Aptima® STIs

STI testing for improved reproductive and sexual health

The Aptima STI testing portfolio addresses a global need to detect and prevent the spread 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 STIs such as chlamydia, gonorrhea, trichomoniasis, herpes and emerging pathogens like the Zika virus. Hologic is committed to protecting the reproductive health of women and men through early detection of STIs.

The Aptima STI testing menu empowers accurate detection for better treatment

Aptima Combo 2® assay (for CT/NG)

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.1,2 In 1994, Hologic pioneered the field of molecular diagnostics with DNA probe tests for chlamydia and gonorrhea testing, later followed by the first FDA-cleared NAAT duplex: the Aptima Combo 2 assay.3

Aptima® Trichomonas vaginalis assay

Over 3.7 million people in the United States have trichomoniasis, a higher prevalence than chlamydia and gonorrhea infections combined.4 The Aptima Trichomonas vaginalis assay was the first NAAT for trichomoniasis to receive FDA clearance and CE-mark, with up to 100% sensitivity.5 Untreated trichomoniasis infections are associated with PID, preterm delivery, prolonged HPV infections and an increased risk for transmission and acquisition of HIV.6 The Aptima Trichomonas vaginalis assay is indicated for both symptomatic and asymptomatic patients and meets the critical need for a highly sensitive and specific trichomoniasis test as recommended by the CDC.5,6

Aptima® Herpes Simplex Viruses 1 & 2 assay

Globally, over 4.1 billion people are infected with HSV-1 and HSV-2.7 Differentiating between HSV types 1 and 2 is important for managing herpes infections and identifying the risk of transmission to neonates and among sex partners.8 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.7 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.9

Aptima® Zika virus assay*

The Zika virus is spread through sexual contact, through Aedes species mosquitoes, from pregnant mothers to their babies and through blood transfusions.10 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.11 The Aptima Zika virus assay* (Emergency Use Authorization) is a highly sensitive molecular diagnostic test that detects the virus in serum, plasma and processed urine.12 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 efficiencies.

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

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.13-16

*Aptima Zika Virus assay:
This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C.§ 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For additional availability in other countries beyond the U.S., please contact your local sales representatives or distributor.

To learn more about the Aptima STI portfolio, visit HealthDxS.com.


References: 1. Centers for Disease Control and Prevention. Chlamydia – CDC Fact Sheet (Detailed). https://www.cdc.gov/std/chlamydia/stdfact-chlamydia-detailed.htm. Updated October 17, 2016. Accessed November 29, 2017.  2. CDC. Gonorrhea – CDC Fact Sheet (Detailed). https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea-detailed.htm. Updated October 28, 2016. Accessed November 29, 2017.  3. U.S. Food & Drug Administration. 510(k) Premarket Notification Database: Gen-Probe. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed November 29, 2017.  4. Satterwhite CL, Torrone E, Meites E, et al. Sexually transmitted infections among US women and men: prevalence and incidence estimates, 2008. Sex Transm Dis. 2013;40:187-93.  5. Aptima Trichomonas vaginalis assay (Panther system) [package insert]. 503684-IFU-PI. San Diego, CA: Hologic, Inc.; 2017.  6. CDC. Trichomoniasis. https://www.cdc.gov/std/tg2015/trichomoniasis.htm. Updated August 12, 2016. Accessed November 29, 2017.  7. World Health Organization. Herpes simplex virus. http://www.who.int/mediacentre/factsheets/fs400/en/. Published January 2016. Accessed November 29, 2017.  8. CDC. 2015 Sexually Transmitted Diseases Treatment Guidelines. https://www.cdc.gov/std/tg2015/. Updated January 25, 2017. Accessed November 29, 2017.  9. Aptima HSV 1 & 2 assay [package insert]. AW-15346-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2016.  10. CDC. Zika Virus: Transmission. https://www.cdc.gov/zika/transmission/index.html. Updated June 28, 2017. Accessed November 29, 2017.  11. Kandel N, et al; World Health Organization. Detecting Guillain-Barré syndrome caused by Zika virus using systems developed for polio surveillance. http://www.who.int/bulletin/volumes/94/9/16-171504/en/. Published July 5, 2016. Accessed November 29, 2017.  12. Aptima Zika Virus assay [package insert]. AW-15406, Rev. 002. San Diego, CA: Hologic, Inc.; 2016.  13. Data on file. Hologic, Inc.; 2017.  14. UNITAID. HIV/AIDS Diagnostic Technology Landscape. 2nd ed. Geneva, Switzerland: World Health Organization; 2012.  15. Roche. Cobas 4800 System [Technical Specifications]. 472-53145-0814. Indianapolis, IN: Roche Diagnostics; 2014.  16. Roche. Cobas 6800 System Specifications. https://www.cobas68008800.com/cobas_6800_details. Published January 1, 2015. Accessed November 29, 2017.

Information provided on this tab is intended for audiences outside the United States. Consult "USA" tab for products and claims available in the United States.

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

Aptima Combo 2 assay (for CT/NG)

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.1,2 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.

Aptima Trichomonas vaginalis assay

153 million people globally have trichomoniasis, a higher prevalence than chlamydia and gonorrhea infections combined.3 The Aptima Trichomonas vaginalis assay was the first CE-marked NAAT for trichomoniasis with up to 100% sensitivity.4 Untreated trichomoniasis infections are associated with PID, preterm delivery, prolonged HPV infections and an increased risk for transmission and acquisition of HIV.5 The Aptima Trichomonas vaginalis assay is a highly sensitive and specific test indicated for both symptomatic and asymptomatic patients.4

Aptima herpes simplex viruses 1 & 2 assay

Globally, over 4.1 billion people are infected with HSV-1 and HSV-2.6 Differentiating 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

Aptima Mycoplasma genitalium assay

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.9 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.9

Aptima Zika virus assay

The Zika virus is spread through sexual contact, through Aedes species mosquitoes, from pregnant mothers to their babies and through blood transfusions.10 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.11 The Aptima Zika Virus assay is a highly sensitive molecular diagnostic test that detects the virus in serum, plasma and processed urine.12 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.13-16

 
To learn more about the Aptima STI portfolio, visit HealthDxS.com.

References: 1. Centers for Disease Control and Prevention. Chlamydia – CDC Fact Sheet (Detailed). https://www.cdc.gov/std/chlamydia/stdfact-chlamydia-detailed.htm. Updated October 17, 2016. Accessed November 29, 2017.  2. CDC. Gonorrhea – CDC Fact Sheet (Detailed). https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea-detailed.htm. Updated October 28, 2016. Accessed November 29, 2017.  3. World Health Organization. Prevalence and incidence of selected sexually transmitted infections. Methods and results. http://apps.who.int/iris/bitstream/10665/44735/1/9789241502450_eng.pdf. Published 2011. Accessed November 29, 2017.  4. Aptima Trichomonas vaginalis assay [package insert]. 503797, Rev. 002. San Diego, CA: Hologic, Inc.; 2017.  5. CDC. Trichomoniasis. https://www.cdc.gov/std/tg2015/trichomoniasis.htm. Updated August 12, 2016. Accessed November 29, 2017.  6. World Health Organization. Herpes simplex virus. http://www.who.int/mediacentre/factsheets/fs400/en/. Published January 2016. Accessed November 29, 2017.  7. CDCNovember 29October 2, 2017.  8. Aptima HSV 1 & 2 assay [package insert]. AW-15346-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2016.  9. Aptima Mycoplasma genitalium assay [package insert]. AW-14170-001, Rev. 005. San Diego, CA: Hologic, Inc.; 2017.  10. CDC. Zika Virus: Transmission. https://www.cdc.gov/zika/transmission/index.html. Updated June 28, 2017. Accessed November 29, 2017.  11. Kandel N, et al; World Health Organization. Detecting Guillain-Barré syndrome caused by Zika virus using systems developed for polio surveillance. http://www.who.int/bulletin/volumes/94/9/16-171504/en/. Published July 5, 2016. Accessed November 29, 2017.  12. Aptima Zika Virus assay [package insert]. AW-15406, Rev. 002. San Diego, CA: Hologic, Inc.; 2016.  13. Data on file. Hologic, Inc.; 2017.  14. UNITAID. HIV/AIDS Diagnostic Technology Landscape. 2nd ed. Geneva, Switzerland: World Health Organization; 2012.  15. Roche. Cobas 4800 System [Technical Specifications]. 472-53145-0814. Indianapolis, IN: Roche Diagnostics; 2014.  16. Roche. Cobas 6800 System Specifications. https://www.cobas68008800.com/cobas_6800_details. Published January 1, 2015. Accessed November 29, 2017.
Want Image Slider on Tab Click
no