COVID-19 Detection Kit
COVID-19 Detection Kit

COVID-19 Detection Kit

Security Pro USA

This product is available.

(COVID-19) qPCR Detection Kit

This product is intended for MEDICAL TESTING FACILITIES ONLY 

The Senteligo SARS-CoV-2 (COVID-19) qPCR Detection Kit is an in vitro diagnostic test, based on real-time PCR (qPCR) technology, for the qualitative detection of the RNA from SARS-CoV-2 (COVID-19) in upper respiratory tract (e.g. nasopharyngeal fluids, nasal swab) and lower respiratory specimen (e.g. bronchoalveolar lavage, sputum, tracheal aspirate) for Coronavirus disease 2019 (COVID-19) as established by WHO (WHO, 2020) and the US CDC (CDC, 2020) (e.g. fever, cough, shortness of breath, travel history to China).

The SENTELIGOTM SARS-CoV-2 (COVID-19) qPCR Detection test includes an internal control (primer/probe set for human RNAseP gene) to identify possible qPCR inhibition, confirm the integrity of the reagents, and verify the quality of sample extraction. The SENTELIGOTM SARS-CoV-2 (COVID- 19) qPCR Detection test also includes a positive control, which is labelled as “Template DNA”. Template DNA is a synthetic DNA which contains the target regions of the N1, N2 and RNAseP genes that are amplified with the primer-probe sets included in this kit. It is not isolated from the virus, it does not have the entire virus genome and has no infectious properties. Positive controls represent a source of cross-contamination. Precautions should be taken to prevent and minimize the risk.

Primer/probe sets included in the SENTELIGOTM SARS-CoV-2 (COVID-19) qPCR Detection test are:

Ø The probes in the primer/probe sets that are targeting COVID-19 are labelled with the FAMTM fluorophore

Ø The probes in the primer/probe sets that are targeting the RNAseP are also labelled with the FAMTM fluorophore

Primer/probe sets of the SENTELIGOTM SARS-CoV-2 (COVID-19) qPCR Detection test is based on current sequence alignments of SARS- CoV-2. This allows for the RNA detection and differentiation (COVID-19). SENTEBIOLAB will perform routine in silico analysis and post-market surveillance to ensure that in the case of new mutations in the virus during the outbreak, a proper update of the test will be performed, and customers will be properly notified.

The test is a one-step reverse transcription qPCR test utilizing PCR amplification of the targets, and as 3 separate PCR amplicons by fluorescent dye labelled probes. The test contains internal controls that monitor the performance of the test. All kit components are manufactured ready to use immediately upon arrival.

  1. MATERIALS AND DEVICES (REQUIRED BUT NOT PROVIDED)

    • Ø  Appropriate real-time PCR instrument, compatible with the fluorophores used in this test: The protocol shown below is the optimized protocol for the BioRad CFX Connect (1855201) qPCR device. If you use a different device, a preliminary trial should be performed using only negative control and positive control, and the reaction conditions should be optimized in accordance with the recommendations of the manufacturers of the kit and the device used, when necessary.

    • Ø  Appropriate nucleic acid extraction system or kit

    • Ø  Appropriate single-step RT-PCR kit

    • Ø  Vortex mixer

    • Ø  Centrifuge with a rotor for 2 mL reaction tubes

    • Ø  Pipettes (adjustable)

    • Ø  Pipette tips with filters (disposable)

    • Ø  Powder-free gloves (disposable)

    • Ø  Ice

    • Ø  Biosafety cabinet, ideally BSL-2 facility.

 

KIT COMPONENTS

Cap Color

Component

Symbol

Catalog Number

Description

Amount

Brown

SenteligoTM SARS-CoV-2 N1 Primer/ProbeMix

N1

COVID-N1

Proprietary blend of N1 primers and probe

(50 reactions)

Brown

SenteligoTM SARS-CoV-2 N2 Primer/ProbeMix

N2

COVID-N2

Proprietary blend of N2 primers and probe

(50 reactions)

Brown

SenteligoTM Human RNAseP Primer/ProbeMix

RNAseP

COVID- RNAseP

Proprietary blend of RNAseP primers and probe

(50 reactions)

Blue

Positive Control DNA

Control DNA

COVID-PC

Plasmid DNA containing positive control template

(50 reactions)


The kit is shipped at ambient temperature. The components of the kit should arrive lyophilized. If one or more of the components are not lyophilized upon receipt, or are compromised during shipment, contact your distributor for assistance.

  • Ø  All components should be stored between +4°C and -20°C upon arrival to prevent degradation of reagents.

  • Ø  After dissolving the lyophilized products, repeated thawing and freezing of components (more than three times) should be avoided, as this might affect the performance of the assay. After dissolving, the reagents should be frozen in multiple aliquots if they are to be used intermittently.

  • Ø  For dissolved products, storage between +2°C and +8°C should not exceed a period of one month.

  • Ø  If you work in an area prone to power outages, it is recommended to have a back-up generator for your freezer as well as a temperature data log system to ensure that the SENTELIGOTM SARS-CoV-2 (COVID-19) qPCR Detection test kit remains between +4°C and -20°C.

  • Ø  Protect Primer/Probe Mixes from light.

  • Ø  Expired products should not be used, as the integrity of the components cannot be guaranteed.

  • Ø  The product is not a biological waste. See Material Safety Data Sheets for hazard classification. Disposal should be in accordance with applicable regional, national, and local laws and regulations.

WARNINGS AND PRECAUTIONS

Read this Instructions for Use carefully before using the product. Before first use check the components for:

Ø Integrity
Ø Correct labelling
Ø In lyophilized form upon arrival

Users should pay attention to the following:

  • Ø  Use of this product should be limited to personnel instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

  • Ø  Patient samples should always be treated as infectious and/or biohazardous. Use standard precautions.

  • Ø  Wear protective gloves, lab coat, and eye protection when handling patient samples. Always wear gloves when handling kit components.

  • Ø  Always use DNase/RNase-free disposable pipette tips with filters.
    ØUse segregated working areas for sample preparation, reaction setup, and amplification/detection activities. The workflow in the laboratory should proceed in a unidirectional workflow. To prevent contamination, change PPE between areas.

Ø Store and extract positive materials (specimen, controls, and amplicons) separately from other reagents. Dedicate supplies and equipment to separate working areas and do not move them from one area to another.

Ø Consult appropriate Material Safety Data Sheets (SDS) for safety. The MSDS for the SENTELIGOTM SARS-CoV-2 (COVID-19) qPCR Detection test kit is provided with the shipment. If not provided with shipment the SDS can be retrieved from Sentebiolab website: www.sentebiolab.com.tr

  • Ø  Do not open the reaction tubes/plates post amplification.

  • Ø  Do not autoclave reaction tubes/plates after the PCR, since this will not degrade the amplified

    nucleic acid and may pose a contamination risk to the laboratory area.

  • Ø  Do not use components of the kit that have passed expiration date.

  • Ø  Discard sample and assay waste according to your local safety regulations.