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Diagnovital HS SARS-CoV-2 is a qualitative test for the detection of the 2019 novel coronavirus (SARS-CoV-2) in upper respiratory swab samples collected in Copan Universal Transport Medium System (UTM-RT) or BD Universal Viral Transport System (UVT) and is run on Applied Biosystems QuantStudio 5 in combination with Tianlong Generotex 96 extraction system and Tianlong Viral DNA/RNA Extraction Kit. In addition, the test utilizes external controls (positive control and a negative control).

Diagnovital HS SARS-CoV-2 test is based on conventional RT-PCR technology including extraction and purification of the nucleic acid genome of SARS-CoV-2 followed by PCR amplification and detection. The test is run on Applied Biosystems QS5. Nucleic acid from patient samples and controls are extracted using the Tianlong Generotex 96 extraction system and Tianlong Viral DNA/RNA Extraction Kit. Nucleic acid is released by the lysis reagent and bound to magnetic beads. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors, are removed with subsequent wash steps and purified nucleic acid is eluted in elution buffer. 
selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers and probes specific to conserved regions of the N1 and N2 genes for SARS-CoV-2.
selective amplification of RNA Internal Control is achieved by the use of non-competitive, sequence specific forward and reverse primers and a probe which have no homology with the coronavirus genome. A thermostable DNA polymerase enzyme is used for amplification. 

 

Sensitivity
SYSTEM (COPIES/ ΜL)
Applied Bioscience QuantStudio 5 156.25 cp/ml 

 

Other Features
TARGET REGION N gene (N1 and N2 region)
SAMPLE TYPE Human respiratory samples(nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage
EXTRACTION CONTROL RNAseP gene
STORAGE -15°C/ -25°C

 

Validated Extraction Methods and Instruments
VALIDATED EXTRACTION METHODS Tianlong Generotex 96 
extraction system
VALIDATED INSTRUMENTS Thermo Fischer QuantStudio 5 Real Time PCR Detection System

 

Ordering Info
PRODUCT TEST SIZE CATALOG NO
Diagnovital SARS-CoV-2 HS Real-Time PCR Kit 25 Tests 09071125
Diagnovital SARS-CoV-2 HS Real-Time PCR Kit 50 Tests 09071150
Diagnovital SARS-CoV-2 HS Real-Time PCR Kit 100 Tests 09071100