MOLECULAR DIAGNOSTIC TESTS

COVID-19 Real Time RT-PCR Kit

COVID-19 Real Time RT-PCR Kit

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CoV 2019, whose genetic material is single-strand RNA and a member of the corona family, was identified in November 2019, it is a pathogen with a strong pandemic effect. CoV 2019 (Genbank acc. MN908947), whose genome has been sequenced, has high similarity to the SARS virus. Test-it COVID-19 Real Time RT-PCR Diagnostic Kit detects SARS-CoV-2

(2019-nCoV) from respiratory tract samples (nasopharyngeal, oropharyngeal, sputum and bronchoalveolar lavage samples). COVID-19 Real Time RT-PCR Diagnostic Kit scans the N1, N2 gene regions on the N gene determined by WHO and USA-CDC.

COVID-19 Real Time RT-PCR Diagnostic Kit detects SARS-CoV-2

(2019nCoV) RNA from respiratory tract samples (nasopharyngeal, oropharyngeal, sputum and bronchoalveolar lavage samples). In the diagnostic kit, RNAse P (RP) mRNA at the human mRNA level was chosen as the internal control. The kit, which receives radiation from FAM and HEX wavelengths, works in multiplex with a single tube.

  • The kit includes positive control and negative control.
  • Realtime PCR run time is approximately 90 minutes.
  • The RNA isolation step is recommended before it can be run.

Limit of Detection (LOD):

The LOD study was conducted to determine the low performance of the COVID-19 Real Time RT-PCR Kit. In replicate studies with the same number of replicates, the number of copies giving at least 95% true positive indicates the LOD of the kit. LOD values were calculated as multiplex for N1 and N2 gene regions in the COVID-19 Real Time RT-PCR Kit.

The study was carried out using Qiagen RotorGene with 20 repetitions of dilute serial samples of synthetic DNA containing the N1 and N2 gene regions. The number of copies and positives found in each reaction are as follows:

Product Type Sample Type Kit Size Additional Materials
COVID-19 Real Time  RT-PCR Kit Molecular Diagnostic Kit RNA 100

Master Mix

Positive Control

Negative Control

N1 Gene Region
Copy Number/Reaction

Positive Sample

100 20/20
50 20/20
30 19/20
20 18/20
10 13/20

Gene Region LOD(Copy Number/Reaction )
N1 + N2 30

*Copy Number / Reaction: Shows the total number of copies added to the reaction.