Product Details
Neisseria gonorrhoeae (NG) real-time PCR detection kit
(lyophilized)
--24 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-H0023S1 |
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 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℃
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!
Company Profile
Bio key Health is a high-tech enterprise with integrating R&D,
production and sales&marketing in Guangzhou. Since 2003. Bio
Key was founded by the "Thousand Talents Program" entrepreneurial
team and the overseas senior automation equipment development
engineer team.
The company's core team has been in the field of IVD research and
entrepreneurship for more than 10 years, and has mastered a wealth
of molecular diagnostic POCT industrial application technology,
SmartTRF immune detection technology, RT qPCR nucleic acid
detection technology and independent research and development
capabilities of instruments.
It has a number of independent core technologies in the fields of
automation engineering, micro-precision manufacturing,
immunofluorescence, nucleic acid detection and gene sequencing.
Since its establishment, the company has applied for more than 60
patents and currently has 17 authorized patents. The company has
two R&D centers for diagnostic reagents and instruments and
equipment, totaling more than 500 square meters; it has established
more than 2,000 square meters of GMP workshops and equipment
production plants; it has SmartTRF new immune detection technology,
nucleic acid detection technology (POCT) and three scientific
services.