Trichomonas vaginalis (TV) RT-PCR Detection Kit (Lyophilized)
Operation Manual
--48 tests/kit
Intended use:
By using real time PCR systems, Trichomonas vaginalis (TV) real
time PCR kit is used for the in vitro qualitative detection of TV.
It can be used for the laboratory diagnosis and monitoring of TV
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 Trichomonas vaginalis
(TV). The RT-PCR reaction solution and real-time fluorescent
quantitative PCR detection technology is applied on the
fluorescence quantitative PCR instrument for realizes the rapid
detection of TV 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.
TV product lyophilization pacakage:
Main components:
| No. | Components |
BIK-QL-H0020S |
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 TV and internal control were
constructed artificially, and they were not infectious.
Specimen requirements:
1. Specimen type
Urine or female vaginal secretions 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.
Performance indexes of product:
- Accuracy:Use national reference products or enterprise
positive/negative reference products for testing, and the results
are all positive/negative.
- Detection limitation:1000 copies/mL.
- Precision: The coefficient of variation (CV) of Ct values is≤5%.
- Specificity: The detection results of this kit have no cross
reaction with Urealytic Mycoplasma, Mycoplasma hominis, Ureaplasma
urealyticum, Mycoplasma pneumoniae,Neisseria gonorrhoeae,Chlamydia
trachomatis,herpes simplex virus type Ⅱ,Mycoplasma genitalium.
Operation details please check from IFU!
