- Abbott's multiplex test runs on its most advanced molecular PCR
platform, the Alinity™ m system, which provides fast results in
high volumes – detecting four infections simultaneously
- Test provides a critically important tool as people return to
regular STI testing; a pause in testing during the pandemic
contributed to an increase of STI cases 1,2
- Pandemic has shown value of at-home testing and sample
collection, and Abbott plans to bring that convenience and
discretion to additional areas in the future, including for
STIs
ABBOTT
PARK, Ill., May 4, 2022
/PRNewswire/ -- Abbott (NYSE: ABT) announced today it has received
FDA clearance for its Alinity™ m STI Assay. The test simultaneously
detects and differentiates four common sexually transmitted
infections (STIs). STIs, when left untreated, can lead to severe
health complications, including increased risk of getting certain
cancers and infertility.3
The first-of-its-kind multiplex test will help address
increasing STI rates, after disruptions in delivery of care
during the pandemic contributed to a decline in routine STI
screening and an increase in cases.1
The Alinity m STI test for Chlamydia trachomatis (CT), Neisseria
gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma
genitalium (MG) requires one swab sample or a urine sample
collected in a healthcare setting by either a clinician or by the
patient. The test runs on Abbott's Alinity m system — the company's
most advanced high-volume laboratory molecular instrument. Alinity
m uses polymerase chain reaction (PCR) technology, with high
sensitivity in detecting infectious diseases. This test can help
healthcare providers save time, increase efficiency and better
serve patients.
"Over the past several years, STI cases have been on the rise,
and we expect to see increasing rates as people resume testing
after delaying during the pandemic," said Kathryn Becker, Ph.D., global director of
scientific affairs innovation in Abbott's diagnostics business.
"With that comes an increased need for effective and efficient
testing. This four-plex STI test gives healthcare providers a more
holistic picture of someone's health in a single test, helping to
support the best treatment plan to address these common STIs
individually or as co-infections."
The need for efficient STI testing
According to the Centers for Disease Control and Prevention
(CDC), 20% of the U.S. population has an STI4. Every
year for the past six years of available data, the CDC
reported that cases of chlamydia, gonorrhea, and syphilis reached
an all-time high. 1
Advanced molecular testing allows those living with these
infectious diseases to be diagnosed correctly and can help
healthcare providers determine how individuals are responding to
treatment. While the COVID-19 pandemic may have contributed to less
sexual activity for some and limited availability of clinical
services for STIs, there's a potential risk of even higher
increases of STI cases if sexual activity resumes, but regular STI
testing and treatment does not.5
The pandemic accelerated the demand for additional channels for
healthcare delivery, a trend reflected in Abbott's commitment to
improving the quality and accessibility of diagnostic testing. "The
pandemic showed us the value of having aspects of testing available
to people in their homes," said Becker. "As we look to the future
of testing, we will be focused on bringing that kind of convenience
and discretion for STIs and other conditions."
About Alinity m
Assays available for use on the Alinity m system in the U.S.
include: SARS-CoV-2 (Emergency Use Authorization), Resp-4-Plex
(Emergency Use Authorization), HCV (Hepatitis C), HBV (Hepatitis
B), HIV-1 (Human Immunodeficiency Virus type 1), and STI
(CT/NG/TV/MG). Alinity m systems are designed to be more efficient
– running more tests in less time and minimizing human errors –
while continuing to provide quality results. The system helps to
improve laboratory workflow and efficiency with its large capacity
and fast turnaround time, running up to 1,080 tests in a 24-hour
period based on laboratory practice and workflow. The availability
of the Alinity m system and tests varies by geography. More
information is available at www.molecular.abbott.
About Abbott
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 113,000 colleagues
serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
1. Reported STDs Reach All-time High for 6th Consecutive Year,
https://www.cdc.gov/media/releases/2021/p0413-stds.html
2. Casey N. Pinto, Justin K. Niles, Harvey
W. Kaufman, Elizabeth M.
Marlowe, Damian P. Alagia,
Guangqing Chi, Barbara Van Der Pol, Impact of the COVID-19
Pandemic on Chlamydia and Gonorrhea Screening in the U.S., American
Journal of Preventive Medicine, Volume 61, Issue 3, 2021, Pages
386-393, https://doi.org/10.1016/j.amepre.2021.03.009.
3. U.S. Department of Health and Human Services, Sexually
Transmitted Infections (STIs), 2022.
4. CDC estimates 1 in 5 people in the U.S. have a sexually
transmitted infection,
https://www.cdc.gov/media/releases/2021/p0125-sexualy-transmitted-infection.html
5. Samuel M Jenness, Adrien Le
Guillou, Christina Chandra,
Laura M Mann, Travis Sanchez,
Daniel Westreich, Julia L Marcus,
Projected HIV and Bacterial Sexually Transmitted Infection
Incidence Following COVID-19–Related Sexual Distancing and Clinical
Service Interruption, The Journal of Infectious Diseases, Volume
223, Issue 6, 15 March 2021, Pages
1019–1028, https://doi.org/10.1093/infdis/jiab051
6. Alinity m System Operations Manual 54-605001/R10.
View original
content:https://www.prnewswire.com/news-releases/abbott-obtains-fda-clearance-for-first-test-that-simultaneously-detects-four-common-sexually-transmitted-infections-stis-as-cases-are-on-the-rise-301539566.html
SOURCE Abbott