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.

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.