|
Product Details:
|
| Package: | 48 Tests/kit | Expiration Date: | 12 Months |
|---|---|---|---|
| Storage: | -20±5℃ | Applicable: | Micgene 244/244 IVD(BIO-KEY) |
| LoD: | 1×10000 Copies/ml | CV: | ≤5% |
| Highlight: | MG Infection STD STI Test Kit,Mycoplasma Genitalium PCR Kit,Mycoplasma Genitalium PCR Test Kit |
||
Intended use:
Principle:
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 |
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!
Contact Person: Ms. Lisa