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TB study in Venezuela has started!

Recently, a study has started for evaluating the Aeonose for diagnosing tuberculosis in the Warao Amerindian population in Venezuela. This population has a high adult and pediatric TB prevalence (comparable to epidemic regions in Africa). At the same time, HIV prevalence is high as well among adults in some villages (up to 20%).

The study is being coordinated by Dr. Jacobus de Waard, Head of the Tuberculosis Laboratory, Universidad Central de Venezuela.

In December 2014, the study was mentioned in a local newspaper in Caracas, Venezuela.

enose-G

After developing a calibration model for TB in Venezuela, the Aeonose will be evaluated during a blind study.


TB study in Paraguay has started!

A TB study focusing on extra-pulmonary tuberculosis has just started at Instituto de Enfermedades Respiratorias y del Ambiente (INERAM) in Asuncion, Paraguay.

The study is being coordinated by Dr Cecile Magis and Dr Jan-Bart Yntema from Radboud University, Nijmegen, The Netherlands.

First, they will include pulmonary-TB patients and healthy controls in order to build a TB-model for Paraguay. It is important to know if this TB-model differs from models being recorded elsewhere in the world. Next, they will include extra-pulmonary TB patients as mentioned before.

For some impressions, see the pictures below:

Far left: Jan-Bart Yntema. Not in picture: Cecile Magis

Far left: Jan-Bart Yntema. Not in picture: Cecile Magis








Exhaled-breath-test using the Aeonose

Exhaled-breath-test using the Aeonose


Focus-TV

Uitzending Business update op Focuz-tv aflevering 116 van 24 mei 2014 laat Dr. Kenneth Kross aan het woord over de behaalde resultaten met de Aeonose in de screening naar Hoofd en Halskanker.

Dr. Kenneth Kross

Dr. Kenneth Kross, item Aeonose start op 18 minuten en 25 seconden






Head & Neck Cancer calibration study with Aeonose

In Maastricht UMC in cooperation with Dr. K.Kross, we performed a calibration study (32 patients and 26 healthy controls) to assess the diagnostic value of an implementation of a generic electronic nose (Aeonose) using exhaled breath to detect H&N Cancer

In the calibration study we found a sensitivity of 88.5% and a specificity of 87.5% discriminating healthy controls from H&N patients.

This is shown in the ROC-curve drawn below:

H&N ROC curve

Head and Neck Cancer ROC curve


An efficacy study will start soon, led by Dr. K.Kross at Maastricht UMC, and the University hospitals in Groningen (NL), Liege (B) and Turku (Fin).

We will also validate the model by several studies in other university and peripheral hospitals in the Netherlands.


Bangladesh study

In Bangladesh, we performed a Proof of Principle Study (15 patients and 15 healthy controls) and a Validation Study (194 participants of which 148 patients) to assess the diagnostic value of an implementation of a generic electronic nose (Aerekaprobe) using exhaled air to detect active tuberculosis.



Results have been published in ‘Tuberculosis’:


Tuberculosis (Edinb). 2013 Mar;93(2):232-8. doi: 10.1016/j.tube.2012.10.002. Epub 2012 Nov 3.

Diagnosis of active tuberculosis by e-nose analysis of exhaled air.

Bruins M, Rahim Z, Bos A, van de Sande WW, Endtz HP, van Belkum A.



In the validation study we found a sensitivity of 93.5% and a specificity of 85.3% discriminating healthy controls from TB patients, and a sensitivity of 76.5% and specificity of 87.2% when identifying TB patient within the entire test population (best-case numbers).


This is shown in the ROC-curve drawn below:

ROC TB curve

ROC TB curve

Source: paper in ‘Tuberculosis’, mentioned above.


Receiver operating characteristic (ROC) curves show a clear differentiation between TB and non-TB cases.

Different types of control groups were included to compensate for e.g. socio-economical differences and general health issues. The fast time-to-result of the battery operated Aerekaprobe could enable proactive searches for new TB cases, without the need for highly-skilled operators.


In this Bangladesh study, however, patients had to exhale into bags, which were analyzed afterwards.


Bangladesh TB screening


On the one hand, this is quite a time consuming procedure, but at the same time possibly causes introducing systematic errors because of interaction between the exhaled breath and the bags themselves.


Aeonose











For these reasons, we have developed a dedicated eNose for exhaled-breath analysis, the Aeonose. In case of the Aeonose, bags aren’t needed anymore, and the analysis is being performed within minutes after the patient has breathed into the apparatus.









Using the Aeonose, TB-studies on several locations have started or are about to start. As soon as results can be shown, they will be presented on this blog:


  • Indonesia (Yogyakarta). This study is being conducted by Ms. Morita Saktiawati (PhD-student at University Medical Center Groningen, the Netherlands. Supervisor: Prof. Tjip van der Werf). With respect to distinguishing TB from non-TB patients, preliminary results (some 65 individuals have been included up till now) show sensitivity / specificity values of approx.  80% with room for improvement. A longitudinal study is in progress as well.
  • Kenia. TB in children is being investigated by Dr Rinn Song (Harvard University) using the Aeonose. In progress.
  • South Africa. Phase 3 study on pulmonary TB, headed by Prof Keertan Dheda (University of Cape Town) to commence soon including some 1000 individuals.
  • Paraguay. In June 2014, this study will start focusing on extra-pulmonary TB. Headed by Dr Cecile Magis and Dr Jan-Bart Yntema from Radboud University Medical Center, Nijmegen, The Netherlands.

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