected Personal Data from children without verification of parental consent, we take steps to remove that information from our servers.

Changes to This Privacy Policy

We may update our Privacy Policy from time to time. We will notify you of any changes by posting the new Privacy Policy on this page.

We will let you know via email and/or a prominent notice on our Service, prior to the change becoming effective and update the "effective date" at the top of this Privacy Policy.

You are advised to review this Privacy Policy periodically for any changes. Changes to this Privacy Policy are effective when they are posted on this page.

Contact Us

If you have any questions about this Privacy Policy, please contact pdo@nipd.com

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