Cowingene STI Multiplex Detection Kit-STI 7(Lyophilized)

REF: ST13022U Validated Specimen: vaginal swab、cervical swab、urethral swab, urine. Analytes:2 tubes:CT、NG、MH、MG、UU、UP、TV

Cowingene STI Multiplex Detection Kit-STI 7(Lyophilized)


 
Intented Use

The 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 (STI 7 Detection Kit) is intended for the in vitro qualitative detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma hominis (Mh),Ureaplasma urealyticum (UU), Ureaplasma parvum (UP), Mycoplasma genitalium (Mg) and 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

REF Product Name Type Package Size
ST13022U Cowingene STI Multiplex Detection Kit-STI 7 Lyophilize 16 tests/kit

 

Specification

Detection Target

hlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma hominis (Mh),Ureaplasma urealyticum (UU), Ureaplasma parvum (UP), Mycoplasma genitalium (Mg) and Trichomonal vaginitis (TV)

Storage

2-30℃ for 18 months

LoD

The LoD of the kit for detecting CT, NG, Mh, UU,UP, Mg and TV is 400Copies/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 with high-risk HPV (16/18), Staphylococcus epidermidis/Staphylococcus saprophyticus, Escherichia coli, Lactobacillus crispatus, Prevotella,Adenovirus, Cytomegalovirus, Herpes simplex virus I/II, Candida albicans, Gardnerella vaginalis, Group B Streptococcus, Haemophilus ducreyi, Treponema pallidum, Human immunodeficiency virus, Lactobacillus casei and human genomic DNA.

Interfering  Substances

The results show that when the samples contain blood, cervical mucus, 60mg/L of clindamycin suppository,vaginal lubricant, 60mg/mL of mucin and 40mg/L of amphotericin, there is no impact on the test results of the kit.

Precision

The %CV of repeatability (within-lot) and reproducibility (inter-lot, day, run, operators and labs) are all ≤5.0% of CT, NG, Mh, UU, UP, Mg and TV target

 

Recommended Supporting  Reagents

REF Product Name Certification Package Size
CW03021Q Cowingene Sample Collection Kit(Self-collected vaginal) CE 1 test/kit
CW04021Q Cowingene Sample Collection Kit(Self-collected urine) CE 1 test/kit
CW06021Z Cowingene Sample Diluent Reagent  CE 10 mL/bottle
CW07023Q Cowingene NATBox system CE 1 Unit

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