Allplex™ STI/BV Panel Assays

Comprehensive assay for the detection and identification of
28 pathogens using Real-time PCR assay

  • REAL TIME
  • CE IVD
NOT AVAILABLE IN THE US

Outline

The term sexually transmitted diseases (STDs) is used to refer to a variety of clinical syndromes caused by pathogens that can be acquired and transmitted through sexual activity. Sexually transmitted Infections (STIs) have a profound impact on sexual and reproductive health worldwide.

More than 30 different bacteria, viruses and parasites are known to be transmitted through sexual contact. Each year, there are estimated 357 million new infections with 1 of 4 STIs: chlamydia (131 million), gonorrhoea (78 million), syphilis (5.6 million) and trichomoniasis (143 million). Gonorrhoea and chlamydia are major causes of pelvic inflammatory disease (PID) and infertility in women. More than 500 million people are living with genital HSV (herpes) infection. Herpes and syphilis can increase the risk of HIV acquisition three-fold or more. Mother-to-child transmission of STIs can result in stillbirth, neonatal death, low-birth-weight and prematurity, sepsis, pneumonia, neonatal conjunctivitis, and congenital deformities. A person can have an STI without having obvious symptoms of disease. Common symptoms of STIs include vaginal discharge, urethral discharge or burning in men, genital ulcers, and abdominal pain.

Vaginitis is a name for swelling, itching, burning or infection in the vagina that can be caused my several different germs. The most common kinds of vaginitis are bacterial vaginosis (BV) and yeast, a fungus (candida spp.). Vaginitis is rarely dangerous. In most women, it is easy to treat. But if patient is pregnant, an infection may cause special problems. Allplex™ STI/BV Panel Assays is a multiplex real-time PCR assay developed using the proprietary DPO™ & MuDT™ technology. This assay detects and identifies 4 viruses, 16 bacteria, 1 parasite and 7 candida spp. related to sexually transmitted infections, and provides multiple quantification information of targets using individual Ct value in a single channel.

1) CDC [Sexually transmitted diseases treatment guidelines, 2015.] MMWR 2015
2) WHO-Sexually transmitted infections Fact sheets http://www.who.int/mediacentre/factsheets/fs110/en/
3) European (IUSTI/WHO) [Guideline on the Management of Vaginal Discharge] 2011
4) ASHA-Vaginitis http://www.ashasexualhealth.org/stdsstis/vaginitis/

Features

  1. Multiplex Real-time PCR (TAT: 2.5 hr)
  2. Simultaneous detection of 4 viruses, 16 bacteria, 1 parasite and 7 candida spp. related to sexually transmitted infections
  3. Flexible choice of disease/symptom or gender based panels for efficient patient care and cost-effectiveness
  4. More information per sample than any other method: individual Ct value of each analyte in a single channel
  5. Providing quantitative information for 3 major bacteria associated with vaginosis
  6. Convenient workflow using Seegene’s automation platform

Analytes

STI Essential Assay
CE0086
Genital ulcer Assay
CE0086
- Chlamydia trachomatis (CT)
- Neisseria gonorrhoeae (NG)
- Mycoplasma genitalium (MG)
- Mycoplasma hominis (MH)
- Trichomonas vaginalis (TV)
- Ureaplasma urealyticum (UU)
- Ureaplasma parvum (UP)
- Herpes simplex virus type 1 (HSV-1)
- Herpes simplex virus type 2 (HSV-2)
- Varicella-zoster virus (VZV)
- Cytomegalovirus (CMV)
- Lymphogranuloma venereum
  (LGV, Chlamydia trachomatis Serovar L)
- Treponema pallidum (TP)
- Haemophilus ducreyi (HD)
Candidiasis Assay
CE-IVD  Marked
Bacterial Vaginosis Assay
CE-IVD  Marked
- Candida albicans (CA)
- Candida glabrata (CG)
- Candida tropicalis (CTp)
- Candida parapsilosis (CP)
- Candida krusei (CK)
- Candida lusitaniae (CL)
- Candida dubliniensis (CD)
- Gardnerella vaginalis (GV)
- Atopobium vaginae (AV)
- Lactobacillus spp.* (Lacto)
- Bacteroides fragilis (BF)
- Megasphaera type 1 (Mega1)
- Bacterial vaginosis-associated bacteria 2 (BVAB2)
- Mobiluncus spp.** (Mob)
* L. crispatus, L. gasseri and L. jensenii ** M. mulieris and M. curtisii

Specimens

- Genital swab
- Urine (except Bacterial Vaginosis Assay)
- Liquid based cytology specimen
  (e.g., ThinPrep® and SurePath™)

Result Preview

- Result of Allplex™ STI Essential Assay

[Seegene Viewer]
The result represents co-infection of U. urealyticum (UU) and C. trachomatis (CT) in FAM and Cal Red 610 channel with Ct values of 34.37 (Graph 1) and 33.08 (Graph 2), respectively. Allplex™ STI Essential Assay is able to provide the information of sexually transmitted infection pathogens by analyzing individual Ct value using Seegene viewer.

Ordering Information

Product Cat. No. Size
Allplex™ STI Essential Assay SD9801Y
SD9801X*
50 rxns
100 rxns
Allplex™ Genital ulcer Assay SD9802Y
SD9802X*
50 rxns
100 rxns
Allplex™ Candidiasis Assay SD9803Y
SD9803X*
50 rxns
100 rxns
Allplex™ Bacterial Vaginosis Assay SD9804X* 100 rxns
'* ': For use with Microlab NIMBUS IVD & STARlet IVD only.

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Real-time : Real-time PCR
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