FOR RESEARCH USE ONLY
INTENDED USE
This kit is used for qualitative diagnostic testing of 3 common STI pathogens nucleic acid in vaginal swabs and urine from Sexually Transmitted Infection(STI) suspected patients.
This product is a multiplex probe-based Taqman® qPCR assay system.
Specific primers and probes are designed for the detection of specific genes of 3 common STI pathogens.
This kit is a fully premix freeze-dried system. Taq enzyme, UDG enzyme, reaction buffer, specific primers and probes required for amplification are all lyophilized in PCR tubes. Detection can be performed directly after adding dissolving solution and extracted nucleic acid.
Target | Trichomonas vaginalis |
| Neisseria gonorrhoeae | |
| Chlamydia trachomatis |
| Components | 48 samples/kit | Ingredient |
| ST02 Lyophilized Reagent | 48*4 strip tubes | Specific primer&probes, dNTP/dUTP, Mg2+, Taq polymerase and UDG enzyme |
| STI Lysis Buffer | 5 mL*1 tube | Surface active agent, balanced salt solution |
| One Test Glass Beads | 8 tubes*3 bags | Glass beads |
| STI Positive Control | 400 μL*1 tube | Plasmid containing every target gene sequence |
| STI Negative Control | 400 μL*1 tube | Plasmid containing internal control sequence |
| Dissolving Solution | 1 mL*2 tubes | Stabilizer |
-20℃±5℃ storage for 12 months.
Room temperature transportation less than 1 month(No more than 37℃).
Repeated freezing and thawing should not exceed 7 times.
Valid for 12 months.
Disposable powder free gloves and other personal protective equipment.
Pipettes (adjustable) and Sterile pipette tips.
Vaginal swabs/urine sample collection device.
1.5 mL centrifuge tubes and racks.
Bench top centrifuge for centrifuge tubes and PCR tubes.
Vortex mixer.(Power≥40w)
Centrifuge tube holder for vortex mixer. (not necessary,can replace part of manual operation)
Metal bath/water bath.(1.5mL centrifuge tube,95℃)
Real-time PCR instrument with FAM/VIC/ROX/CY5 fluorescence channels.(Such as ABI7500, Bio-rad CFX96, QuantStudio, SLAN-96S, BTK-96)
PERFORMANCE SPECIFICATIONS
Detection limitation: 1000 Copies/mL.
Precision: The coefficient of variation (CV, %) of Ct value of within-batch/between-batch precision is ≤ 5%.
Accuracy: The conformity rate of negative/positive reference: 100%.
Specificity:The target organisms had been analyzed in silico for potential cross-reactivity with the primers or probe sequences.Homology with other species is all below 90%. Specificity analysis showed that there is no cross reaction between the pathogens detected by this kit.