A Medical Test could make it Easy to Detect a New Member of the Sexually transmitted diseases

It can be hard to be identified if you keep to a subtle nature, which is the case for the tiniest bacteria ever discovered by the scientific community.

The bacteria known as Mycoplasma Genitalium Bacteria is said to be more widespread than the Gonorrhea bacteria. It is a newbie STD infection in the list of sexually transmitted diseases

M. Gen has been tough to identify due to its size and lack of a reliable technique to determine whether a patient is infected or not

However, a recent milestone in developing a method for detecting the bacteria or the STD infection has been developed by a company known as name Hologic Inc. The company—previously known as Gen-Probe---is based in San Diego.

The company is known for its success in automating blood scans for sexually transmitted diseases including all types of Hepatitis and HIV and recently has been the fifrst company to be accredited by the FDA to conduct their Mycoplasma genitalia tests on patients.

Other companies have recently joined Hologic Inc. in developing such diagnostic tests.

 In May, the FDA formalized a second mycoplasma genitalium identification test for Swiss pharmaceutical company, Roche, while SpeedDX the Australian pharmaceutical company has applied for approval for their inhouse test capable of identifying the resistance of M. genitalium to antibiotics.

M. Gen is relativelynew in the list of Sexually Transmitted Infections

Mycoplasma Genitalium Bacteria is relatively new in the classification of sexually transmitted diseases when compared to other known forms. The M. genitalium was first discovered in 1980 by the CDC but wasn't declared a threat until 2015.

Research by the CDC shows the bacteria attributes to 15%-30% of urethra inflammation in men and 30% of cervical inflammation in women.

The bacteria have also been associated with complications during birth, infertility, and pelvic inflammation in women. However, there hasn't been sufficient evidence to link these cases to M. gen bacteria as scientific proof of the microbe.

The newly approved tests by the FDA will be of great help to scientists and medical researchers in acquiring a clear perspective of how the microbe affects its host and the prevention steps to take to prevent further infection.

A professor at the University of Washington, Lisa Manhart, is one of the experts in epidemiology, especially in the study of the Mycoplasma genitalium bacterium.

She says that the approval of the FDA for the M. gen tests is going to help doctors and clinicians to differentiate the occurrence of the M. gen bacterium as opposed to a highly similar microbe e.g., chlamydia trachomatis.

The professor says that an FDA approved test goes a long way to create a dependable platform for diagnosis since the approval indicates that the test has been tested under all conditions, both standard and extreme.

Lisa adds that the tests will, in the future help to provide a clear picture of the relationship between the M. gen microbe and pelvic inflammation in women.

It has been noted that pelvic inflammation is linked to infertility cases, especially in women. However, more research is needed to associate the microbe with complications in reproduction.

The few studies performed to associate the two have been futile, says the professor. Mostly based on small observational data, the studies have only been successful in correlating the two without providing a definitive reason to signify that one leads to another.

Therefore it is hard for researchers to draw any conclusions regarding the effects of the bacteria on infertility at present.

To show proof of concept of how the developed tests work, scientists gathered 12,000 specimens acquired from 3,300 patients and then compared the results against a range of 3 assays.

The M. gen test developed by HologicInc could prove infection at a success rate that ranges between 77.8%  and 99.6%. Consistence was observed in the test results that demonstrate the non-existence of the bacterium with a success rate of 97.8% and 99.6 %.

Additionally, male urine, female urine, and urethral samples proved to be the best to test when looking to detect the non-existence of the bacterium.

Damon Getman, a senior scientist at HologicInc, says that when developing a medical diagnostic test, factors that are highly considered include sensitivity and specificity.

Specificity is defined as the ability to prove the non-existence of infection, while sensitivity is the ability of a test to confirm an infection

Putting into consideration the stigmatic consequences of telling a tested patient that they have an STD, the Hologic test is mostly based on specificity rather than sensitivity.

Acquiring a practical diagnostic test is not based on the perfection of proving both the sensitivity and specificity of the test but rather in determining what your focus is for the test. "Are you looking for proof of infection? or do you want inaccurate results?"


Proof of Concept

A variety of types of Mycoplasma bacteria currently reside in human bodies. While most are harmless, they can distort the results of the M. gen tests.

The diagnosis of the M. gen bacterium is based on a replication process of RNA (ribonucleic acid) to detect bacterial presence. Hologic acquired the innovative procedure from Gen-Probe when they purchased the company in 2012.

Getman explains that Rna is in large quantities in M. Gen – compared to DNA – with an estimate of about 1,000 copies per cell.

A comparison of the Rna patterns in M. Gen indicates that there is almost no difference when compared to other types of mycoplasma bacteria. The differences observed lie in the base pairs which connect the genetic sequence.

Scientists develop molecular primers and probes which bond at different points in M. gen Rna, which makes it unique to other present mycoplasma bacteria species.

These molecular diagnostic tools zero on their targets with extreme prejudice. For the Hologic M. Gen test, the detection relies on an area of 80 base pairs singled out of an RNA strand of an estimated 500,000 base pairs.


Considering that the tiny probes have a low probability of attaching themselves on their targeted points than more significant aspects of attachment, the scientists saw it as a problem that could lead to missing the infection.

 Regardless, focusing on the areas that make M. Gen unique from other M. bacteria also meant that it was also a low probability for a primer to attach to other similar bacteria thus decreasing the likelihood of a false positive


Final Words

This discovery is a milestone in the search for a method to detect Mycoplasma Genitulium. Hopefully it will help detect this bacterium like found ways to spot other sexually transmitted diseases.