Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit ( NATBox)

REF: ST12023W Validated specimen: vaginal swab, cervical swab, urethral swab, urine. Analytes: 1 cartridge:MG、MH.

Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit(NATBox)


 
Intented Use

The Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit (MG/MH Detection Kit) is intended for the in vitro qualitative detection of Mycoplasma Genitalium (MG), Mycoplasma Hominis (MH) 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

 

Order Information

REF Product Name Type Package Size
ST12023W Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit NATBox 24 tests/kit

 

Specification

Detection Target

Mycoplasma Genitalium (MG), Mycoplasma Hominis (MH)

Certification

CE-IVD

Storage

2-8℃ for 12 months

LoD

The LoD of the kit for detecting Mycoplasma Genitalium and Mycoplasma Hominis is 400 copies/mL

Validated Specimen

Vaginal swab, cervical swab, urethral swab, urine.

Compatible Instruments

NATBox® Mini II

 

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, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Ureaplasma urealyticum, Staphylococcus epidermidis, Escherichia coli, Gardnerella vaginalis, Candida albicans, Lactobacillus crispatus, Adenovirus, Cytomegalovirus, Group B Streptococcus, HSV 2, 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 ≤10.0% of MH and MG target.

 

Recommended Supporting  Reagents

REF Product Name Certification Package Size
CW02021Z Cowingene Sample Release Reagent CE 100 mL(10*10mL)
CW03021Q Cowingene Sample Collection Kit(Self-collected vaginal) CE 1 test/kit
CW04021Q Cowingene Sample Collection Kit(Self-collected urine) CE 1 test/kit

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