WEBVTT

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Hello, everyone.

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My name is Alex Shakir.

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I'm an assistant professor

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in the Department of Pathology
at the University of Utah,

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and a medical director
at Irwin Laboratories, where I oversee

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molecular testing
for sexually transmitted infections.

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Today, I would like to give you a brief
update on testing of sexually transmitted

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infections, which is an ongoing pandemic
here in the United States and globally.

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I'll discuss
some key points in the diagnosis of common

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sexually transmitted infections and
what the future of STI testing looks like.

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Here are the objectives
of today's presentation.

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The first would be to recognize
the importance of screening and testing

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for sexually transmitted infections,
or STIs, as they're commonly known.

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And I would review some key updates
from the 2021 CDC recommendations

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for for common STI infections, namely

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chlamydia,
gonorrhea, chukerman and Mycoplasma.

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The next objective is to understand
the clinical presentation

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of these organisms
associated with SCA infections

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and finally, understand
the methodologies used

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in the diagnosis of these common
STI agents.

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For the purpose of clarity
in today's presentation.

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The terms male and female will be used
and will refer

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to those assigned male
or female at both respective FLI.

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So let's get started with this
slide from the CDC.

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STI surveillance from 2019
that shows the rise of the three

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most commonly reported
STIs in the United States.

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This infographic showed a significant rise

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in cases for chlamydia,
gonorrhea and syphilis from prior years,

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and in 2019,
it was the sixth consecutive year

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where STIs with continued to rise
in the United States.

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In a more recent report
from 2021, cases of gonorrhea

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and syphilis were up
10% and 7%, respectively,

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compared to that in 2019.

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And overall,
there were 2.5 million reported

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cases of chlamydia, gonorrhea and syphilis
combined in the United States.

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Not all STIs are nationally notifiable.

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Gonorrhea
and chlamydia have been for decades,

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but there are other
STIs that need to be added to this list.

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Most of the skies are asymptomatic,
and only those that are diagnosed

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are being reported,
and there are not enough

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screening programs
for some of these STIs as well.

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So the burden of STIs has had a major
impact on our health care and economy.

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And this slide from CDC shows 1 in 5
people in the US are infected with an STI.

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And this incidence continues
to increase year by year.

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This has also led to more than 26
million cases in 2019,

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leading to almost $16 billion
in total Medicare medical costs.

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This slide represents
the different clinical manifestations

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of STI, those that cause arthritis
and severe situs.

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Virgin Itis, pelvic inflammatory disease

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and genital warts,
and gentle also disease.

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Some of these have overlapping
clinical manifestations

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and often
these agents can be Co detected as well.

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For the purpose of today's presentation,
I will focus on four agents

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of uro arthritis and societies
namely chlamydia, trachoma,

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Neisseria, gonorrhea, trachoma, batch
analysis and Mycoplasma genital. You.

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So let's move on to discussing
specific pathogens

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that are linked
to this increasing incidence of STIs.

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The first one I would like to go over
is chlamydia trachoma.

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Morris.

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Chlamydia are obligate
intracellular bacteria.

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They contain small genomes
about one megabase in size,

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and the genomes are reduced due to their
obligatory intracellular life cycle.

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Chlamydia also contain a 7.5 kb

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cryptic plasmid
that contributes to its pathogenicity.

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In general,
these small intracellular organisms

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lack several metabolic
and biosynthetic pathways

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and depend on the host cells for growth
intermediates and energy production.

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Chlamydia

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in the host cell can exist as two stages.

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The first is called
the infectious particle or the elementary

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body, and the second is the cytoplasmic

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reproductive form or the regulate body.

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The elementary body attaches to and enters
the host cell,

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where it transforms into a reticulate body
within an inclusion.

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Within this inclusion.

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The reticulate body
divide by binary fission

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and then reorganize
to form multiple elementary bodies.

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That then leaves the host cell.

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To continue this life cycle.

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And here are some images of an

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inclusion that's been stained by Kim,

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or by a fluorescently labeled antibody
within a host cell.

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Somebody to check them out
is the most common notifiable STI

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in the United States, and it is classified
into 15 different sectors

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based on the epitope analysis of the major
outer membrane protein.

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There are 15 servers
that are linked to different

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clinical manifestation servers.

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A, B1, B2 and C.

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Costa Como, which is the leading cause

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of non congenital blindness
in developing nations.

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Servers D through K are associated
with states and cause you detritus.

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Server side is conjunctivitis
and pneumonia.

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In neonates and the l servers
l one through three cause

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invasive urogenital or indirect infection
known as lymphoid granuloma.

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Venereal untreated chlamydia.

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Check them out as infections can lead

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to pelvic inflammatory disease
epidemic latest and product itis

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with rare complications such as pro
hepatitis and reactive arthritis.

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Chlamydia can infect the oropharynx,
rectum, eye and urogenital tract,

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and most of the.

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These infections tend to be asymptomatic,

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so screening and treating is crucial
for reducing this infection burden.

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Untreated chlamydia infection

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has also been linked to problems
during pregnancy, including preterm

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labor, premature rupture of membranes,
and low birth weight in neonates.

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And that's why screening
and treatment of mothers is also critical

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for prevention of this important sequelae.

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Newborns can become infected
during delivery as the baby passes

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through the birth canal,

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and exposed newborns can develop
eye infections such as conjunctivitis

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or also subacute pneumonia,

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usually 1 to 3 months after birth.

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Ophthalmic neonatal room
caused by the media.

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Trachoma this is an eye infection
and should be considered for all infants,

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each less than 30 days
that have conjunctivitis,

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especially if the mother has a history
of chlamydia infection.

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Because the efficacy
of atomizing treatment for

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this conjunctivitis is approximately 80%

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okay, the second course
of therapy is often required.

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So let's

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move on to how we test for chlamydia.

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Nucleic acid amplification tests or Nat,

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are the tests of choice at all
potentially infected sites.

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These have the highest sensitivity
and high specificity compared

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to other testing methodologies,

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and this approach is similar to the one

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for gonorrhea,
as I'll describe in the next section.

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There are several commercially available
FDA cleared tests that are now recommended

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for screening and diagnosis for chlamydia
check matters, and these usually involve

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using less invasive samples,
such as vaginal swabs or urine.

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CDC also recommends
using nucleic acid tests to test

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for rectal and virtual sites in both

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MSM and women.

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One thing to keep in mind is these FDA
cleared assays that are commercially

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available cannot distinguish
between non LGV and LGV strains.

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However,
there are certain reference laboratories

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or public health
laboratories that do offer PCR testing.

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Culture is another

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method that some drug reference
laboratories may offer.

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It was considered the gold standard
method for testing where cell cultures

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are used using different cell lines,
such as McCoy,

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monkey, kidney, or Hep two are used,

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and these involves
growing cell lines in vitro

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and infecting them with the patient's
specimen and detection of chlamydia

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by using fluorescently labeled antibodies.

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This method, though it has high
specificity, it generally is very low

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sensitivity and generally difficult
to maintain and sanitize,

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but it can be useful in certain
medical legal settings.

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In some jurisdiction can be used to assess
treatment failure, and for sites

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that are otherwise not validated
for nucleic acid amplification testing.

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And lastly, serological testing
has been used in the past

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for chlamydia infection,
but these are not widely available.

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And also they are not recommended
for detection of active infection

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or the diagnosis
of uncomplicated urogenital infection.

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They can be used,
as an aid in the diagnosis of LGV

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or screening for tubal factor infertility.

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And this table

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summarizes the the test performances
for detection of chlamydia,

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including the assays
that have been historically used.

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And by far,
you can see that nucleic acid testing

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is the most sensitive and specific method.

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So let's move on to the next most common

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STI infection,
which is Neisseria gonorrhea.

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Neisseria
gonorrhea is recognized as a strict human

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pathogen that commonly infects
the urogenital tract,

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including urethra of male
and under cervix of reproductive females,

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and it can also colonize the rectum,
conjunctiva, and pharynx, as well.

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These are gram negative diplo cocci

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and are adapted to growth
on mucous membranes.

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They tend to be generally fastidious
and are environment to lead labial

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and cannot tolerate drying, so they prefer
to be in a mucus rich environment.

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Gonorrhea is the second most

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commonly reported communicable disease,
but often appear

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appear to be asymptomatic in women,
and at least 50% of women

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can have asymptomatic urogenital infection
with Neisseria gonorrhea.

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The clinical sequelae is very similar to,
chlamydia trachoma,

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and they are often Co detected

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or contested in multiple

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FDA cleared nucleic acid amplification

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test or PCR tests.

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They cause both ureter in

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men and service status in women.

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But rectal gonorrhea and pharyngeal
gonorrhea infections are also increasing,

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leading to either anal rectal pain,
bleeding with pharyngeal gonorrhea

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leading to throat, 
pain, pharyngeal exudates,

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or cervical lymph at an Itis.

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Severe cases of

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Neisseria
gonorrhea can lead to disseminated

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clinical co-infections, which I'll discuss
in the next couple of slides.

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But an important clinical manifestation
also is going to cause

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collections of conjunctivitis,
or ophthalmic neonatal REM,

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which can be acquired during delivery
and again can occur

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within the first 20 days of life
from infected mothers.

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This infection can lead to corneal
scarring,

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perforation of the eye,
and blindness in neonates.

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So what are the testing methodologies
for Neisseria gonorrhea?

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Because of its high specificity,

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about more than 99% and sensitivity,

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a gram stain from a male urethral specimen

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which demonstrates
polymorph on leukocytes.

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And these gram negative developed
Coxsackie within these polymorphous

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leukocytes can be considered diagnostic
for infection with Neisseria gonorrhea.

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But keep in mind
this is only in, say, symptomatic men.

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However, because of the lower
sensitivity, a negative gram stein

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should not be considered sufficient

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for ruling on infection
in asymptomatic individuals,

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and also this should not be used in
specimens from women

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such as and or cervical,
pharyngeal, or rectal specimens.

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Specimens collected for gonorrhea

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culture can be obtained using swabs.

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Such as those that have rayon or Dacron

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but usually cotton tip or footies shaft

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swabs are inhibitory or toxic
to these organisms.

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Culture.

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Media transport systems are preferred
because they have some advantages over

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swab transport systems,
and also because they, they are involved

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with better recovery of these organisms
as they tend to be fastidious

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culture specimens can be streaked
on selective media

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in the clinical laboratory,
such as their multi

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hot chocolate agar,
and a wide variety of biochemical tests

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can be performed
to, identify the organism.

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Molotov has emerged as a good method

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to identify,
nicer gonorrhea from clinical specimens.

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But generally, culture
tends to be quite less

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sensitive
compared to nucleic acid amplification.

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But culture is still important, as,

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an isolate is required
for susceptibility testing, and also

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has been recommend in some jurisdictions
for endo cervical and urethral specimens.

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Nucleic acid amplification tests

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by far are the most recommended test,
according to CDC guidelines.

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For women, a self collected or a clinician
should collect vaginal swab

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for males of first catch, urine
are the recommended sample types.

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And also rectal pharyngeal swabs for

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but MSM and women as well.

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There are several FDA
to test in combination with chlamydia.

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Trachoma is that are available
to detect Neisseria gonorrhea as well.

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Care should be taken with separate phytic

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Neisseria
found in some of these mucosal sites.

239
00:15:15.566 --> 00:15:19.666
But the newer generation of nucleic acid
tests have better specificity

240
00:15:20.700 --> 00:15:23.700
and sensitivity
to detect Neisseria gonorrhea

241
00:15:23.833 --> 00:15:26.833
in these specimens.

242
00:15:27.433 --> 00:15:28.266
This table here

243
00:15:28.266 --> 00:15:33.433
summarizes the test performance of various
methods, with nucleic acid testing again

244
00:15:33.733 --> 00:15:38.500
being the most sensitive and specific
and recommended for all sources.

245
00:15:40.033 --> 00:15:41.666
So I want to switch gears.

246
00:15:41.666 --> 00:15:45.833
And next talk about eight common protozoan

247
00:15:46.833 --> 00:15:49.833
STI caused by two common vaginal

248
00:15:50.900 --> 00:15:51.133
tick.

249
00:15:51.133 --> 00:15:54.133
Harmonious vaginosis is a unicellular,
anaerobic

250
00:15:54.366 --> 00:15:58.433
related protozoan which inhabits the lower
genital urinary tract.

251
00:15:58.766 --> 00:16:01.766
It is the most common
curable STI in young women,

252
00:16:02.433 --> 00:16:06.066
but is also the most prevalent non-viable
STI as well.

253
00:16:06.366 --> 00:16:09.366
However, it is not a reportable infection

254
00:16:10.100 --> 00:16:14.666
symptomatic in women, often
present as diff but diffuse

255
00:16:14.666 --> 00:16:19.866
malodorous yellow green vaginal discharge
as symptoms of vaginal itis,

256
00:16:20.133 --> 00:16:23.833
which but can also develop U detritus
and Soviet Soviet scientists

257
00:16:24.866 --> 00:16:26.266
in untreated infections.

258
00:16:26.266 --> 00:16:30.400
These can also lead to complications
such as pelvic inflammatory disease,

259
00:16:30.733 --> 00:16:33.733
preterm delivery, and low birth weight.

260
00:16:34.266 --> 00:16:37.933
Many infections, 
do not produce symptoms at all,

261
00:16:38.666 --> 00:16:42.566
and especially in men,
these often tend to be asymptomatic

262
00:16:44.100 --> 00:16:44.500
to common.

263
00:16:44.500 --> 00:16:48.833
Its vaginal also causes
increases in HIV transmission,

264
00:16:48.833 --> 00:16:52.000
especially in HIV endemic areas.

265
00:16:53.700 --> 00:16:56.200
So diagnostic testing for took home
owners,

266
00:16:56.200 --> 00:17:00.400
should be performed for women
seeking care for vaginal discharge.

267
00:17:01.066 --> 00:17:05.633
However, there are no defined
STD guidelines as they are

268
00:17:05.633 --> 00:17:08.766
for chlamydia and I sero gonorrhea
for screening for chukerman.

269
00:17:08.766 --> 00:17:10.566
As for each analysis,

270
00:17:10.566 --> 00:17:14.666
annual screening may be considered
for persons receiving care in high

271
00:17:14.666 --> 00:17:19.000
prevalence settings, such as those in city
clinics and correctional facilities,

272
00:17:19.533 --> 00:17:25.333
and also for women at high risk
for infection or with high

273
00:17:25.333 --> 00:17:29.666
risk of acquiring infections
such as multiple sex partners,

274
00:17:30.166 --> 00:17:34.166
transsexual sex, drug misuse,
or a history of STIs.

275
00:17:35.600 --> 00:17:39.133
Serious adverse outcomes
have been seen among pregnant women.

276
00:17:39.133 --> 00:17:42.866
Therefore, screening
or treatment of pregnant women is is

277
00:17:43.466 --> 00:17:45.966
should be performed but

278
00:17:45.966 --> 00:17:48.966
is not very well defined or recommended.

279
00:17:49.233 --> 00:17:53.066
And in addition, oral and rectal testing
is not recommended as well.

280
00:17:54.266 --> 00:17:56.333
Retesting after three months

281
00:17:56.333 --> 00:18:00.733
after initial treatment should be done
because of high rate of infection.

282
00:18:00.733 --> 00:18:03.733
Reinfection for this organism.

283
00:18:04.466 --> 00:18:06.766
So how is T vaginal is diagnosed?

284
00:18:06.766 --> 00:18:09.733
One of the most common
methods is microscopic

285
00:18:09.733 --> 00:18:12.833
examination
of wet preps from genital secretions.

286
00:18:13.166 --> 00:18:15.900
But you're looking for trapezoid forms

287
00:18:15.900 --> 00:18:18.900
of Chukerman is, vaginal less.

288
00:18:19.900 --> 00:18:23.400
And this method usually is better

289
00:18:23.400 --> 00:18:27.400
when confirmed with culture
from vaginal specimens.

290
00:18:27.400 --> 00:18:30.933
However, the sensitivity of that amount
is very low

291
00:18:31.333 --> 00:18:35.233
and it misses
more than 50% of the commonest infections.

292
00:18:36.700 --> 00:18:39.600
Culture was considered
the gold standard method

293
00:18:39.600 --> 00:18:43.500
before
nucleic acid test became widely available,

294
00:18:44.433 --> 00:18:47.600
and generally this also is not,

295
00:18:47.766 --> 00:18:50.600
performed routinely anymore,

296
00:18:50.600 --> 00:18:55.566
since it has lower sensitivity
and requires more, labor

297
00:18:56.033 --> 00:19:01.200
involved to inoculate these cultures
and periodically look for

298
00:19:02.333 --> 00:19:05.333
took homeowners vaginal as trophies awards
within the culture,

299
00:19:05.833 --> 00:19:09.433
the sensitivity tends to be quite low,
especially in men.

300
00:19:09.566 --> 00:19:13.200
However, this specificity is quite high,

301
00:19:13.200 --> 00:19:16.200
about 100%.

302
00:19:16.533 --> 00:19:20.400
Nucleic acid testing
have been recommended by the CDC

303
00:19:20.800 --> 00:19:24.900
as the method to diagnose check
harmonious vaginal infection, and

304
00:19:24.900 --> 00:19:29.566
this is the preferred and most sensitive
method for testing this disease.

305
00:19:30.333 --> 00:19:34.766
Nucleic acid testing
both by PCR or transit transcription

306
00:19:34.766 --> 00:19:37.800
needed amplification and also by DNA probe

307
00:19:37.800 --> 00:19:40.800
assays have replaced culture

308
00:19:41.266 --> 00:19:43.633
and wet mount preps

309
00:19:43.633 --> 00:19:46.600
throughout the United States,

310
00:19:46.600 --> 00:19:49.233
and there are several FDA

311
00:19:49.233 --> 00:19:52.333
cleared assays that are now been approved.

312
00:19:52.833 --> 00:19:53.800
For testing.

313
00:19:53.800 --> 00:19:56.800
Chukerman is batch analysis.

314
00:19:57.300 --> 00:19:59.433
And these assays also include

315
00:19:59.433 --> 00:20:02.433
testing for chlamydia and Neisseria
gonorrhea.

316
00:20:02.833 --> 00:20:06.500
Overall, nucleic acid test
tend to have high sensitivity

317
00:20:06.900 --> 00:20:10.200
95 to 100% compared to microscopy

318
00:20:10.200 --> 00:20:13.366
and culture, and a wide variety of samples

319
00:20:13.366 --> 00:20:17.266
have now been validated
for use on nucleic acid testing,

320
00:20:18.466 --> 00:20:21.033
including inter cervical, vaginal,

321
00:20:21.033 --> 00:20:23.566
urine specimens or liquid based pap

322
00:20:23.566 --> 00:20:26.566
test samples, as well.

323
00:20:26.666 --> 00:20:28.600
The last organism I wanted to discuss

324
00:20:28.600 --> 00:20:31.600
today is Mycoplasma genitalia.

325
00:20:32.166 --> 00:20:35.100
This is a recently described STI

326
00:20:35.100 --> 00:20:38.100
and is considered
the new kid on the block.

327
00:20:38.533 --> 00:20:41.366
Mycoplasma
genitalia belong to the more cuties

328
00:20:41.366 --> 00:20:44.466
class
and are the smallest replicating bacteria.

329
00:20:45.100 --> 00:20:48.533
They lack a cell wall
and therefore beta lactam

330
00:20:48.533 --> 00:20:52.466
antibiotics are generally ineffective
against this organism.

331
00:20:53.433 --> 00:20:56.933
Currently,
there are no US recommendations

332
00:20:56.933 --> 00:20:59.933
for screening for mycobacterium
genital. You.

333
00:21:00.700 --> 00:21:04.766
However, individuals with persistent
nonclinical should unit riders

334
00:21:05.266 --> 00:21:08.533
or server side is that have otherwise

335
00:21:08.533 --> 00:21:12.600
been negative for Neisseria gonorrhea
or chlamydia are recommended to be tested

336
00:21:12.900 --> 00:21:16.200
for Mycoplasma genitalia
by nucleic acid testing.

337
00:21:18.066 --> 00:21:20.000
CDC guidelines recommend

338
00:21:20.000 --> 00:21:23.266
a sequential treatment, for Mycoplasma

339
00:21:23.866 --> 00:21:29.100
genitalia,
which is like a two step, method using

340
00:21:29.100 --> 00:21:33.700
doxycycline, followed either by,
as it were, mycin or moxifloxacin.

341
00:21:34.233 --> 00:21:37.033
And this recommendation for treatment

342
00:21:37.033 --> 00:21:40.866
is generally guided
by the resistance testing.

343
00:21:41.500 --> 00:21:44.600
Since there's been increasing
macrolide resistance

344
00:21:44.933 --> 00:21:48.933
in mycoplasma, genital,
in the United States and globally.

345
00:21:49.300 --> 00:21:53.800
So for that reason, CDC has now placed
mycoplasma joint ilium on its

346
00:21:53.800 --> 00:21:59.133
watch list for a emerging, drug
resistant organism.

347
00:21:59.800 --> 00:22:04.633
The prevalence of mycoplasma
genital ilium, is now increasing more

348
00:22:04.633 --> 00:22:09.333
and more as we are being able to test,
with nucleic acid testing.

349
00:22:09.766 --> 00:22:13.000
Generally,
these infections are asymptomatic,

350
00:22:13.266 --> 00:22:17.233
but co-infections with other
STIs are also common.

351
00:22:18.066 --> 00:22:21.633
In men, 30 to 40% of non gynecological use

352
00:22:22.000 --> 00:22:25.000
cases are associated
with Mycoplasma genitalia.

353
00:22:25.500 --> 00:22:29.233
And in the MSM population,
there's been reports of 1

354
00:22:29.233 --> 00:22:32.500
to 26% of prevalence of Mycoplasma

355
00:22:32.966 --> 00:22:36.466
Gentileschi in this cohort of individuals,

356
00:22:37.233 --> 00:22:40.900
and a higher prevalence is also reported
among men with rectal symptoms.

357
00:22:41.633 --> 00:22:44.000
In women, it's often detected

358
00:22:44.000 --> 00:22:46.733
in individuals

359
00:22:46.733 --> 00:22:51.600
with societies about 10 to 30%,
and can be high prevalence

360
00:22:51.600 --> 00:22:54.800
in pregnant women
with about 12 to 18%, as well.

361
00:22:55.600 --> 00:22:59.633
So in pregnant women,
these also can increase the risk of pelvic

362
00:22:59.633 --> 00:23:04.700
inflammatory disease, endometriosis
and in for infants, infertility.

363
00:23:06.266 --> 00:23:06.966
So in

364
00:23:06.966 --> 00:23:10.900
in in often
in women these are also asymptomatic.

365
00:23:11.166 --> 00:23:15.066
And so the consequences associated
with these asymmetric asymptomatic

366
00:23:15.633 --> 00:23:18.466
infections is generally unknown.

367
00:23:18.466 --> 00:23:21.900
So there are some challenges
in discerning the independent role

368
00:23:21.900 --> 00:23:24.900
of micro plasma genital ilium.

369
00:23:24.900 --> 00:23:27.900
But hopefully as we detect this

370
00:23:28.000 --> 00:23:30.866
with other STIs,
we'll get more information

371
00:23:30.866 --> 00:23:35.233
about the role of this important
and emerging pathogen,

372
00:23:37.166 --> 00:23:41.866
Mycoplasma gi,
until you can be diagnosed with culture.

373
00:23:41.866 --> 00:23:45.633
But this is again
performed in specialized laboratories,

374
00:23:46.000 --> 00:23:48.966
for example, in the University of Alabama.

375
00:23:48.966 --> 00:23:51.400
However, nucleic acid amplification

376
00:23:51.400 --> 00:23:54.400
tests are the recommended test for,

377
00:23:54.400 --> 00:24:00.233
the diagnosis of genital allium
infections, and the preferred specimens

378
00:24:00.233 --> 00:24:05.266
include a first white urine sample
in males and a vaginal swab in females.

379
00:24:06.833 --> 00:24:09.833
There are now two FDA cleared

380
00:24:10.033 --> 00:24:13.233
nucleic acid amplification tests
available, including the Hologic

381
00:24:13.233 --> 00:24:17.100
aptamer assay and the Abbott LNT assays.

382
00:24:18.100 --> 00:24:19.900
More recently, Roche Cobas

383
00:24:19.900 --> 00:24:23.900
also has a FDA clearance
for detection of micro

384
00:24:24.266 --> 00:24:27.300
mycoplasma genital allium,
along with chick ammonia, as well.

385
00:24:28.700 --> 00:24:30.766
Resistance marker detection.

386
00:24:30.766 --> 00:24:34.200
Is only available
as in a research setting

387
00:24:34.533 --> 00:24:38.466
or under laboratory developed conditions.

388
00:24:39.933 --> 00:24:43.666
In clinical practice,
if usually if testing is unavailable.

389
00:24:44.033 --> 00:24:48.066
Mycoplasma gentileschi should be
suspected in cases of persistent.

390
00:24:48.066 --> 00:24:49.900
I recommend you to try this.

391
00:24:49.900 --> 00:24:51.933
And then

392
00:24:51.933 --> 00:24:53.733
tested by either lab

393
00:24:53.733 --> 00:24:56.733
developed or FDA cleared assays.

394
00:24:57.100 --> 00:24:59.066
So for the last part of today's

395
00:24:59.066 --> 00:25:03.966
talk, I just wanted to switch gears
and focus a little bit on the current

396
00:25:03.966 --> 00:25:07.833
and future molecular diagnostic options
for these important

397
00:25:08.000 --> 00:25:11.000
STI pathogens.

398
00:25:11.800 --> 00:25:14.133
So what is the current
molecular landscape?

399
00:25:14.133 --> 00:25:18.133
So there are more than 25 FDA
cleared assays

400
00:25:18.133 --> 00:25:20.666
available commercially for chlamydia.

401
00:25:20.666 --> 00:25:23.166
Check them
out. Is and Neisseria gonorrhea.

402
00:25:23.166 --> 00:25:27.033
Some of these do include check them on
is batch analysis.

403
00:25:27.366 --> 00:25:31.066
And a couple now are also FDA cleared
as mentioned earlier for

404
00:25:31.066 --> 00:25:32.466
mycoplasma genital ilium

405
00:25:34.066 --> 00:25:37.333
from a multicenter clinical cohort study.

406
00:25:37.333 --> 00:25:41.166
In 2016,
it was observed that the most prevalent

407
00:25:41.166 --> 00:25:45.300
single infection in females was check
homeowners

408
00:25:45.600 --> 00:25:49.133
vaginal followed by m genital.

409
00:25:49.133 --> 00:25:53.066
You Cambodia check
matters and Neisseria gonorrhea.

410
00:25:55.000 --> 00:25:56.466
Among male subjects,

411
00:25:56.466 --> 00:25:59.866
the most prevalent
single infection was chlamydia.

412
00:25:59.866 --> 00:26:03.766
Check them out is followed by
m genitalia and nice pseudo gonorrhea.

413
00:26:04.466 --> 00:26:08.433
And so these findings
support the monitoring of check hormones

414
00:26:08.800 --> 00:26:13.100
and microfibres Mycoplasma J and helium
infections in high risk population.

415
00:26:13.666 --> 00:26:16.666
As an effort
for screening in public health

416
00:26:16.733 --> 00:26:19.733
STI screening programs.

417
00:26:20.500 --> 00:26:21.166
There are several

418
00:26:21.166 --> 00:26:25.000
new generation molecular assays
in the market that have increased

419
00:26:25.000 --> 00:26:29.700
sensitivity and specificity, specificity,
and most of these new generation

420
00:26:29.700 --> 00:26:33.833
molecular assays are high throughput
with increased efficiencies.

421
00:26:34.433 --> 00:26:37.200
These are also FDA cleared
for several sample types.

422
00:26:37.200 --> 00:26:39.833
Both urogenital and extra genital sources,

423
00:26:40.833 --> 00:26:43.833
and they are often sample two result.

424
00:26:44.033 --> 00:26:48.433
Some assays
often offer multiple pathogen detection,

425
00:26:48.833 --> 00:26:54.166
all on one assay
using a simple single swab specimen,

426
00:26:54.933 --> 00:26:59.500
so this one sample or single swab specimen
for multiple assays

427
00:27:00.066 --> 00:27:04.766
has shown to improve clinical flow
and diagnostic capacity for STI testing.

428
00:27:05.833 --> 00:27:07.800
There are now novel rapid

429
00:27:07.800 --> 00:27:10.800
diagnostic methods available, as well,

430
00:27:11.066 --> 00:27:14.333
including those with moderate complexity,

431
00:27:14.333 --> 00:27:18.266
such as a separate assay
or more point of care tests.

432
00:27:18.700 --> 00:27:22.200
Such as the Binx Health EOS,

433
00:27:22.233 --> 00:27:25.233
STI and the Visby STI panel.

434
00:27:25.700 --> 00:27:30.566
Both assays,
are now FDA cleared point of care

435
00:27:31.000 --> 00:27:36.433
clear wave tests
that may help with detection

436
00:27:37.600 --> 00:27:39.866
and screening for chlamydia.

437
00:27:39.866 --> 00:27:42.866
Check them out as Neisseria
and in some cases

438
00:27:43.000 --> 00:27:45.633
check Mona's vaginal list as well.

439
00:27:45.633 --> 00:27:47.200
Both assays are rapid.

440
00:27:47.200 --> 00:27:51.933
Usually, you get a result
while you wait at the clinician's office

441
00:27:51.933 --> 00:27:56.833
within 30 minutes, and they have shown
to have high sensitivity and specificity.

442
00:27:56.966 --> 00:27:59.066
Specificity overall.

443
00:27:59.066 --> 00:28:02.566
But be excited to see how these assays are
implemented

444
00:28:02.566 --> 00:28:06.233
across clinics in the United States.

445
00:28:06.566 --> 00:28:10.500
And studies are still undergoing
to see the impact of these FDA

446
00:28:10.500 --> 00:28:16.400
cleared point of care tests
on, decreasing rates for STI infections.

447
00:28:18.633 --> 00:28:21.033
And finally, for STI,

448
00:28:21.033 --> 00:28:24.900
self collection seems the way to improve
screening and testing.

449
00:28:26.900 --> 00:28:28.900
With some of the constraints
we encountered

450
00:28:28.900 --> 00:28:32.566
encountered during the pandemic, providers
were seeking more ways

451
00:28:32.566 --> 00:28:36.233
to ensure patients were getting
appropriately screen and tested.

452
00:28:37.333 --> 00:28:41.266
There are at least five
commercially available FDA cleared

453
00:28:41.566 --> 00:28:44.266
nucleic acid assays for self collected

454
00:28:44.266 --> 00:28:47.266
virtual swabs and for sketchy urine.

455
00:28:47.666 --> 00:28:52.500
And there's been a lot of literature
lately that has shown that self collected

456
00:28:52.500 --> 00:28:56.766
urogenital specimens
are comparable to provider collected

457
00:28:56.966 --> 00:28:59.966
genital specimens
and have shown accurate results.

458
00:29:00.800 --> 00:29:03.633
Rectal and throat
self collection are not FDA cleared,

459
00:29:03.633 --> 00:29:06.966
but there have been studies
showing equivalent or better detection

460
00:29:06.966 --> 00:29:10.200
rates for both chlamydia
chuck and Neisseria gonorrhea.

461
00:29:12.033 --> 00:29:16.300
So CDC has stated that self collected
rectal swabs are a reasonable

462
00:29:16.300 --> 00:29:20.000
alternative to clinician collected
rectal swabs in low resource settings.

463
00:29:20.500 --> 00:29:22.633
So this is really important to increase

464
00:29:24.433 --> 00:29:26.966
STI testing overall.

465
00:29:26.966 --> 00:29:30.933
And this has also been shown
to improve patient satisfaction as well.

466
00:29:31.966 --> 00:29:34.733
However labs should validate this process

467
00:29:34.733 --> 00:29:40.233
and be able to provide
optimal healthcare for STI infections.