Neisseria gonorrhoeae (NG) real-time PCR detection kit
(lyophilized)
--96 tests/kit
Intended use:
This kit, adopting Real-Time PCR-Fluorescence technology, is used
for detection of NG. It can be used for the laboratory diagnosis
and monitoring of NG 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 NG. 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 NG 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.
NG product lyophilization pacakage:
Main components:
| No. | Components | BIK-QL-H0023 |
1 | PCR Enzyme Mix (Lyophilized) | 96 tests/bottle |
| 2 | NG Primer-Probe Mix | 100 μL/vial |
| 3 | Enzyme Mix Buffer (5×) | 400 μL/vial |
| 4 | Positive Control | 100 μL/tube |
| 5 | Negative Control | 100 μL/tube |
| 6 | RNase-free water | 1mL/tube |
| 7 | Paraffin oil | 1.5mL/tube*2 |
Note:Do not mix the components from different batches for
detection. The Positive Control of NG and internal control were
constructed artificially, and they were not infectious.
Specimen requirements:
1. Specimen type
Male urinary tract secretions or female reproductive tract
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.
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!
