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.
|Applied Bioscience QuantStudio 5||156.25 cp/ml|
|TARGET REGION||N gene (N1 and N2 region)|
|SAMPLE TYPE||Human respiratory samples(nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage|
|EXTRACTION CONTROL||RNAseP gene|
|Validated Extraction Methods and Instruments|
|VALIDATED EXTRACTION METHODS||Tianlong Generotex 96
|VALIDATED INSTRUMENTS||Thermo Fischer QuantStudio 5 Real Time PCR Detection System|
|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|