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Clinical Molecular Testing

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HPV HR14

Human Papillomavirus (HPV) is the most common sexually transmitted infection (STI). There are many different types of HPV. Some types can cause health problems including cervical cancer in women.

Evolution of Screening and Diagnosis

The mRNA testing technology distinguishes itself from the DNA testing technology in terms of clinical outcomes.1,2,3

Disease Progression & mRNA Expression

HPV DNA levels may decrease, however, our assay targets E6/E7 mRNA, which increases with disease progression. HPV mRNA testing can screen for cervical carcinoma condition.4

The assay can identify 14 high-risk types (16/18/31/33/35/39/45/51/52/56/58/59/66/68) of HPV infections.

Liquid Based Cytology

HPV mRNA testing with ThinPrep specimen collection kit for greater patient comfort.

References:
1. ThinPrep 2000 System [Instructions for Use]. MAN-02624-001 Rev. 004. Marlborough, MA: Hologic, Inc.; 2017
2. Wright TC, et al. Interim Guidance for the Use of Human Papillomavirus DNA Testing as an Adjunct to Cervical Cytology for Screening. Obstet Gynecol 2004;103(2):304-309.
3. Aptima HPV Assay [package insert]. AW-12820, Rev 004. San Diego, CA: Hologic, Inc.; 2019.
4. Doorbar J. Molecular biology of human papillomavirus infection and cervical cancer. Clin Sci (Lond). 2006 May;110(5):525-41. doi: 10.1042/CS20050369. PMID: 16597322

STI-7

Vaginitis Screening 

Overlapping symptoms make vaginitis clinical diagnosis a challenge.1

Co-infections and overlapping symptoms make clinical diagnosis a challenge. Up to 30% diagnosed with a BV co-infection are also co-infected with Candida species.

Some types of vaginitis are transferred through sexual activity, while others arise because of an imbalance in the bacterial or fungal makeup of the vaginal microbiome.2 Combined, bacterial vaginosis (BV), candida vaginitis (commonly known as a yeast infection, CV), and trichomoniasis (Trichomonas vaginalis, TV).

If these conditions are left untreated, it could l had to prolonged infection, increased risk of acquiring new STI and more long term conditions.3,4

BV

  • PID
  • Cervicitis
  • Elevated risk of acquisition of STIs (CT, NG, HSV-1 & -2, HIV)
Trichomoniasis

  • Increased risk of HIV acquisition and transmission
  • Prolonged HPV infection
  • Concurrent STIs (CT, NG, HSV-1 & -2)

Chlamydia Trachomatis and Neisseria Gonorrhoeae (CTNG) Screening

Chlamydia (CT) and gonorrhea (NG) can have serious long-term consequences including pelvic inflammatory disease (PID), ectopic pregnancy and infertility. Testing and treatment are critical to protecting sexual and reproductive health.5

Detection of up to SIX infections with just one vaginal swab:
BV, TV, gonorrhea, chlamydia, C.species and C.glabrata.

References:
1. Cartwright CP, et al. Comparison of nucleic acid amplification assays with BD affirm for diagnosis of vaginitis in symptomatic women. J Clin Microbiol 2013 Nov; 51(11): 3694-9.
2. Paladine HL. Vaginitis: Diagnosis and Treatment. Am Fam Physician. Am Fam Physician. 2018 Mar 1;97(5):321-329.
3. Allsworth J, et al. Trichomoniasis and other sexually transmitted infections: results from the 2001-2004 National Health and Nutrition Examination Surveys. Sex Transm Dis. 009;36(12):738-744.
4. MMWR, Vol. 64, Nr. 3. Sexually transmitted diseases treatment guidelines, June 5, 2015.
5. Workowski, et al. Sexually Transmitted Infections Treatment Guidelines 2021. MMWR Recomm Rep 2021;70.