Cowingene STI Multiplex Detection Kit-STI 3(Liquid)

REF: ST14021X Validated Specimen: urine, male urethral swab, female cervical swab, and female vaginal swab samples. Analytes: 1 tube:CT、NG、TV

Cowingene STI Multiplex Detection Kit-STI 3 (Liquid)


 
Intented UseThe Cowingene STI Multiplex Detection Kit (STI Detection Kit) is intended for the in vitro qualitative detection of multiplex sexually transmitted infection pathogens, 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, Ureaplasma urealyticum, Ureaplasma parvum,Mycoplasma hominis, Herpes simplex virus type 1, Neisseria gonorrhoeae, Herpes simplex virus type 2, Mycoplasma genitalium, Candida albicans, Treponema pallidum,Gardnerella vaginalis, Trichomonas vaginalis, etc.

This kit is intended for the in vitro qualitative detection of Chlamydia trachomatis (CT),Neisseria gonorrhoeae (NG), Trichomonal vaginitis (TV) 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.

 

Order Information

REFProduct NameTypePackage Size
ST14021XCowingene STI Multiplex Detection KitLiquid48 tests/kit

 

Specification

Detection Target

Chlamydia trachomatis (CT),Neisseria gonorrhoeae (NG), Trichomonal vaginitis (TV)

Storage

≤-20℃ for 18 months

LoD

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

Validated Specimen

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

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,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 and TV 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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