The Cowingene Treponema Pallidum Detection Kit (TP Detection Kit) is intended for the qualitative detection of Treponema Pallidum (TP) in urine, skin lesion swab, male urethral swab and female vaginal swab samples, and provides aid to the diagnosis of patients with genitourinary tract infections.
Cowingene Treponema Pallidum Detection Kit (Liquid)
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Cowingene Treponema Pallidum Detection Kit (Liquid)
Intented Use
Order Information
| REF | Product Name | Type | Package Size |
| ST16011X | Cowingene Treponema Pallidum Detection Kit | Liquid | 48 tests/kit |
Specification
| Detection Target | Treponema pallidum (TP) |
| Storage | ≤-20℃ for 18 months |
| LoD | 400 Copies/mL. |
| Validated Specimen | Female vaginal swab, Female cervical swab, Male urethral swab, urine. |
| Compatible Instruments | Open real-time PCR platforms equipped with FAM and Cy5 detection channels, including but not limited to ABI 7500, Roche LightCycler 480, Bio-Rad CFX96, QuantStudio™ 5, SLAN 96, Molarray MA-6000, Rotor-Gene Q, and Mic qPCR Cycler. |
Performance Characteristics
| Cross-reactivity | There is no cross-reactivity between this kit and other genitourinary tract infection pathogens such as high-risk Human papillomavirus type 16, Human papillomavirus type 18, Herpes simplex virus type Ⅱ, Chlamydia trachomatis, Neisseria gonorrhoeae, Ureaplasma urealyticum, Mycoplasma hominis, Mycoplasma genitalium, Staphylococcus epidermidis, Escherichia coli, Gardnerella vaginalis, Candida albicans, Trichomonas vaginalis, Lactobacillus crispatus, Adenovirus, Cytomegalovirus, Group B Streptococcus, Human immunodeficiency virus, Lactobacillus casei and human genomic DNA, etc. |
| Interfering Substances | The interfering samples which contain bilirubin (0.2mg/mL), cervical mucus (10%), white blood cells (109 cells/mL), mucin (60mg/mL), whole blood (10%), semen (10%), levofloxacin (0.2mg/mL), erythromycin (0.3mg/mL), penicillin (0.5mg/mL), azithromycin (0.3mg/mL), Jieryin lotion (10%), Fuyanjie lotion (10%) will not affect the test results. |
| Precision | The %CV of repeatability and reproducibility are all ≤5.0% of TP target. |
Recommended Supporting Reagents
| Product Name | Cat No. | Package | Details | Regulatory Achieved |
| Cowingene Sample Collection Kit | CW03021Q | 1 test/kit | Cervical/Vaginal/Urethral Swab | CE-IVDR |
| CW04021Q | 1 test/kit | Urine | CE-IVDR | |
| Cowingene Viral DNA/RNA Column | CW01021Y | 50 tests/kit | DNA/RNA Extraction, Column Spin | CE-IVDR |
| Cowingene DNA/RNA Extraction Kit | CW05021X | 48 tests/kit | DNA/RNA Extraction, Maual | CE-IVDR |
| CW05021N | 40 tests/kit | DNA/RNA Extraction,Single-Test Format, Automatic | CE-IVDR | |
| CW05021M | 64 tests/Kit | DNA/RNA Extraction,Multi-Test Format, Automatic | CE-IVDR | |
| NATPure System | CW11022Q-16 | CWNP-16 | DNA/RNA Extraction Machine | CE-IVDR |
| CW11022Q-32 | CWNP-32 | DNA/RNA Extraction Machine | CE-IVDR |
