Morzon SARS-CoV -2 qPCR Kit is a real-time RT-PCR test intended for the qualitative detection of RdRp and N gene of SARS-CoV-2 RNA in single tube in which human RNase P is simultaneously detected.
Morzon SARS-CoV-2 qPCR Kit is a one-step real time reverse transcription PCR assay in which RNA templates are first reverse-transcribed to produce complementary DNA (cDNA) strands and subsequently DNA polymerase-mediated cDNA amplification occurs. During cDNA replication in the PCR process, the hydrolysis probe hybridizes to the template and is digested by the 5′-3′ endonuclease activity of the Thermus aquaticus (Taq)DNA polymerase as the PCR primer is extended. The probe is digested only if cDNA replication occurs, separating the fluorescent and quencher molecules. The PCR products are detected within minutes by monitoring the increase in fluorescence that occurs exponentially with successive PCR amplification cycles. The method is performed directly on RNA extracted from the patient specimens. The detection of SARS-CoV-2 RNA is done in single tube in which human RNase P is simultaneously detected. COVID-19 real-time PCR assay utilizes human RNase P as an internal control, which controls for target isolation and amplification. The oligonucleotide primers and probes for detection of SARS-CoV-2 were selected from regions of the virus conserved region of RdRp and N gene. The kit is designed for specific detection of the SARS-CoV-2 (two primer/probe sets).

NOTE: Test results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.