Cowingene Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium Detection Kit (Lyophilized)

REF : ST04012X validated specimen: urine, male urethral swab, female cervical swab, female vaginal swab samples

Cowingene Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium Detection Kit (Lyophilized)


 
Intented UseThe Cowingene Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium Detection Kit (CT/NG/MG Detection Kit) is intended for the qualitative detection of Chlamydia trachomatis (CT), Neisseria Gonorrhoeae (NG), Mycoplasma genitalium (MG) in urine, male urethral swab, female cervical swab, and female vaginal swab samples, and provides aid to the diagnosis and treatment 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. Common species include Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, etc.

 

Order Information

REFProduct NameTypePackage Size
ST04012XCowingene Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium Detection KitLyophilized48 tests/kit

 

Specification

Detection Target

CT, NG, MG Targets

Storage

2-30℃ for 18 months

LoD

400 Copies/mL.

Validated Specimen

urine, male urethral swab, female cervical swab, and female vaginal swab samples

Compatible Instruments

Open real-time PCR platforms equipped with FAM, VIC/HEX, ROX, 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, Treponema pallidum, Ureaplasma urealyticum, Mycoplasma hominis, 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, NG, MG Targets.


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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