Indian scientists developing a diagnostic algorithm for female genital TB

Dr Aparna Srikantam, LEPRA
Genital tuberculosis (TB) is one of the major causes of tubal infertility. Some studies show that only two per cent of women with genital TB have live births. Genital TB is usually asymptomatic so needs higher degree of clinical suspicion so that accurate and confirmed diagnosis of TB can be made and standard anti-TB treatment provided as early as possible. But the challenge is that current range of standard diagnostic tests are less likely to pick up every case of genital TB.

Not only most cases are asymptomatic but also the number of bacteria in the sample is very low (compared to the number of TB bacteria which is present in samples of people with pulmonary TB). So the need of the hour is to have a highly specific anti-TB test to accurately diagnose genital TB at the earliest and link the person to standard anti-TB treatment as per the Revised National TB Control Programme (RNTCP).

Indian Council of Medical Research (ICMR) embarked upon a research study in November 2012 to develop an algorithm for diagnosing and treating female genital TB patients. There are 4 research sites: All India Institute of Medical Sciences (AIIMS) Delhi, Post-Graduate Institute of Medical Education and Research (PGIMER) Chandigarh, King George’s Medical University (KGMU) Lucknow and LEPRA Blue Peter Public Health and Research Centre (and Gandhi Medical College and Hospital) Hyderabad.

Dr Nomita Chandhiok, ICMR
(CNS file photo: April 2014)
Dr Nomita Chandhiok, Deputy Director General of ICMR said: "If women with genital TB are diagnosed late, the infertility risk and other harm done to their tissue are likely to be much more severe. The solution lies in early case detection and providing standard treatment for genital TB without delay. This multi-centric ICMR study aims to evolve a common algorithm for diagnosis and management of female genital TB which is nationally applicable. We expect the results to come by November 2015."

Genital TB is responsible for infertility in 5-10 per cent of women. In Australia, 1 per cent infertility in women is attributed to genital TB but in India, some studies show that 19 per cent infertility in women is attributed to genital TB.

Women with genital TB present with bleeding discharge, ulcers, among other symptoms if any. Genital TB is always hard to diagnose, because of the fact that it is a silent invader of the genital tract.

Dr Aparna Srikantam, Principal Investigator (PI) of Hyderabad site of the ICMR study on female genital TB said to Citizen News Service (CNS) that a consortium of microbiologists and gynaecologists from 4 research sites in India have come together for this ICMR study, of which one site is in Hyderabad (remaining sites in Chandigarh, Lucknow and Delhi). The main PI of this study is in AIIMS Delhi. When we began this study and analyzed available information “we were surprised that there is no standard protocol to diagnose genital TB in women.” That is why ICMR responded to this research need and embarked upon this multi-centric study.

In Hyderabad site, LEPRA India's Blue Peter Public Health and Research Centre is managing microbiological component of the study and partnering with Gandhi Medical College and Hospital for gynaecological component. Dr Anupama Hari, Professor and Head of Department of Gynaecology and Obstetrics, Gandhi Medical College and Hospital, Hyderabad is leading the gynaecological component of this study in Hyderabad.

About 50-60 patients of infertility come to the outdoor patients’ department (OPD) of Gandhi Medical College and Hospital every day. These infertile couples are screened and those who are clinically identified as cases of presumptive genital TB (not confirmed TB disease) are followed up for the next two years. Before selecting these couples as study participants these couples are screened for chlamydia and gonorrhea (sexually transmitted infections) and both these STIs ruled out.

These couples with infertility are then encouraged to opt for a battery of tests which include conventional, WHO and India’s RNTCP approved solid and liquid culture testing, as well as other newer tests which are being researched upon presently to find out how sensitive and specific they are to diagnose female genital TB.

So far 120 couples have been screened in Hyderabad. Out of these 120 couples, 15 confirmed to have TB disease, and were promptly linked to the RNTCP’s Directly Observed Treatment Shortcourse (DOTS) centre in Gandhi Medical College and Hospital for standard anti-TB treatment and care (and released from the study). Rest of the couples where genital TB has not yet been confirmed are being followed up closely and research is going on to identify and develop an algorithm for accurately diagnosing genital TB.

Dr Aparna Srikantam said that all women undergo laparoscopy followed by histopathological tests, solid and liquid culture tests, Polymerase Chain Reaction (PCR) tests and immunohistochemistry tests. In PCR technology, a different set of specific primers (or probes) can be used. This study is using a unique set of primers (probes) and researching how sensitive and specific it is for diagnosing genital TB accurately. Apart from immunohistochemistry and PCR testing, all tests are done in Hyderabad. Samples are sent to AIIMS for immunohistochemistry and PCR tests.

Diagnosing every form of TB at the earliest, accurately, and providing standard effective anti-TB treatment are few of the key principles of effective TB care and control. Let us hope this ICMR study outcomes in November 2015 inform TB control programmes effectively.

Bobby Ramakant, Citizen News Service (CNS)
19 September 2014