INTENDED USE
The Neisseria Gonorrhoeae (NG), Chlamydia Trachomatis (CT) and Ureaplasma
Urealyticum (UU) qPCR Kit is designed for the qualitative detection of Neisseria
Gonorrhoeae (NG), Chlamydia Trachomatis (CT) and Ureaplasma Urealyticum (UU) DNA
in male urethral swab specimens and female cervical swab specimens. The test results
may be used to aid in the diagnosis of Gonorrhoeae (NG), Chlamydia Trachomatis (CT)
and Ureaplasma Urealyticum (UU) infections and provide a molecular diagnostic basis for
the early diagnosis of venereal diseases and the preliminary screening of high-risk groups
of venereal diseases, but should not be used as the sole basis for diagnosis or exclusion,
and the disease conditions must be comprehensively analyzed in conjunction with clinical
manifestations of patients and other laboratory tests.
The Neisseria Gonorrhoeae (NG), Chlamydia Trachomatis (CT) and Ureaplasma
Urealyticum (UU) qPCR Kit is intended for use by qualified and trained laboratory
personnel who are proficient in performing real-time PCR assays.
For professional in vitro diagnostic use only.
SUMMARY
Neisseria Gonorrhoeae (NG), commonly known as gonorrhoeae, is a pathogenic
pathogen that causes human gonorrhea. After infection in male patients, it often causes
acute urethritis, epididymitis, prostatitis and so on with purulent secretions and severe
urination difficulties. Female patients mainly infected with the endometrium of the cervix,
can cause urethritis, cervicitis, pelvic inflammation, infertility.
Chlamydia trachomatis (CT) is one of the most common venereal disease pathogens at
home and abroad. It causes non-gonococcal urethritis, epididymitis, prostatitis, and
proctitis in males and it causes cervicitis, endometritis, salpingitis and pelvic inflammatory
disease, leading to tubal infertility and ectopic pregnancy in females, often occurs in
mother-to-child transmission.
Ureaplasma Urealyticum (UU) is a kind of minimum prokaryotic microorganism between
bacteria and viruses, mainly distributed in the human urogenital tract, and is one of the
main pathogens of non-gonococcal urethritis. Male infection can lead to the occurrence of
non-gonococcal urethritis, acute epididymitis, prostatitis, etc. After female infection, can
cause including endometritis, salpingitis, ovaritis, etc. Intrauterine infection can cause
abortion, stillbirth, premature birth and other adverse consequences.
PRINCIPLE
The Neisseria Gonorrhoeae (NG), Chlamydia Trachomatis (CT) and Ureaplasma
Urealyticum (UU) qPCR Kit is a multiplex fluorescent probe-based Taqman 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 triple detections in a single tube, including three independent genes
for NG/CT/UU and an internal control which targets the human β-actin gene to assess
specimen quality. Specific primers and probes were designed for the detection of proA
gene of NG, trp gene of CT and mba gene of UU. Internal control (β-actin) 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.
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.
