The Food and Drug Administration has granted a waiver to the
makers of the Syphilis Health Check test that makes the rapid test more
widely available in community health settings. A blood sample from a
finger stick is collected and tested for syphilis antibodies, with
results available in minutes.
(Diagnostics Direct LLC)
By
Email the author | Follow on Twitter
on January 22, 2015 at 8:00 AM, updated January 22, 2015 at 8:08 AM
CLEVELAND, Ohio – Syphilis is back.
Actually, it never went away. But after a steady increase in the number of reported cases in Cuyahoga County, peaking in 2010 at 161, the numbers started going back down again.
The decline was short-lived; the preliminary number of syphilis cases reported in 2014 – 122 - was up more than 28 percent from the year before.
Of those cases, 37 were primary and secondary syphilis, the most contagious stages of the disease (up from 29 the year before); left untreated, people can pass the disease to others for up to two years.
The rise in cases is alarming enough that the Cleveland Department of Public Health is stepping up its ongoing campaign to urge people - specifically gay and bisexual males ages 16 to 35 who represent most of the new cases - to know their health status, said Health Commissioner Myron Bennett.
And the Ohio Department of Health is in the early stages of exploring the feasibility of purchasing rapid syphilis screening tests for use in select local health departments across the state.
Cleveland accounted for 28 of the county's primary and secondary syphilis cases, for a rate of 7.2 per 100,000 people.
Why the resurgence?
Until the end of the 1990s, syphilis primarily occurred among heterosexual men and women of racial and ethnic minority groups. Since then, men who have sex with other men account for the majority of primary and secondary syphilis cases.
Free, confidential syphilis and HIV testing is available to anyone age 13 and older at the Sexually Transmitted Disease Clinics at J Glen Smith Health Center, 11100 St. Clair Ave., and Thomas McCafferty Health Center, 4242 Lorain Ave., both in Cleveland. The Free Medical Clinic of Greater Cleveland, at 12201 Euclid Ave., also provides testing as well as treatment.
SOURCE: Centers for Disease Control and Infection, Cleveland Department of Public Health
"Some of this is related to the fact that even HIV is being considered a treatable condition," says Dr. Robert Salata, chief of infectious diseases at University Hospitals Case Medical Center. "For that reason, certain high-risk practices are coming back into play."
Caught early, the disease can be treated with penicillin or other antibiotics. But if ignored until later stages, the results are destructive, sometimes deadly.
The message of prevention is already widespread, but the syphilis increase is proof that safe sex practices aren't being adopted by everyone, Bennett said.
"They no longer see it as a fatal risk, so we've decided to focus on the importance of getting checked," he said. "That way, we can narrow that transmission net."
Data released in December by the Centers for Disease Control and Prevention show an increase in syphilis cases nationally in 2013.
The numbers of primary and secondary cases rose 10 percent over 2012, to 17,357 cases, a rate of 5.5 per 100,000 people. According to the CDC, about 55,000 people in the U.S. are newly infected with syphilis annually.
Ruling allows wider use of rapid syphilis test
The rise in syphilis cases locally and nationally makes a move by the Food and Drug Administration even more significant.
The FDA first granted clearance in 2011 for the use of the Syphilis Health Check test, which is made in a French lab for New Jersey-based Diagnostics Direct. The test detects the presence of syphilis antibodies.
In December, the FDA granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the test. Following a review of new data submitted showing the test's ease of use and accuracy, the FDA no longer considers the test to fall under the moderate- and high-complexity designation.
Now, it can be used in non-lab settings - health fairs, community health clinics, and even prisons - and no specialized training is needed to administer it.
The rapid test involves the collection of a blood sample from a finger stick. Results are available in as little as 12 minutes. If the test is positive, a patient then undergoes a clinical exam and a second test to confirm the presence of the infection.
"Between 12 and 15 million syphilis tests are done in this country every year, none of which can be done on the spot," said Diagnostics Direct President and CEO Norman Proulx.
"That's why the CLIA waiver is such a big deal – the test is given to the person immediately," he said. "A simple finger prick of whole blood, in 10 minutes, gives you the answers. It brings the answer much closer to the patient while the patient is within the confines of the medical group.
"And," Proulx said, "You don't need a PhD chemist to [perform] the test."
In contrast, other tests used for screening purposes are typically run only a few times a week in large batches; a positive result requires a second test for confirmation.
The cost of the Syphilis Health Check test is comparable to similar rapid HIV tests on the market, Proulx said.
It will likely be spring before the Ohio Department of Health begins using the test for contact tracing - identifying, notifying and testing people who may have been exposed to someone diagnosed with syphilis - and only in areas of the state with a high transmission rate, department spokeswoman Melanie Amato told The Plain Dealer.
Before that happens, though, ODH is awaiting more updated information from the CDC about the syphilis incidence rate. The department will then train staff at both the state and local levels on the use of the test.
One of the advantages of a rapid test is its potential use in pregnant women who haven't had any prenatal care or screenings, says UH's Salata. "The speed of diagnosis can be critical."
Being able to get test results in a matter of minutes – and not days – could be the difference between someone getting treatment and someone not bothering to return to a health clinic for follow-up care, Salata said.
And in the case of a pregnant woman in labor, knowing her health status is essential in order to provide critical treatment to her baby.
In 2013, 348 cases of congenital syphilis – which occurs when a pregnant woman with untreated syphilis passes it on to her baby – were reported in the U.S., a 4 percent increase since 2012. No cases of congenital syphilis were reported in Cuyahoga County in 2014.
"In terms of public health importance, we need to be able to get information more rapidly than we have and get them into treatment," Salata said.
Actually, it never went away. But after a steady increase in the number of reported cases in Cuyahoga County, peaking in 2010 at 161, the numbers started going back down again.
The decline was short-lived; the preliminary number of syphilis cases reported in 2014 – 122 - was up more than 28 percent from the year before.
Of those cases, 37 were primary and secondary syphilis, the most contagious stages of the disease (up from 29 the year before); left untreated, people can pass the disease to others for up to two years.
The rise in cases is alarming enough that the Cleveland Department of Public Health is stepping up its ongoing campaign to urge people - specifically gay and bisexual males ages 16 to 35 who represent most of the new cases - to know their health status, said Health Commissioner Myron Bennett.
And the Ohio Department of Health is in the early stages of exploring the feasibility of purchasing rapid syphilis screening tests for use in select local health departments across the state.
Cleveland accounted for 28 of the county's primary and secondary syphilis cases, for a rate of 7.2 per 100,000 people.
Why the resurgence?
The facts on syphilis
- Syphilis,
caused by a type of bacteria, is transmitted during vaginal, anal or
oral sex through direct contact with a syphilis sore. It can also be
spread through contact from sores on the lips and in the mouth. Symptoms
can include sores, body rashes, fever, swollen lymph glands, sore
throat, patchy hair loss, headaches, weight loss, muscle aches and
fatigue.
Until the end of the 1990s, syphilis primarily occurred among heterosexual men and women of racial and ethnic minority groups. Since then, men who have sex with other men account for the majority of primary and secondary syphilis cases.
Free, confidential syphilis and HIV testing is available to anyone age 13 and older at the Sexually Transmitted Disease Clinics at J Glen Smith Health Center, 11100 St. Clair Ave., and Thomas McCafferty Health Center, 4242 Lorain Ave., both in Cleveland. The Free Medical Clinic of Greater Cleveland, at 12201 Euclid Ave., also provides testing as well as treatment.
SOURCE: Centers for Disease Control and Infection, Cleveland Department of Public Health
"Some of this is related to the fact that even HIV is being considered a treatable condition," says Dr. Robert Salata, chief of infectious diseases at University Hospitals Case Medical Center. "For that reason, certain high-risk practices are coming back into play."
Caught early, the disease can be treated with penicillin or other antibiotics. But if ignored until later stages, the results are destructive, sometimes deadly.
The message of prevention is already widespread, but the syphilis increase is proof that safe sex practices aren't being adopted by everyone, Bennett said.
"They no longer see it as a fatal risk, so we've decided to focus on the importance of getting checked," he said. "That way, we can narrow that transmission net."
Data released in December by the Centers for Disease Control and Prevention show an increase in syphilis cases nationally in 2013.
The numbers of primary and secondary cases rose 10 percent over 2012, to 17,357 cases, a rate of 5.5 per 100,000 people. According to the CDC, about 55,000 people in the U.S. are newly infected with syphilis annually.
Ruling allows wider use of rapid syphilis test
The rise in syphilis cases locally and nationally makes a move by the Food and Drug Administration even more significant.
The FDA first granted clearance in 2011 for the use of the Syphilis Health Check test, which is made in a French lab for New Jersey-based Diagnostics Direct. The test detects the presence of syphilis antibodies.
In December, the FDA granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the test. Following a review of new data submitted showing the test's ease of use and accuracy, the FDA no longer considers the test to fall under the moderate- and high-complexity designation.
Now, it can be used in non-lab settings - health fairs, community health clinics, and even prisons - and no specialized training is needed to administer it.
The rapid test involves the collection of a blood sample from a finger stick. Results are available in as little as 12 minutes. If the test is positive, a patient then undergoes a clinical exam and a second test to confirm the presence of the infection.
"Between 12 and 15 million syphilis tests are done in this country every year, none of which can be done on the spot," said Diagnostics Direct President and CEO Norman Proulx.
"That's why the CLIA waiver is such a big deal – the test is given to the person immediately," he said. "A simple finger prick of whole blood, in 10 minutes, gives you the answers. It brings the answer much closer to the patient while the patient is within the confines of the medical group.
"And," Proulx said, "You don't need a PhD chemist to [perform] the test."
In contrast, other tests used for screening purposes are typically run only a few times a week in large batches; a positive result requires a second test for confirmation.
The cost of the Syphilis Health Check test is comparable to similar rapid HIV tests on the market, Proulx said.
It will likely be spring before the Ohio Department of Health begins using the test for contact tracing - identifying, notifying and testing people who may have been exposed to someone diagnosed with syphilis - and only in areas of the state with a high transmission rate, department spokeswoman Melanie Amato told The Plain Dealer.
Before that happens, though, ODH is awaiting more updated information from the CDC about the syphilis incidence rate. The department will then train staff at both the state and local levels on the use of the test.
One of the advantages of a rapid test is its potential use in pregnant women who haven't had any prenatal care or screenings, says UH's Salata. "The speed of diagnosis can be critical."
Being able to get test results in a matter of minutes – and not days – could be the difference between someone getting treatment and someone not bothering to return to a health clinic for follow-up care, Salata said.
And in the case of a pregnant woman in labor, knowing her health status is essential in order to provide critical treatment to her baby.
In 2013, 348 cases of congenital syphilis – which occurs when a pregnant woman with untreated syphilis passes it on to her baby – were reported in the U.S., a 4 percent increase since 2012. No cases of congenital syphilis were reported in Cuyahoga County in 2014.
"In terms of public health importance, we need to be able to get information more rapidly than we have and get them into treatment," Salata said.
Real Estate
No comments:
Post a Comment