Cowingene Group B Streptococcus Detection Kit (NATBox)
Cowingene Group B Streptococcus Detection Kit (NATBox)
The Group B Streptococcus Detection Kit (GBS Detection Kit) is intended for the in vitro qualitative detection of Group B Streptococcus (GBS) in female vaginal swab samples. It is recommended to get screened for GBS bacteria during the 36th or 37th week of each pregnancy. This is one of the best ways to prevent GBS disease in the newborn's first week of life.
Order Information
| REF | Product Name | Type | Package Size |
| ST06013W | Cowingene Group B Streptococcus Detection Kit | NATBox | 24 tests/kit |
Specification
| Detection Target | Group B Streptococcus(GBS) |
| Certification | CE-IVD |
| Storage | 2⁓8℃ for 12 months |
| LoD | The LoD of the kit for detecting GBS is 400 copies/mL. |
| Validated Specimen | Female vaginal swab |
| Compatible Instruments | NATBox® Mini II |
Performance Characteristics
| Cross-reactivity | There is no cross-reactivity with HPV16(3.5×10⁶Copies/mL), HPV18(6.0×10⁶Copies/mL),HSV II(5.1×10⁶Copies/mL), Treponema pallidum(8.6×10⁶Copies/mL), Ureaplasma urealyticum(1.2×10⁷Copies/mL), Mycoplasma hominis(10⁸Copies/mL), Mycoplasma genitalium(2.2×10⁶Copies/mL),Chlamydia trachomatis(4.2×10⁷Copies/mL),Neisseria gonorrhoeae(1.3×10⁷CFU/mL),Escherichia coli(1.1×10⁶CFU/mL), Gardnerella vaginalis(2.3×10⁶CFU/mL), Candida albicans(6.2×10⁵CFU/mL), Trichomonas vaginalis(4×10⁶Copies/mL), Lactobacillus crispatus(6.2×10⁶CFUs/mL), Adenovirus(1.3×10⁸Copies/mL), Cytomegalovirus(9.8×10⁶CFU/mL), Human immunodeficiency virus(5.4×10⁸Copies/mL), Lactobacillus casei(8.4×10⁵CFU/mL) and human genomic DNA. |
| Interfering Substances | The interfering samples which contain bilirubin (0.2mg/mL), cervical mucus (10%), white blood cells (106 of 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 (within-lot) and reproducibility (inter-lot, day, run, operators and labs) are all ≤10.0% of GBS 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 |
| CW07023Q | Cowingene NATBox System | CE | 1 unit |
| CW09021W | Cowingene Sample Diluent Reagent | CE | 1 ml/vial, 24 vials/kit |
