Oakland County Health Division
Expanded STI Testing Targets Emerging Bacterium Mycoplasma genitalium (M gen)
Our submission addresses a potential factor that contributes to increased HIV transmission. Due to the number of patients presenting to our health clinics for STI testing who tested negative, yet continued to experience persistent symptoms, the Oakland County Health Division (OCHD) Laboratory underwent the process to become lab certified to test for Mycoplasma genitalium (M gen). Due to our initial prevalence study with over 5,000 patients showing 11.7% positivity, OCHD is now testing every patient that presents to our clinics to provide the highest standard of care to our patients. Since we began testing for M gen in August 2016, this infection is consistently more prevalent than syphilis, gonorrhea, and chlamydia, and is equally prevalent in men and women. With this high prevalence, the fact that M gen infection significantly increases risk of HIV transmission, clearing the often asymptomatic infection, will reduce potential HIV transmission in a high risk population. Oakland County, Michigan has a population of over 1.2 million and covers approximately 900 square miles of land in southeast Michigan (https://www.oakgov.com/advantageoakland/busi-ness/Pages/county-profile-default.aspx).
Oakland County is 76.2% Caucasian, 14.4% African American/black, 6.8% Asian, 3.9% Hispanic/Latino and 0.3% American Indian/Alaskan Native, according to 2010 US Census data. The Oakland County complex is housed in Pontiac, Michigan, slightly southeast of the center of Oakland County. There are two Oakland County Health Division clinics: one is located in the county complex in Pontiac (North Office) and one is located in Southfield (South Office), just north of Wayne County and the City of Detroit, and just west of Macomb County.
The main objective of our M gen testing is to provide the best standard of care available to our patients. Our secondary objective is to contribute to the current body of knowledge on M gen, as research in the United States has been limited. The process began with the OCHD laboratory becoming certified to conduct M gen testing. This was a lengthy process that required over 500 test samples be run and verification of our results by the only other public health lab in the country certified at that time, to ensure the quality and accuracy of the testing. Once the certification process was complete, our public health nursing staff in the STI clinic began to collect an extra sample from patients for M gen testing. The communicable disease (CD) unit and health education staff, worked with the nursing staff to establish educational talking points and recommendations for patients that test positive for M gen.
Our main objective has been met. Based on our data of a prevalence of over 11%, our OCHD administration is supportive of continuing testing for all our patients, both in-county and out of county. When it comes to communicable disease, public health has no boundaries and we treat all patients who come to our clinics, regardless of residency or ability to pay. We continue to test for M gen to provide our patients with the best care that we can; which includes properly diagnosing and treating patients presenting to OCHD clinics. Our secondary objective has not yet been met, but we are currently preparing our data for publication.
M gen is an emerging STI that often can present asymptomatically and increase transmission of HIV and other STIs (https://www.cdc.gov/std/tg2015/emerging.htm). Since there are very few labs, commercial or private, that are able to test for this organism, the public health impact is immense. The consequences of unidentified, untreated infections are severe. By continuing to test for and present data on M gen in Oakland County, other public health agencies and private labs may begin to address this emerging issue as well.
Testing began because symptomatic patients were presenting multiple times, to OCHD STI clinics, receiving appropriate treatment based on their symptoms, yet testing negative for STIs in our standard panel. Not only was this adversely affecting the patient presenting to the clinic, but their sexual partners as well. M gen is an emerging STI that often can present asymptomatically and increases risk of transmission of HIV and other STIs (https://www.cdc.gov/std/tg2015/emerging.htm).
Due to the evidence our initial pilot testing provided, we are currently testing any patient that presents to our clinic for M gen. We see approximately 1,000 patients per month in our clinics. Prior to recent laboratory advances, nothing had been done to address the prevalence of M gen because culture of this organism took six months. With newly developed nucleic amplification testing available, looking at prevalence in a community STI clinic became feasible. M gen was first mentioned by the CDC as an emerging issueâ€ in fall 2015, yet has been tested for in other countries for years. In testing for this organism, we can better identify the type of infection in our patients and therefore can now effectively treat and educate them. Since this organism is often found to be resistant to azithromycin, identifying the correct source of infection in a patient can be critical in treating the patient.
This practice is innovative because OCHD lab has been testing for M gen since August 2016; being the first laboratory in Michigan and the second public health laboratory in the country to test for this organism. Additionally, our laboratory is active in sending validated samples to other labs around the country to help establish this critical testing in other communities.
This innovative practice is evidence-based due to the wealth of data that we have illustrating that the positivity of M gen is the highest of all the organisms we test for. In our first pilot study, the OCHD lab tested 500 samples from patients presenting to our STI clinics for M gen and found that just over 12%, whether symptomatic or asymptomatic, tested positive for M gen. Based on this information, we felt it was crucial to fund additional testing to establish baseline prevalence for this STI within our patient population. Our next analysis point was just over 5,000 patients, which yielded an overall M gen positivity of 11.7%. Our current data suggests that the positivity rate fluctuates slightly month to month, but the overall positivity rate from late August 2016 to November 2017 was 11.5% with an overall sample size of 12,334. This sample size is the largest single-site sample size in the world based on currently published research.
HIV in the U.S.
The objective of our initiative is to continue to provide the best patient care available to our patients and to assess the prevalence of M gen infection within our STI clinic patient population. Currently, we are analyzing our data to see if there is a distinct seasonal trend, which has been reported in the literature as well as to look for trends in reduction of co-infections. To continue testing and counseling patients and reporting findings, many different parts of OCHD are working together. The process began with the OCHD laboratory becoming certified to conduct M gen testing. This was a lengthy process that required many test samples be run and tested to ensure the quality and accuracy of the testing. Since M gen is not a bacterium many laboratories test for, acquiring samples to test for certification was a lengthy process. Once the certification process was complete, our public health nursing staff in the STI clinic began to collect an extra sample from patients for M gen testing. The communicable disease (CD) unit and health education staff, worked with the nursing staff to establish educational talking points and recommendations for patients that test positive for M gen. The CD unit also analyzes the data to report back to the laboratory and nursing staff.
This testing initiative requires the expertise and skill of several branches within the health division. This project has not only yielded information related to our objectives, but has opened communications further between the laboratory staff, clinic nurses and epidemiologists.
The main objective of our M gen testing is to provide the best standard of care available to our patients. Our secondary objective is to contribute to the current body of knowledge on M gen, as research at the current time is limited. To date, we have found the positivity rate for M gen is higher than chlamydia, gonorrhea and syphilis. Based on this information, we are positive this test should be added to the standard STI panel. M gen is an emerging organism that the general public is not familiar with. In addition to expanding testing, education must be done by local health departments as well as private physicians, as this organism has been identified as a cause of urethritis, pelvic inflammatory disease, infertility and critically the transmission of other STIs. It is much more cost effective to test and treat for M gen than it is to manage chronic HIV infection as well as the devastating emotional cost to patients.
Inability to identify M gen as the source of infection can lead to potentially ineffective antibiotic use and decreased quality of life in patients due to treatment failure. Several patients presented to the clinics with M gen before testing was available, were treated based on symptoms and despite treatment, and their symptoms persisted. Once the source of these patients' infections, M gen, was identified, they were properly treated, and symptoms resolved.
The additional test for M gen in our clinics has not added considerable burden for our clinic nurses, therefore adding it to the standard STI panel would not stress the system. If there is lab capacity, the only burden on the part of the local health department is the cost of the reagents to do the testing and the clinical laboratory scientist's time. Once a lab becomes certified to test for M gen, the Nucleic Acid Amplification Test (NAAT) has high sensitivity and specificity. M gen testing is no more complex than other standard NAAT testing, therefore yielding highly accurate results. The positivity rate in Oakland County is high, currently 11.5% in clinic patients, which is inclusive of both symptomatic and asymptomatic individuals. This rate of positivity is consistent with similar studies conducted in Australia and Scandinavian countries. Overall, sustaining this practice is beneficial. Identifying M gen as the infectious agent in a patient will lead to less treatment failure, as we will be treating for the correct organism. Restoring the microbiome protects the individual from HIV transmission, increased risk of infertility and other STIs.
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