Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit (Lyophilized)

REF: ST01022U validated specimen: Cervical swab,Anorectal swab,Urine,Self-collected vaginal Analytes:4 tube;Chlamydia trachomatis (CT),Neisseria gonorrhoeae (NG),Herpes simplex virus type 1 (HSV1),Herpes simplex virus type 2 (HSV2),Ureaplasma urealyticum(UU),Ureaplasma parvum (UP),Mycoplasma hominis (MH),Mycoplasma genitalium (MG),Candida albicans (CA),Gardnerella vaginalis (GV),Trichomonas vaginalis (TV),Group B Streptococcus(GBS),Hemophilus ducreyi(HD),Treponema pallidum(TP).

Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit (Lyophilized)


 
Intented Use

The Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit (STI 14 Detection Kit) is intended for the in vitro qualitative detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma hominis (Mh), Herpes simplex virus type 1(HSV1), Ureaplasma urealyticum (UU), Herpes simplex virus type 2 (HSV2), Ureaplasma parvum (UP), Mycoplasma genitalium (Mg), Candida albicans (CA), Gardnerella vaginalis (GV), Trichomonal vaginitis (TV), Group B Streptococcus (GBS), Haemophilus ducreyi (HD), and Treponema pallidum (TP) 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, 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.

 

Order Information

ÁRBITRO Product Name Type Package Size
ST01022U Cowingene 14 Kinds of Sexually Transmitted Infection Detection Kit Liofilizado 16 tests/kit

 

Specification

Detection Target

Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma hominis (Mh), Herpes simplex virus type 1(HSV1), Ureaplasma urealyticum (UU), Herpes simplex virus type 2 (HSV2), Ureaplasma parvum (UP), Mycoplasma genitalium (Mg), Candida albicans (CA), Gardnerella vaginalis (GV), Trichomonal vaginitis (TV), Group B Streptococcus (GBS), Haemophilus ducreyi (HD), and Treponema pallidum (TP)

Certification

CE-IVD

Storage

2-30℃ for 18 months

LoD

The LoD of the kit for detecting CT, NG, UU, UP, HSV1, HSV2, Mg, Mh, GBS, TP, HD, CA, TV and GV 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 with high-risk HPV(16/18), Staphylococcus epidermidis/Staphylococcus saprophyticus, Escherichia coli, Lactobacillus crispatus, Prevotella, Adenovirus, Cytomegalovirus, human immunodeficiency virus, Lactobacillus casei and human genomic DNA.

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, MH, HSV1, UU, HSV2, UP, MG, CA, GV, TV, GBS, HD and TP target.

 

Recommended Supporting  Reagents

ÁRBITRO Product Name Certification Package Size
CW03021Q Cowingene Sample Collection Kit(Self-collected vaginal) CE 1test/kit
CW04021Q Cowingene Sample Collection Kit(Self-collected urine) CE 1test/kit
CW01021Y Columna de ADN/ARN viral de Cowingene CE 50tests/kit
CW02021Z Reactivo de liberación de muestras de Cowingene CE 100mL(10*10mL)
CW05021X Cowingene DNA/RNA Extraction kit CE 48 pruebas/kit

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