STI testing for improved reproductive and sexual health

CE-marked assays within the Aptima STI testing portfolio address a global need for the detection and prevention of sexually transmitted infections (STIs, also known as sexually transmitted diseases or STDs). Our diverse STI testing menu allows lab personnel to deliver results to healthcare providers with confidence, empowering informed choices when it comes to patient care. At Hologic, we focus on improving testing and technology to enable healthier lives everywhere, every day.

Our molecular diagnostic offerings allow healthcare providers to collect one patient specimen that yields multiple test results on the fully automated Panther system.

Aptima STI assays bring The Science of Sure to life. Our nucleic acid amplification tests (NAATs) target common STDs such as chlamydia, gonorrhea, trichomoniasis, herpes and emerging pathogens like Mycoplasma genitalium and the Zika virus. Hologic is committed to improving healthcare globally with these CE-marked assays.

 

The Aptima STI testing menu empowers accurate detection for better treatment

 

Accurate STI testing and treatment is critical to preserving the well-being of patients around the world. Chlamydia and gonorrhea are proven to have serious long-term consequences including pelvic inflammatory disease (PID), infertility and ectopic pregnancy. In 1994, Hologic pioneered the field of molecular diagnostics with DNA probe tests for chlamydia and gonorrhea testing, later followed by the first CE-marked NAAT duplex: the Aptima Combo 2 assay.

 

 

 

153 million people globally have trichomoniasis, a higher prevalence than chlamydia and gonorrhea infections combined. The Aptima Trichomonas vaginalis assay was the first CE-marked NAAT for trichomoniasis with up to 100% sensitivity. Untreated trichomoniasis infections are associated with PID, preterm delivery, prolonged HPV infections and an increased risk for transmission and acquisition of HIV. The Aptima Trichomonas vaginalis assay is a highly sensitive and specific test indicated for both symptomatic and asymptomatic patients.

 

 

 

Globally, over 4.1 billion people are infected with HSV-1 and HSV-2.⁶Differentiating between HSV types 1 and 2 is important for managing herpes infections and identifying the risk of transmission to neonates and among sex partners.⁷ NAAT testing is increasingly preferred over viral culture to diagnose genital herpes due to higher sensitivity, ease of specimen collection and transportation and faster results.⁶ The Aptima^® HSV 1 & 2 assay is a NAAT that distinguishes between HSV-1 and HSV-2 and gives healthcare providers the specific knowledge required to manage patient care.⁸

 

 

 

 

Mycoplasma genitalium is an STI that is more common than gonorrhea in some populations.⁹ M. genitalium infections were first discovered in the 1980s and can lead to serious reproductive consequences including PID, infertility and ectopic pregnancy. In response to high infection rates and lack of accurate testing, Hologic developed the first and only CE-marked sample-to-result assay for the detection of this elusive pathogen: the Aptima Mycoplasma genitalium assay.

 

 

 

The Zika virus is spread through sexual contact, through Aedes species mosquitoes, from pregnant mothers to their babies and through blood transfusions. Babies born to Zika-infected mothers can develop microcephaly and other severe birth defects, while in adults the virus can cause a debilitating nerve condition called Guillain-Barré syndrome. The Aptima Zika Virus assay is a highly sensitive molecular diagnostic test that detects the virus in serum, plasma and processed urine. Our assay is designed to offer healthcare providers the confidence they need to manage patients who may have been exposed to the virus.

 

 

An expanding STI testing menu on the Panther system

Hologic developed the Panther system to eliminate the need for batch processing and to automate all aspects of nucleic acid testing on a single, integrated platform for improved laboratory productivity and operational efficiency.

The Panther System Offers:

• The ability to run up to 4 assays simultaneously and up to 4 results from a single sample
• Sample-to-result automation for walkaway freedom
• Scalable workflow to meet the volume demands of different types of STI programs
• Testing for women’s health, virology and STIs on a single, integrated instrument
• The ability to add the Panther Fusion module, incorporating the flexibility of polymerase chain reaction (PCR) with the power of transcription mediated amplification (TMA)

To support today’s busy laboratories, the Panther system provides unprecedented control of workflow – driven by random-access and continuous loading of samples, reagents and consumables – to improve laboratory productivity and accelerate results. The Panther system offers the highest output volume per square foot among all comparable molecular diagnostic test systems.