UP+UU real-time PCR detection kit (lyophilized)
--24 tests/kit
Intended use:
This kit, adopting Real-Time PCR-Fluorescence technology, is used
for detection of Ureaplasma parvum and Ureaplasma
urealyticum(UP+UU). It can be used for the laboratory diagnosis and
monitoring of UP+UU infection. The test results are only for
clinical reference, not for case confirmation or exclusion.
Principle:
The specific primers and specific fluorescent probes are designed
for the nucleic acid conserved region of UP+UU. The PCR reaction
solution and real-time fluorescent quantitative PCR detection
technology is applied on the fluorescence quantitative PCR
instrument to realize the rapid detection of UP+UU through the
change of fluorescence signal. The detection system contains a
human internal control (IC) gene, which is used to monitor whether
the specimens and the process of nucleic acid extraction is
qualified.
UP+UU product lyophilization pacakage:
Main components:
| NO. | Components | BIK-QL-H0022S1 |
1 | PCR Enzyme Mix(Lyophilized) | 24 tests/kit |
| 2 | Positive Control | 100 μL/tube |
| 3 | Negative Control | 100 μL/tube |
| 4 | RNase-free water | 1mL/tube |
| 5 | Paraffin oil | 1.5mL/tube |
Note:Do not mix the components from different batches for
detection. The Positive Control of UP+UU and internal control were
constructed artificially, and they were not infectious.
Specimen requirements:
1. Specimen type
Male urethral secretions or female cervical secretions.
2. Specimen Preservation
The specimen can be stored for 3 months at -20±5℃ and for a long
time below -70℃
PCR Amplification condition:
PCR amplification according to the following procedures:
| Step | Cycle number | Temperature | Time |
| 1 | 1 | 95℃ | 3min |
| 2 | 40 | 95℃ | 10s |
| 60℃ | 30s collect fluorescent |
Instrument detection channel selection: FAM and HEX/VIC.
Quality control:
Negative Control: None of the FAM, VIC/HEX & Internal Control (ROX)
channels have a Ct value or Ct ＞ 40;
Positive Control: FAM, VIC/HEX & Internal Control (ROX) channels Ct
≤ 30;
The above two items should be met simultaneously in one experiment.
Otherwise, the experiment is invalid and should be repeated.
Data analysis and interpretation:
| FAM (UP) | VIC/HEX (UU) | ROX (IC) | Interpretation test results |
1 | - | - | - | Result invalid,test again |
| 2 | + | - | +/- | UP(+) |
| 3 | - | + | +/- | UU(+) |
| 4 | + | + | +/- | UP and UU(+) |
| 5 | - | - | + | Negative(-) |
NOTE: ‘+’ is positive, ‘-’ is negative.
Operation details please check from IFU!
