The 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 Influenza
A and B Virus and Respiratory Syncytial Virus (RSV) in nasopharyngeal (NP) swab,
oropharyngeal (OP) swab and sputum specimens collected by a healthcare worker, from
patients suspected of respiratory tract by healthcare provider.
Positive results indicate the presence of Influenza virus and RSV 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 Influenza virus and RSV 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 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
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. Flu A has the strongest antigenic variation,
which often causes worldwide pandemic. Flu B 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 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 is 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 template amplification, 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 detection in a single tube, including three independent
genes of the virus and an internal control targeting the human RNAse P (RNP) gene to
assess specimen quality. Specific primers and probes were designed for the detection of
conserved region of Influenza A and B Virus and RSV. Internal control (RNase P gene)
provides a nucleic acid extraction procedural control and a secondary negative control.
The Positive control provides a nucleic acid extraction and a reverse transcription control
to validate the overall procedure and reagent integrity.
WARNINGS AND PRECAUTIONS
1. Please read this instruction for use carefully before beginning the experiment, and
strictly follow the instructions.
2. This product should be only used by trained laboratory personnel in safety-protected
laboratories and wear appropriate protective devices.
3. This product should be protected from light. Please use sterile, DNase-free, and
RNase-free tubes and tips during the detection.
4. Nucleic acid extraction should be performed as soon as possible after specimen
collection to avoid viral nucleic acid degradation; if it cannot be performed as soon as
possible, it should be stored in accordance with appropriate specimen collection and
storage guidelines.
5. As this test involves extraction of viral RNA and PCR amplification, care should be
taken to avoid contamination of the amplification reaction mixture of the kit. Regular
monitoring of laboratory contamination is recommended.
6. Handle all reagents, controls and samples according to good laboratory practice in
order to prevent carryover of samples or controls.
7. Dispose of all materials that have come in contact with samples and reagents in
accordance with country, state, and local regulations.
8. Thoroughly clean up and disinfect all laboratory work surfaces with a freshly prepared
solution with 70% ethyl alcohol or DNA/RNase decontamination agents.
