Mycoplasma genitalium (MG) real-time PCR detection kit
(lyophilized)
--48 tests/kit
Intended use:
This kit, adopting Real-Time PCR-Fluorescence technology, is used
for detection of MG. It can be used for the laboratory diagnosis
and monitoring of MG 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 MG. The PCR reaction
solution and real-time
MG product lyophilization pacakage:
Main components:
| NO. | Components | BIK-QL-H0019S |
1 | PCR Enzyme Mix(Lyophilized) | 48 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 MG and internal control
were constructed artificially, and they were not infectious.
Specimen requirements:
1. Specimen type
Urine or urethral swabs for men, and female urine, cervical swabs,
or vaginal swab samples
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:
| Ct value |
| Negative Control | No Ct |
| Positive Control | ≤30 |
| IC of samples | ≤38 |
Note: Negative Control, Positive Control and IC of samples must be
performed correctly, otherwise the sample results is invalid.
Data analysis and interpretation:
The following sample results are possible:
| Ct value | Result Analysis |
| 1# | No Ct | negative |
| 2# | ≤38 | Positive |
| 3# | 38~40 | Re-test; if it is still 38~40, report as 2# |
Operation details please check from IFU!
