INTENDED USE
The SARS-CoV-2, Influenza A/B and RSV RT-qPCR Kit is a real-time (rt) reverse
transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative
detection of the SARS-CoV-2, Influenza A and B, RSV viruses in nasopharyngeal (NP) swab,
oropharyngeal (OP) swab and sputum specimens collected by a healthcare worker, from
patients suspected of respiratory tract infection by healthcare provider.
Positive results indicate the presence of Influenza virus, RSV and 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. Negative results do not preclude Virus 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.
The SARS-CoV-2, Influenza A/B and RSV RT-qPCR Kit is intended for use by qualified and
trained laboratory personnel who are proficient in performing real-time RT-PCR assays.
For professional in vitro diagnostic use only.
SUMMARY
The novel coronaviruses (SARS-CoV-2) belong to the β genus. COVID-19 is an acute
respiratory infectious disease. People are generally susceptible. Currently, the patients
infected by the novel coronavirus are the main source of infection asymptomatic infected
people can also be an infectious source. Based on the current epidemiological investigation,
the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include
fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and
diarrhea are found in a few cases.
Influenza is a kind of highly acute respiratory infectious diseases caused by the infection of
influenza virus, it can be suddenly onset and rapidly spread in a short term, resulting in
different degrees of prevalence, with high incidence rate and a certain mortality rate. The
symptoms caused by influenza A and B virus are similar. The most obvious characteristics
are acute high fever and cough. Other symptoms include chills, headache, muscle ache,
fatigue, nasal congestion and runny nose, etc. IFA has the strongest antigenic variation,
which often causes worldwide pandemic. IFB has a relative weak variability, generally
causes mild diseases, mainly attacks children, and may cause local outbreaks.
Respiratory syncytial virus belongs to the genus pneumovirus of the family paramyxoviridae
and has only one serotype. It mainly causes lower respiratory tract infections such as
bronchiolitis and pneumonia in infants under 6 months, and upper respiratory tract infections
in older children and adults. The virus is an RNA virus, which is highly infectious, and there
are currently no specific drugs and vaccines.
PRINCIPLE
The SARS-CoV-2, Influenza A/B and RSV RT-qPCR Kit is a multiplex fluorescent
probe-based Taqman RT-qPCR assay system. The Taqman fluorescent probe is a specific
oligonucleotide based on a reporter-quencher mechanism. For each probe, the 5’-end is
labeled with a fluorophore, while the 3’-end was labeled with a quencher. When the probe is
intact, the fluorescence emitted by the fluorophore is absorbed by the quencher, and no
fluorescent signal is detected. However, during amplification of the template, the probe will be
degraded due to the 5'-3’ exonuclease activity of Taq DNA polymerase, and the fluorescent
reporter and the quencher are cleaved and separated, then a fluorescent signal can be
detected. The generation of each molecular amplicon is accompanied by the generation of a
fluorescent signal. Real-time monitoring of the entire PCR process can be assessed by
monitoring the accumulation of fluorescent signals.
This product provides quadruple detections in a single tube, including NS1 gene of Flu virus,
ORF1ab gene of SARS-CoV-2, N gene of RSV and an internal control which targets the
human RNase P (RNP) gene to assess specimen quality. Specific primers and probes were
designed for the detection of conserved region of Flu virus,RSV and SARS-CoV-2. Internal
control (RNase P gene) provides a nucleic acid extraction procedural control and a
secondary negative control. Positive control provides a nucleic acid extraction and a reverse
transcription control to validate the entire procedure and reagent integrity.
