Cowingene Treponema Pallidum Detection Kit (NATBox)
Cowingene Treponema Pallidum Detection Kit (NATBox)
The Cowingene Treponema Pallidum Detection Kit (TP Detection Kit) is intended for the qualitative detection of Treponema Pallidum (TP) in urine, male urethral swab, female cervical swab, and female vaginal swab samples, and provides aid to the diagnosis of patients with genitourinary tract infections. Sexually transmitted infection (STI) remains one of the important threats to global public health security. The disease can lead to infertility, premature birth, tumors and various serious complications. There are many types of STI pathogens, including bacteria, viruses, chlamydia, mycoplasma and spirochetes, etc.
Syphilis is a bacterial sexually transmitted infection (STI) caused by Treponema pallidum which results in substantial morbidity and mortality, and it is curable. Syphilis is transmitted through sexual contact with the infectious lesions, via blood transfusion or from a pregnant woman to her fetus. Mother-to-child transmission of syphilis is usually devastating to the fetus in cases that were not detected or treated sufficiently early in pregnancy. Maternal syphilis, when untreated, treated late or not treated with penicillin, results in adverse birth outcomes (ABOs) estimated in 50 − 80% of cases, depending on the stage of syphilis. These ABOs are often severe and include stillbirth (most commonly), neonatal death, prematurity, low birth weight, and congenitally infected infants.
Order Information
| REF | Product Name | Type | Package Size |
| ST16013W | Cowingene Treponema Pallidum Detection Kit | NATBox | 24T |
Specification
| Detection Target | Treponema Pallidum (TP) |
| Storage | 2-8℃ for 12 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
| REF | Product Name | Certification | Package Size |
| CW03021Q | Cowingene Sample Collection Kit（Cervical/Urethral/Vaginal Swabs Collection） | CE | 1 test/kit, 20 tests/box |
| CW04021Q | Cowingene Sample Collection Kit（Urine Sample Collection） | CE | 1 test/kit, 10 tests/box |
| CW07023Q | Cowingene NATBox System | CE | 1 unit |
| CW09021W | Cowingene Sample Diluent Reagent | CE | 1 ml/vial, 24 vials/kit |
