Cowingene Chlamydia Trachomatis and Neisseria Gonorrhoeae Detection Kit(Lyophilized)

REF: ST03012X validated specimen: Female vaginal swab, Female cervical swab, Male urethral swab, urine. Analytes: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG)

Cowingene Chlamydia Trachomatis and Neisseria Gonorrhoeae Detection Kit (Lyophilized)


 
Intented UseThe Cowingene Chlamydia Trachomatis and Neisseria Gonorrhoeae Detection Kit(CT/NG Detection Kit) is intended for the in vitro qualitative detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) 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. Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most common bacterial sexually transmitted infections worldwide.

 

Order Information

REFProduct NameTypePackage Size
ST03012XCowingene Chlamydia Trachomatis and Neisseria Gonorrhoeae Detection KitLyophilized48 tests/kit

 

Specification

Detection Target

Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG)

Storage

2-30℃ for 18 months

LoD

The LoD of the kit for detecting CT and NG is 400 copies/mL.

Validated Specimen

Female vaginal swab, Female cervical swab, Male urethral swab, urine.

Compatible Instruments

Open real time PCR machine with channels FAM, VIC/HEX, ROX, CY5, i.e. ABI 7500, Roche 480, Bio-Rad CFX96, etc.

 

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, Treponema pallidum, 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 CT and NG target.

 

Recommended Supporting  Reagents

Product NameCat No.PackageDetailsRegulatory 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 ColumnCW01021Y50 tests/kitDNA/RNA Extraction, Column SpinCE-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-32CWNP-32DNA/RNA Extraction MachineCE-IVDR

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